WO2015072517A1 - Patch - Google Patents

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Publication number
WO2015072517A1
WO2015072517A1 PCT/JP2014/080079 JP2014080079W WO2015072517A1 WO 2015072517 A1 WO2015072517 A1 WO 2015072517A1 JP 2014080079 W JP2014080079 W JP 2014080079W WO 2015072517 A1 WO2015072517 A1 WO 2015072517A1
Authority
WO
WIPO (PCT)
Prior art keywords
patch
sensitive adhesive
support
pressure
skin
Prior art date
Application number
PCT/JP2014/080079
Other languages
French (fr)
Japanese (ja)
Inventor
智範 猪飼
彰人 竹崎
藤澤 博充
Original Assignee
ニチバン株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ニチバン株式会社 filed Critical ニチバン株式会社
Priority to JP2015547788A priority Critical patent/JPWO2015072517A1/en
Publication of WO2015072517A1 publication Critical patent/WO2015072517A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/023Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/01Non-adhesive bandages or dressings
    • A61F13/01034Non-adhesive bandages or dressings characterised by a property
    • A61F13/01038Flexibility, stretchability or elasticity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

  • the present invention relates to a patch, particularly a patch for wound covering or post-surgical wound protection, and further to a patch for healing wounds, treating scars, or preventing formation of scars and keloids.
  • Patent Document 1 discloses a hydrocolloid patch having a specific elongation force.
  • U.S. Patent No. 6,057,056 describes devices, bandages, kits, and methods that are configured to shield wounds from intrinsic and / or extrinsic stresses and can improve scar and / or keloid formation.
  • Patent Document 3 discloses a patch that is applied in accordance with a peripheral zone adjacent to the affected part such as keloid, an elastic body that covers the affected part, and the adhesive material that supports the elastic body from above.
  • a body for treating skin disorders has been disclosed, comprising a support patch that is attached so that at least a part of the elastic body is applied to the elastic body and presses the elastic body toward the affected area.
  • JP 2012-135582 A Special table 2009-545382 Japanese Patent Publication No. 07-079827
  • An object of the present invention is to provide a patch for wound covering or post-operative wound protection, particularly a wound patch that can suppress both elongation and contraction of the skin, has excellent followability to the skin, and can be applied for a long period of time.
  • An object of the present invention is to provide a patch for healing, treatment of scars or prevention of scar / keloid formation.
  • the invention made in order to solve the above-mentioned problems is that the 10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the bending resistance (mm) and basis weight (by the cantilever method) g / m 2 ) is a patch for wound covering or postoperative wound protection having a product of 3000 or more.
  • the patch of the present invention can suppress both stretching and shrinkage of the skin, and is excellent in followability to the skin and can be applied for a long time.
  • the patch of the present invention is also excellent in the effect of suppressing the shrinkage of the skin that the conventional patch has not sufficiently provided.
  • the present inventors can sufficiently suppress the elongation of the skin when the 10% tensile load of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method. It has been found that the shrinkage of the skin can be sufficiently suppressed when the ratio is 3000 or more.
  • the gist of the present invention is as follows.
  • “10% tensile load” is measured according to JIS K 7113 of Japanese Industrial Standard.
  • the “bending softness by cantilever method (mm)” can be measured according to JIS L 1096.
  • the “basis weight (g / m 2 )” is the weight (g) per unit area of the patch expressed in grams per square meter.
  • a patch comprising a support and an adhesive layer provided on one side of the support
  • 10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more
  • the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more.
  • ⁇ 4> The patch according to any one of ⁇ 1> to ⁇ 3>, wherein the stress relaxation time in at least one of the longitudinal direction and the short direction of the patch is 10 s or more.
  • ⁇ 5> The adhesive material according to any one of ⁇ 1> to ⁇ 4>, wherein the 10% tensile load in the longitudinal direction and the lateral direction is 18 N / 25 mm or more.
  • ⁇ 6> The patch according to any one of ⁇ 1> to ⁇ 5>, wherein the pressure-sensitive adhesive layer contains a urethane-based pressure-sensitive adhesive or a foamed acrylic pressure-sensitive adhesive.
  • ⁇ 7> The patch according to any one of ⁇ 1> to ⁇ 6>, wherein the support comprises a woven fabric or a nonwoven fabric.
  • ⁇ 8> The patch according to any one of ⁇ 1> to ⁇ 7>, wherein the support includes micropores.
  • ⁇ 9> The patch according to any one of ⁇ 1> to ⁇ 8>, which is used for wound healing, scar treatment, or scar / keloid formation prevention.
  • the patch according to ⁇ 9> which is used for healing a wound of a wound by surgery, treating a scar, or preventing scar / keloid formation.
  • a patch comprising a support and an adhesive layer provided on one side of the support, at least one 10% tensile load in the longitudinal direction or the short direction of the patch is 18 N / 25 mm or more.
  • the product of the bending resistance (mm) by the cantilever method and the basis weight (g / m 2 ) is 3000 or more
  • a patch comprising the pressure-sensitive adhesive layer containing a urethane-based pressure-sensitive adhesive or a foamed acrylic pressure-sensitive adhesive.
  • 10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more.
  • a patch material in which the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is 25 or more.
  • the patch of the present invention not only the stretch of the skin but also the shrinkage can be suppressed, so that the external force applied to the skin having a wound due to an injury or an operation can be sufficiently reduced.
  • it is excellent in followability to skin, moisture permeability, adhesion, etc., and can be applied for a long time. Therefore, according to the patch of the present invention, it is possible to promote the healing of wounds and the treatment of scars on wounds and wounds after surgery, and to effectively prevent the formation of scars and keloids.
  • the patch of the present invention (hereinafter also referred to as “the patch”) includes a support and an adhesive layer provided on one side of the support. Further, the patch material includes a peeler and / or a carrier as necessary. One or more other layers may be interposed between the support and the support, between the support and the pressure-sensitive adhesive layer, and / or between the pressure-sensitive adhesive layer and the release body. A support body, an adhesive layer, a peeling body, a support body, and other layers will be described later. In addition, let the long direction of a sticking material be a longitudinal direction, and let a short direction be a transversal direction.
  • the direction corresponding to the long side is the longitudinal direction
  • the direction corresponding to the short side is the short direction
  • the longer direction when cut is the longer direction
  • the shorter direction is the shorter direction.
  • the adhesive material has a 10% tensile load of 18 N / 25 mm or more in at least one of the longitudinal direction and the short direction. Since the patch has such physical properties, it is difficult to be deformed by external force, scar tissue extension, or the like, and can sufficiently suppress the elongation of the skin.
  • the tensile load is preferably 18 N / 25 mm or more and 500 N / 25 mm or less, more preferably 18 N / 25 mm or more and 300 N / 25 mm or less, further preferably 20 N / 25 mm or more and 200 N / 25 mm or less, more preferably 25 N / 25 mm or more and 150 N / 25 mm or less is particularly preferable, and 30 N / 25 mm or more and 150 N / 25 mm or less is most preferable.
  • the tensile load is less than 18 N / 25 mm, the patch is likely to be deformed by an external force or the like, and the effect of suppressing the elongation of the skin may be insufficient.
  • the tensile load exceeds 500 N / 25 mm, the elongation of the skin can be suppressed.
  • the adhesive material only needs to satisfy at least one of the longitudinal direction and the short-side direction, but in order to sufficiently reduce the external force on the skin and effectively suppress the elongation of the skin, It is preferable that both the direction and the short direction satisfy the above conditions.
  • the measurement of the tensile load in this invention performed the tensile test according to JISK7113, and measured the 10% tensile load.
  • the patch has a product of bending resistance (mm) and basis weight (g / m 2 ) by the cantilever method of 3000 or more.
  • the value of the product of the bending resistance and the basis weight is related to the effect of suppressing the stretch and contraction of the skin when the patch is applied to the skin, particularly the effect of suppressing the contraction of the skin. Found that there is. That is, the larger the product of the bending resistance and the basis weight, the higher the effect of suppressing skin shrinkage, and the smaller the product, the lower the effect of suppressing skin shrinkage.
  • the patch of the present invention having a product value of 3000 or more can sufficiently suppress the shrinkage of the skin, promote the healing of wounds and the treatment of scars, and can effectively suppress the formation of scars and keloids. .
  • this value is too large, the effect of suppressing the shrinkage of the skin can be obtained, but the followability of the patch to the skin may be reduced, or normal operation may be difficult to perform when the patch is stuck to the skin.
  • the product of the bending resistance and the basis weight is preferably 3000 or more and 70000 or less, more preferably 3300 or more and 20000 or less, and further preferably 3500 or more and 10,000 or less, It is particularly preferably 3500 or more and 8000 or less, and most preferably 4000 or more and 8000 or less.
  • the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is preferably 25 or more.
  • the value of the product of the bending resistance and the apparent density is also closely related to the effect of suppressing the elongation and contraction of the skin when the patch is applied to the skin, particularly the contraction suppressing effect. I found out. That is, the greater the product of the bending resistance and the apparent density, the higher the skin shrinkage suppressing effect, and the smaller the product value, the lower the skin shrinkage suppressing effect.
  • the patch of the present invention having a product value of 25 or more can sufficiently suppress the shrinkage of the skin, promote the healing of wounds and the treatment of scars, and can effectively suppress the formation of scars and keloids. .
  • the product of the bending resistance and the apparent density is preferably 25 or more and 100 or less, more preferably 25 or more and 70 or less, and further preferably 25 or more and 50 or less, 30 It is especially preferable that it is 50 or more.
  • the apparent density (g / cm 3 ) of the patch is a value obtained by dividing the basis weight (g / m 2 ) by the thickness ( ⁇ m).
  • the moisture permeability is preferably 700 (g / m 2 ⁇ 24 h) or more. Since the adhesive material has a water vapor transmission rate of 700 (g / m 2 ⁇ 24 h) or more, it can be applied for a long time because it has less stuffiness when applied to the skin.
  • the moisture permeability of the patch is more preferably 900 (g / m 2 ⁇ 24 h) or more, further preferably 1000 (g / m 2 ⁇ 24 h) or more, and 1500 (g / m 2 ⁇ 24 h). ) Or more is particularly preferable. The higher the moisture permeability, the better.
  • the upper limit of the preferable moisture permeability is not particularly limited, but is usually 30000 (g / m 2 ⁇ 24 h) or less.
  • the moisture permeability was measured at a temperature of 40 ° C. and a relative humidity of 90% according to the B condition of JIS Z0208. That is, one side of the patch is adjusted to a temperature of 40 ° C. and a relative humidity of 90%, and a moisture absorbent such as calcium chloride is placed on the other side to absorb the moisture that has passed through the patch, and the weight change of the moisture absorbent Was calculated by converting per 1 m 2 for 24 hours.
  • the stress relaxation time of at least one of the longitudinal direction and the short direction is 10 (s) or more. Since the patch material has a stress relaxation time of 10 (s) or longer, even when the patch material is stretched by an external force or the like, it can return to its original state without being stretched. It can promote wound healing and scar treatment for wounds and the like after surgery, and can effectively prevent the formation of scars and keloids.
  • the stress relaxation time of the patch is more preferably 30 (s) or more, further preferably 70 (s) or more, and particularly preferably 100 (s) or more.
  • the stress relaxation time is preferably as high as possible, but is usually 1000 (s) or less.
  • the adhesive material only needs to satisfy the above condition in at least one of the longitudinal direction and the lateral direction, but even when the adhesive material is extended by an external force or the like, the original material is not stretched. In order to be able to return, it is preferable that both the longitudinal direction and the lateral direction satisfy the above conditions.
  • the stress relaxation time is measured by using a strip with a width of 25 mm and a length of 80 mm in each of the short side (CD) direction and the long side (MD) direction of each adhesive material, so that the gap between the chucks is 50 mm. Nichiban Co., Ltd. Carton Tape No. 660 was attached, and the same method as the measurement of the tensile load was performed. After pulling at a speed of 300 mm / min up to 25 N, the load was stopped for 180 seconds when the load became 25 N, and the time (second) when the load decreased to 20 N was defined as the stress relaxation time.
  • the patch has a 10% tensile load, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is within the specified range, thereby suppressing skin elongation.
  • shrinkage can be suppressed. That is, the magnitude of 10% tensile load mainly contributes to the suppression of skin elongation, whereas the product of bending resistance (mm) and basis weight (g / m 2 ) mainly suppresses skin shrinkage. This is based on the discovery that these desired effects are exhibited when these values are equal to or greater than a predetermined numerical value, preferably within a predetermined range.
  • the patch is excellent in followability to the skin.
  • the effect of suppressing the shrinkage of the skin can be further improved by setting the product of the bending resistance (mm) and the apparent density (g / cm 3 ) by the cantilever method to 25 or more.
  • the patch is excellent in moisture permeability, it is difficult to cause stuffiness when it is applied to the skin, and it can be applied for a long time.
  • the thickness of the patch is not particularly limited, but is 6 ⁇ m or more and 6 mm or less, preferably 50 ⁇ m or more and 2 mm or less, more preferably 60 ⁇ m or more and 1 mm or less, and more preferably 80 ⁇ m or more and 0. More preferably, it is 5 mm or less.
  • the form of the patch is not particularly limited as long as it includes the support and the adhesive layer.
  • a rectangle, a square, a quadrangle such as a rhombus, a polygon, a sheet-like form appropriately combining these shapes It can be made into a free form according to the purpose, such as a tape form or a roll form continuously formed in a specific direction.
  • R may be appropriately provided at the corners around.
  • the size of these patch materials can also be freely selected according to the purpose, but when applying to wounds on the skin to prevent scarring and keloid formation, the wounds can be covered sufficiently. Must be size.
  • the patch When the patch is used for medical purposes, such as to prevent scars and keloids, and to be applied to wounds on the skin, it is preferably sterilized to prevent bacterial infection, viral infection, etc. .
  • a method generally used for a patch can be used.
  • a ⁇ -ray sterilization method, an electron beam sterilization method, a high-pressure steam sterilization method, an ethylene oxide gas sterilization method, or the like is used. .
  • the support of the patch of the present invention when it is used as a patch, the 10% tensile load in at least one of the longitudinal direction and the short direction is 18 N / 25 mm or more, and the cantilever
  • the product of the bending resistance (mm) by a method and basic weight (g / m ⁇ 2 >) can be 3000 or more, For example, what consists of the following materials is mentioned.
  • Polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate; Polyamides such as nylon (nylon 6, nylon 66); Polyolefins such as polypropylene, polyethylene, low density polyethylene (LDPE), and high density polyethylene (HDPE); Ethylene / vinyl acetate copolymer (EVA), ethylene / ethyl acrylate copolymer (EEA), ethylene / methyl acrylate copolymer (EMA), ethylene / methyl methacrylate copolymer (EMMA), ethylene / acrylic acid copolymer Olefin copolymers such as coalescence (EAA); Polyvinyl alcohol (PVA); Polychlorides such as polyvinyl chloride and polyvinylidene chloride; Pulp made from wood, etc .; Silicones; It can be selected from polyurethane and the like, or composite materials thereof.
  • a material having low moisture permeability by
  • polyester, polyamide, polyolefin, and polyurethane are preferable as the material for the support.
  • polyethylene terephthalate (PET) nylon, polyethylene, and pulp are more preferable.
  • PET polyethylene terephthalate
  • nylon polyethylene
  • LDPE low-density polyethylene
  • the composite material is preferably a composite material of polyethylene terephthalate (PET) and pulp.
  • the support may be a woven fabric made of the above-mentioned material, or may be a non-woven fabric, a knitted fabric, a film, a foam or the like.
  • a woven fabric and a non-woven fabric are preferable from the viewpoint that the patch has sufficient moisture permeability.
  • the support may be further processed from a woven fabric, a nonwoven fabric, a knitted fabric, a film, a foam, or the like made of the above material.
  • it may be coated with a polyurethane resin, an acrylic resin or the like, or may be laminated with a polyurethane film or the like.
  • the support includes: PET woven fabric with polyurethane coating, PET woven fabric with acrylic coating, PET woven fabric laminated with polyurethane film, PET woven fabric laminated with ether polyurethane film, and composite material of PET and pulp
  • Nonwoven fabrics made of, LDPE film, nylon woven fabric with acrylic coating, and polyurethane foam are preferred supports.
  • the characteristics of the adhesive material largely depend on the physical characteristics of the support.
  • the 10% tensile load in at least one of the longitudinal direction and the short direction of the support is also preferably 18 N / 25 mm or more.
  • the tensile load is preferably 18 N / 25 mm or more and 500 N / 25 mm or less, more preferably 18 N / 25 mm or more and 300 N / 25 mm or less, and further preferably 20 N / 25 mm or more and 200 N / 25 mm or less.
  • 25 N / 25 mm to 150 N / 25 mm is particularly preferable, and 30 N / 25 mm to 150 N / 25 mm is most preferable. If the tensile load of the support is less than 18 N / 25 mm, the patch is likely to be deformed by an external force or the like, and the effect of suppressing skin elongation may be insufficient.
  • both the longitudinal direction and the transversal direction satisfy
  • the breaking strength of the support is preferably 18 N / 25 mm or more, more preferably 50 N / 25 mm or more, and further preferably 100 N / 25 mm or more.
  • additives that are usually used may be added as necessary.
  • the additive include an ultraviolet absorber, an anti-aging agent, a filler, a pigment, a colorant, a flame retardant, and an antistatic agent. These additives may be used alone or in combination, and the content of these additives may be selected in an optimum range depending on the type of the additive. In many cases, the amount is in the range of 0.001 to 30% by mass, preferably 0.01 to 25% by mass, more preferably 0.1 to 20% by mass.
  • UV irradiation to the wound part is blocked by adding an ultraviolet absorber to the support layer or coating the ultraviolet ray absorber on the support layer, so that wound healing, scar treatment, scarring, etc. -It is preferable from the viewpoint of prevention of keloids and the like.
  • the thickness of the support is 5 ⁇ m or more and 5 mm or less, preferably 20 ⁇ m or more and 3 mm or less, and preferably 40 ⁇ m or more and 1 mm or less from the viewpoint that the patch of the present invention sufficiently exhibits the effect of suppressing the stretching of the skin and improves the handleability. Is more preferably 50 ⁇ m or more and 0.5 mm or less, and particularly preferably 60 ⁇ m or more and 0.15 mm or less. If the thickness of the support is less than 5 ⁇ m, the strength of the support is insufficient, and the support may be broken due to friction or the like during use. In addition, handleability may be reduced. On the other hand, if the thickness exceeds 5 mm, it becomes bulky and uncomfortable when it is applied to the skin. In particular, the ability to follow the curved surface of the skin is poor, and it is easy to come into contact with the clothing covered by the adhesive material. There is a risk of peeling off easily.
  • the support can be provided with micropores in order to apply an ointment, cream, gel or the like containing a drug from the top of the support during application.
  • an ointment containing a steroid agent from above the support, inflammation and itching of the wound can be suppressed without peeling off the patch.
  • the size of the micropores is not particularly limited as long as the ointment, cream or gel penetrates into the wound part, but is preferably 0.01 to 30 mm 2 .
  • the pressure-sensitive adhesive layer of the patch of the present invention (hereinafter also referred to as “the pressure-sensitive adhesive layer”) is provided on one side of the support.
  • the pressure-sensitive adhesive layer serves to removably fix the patch of the present invention to the skin.
  • the pressure-sensitive adhesive layer contains at least one pressure-sensitive adhesive. Moreover, it may contain optional components such as a softener, a tackifier, a pH adjuster, a medicinal component, a filler, an antioxidant (antioxidant, antiseptic), a colorant, and a fragrance as necessary.
  • a softener e.g., a tackifier
  • a pH adjuster e.g., a pH adjuster
  • a medicinal component e.g., a tackifier, e.g., a tackifier, a pH adjuster, a medicinal component, a filler, an antioxidant (antioxidant, antiseptic), a colorant, and a fragrance as necessary.
  • the type of pressure-sensitive adhesive contained in the pressure-sensitive adhesive layer is not particularly limited, and examples thereof include a urethane-based pressure-sensitive adhesive, an acrylic pressure-sensitive adhesive, a rubber-based pressure-sensitive adhesive, and a silicone-based pressure-sensitive adhesive.
  • Examples of the urethane-based pressure-sensitive adhesive include those made of a urethane resin obtained by reacting a polyol and a polyisocyanate compound.
  • Examples of the polyol include polyether polyol, polyester polyol, polycarbonate polyol, polycaprolactone polyol, and the like.
  • Examples of the polyisocyanate compound include diphenylmethane diisocyanate, tolylene diisocyanate, hexamethylene diisocyanate, and the like.
  • the NCO / OH molar ratio between the polyol and the polyisocyanate compound used in the reaction is 0.7 / 1.00 to 1.00 / 1.00 so that gelation in the reaction is suppressed and the adhesive strength is increased. It is preferable.
  • a usual method such as a bulk polymerization (solid reaction) method in which the reaction is performed in a molten state, a solution polymerization method, or the like can be used.
  • the solvent used in the solution polymerization method include ketone solvents such as methyl ethyl ketone, methyl isobutyl ketone, and cyclohexanone, ester solvents such as ethyl acetate and butyl acetate, ether solvents such as dioxane and tetrahydrofuran, cellosolve, Glycol ether solvents such as carbitol, glycol ether solvents such as cellosolve acetate, amide solvents such as dimethylacetamide and dimethylformamide, aromatic hydrocarbon solvents such as toluene and xylene, alcohols such as methanol, ethanol and isopropanol These solvents are further included such as system solvent
  • a catalyst When producing a urethane-based pressure-sensitive adhesive, a catalyst, an additive, and the like can be used as necessary.
  • the catalyst include general urethanization catalysts such as nitrogen-containing compounds such as triethylamine and triethylenediamine, and organometallic compounds such as dibutyltin dilaurate, tin octylate and tin stearate.
  • the additive include ultraviolet absorbers such as substituted benzotriazoles, antioxidants such as phenol derivatives, and hydrolysis inhibitors.
  • a chain extender can be used in the production of the urethane adhesive.
  • the urethane-based adhesive can be used in combination with a polyisocyanate curing agent to change the adhesive properties. Increasing the cohesive strength by the combined use of a polyisocyanate curing agent is effective in improving problems such as adhesive residue.
  • the polyisocyanate used as the curing agent can also be used, but a polyol adduct of isocyanate obtained by reaction of these with a bifunctional or higher polyol is preferable, and polymeric polyisocyanate, Isocyanurate modified products and carbodiimide modified products are also preferable.
  • Specific examples include Coronate L, Coronate HL, Coronate 3041, Coronate 2030, Coronate 2031, Coronate HX, Millionate MTL, Millionate MR, and the like manufactured by Nippon Polyurethane Industry.
  • Urethane adhesives are highly safe and are practically used as medical polymer materials. High moisture permeability, good adhesion to the skin, flexible, familiar, and low-irritant adhesive. Therefore, it is suitable for an application to be applied to a human body, and is suitable as an adhesive for a medical patch. Moreover, all of adhesiveness, safety, stability as a material, economy, etc. are satisfied.
  • acrylic pressure-sensitive adhesive examples include acrylic acid esters having an alkyl group having 4 to 12 carbon atoms, such as butyl acrylate, isononyl acrylate, 2-ethylhexyl acrylate, 2-hydroxyethyl acrylate, isooctyl acrylate, n-octyl acrylate, and the like. Or homopolymers of methacrylic acid esters; these (meth) acrylic acid esters as the main component, and other monomers such as (meth) acrylic acid, vinyl acetate, vinylpyrrolidone, acrylamide, hydroxyethyl acrylate, hydroxypropyl acrylate, etc. Examples thereof include a copolymer obtained by copolymerizing with one or more other copolymerizable monomers. Other monomers are usually used in the range of 2 to 50% by mass.
  • the acrylic pressure-sensitive adhesive can be obtained by polymerizing a monomer in a nitrogen atmosphere using a peroxide such as benzoyl peroxide as an initiator in an organic solvent such as toluene, hexane, or ethyl acetate.
  • a peroxide such as benzoyl peroxide
  • organic solvent such as toluene, hexane, or ethyl acetate
  • the acrylic pressure-sensitive adhesive obtained by this method is called a solvent-type acrylic pressure-sensitive adhesive.
  • An emulsion acrylic pressure-sensitive adhesive obtained by emulsifying and dispersing the monomer in water with an emulsifier and then polymerizing can also be used.
  • the acrylic pressure-sensitive adhesive is cross-linked using a cross-linking agent such as a polyvalent isocyanate-based cross-linking agent, a polyvalent epoxy resin-based cross-linking agent, or a polyvalent metal-based cross-linking agent.
  • a cross-linking agent such as a polyvalent isocyanate-based cross-linking agent, a polyvalent epoxy resin-based cross-linking agent, or a polyvalent metal-based cross-linking agent.
  • Tetrad-X manufactured by Mitsubishi Gas Chemical Co., Inc.
  • nursem manufactured by Nippon Chemical Industry Co., Ltd.
  • coronate HL coronate L
  • coronate EH manufactured by Nippon Polyurethane Industry Co., Ltd.
  • These crosslinking agents are usually added to the pressure-sensitive adhesive composition when it is prepared.
  • the crosslinking agent is generally used in an amount of 0.01 to 5 parts by mass, preferably 0.05 to 2 parts by mass with respect to 100 parts by mass of the acrylic pressure-sensitive adhesive (acrylic polymer component). That is, the amount of the crosslinking agent used is appropriately selected from the above range in consideration of adhesive properties, cohesiveness, bleeding properties of medicinal components, and the like. If necessary, a liquid component such as a softening agent can be blended in the acrylic pressure-sensitive adhesive.
  • a foamed pressure-sensitive adhesive because air permeability can be improved and cushioning properties can be improved.
  • Foaming of the pressure-sensitive adhesive can be performed by a usual method, and examples thereof include a method of using a foaming agent and a method of using a vaporizing action generated when an aqueous solution or an organic solvent is heated.
  • the rubber-based adhesive examples include rubber-like elastic bodies such as natural rubber, styrene-isoprene-styrene block copolymer, polyisobutylene, polybutene, polyisoprene, and a mixture of two or more thereof, rosin resin, terpene And the like, to which a tackifier such as a resin, a coumarone-indene resin, or a petroleum resin is added.
  • the rubber-based pressure-sensitive adhesive can be added with softening agents such as liquid polybutene, liquid polyisobutylene and mineral oil; fillers such as titanium oxide and zinc oxide; antioxidants such as butylhydroxytoluene and the like. .
  • those having a styrene-isoprene-styrene block copolymer as a main base are preferable from the viewpoint of adhesiveness.
  • silicone pressure-sensitive adhesive examples include a mixture or partial condensate of silicone rubber and silicone resin.
  • silicone rubber examples include a high molecular weight linear polydiorganosiloxane having a silicon functional group such as a silanol group at both ends, and the silicone resin includes a monofunctional siloxane unit and a tetrafunctional siloxane unit, Examples thereof include polyorganosiloxanes having a branched or network structure having a silicon functional group such as a silanol group or a methoxy group in the molecule.
  • such a silicone rubber is a long-chain copolymer of polydimethylsiloxane
  • the silicone resin is an MQ resin (M units ((CH 3 ) 3 SiO 1/2 ) and Q units).
  • MQ resin M units ((CH 3 ) 3 SiO 1/2 ) and Q units).
  • Silicone resin having a three-dimensional structure made of (SiO 2 )).
  • the composition ratio of the silicone rubber / silicone resin constituting the silicone pressure-sensitive adhesive is not particularly limited, but is preferably 30:70 to 60:40, more preferably 35:65 to 45:55 (mass ratio). ).
  • the composition ratio of silicone rubber / silicone resin particularly preferred in the present invention is 40/60 (w / w) (BIO-PSA4501, Dow Corning), 45/55 (w / w) (BIO-PSA4601, Dow Corning) And the like.
  • a silicone-based pressure-sensitive adhesive is a pressure-sensitive adhesive having pressure-sensitive adhesive properties due to silicon functional groups present in the molecule.
  • Examples of the organic group bonded to the silicon atom include various monovalent hydrocarbon groups such as methyl, ethyl, vinyl, and phenyl, and the adhesiveness can be adjusted by selecting the type of substituent.
  • the silicone-based pressure-sensitive adhesive is rich in air permeability and moisture permeability because the intermolecular distance of the polyorganosiloxane that is the main component thereof is large.
  • each pressure-sensitive adhesive may be used alone or in combination of two or more.
  • these pressure-sensitive adhesives may be used only with pressure-sensitive adhesives.
  • hydrogels containing water, organogels containing organic solvents, hydrocolloids added with hydrophilic polymer compounds It may be used as a hydrocolloid adhesive in the form.
  • the pressure-sensitive adhesive layer may be formed as a single pressure-sensitive adhesive, or may be formed by laminating a plurality of pressure-sensitive adhesive layers. When a plurality of pressure-sensitive adhesive layers are laminated, a plurality of different types of pressure-sensitive adhesives or different sizes of pressure-sensitive adhesives can be laminated. For example, a hydrocolloid adhesive smaller than the support can be used as a part of the bandage pad.
  • urethane pressure-sensitive adhesives or foamed acrylic pressure-sensitive adhesives are preferable from the viewpoints of moisture permeability, low irritation, safety, moderate pressure-sensitive adhesiveness, and the like.
  • the adhesive layer may contain a softener, a tackifier, a pH adjuster, a medicinal component, a filler, an antioxidant (antioxidant, preservative), a colorant, and a fragrance as optional components.
  • a softener can reduce the elasticity of the pressure-sensitive adhesive to give flexibility and improve the pressure-sensitive adhesiveness.
  • the softener include mineral oils such as liquid paraffin, liquid isoparaffin, and naphthenic oil; vegetable oils such as olive oil and olive squalane; animal oils such as lanolin, turtle oil, and beeswax; and synthetic oils such as fatty acid triglyceride and silicone oil.
  • the tackifier can be added as needed because it can make it difficult to cohesive failure while imparting appropriate flexibility to the adhesive.
  • tackifiers include natural rosin derivatives, coumarone-indene resins, terpene oligomers, aliphatic petroleum resins, alkyl-modified phenol resins, polyterpene resins, gum rosins, rosin esters, oily phenol resins, coumarone indene resins, petroleum carbonization. A hydrogen resin etc. are mentioned.
  • the type of the pH adjuster is not particularly limited as long as the object of the present invention is not impaired.
  • karaya gum citric acid, phosphoric acid, sodium hydrogen phosphate, anhydrous sodium hydrogen phosphate, pectin, anhydrous citric acid, alkali metal water
  • examples thereof include oxides and buffer solutions of organic acids.
  • the pressure-sensitive adhesive layer can be adjusted to a pH range of 4.0 to 6.0 by adjusting to the pH of normal skin.
  • antibacterial agents for example, antibacterial agents, anti-inflammatory analgesics, steroid agents, anesthetic agents, antifungal agents, vitamin agents and the like can be mentioned.
  • these drugs exert their effects systemically or locally through percutaneous absorption, or exert their effects locally at the site where they are applied.
  • the drug may contain a drug that suppresses the formation of scars and keloids.
  • Such drugs include antiallergic agents, steroidal agents, TGF- ⁇ signal inhibitors and the like. It is known that allergic reactions are involved in symptoms such as the development / progress of scars and keloids, itching and pain.
  • corticosteroids have a variety of actions, but in the skin, they have an effect of suppressing inflammation and an effect of atrophying tissue.
  • TGF- ⁇ has a very important role in maintaining the homeostasis of the living body, but it is known that abnormalities in TGF- ⁇ signal cause various diseases such as scleroderma, scleroderma and various fibrosis. ing. A common cause of these diseases is thought to be excessive tissue fibrosis induced by excessive TGF- ⁇ signal.
  • the thickness of the pressure-sensitive adhesive layer is not particularly limited, but it is preferably 1 ⁇ m or more and 1 mm or less, preferably 10 ⁇ m or more and 0.5 mm or less from the viewpoint of ensuring the fixation to the skin and the balance with the thickness of the support. Is more preferably 20 ⁇ m or more and 0.1 ⁇ m or less.
  • the coating weight (adhesive thickness) at the time of drying of the pressure-sensitive adhesive layer is preferably 1 g / m 2 or more and 1000 g / m 2 or less, more preferably 10 g / m 2 or more and 200 g / m 2 or less, and 20 g / m.
  • the thickness of the pressure-sensitive adhesive layer or the coating weight is equal to or more than the upper limit, moisture permeability and handleability may be deteriorated. On the other hand, if it is less than the lower limit, there is a possibility that the fixation to the skin cannot be secured.
  • the adhesive strength of the adhesive material provided with an adhesive layer on one side is neither too strong nor too weak, and the adhesive strength against bakelite is about 0.3 to 10 N / 25 mm.
  • the thickness is 2.0 to 6.0 N / 25 mm.
  • the adhesive strength to bakelite was determined by attaching a tape test piece prepared by cutting to a length of 150 mm and a width of 25 mm on a bakelite panel in an atmosphere of 23 ° C. and 50% RH, and applying a 2 kg rubber roll to 300 mm / min. The pressure is reciprocated at a speed of 1 mm.
  • the peel force is measured under the conditions of a peel angle of 180 degrees and a peel speed of 300 mm / min to determine the test piece's bakelite adhesive strength. The measurement is performed three times, and the average value is defined as the adhesive strength of the patch to the bakelite (unit: N / 25 mm).
  • the tackiness of the pressure-sensitive adhesive layer provided on the support is neither too strong nor too weak, and is about 0.4 to 10 (N / 5 mm ⁇ ) in probe tack, preferably 0. About 6 to 5.0 (N / 5mm ⁇ ) is preferable.
  • the peel-off body used for the patch of the present invention (hereinafter also referred to as “the peel-off body”) is provided on the surface of the pressure-sensitive adhesive layer opposite to the surface provided with the support. It is provided in a peelable state.
  • the release body release paper, release film and the like commonly used in the field of patch materials can be used.
  • a paper substrate such as high-quality paper or glassine paper subjected to silicone release treatment, a polyester film, or the like can be used.
  • the thickness of the peeled body is not particularly limited, but is usually 20 ⁇ m or more, preferably 40 ⁇ m or more, and the upper limit is about 500 ⁇ m.
  • the carrier used for the patch of the present invention (hereinafter also referred to as “the carrier”) is provided in a peelable state on the surface of the support opposite to the surface on which the pressure-sensitive adhesive layer is provided. It plays the role which improves the manufacturability and operativity of the patch of this invention.
  • this carrier is transparent or translucent in view of visibility so that the application site can be confirmed at the time of application.
  • the carrier has a relatively high elastic modulus with respect to the support and has an elastic modulus of about 3 to 20 times that of the support.
  • a cut may be provided near the center of the carrier, or two carriers may be provided with a gap between the carriers.
  • a tape or a film may be laminated on the upper part of the cut of the carrier, and a mouth portion may be provided as a gripping piece.
  • the mouth portion may be a film, non-woven fabric, woven fabric, or a laminate thereof, may be an adhesive tape, and may be colored.
  • the end portion of the carrier may be in the form of a waveform or a plurality of cuts, or may be formed larger than the support.
  • the carrier used examples include polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polyamides such as nylon, polyvinyl chloride, and polyvinylidene chloride.
  • polyolefins such as polyethylene and polypropylene
  • polyesters such as polyethylene terephthalate
  • polyamides such as nylon, polyvinyl chloride, and polyvinylidene chloride.
  • it may be a composite carrier laminated with paper, non-woven fabric, woven fabric, knitted fabric, or metal foil. From the viewpoints of cost and cost, polyolefin and polyester films are preferably used.
  • the thickness of the carrier is not particularly limited, but is usually 20 ⁇ m or more, preferably 40 ⁇ m or more, and the upper limit is about 500 ⁇ m.
  • one or more other layers may be interposed between the carrier and the support, between the support and the pressure-sensitive adhesive layer, and / or between the pressure-sensitive adhesive layer and the release body.
  • an undercoat layer, an adhesive layer, or a release agent layer may be provided in order to improve adhesiveness and peelability, or a film, a nonwoven fabric, a woven fabric, or a laminate thereof may be interposed.
  • the method for producing the patch is not particularly limited, and can be produced according to a general method for producing a patch.
  • the pressure-sensitive adhesive layer can be formed, for example, by supplying a pressure-sensitive adhesive to one upper surface of the support or release body by a method such as a coating method or an extrusion method. Moreover, it can form by supplying an adhesive between a support body and a peeling body. Furthermore, the support and the pressure-sensitive adhesive layer can be coextruded.
  • the method of manufacturing a patch includes a step of forming a pressure-sensitive adhesive layer by applying a pressure-sensitive adhesive to the upper surface of the release body layer.
  • the pressure-sensitive adhesive coating method is not particularly limited, such as spread coating, hot melt coating, and emulsion coating, but the melt coating method is particularly preferable when a thin pressure-sensitive adhesive layer having a thickness of 50 ⁇ m or less is obtained. .
  • an adhesive that forms an adhesive layer is applied to the upper surface of a peeled body that is formed in advance in one direction, and the solvent is removed by drying to form an adhesive layer.
  • a patch comprising the support, the pressure-sensitive adhesive layer, and the peelable body laminated in this order can be obtained. it can.
  • the surface of the support may be entirely covered, or may be partially covered.
  • arbitrary forms such as a grid
  • air permeability, moisture permeability, etc. can be further improved, and the irritation at the time of peeling from the skin is further reduced. You can also.
  • the support may be subjected to surface treatment or primer treatment in order to improve the adhesion between the support and the pressure-sensitive adhesive layer.
  • surface treatment of the support for example, any known treatment methods such as embossing, sand matting, corona discharge treatment, plasma treatment, and alkali treatment can be employed.
  • the primer treatment can be performed using any known primer as long as it is a primer that can be used in the composition according to the present invention, for example, using a primer composed of a silane coupling agent or the like. .
  • the patch can suppress not only the expansion of the skin but also the shrinkage when applied to the skin, it can sufficiently reduce the external force applied to the skin having an injury or a wound caused by surgery. it can. Moreover, since it is excellent also in followability to skin, moisture permeability, etc., it can be applied for a long time. Therefore, according to the patch of the present invention, wound healing and scar treatment can be promoted, and scar and keloid formation can be effectively prevented. In particular, it is effective in preventing the formation of scars and keloids.
  • the direction (longitudinal direction and transversal direction) of the sticking material when sticking can be determined according to the size of the wound.
  • the 10% tensile load in the direction perpendicular to the flaw is increased.
  • it can be affixed to the affected area suffering from eczema, burns, acne, pierced holes, BCG inoculation and the like.
  • the wound healing process is one of the biological defense systems that are divided into three stages from the time course, the inflammatory phase, the proliferative phase and the tissue remodeling phase.
  • the inflammatory phase the proliferative phase
  • the tissue remodeling phase the tissue remodeling phase.
  • mechanical strains such as stretching and contraction occur at the wound site
  • the digestion and removal of necrotic tissue by macrophages and the apoptosis of excess cells are suppressed, particularly in the early proliferative phase, leading to scarring of collagen fibers. It is presumed that the reconstruction of the tissue is suppressed and the scar is enlarged to form a keloid.
  • the patch according to the present invention can be used for the treatment of scars caused by trauma or surgery from the viewpoint of promoting wound healing, while scars and keloids are formed in the sense of suppressing the formation of scars and keloids. It can be used for prevention.
  • the usage of the patch is appropriately selected according to the purpose. For example, for the purpose of preventing scar and keloid formation in the wound, it is preferable to continuously apply for about 3 to 12 months. One sticking material can be stuck continuously after it is once stuck until it peels off. This period is usually about 3 to 7 days. After that, it is desirable to apply a new adhesive material, and repeatedly apply a new adhesive material when peeled off.
  • the adhesive material can be used by covering the adhesive material with a dressing material or medical tape as necessary for waterproofing and long-term adhesion.
  • Adhesive Urethane adhesive has a molar ratio of polyether polyol A / polyether polyol B / polyether monool C (mass ratio 43/21/36) in the isocyanate prepolymer with respect to hydroxyl group 100 in the active hydrogen compound.
  • a urethane-based pressure-sensitive adhesive to which hexamethylene diisocyanate prepolymer was added so as to have an isocyanate group of 90 was used.
  • the acrylic adhesive acrylic adhesive 1, acrylic adhesive 2, and acrylic adhesive 3 were used.
  • the acrylic pressure-sensitive adhesive 1 is a coronate (registered as a cross-linking agent) with respect to 100 parts by mass of an alkyl acrylate copolymer comprising isononyl acrylate / 2-methoxyethyl acrylate / acrylic acid (mass ratio 68/30/2).
  • An acrylic pressure-sensitive adhesive to which 0.3 part by mass of HL manufactured by Nippon Polyurethane Industry Co., Ltd.
  • Acrylic pressure-sensitive adhesive 2 is TETRAD (registered trademark) X 0.02 parts by mass as a crosslinking agent with respect to 100 parts by mass of an acrylic acid alkyl ester copolymer consisting of isononyl acrylate / acrylic acid (mass ratio 98/2). It is an acrylic pressure-sensitive adhesive to which 0.1 part by mass of Nasem aluminum (manufactured by Nippon Chemical Industry Co., Ltd.) is added.
  • the acrylic pressure-sensitive adhesive 3 was used as a crosslinking agent with respect to 100 parts by mass of an acrylic acid alkyl ester copolymer composed of isononyl acrylate / acrylic acid (mass ratio 96/4), and 0.03 parts by mass of TETRAD (registered trademark) X It is an acrylic adhesive with the addition of Mitsubishi Gas Chemical Co., Ltd.
  • Base material (support) As a substrate (support), PET woven fabric + PU coating (polyester woven fabric with polyurethane coating), PET woven fabric + PU film laminated product (polyester woven fabric laminated with polyurethane film), PET / pulp nonwoven fabric (nonwoven fabric containing polyester and pulp), Nylon woven fabric + acrylic coating (Nylon woven fabric with acrylic coating), PET woven fabric + acrylic coating (polyester woven fabric with acrylic coating), PET woven fabric + PU film laminated product (polyester woven fabric laminated with ether polyurethane film), Polyurethane film, PP spunbond nonwoven fabric (polypropylene long fiber nonwoven fabric), A polyurethane nonwoven fabric was used.
  • Example 2 [Examples 2, 5 to 7, and Comparative Example 1] Except that the base material described in Table 1 below was used, the patch materials of Examples 2, 5 to 7 and Comparative Example 1 were prepared in the same manner as in Example 1. The adhesive thickness of each obtained patch was also shown in Table 1. The characteristics of each patch were similarly measured using the method described later and are shown in Table 2.
  • Example 3 Apply an ethyl acetate solution of acrylic pressure-sensitive adhesive 1 (the total solid content is about 40% by mass) to one side of the peeled body so that the thickness after drying is 39 g / m 2 , and then dry, A layer was formed, and a PET / pulp nonwoven fabric was laminated as a support to prepare a patch.
  • acrylic pressure-sensitive adhesive 1 the total solid content is about 40% by mass
  • Example 4 and Comparative Examples 2 to 4 Except that the pressure-sensitive adhesive and the base material described in Table 1 below were used, patch materials of Example 4 and Comparative Examples 2 to 4 were prepared in the same manner as Example 3. The adhesive thickness of each obtained patch was also shown in Table 1. The characteristics of each patch were similarly measured using the method described later and are shown in Table 2.
  • the upper crosshead was raised at a speed of 300 mm / min, and the test piece was pulled.
  • the load when the tensile length reached 10% based on the original test piece was defined as a 10% tensile load.
  • the unit of tensile load was expressed as Newton (N) / 25 mm.
  • Three test pieces were cut in each of the short (CD) direction and the long (MD) direction of each patch, and the measurement was performed on all three sheets. The average value of the three sheets was taken as the measured value of the tensile load in each of the CD direction and MD direction.
  • the measurement conditions are summarized as follows.
  • the moisture permeability was measured at a temperature of 40 ° C. and a relative humidity of 90% in accordance with B condition of JIS Z 0208. That is, one side of each patch is adjusted to a temperature of 40 ° C. and a relative humidity of 90%, and about 15 g of a hygroscopic agent (calcium chloride) is placed on the other side to absorb the moisture that has passed through each patch. The mass change amount of the hygroscopic agent was converted to 1 m 2 per 24 hours, and the average value of the three test pieces was defined as moisture permeability.
  • a hygroscopic agent calcium chloride
  • Stress relaxation time As the test piece of each patch, one obtained by cutting three strips each having a width of 25 mm and a length of 80 mm in each of the short side (CD) direction and the long side (MD) direction was used. Nichiban Co., Ltd. Carton Tape No. is attached to both ends so that the distance between chucks is 50 mm. A test piece for measuring tensile strength was prepared by attaching 660. After pulling at a speed of 300 mm / min up to 25 N, the load was stopped for 180 seconds when the load became 25 N, and the time (second) when the load decreased to 20 N was defined as the stress relaxation time. The measurement conditions are summarized as follows.
  • the patch for wound covering or post-operative wound protection of the present invention not only the expansion of the skin but also the shrinkage can be suppressed, so that the external force applied to the skin having a wound due to trauma or surgery can be sufficiently reduced. it can. Moreover, since it is excellent also in followability to skin, moisture permeability, etc., it can be applied for a long time. Therefore, the patch for wound covering or protecting a postoperative wound according to the present invention is suitable for wound healing, scar treatment or prevention of scar or keloid formation.

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Abstract

Provided is a patch for wound coverage or postoperative wound protection, which can suppress stretching and contracting of the skin, excels at following the contours of the skin, and can remain adhered for a long period of time. This patch for wound coverage or postoperative wound protection includes a support body, and an adhesive layer provided on one surface of the support body, wherein the 10% tensile load in at least one of the long direction and the short direction of the patch is 18N/25mm or more, and the product of the bending resistance (mm) according to a cantilever method and the basis weight (g/m2) is 3000 or more.

Description

貼付材Adhesive material
 本発明は、貼付材、特に創傷被覆用又は術後創保護用の貼付材、さらには創傷の治癒用、傷跡の治療用又は瘢痕・ケロイド等の形成予防用の貼付材に関する。 The present invention relates to a patch, particularly a patch for wound covering or post-surgical wound protection, and further to a patch for healing wounds, treating scars, or preventing formation of scars and keloids.
 外傷や手術によって皮膚に出来た創傷は、通常2週間程度で治癒するが、その後も約半年間にわたり変化を続ける。一般的に傷跡は約1ヶ月後には、硬くなって赤みを帯びるが、その後数ヶ月間かけて徐々に軟らかくなり、周囲の皮膚と同じ色になってくる。しかし、何らかの理由により正常な創傷治癒の過程が障害を受けると、傷が治らずに慢性化したり、異常な治り方をしたりすることがある。異常な治り方をするものの一つが瘢痕やケロイドと呼ばれるものである。瘢痕やケロイドが発生するメカニズムは、不明であるが、皮膚にかかる力学的緊張や炎症の強弱との関連も指摘されている。 創傷 Wounds made on the skin by trauma or surgery usually heal in about two weeks, but continue to change for about half a year thereafter. In general, the scar becomes hard and reddish after about one month, but gradually becomes softer over the next several months and becomes the same color as the surrounding skin. However, if the normal wound healing process is damaged for some reason, the wound may not be cured and may become chronic or may be cured abnormally. One of the abnormal cures is called scars or keloids. The mechanism by which scars and keloids occur is unclear, but it has been pointed out that it is related to mechanical tension on the skin and the intensity of inflammation.
 従来から、傷跡の治療や、瘢痕やケロイドの形成を予防する方法として、外傷や手術後の皮膚にかかる外力を減じる方法が用いられている(特許文献1~3参照)。具体的には、特許文献1には、特定の伸長力を有するハイドロコロイド貼付材が開示されている。特許文献2には、創傷を内因的応力及び/又は外因的応力から遮蔽するように構成され、傷跡及び/又はケロイドの形成を改善し得るデバイス、包帯、キット、及び方法が記述されている。また、特許文献3には、ケロイド等の患部に隣接する周辺部区帯に応当して貼付される貼付材と、患部を覆う弾性体と、該弾性体を上方から支持しながら上記貼付材の上に少なくともその一部がかかるように貼り付けて、上記弾性体を患部に向けて押圧するようにする支持用貼付材を具備する皮膚障害治療用体が開示されている。 Conventionally, as a method for treating scars and preventing the formation of scars and keloids, methods for reducing external forces applied to the skin after trauma or surgery have been used (see Patent Documents 1 to 3). Specifically, Patent Document 1 discloses a hydrocolloid patch having a specific elongation force. U.S. Patent No. 6,057,056 describes devices, bandages, kits, and methods that are configured to shield wounds from intrinsic and / or extrinsic stresses and can improve scar and / or keloid formation. Further, Patent Document 3 discloses a patch that is applied in accordance with a peripheral zone adjacent to the affected part such as keloid, an elastic body that covers the affected part, and the adhesive material that supports the elastic body from above. A body for treating skin disorders has been disclosed, comprising a support patch that is attached so that at least a part of the elastic body is applied to the elastic body and presses the elastic body toward the affected area.
特開2012-135582号公報JP 2012-135582 A 特表2009-545382号公報Special table 2009-545382 特公平07-079827号公報Japanese Patent Publication No. 07-079827
 しかし、従来のハイドロコロイド貼付材や包帯、皮膚障害治療用体等では、皮膚の伸びは抑制するが縮みは抑制しない、皮膚への追従性が低い、長時間貼付できない等の不都合がある。そのため、皮膚の伸びと縮みの両方を抑制することができ、皮膚への追従性に優れ、長期間貼付可能である瘢痕・ケロイド形成予防用貼付材が望まれている。本発明の課題は、皮膚の伸びと縮みの両方を抑制することができ、皮膚への追従性に優れ、長期間貼付可能である創傷被覆用又は術後創保護用の貼付材、特に創傷の治癒用、傷跡の治療用又は瘢痕・ケロイド形成予防用の貼付材を提供することである。 However, conventional hydrocolloid patches, bandages, skin disorder treatment bodies and the like have disadvantages such as suppressing skin elongation but not shrinking, low followability to skin, and inability to apply for a long time. Therefore, a patch for preventing scar and keloid formation that can suppress both elongation and contraction of the skin, has excellent followability to the skin, and can be applied for a long period of time is desired. An object of the present invention is to provide a patch for wound covering or post-operative wound protection, particularly a wound patch that can suppress both elongation and contraction of the skin, has excellent followability to the skin, and can be applied for a long period of time. An object of the present invention is to provide a patch for healing, treatment of scars or prevention of scar / keloid formation.
 前記課題を解決するためになされた発明は、貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上である創傷被覆用又は術後創保護用の貼付材である。本発明の貼付材は、皮膚の伸びと縮みの両方を抑制することができ、さらに皮膚への追従性にも優れ、長時間貼付可能である。本発明の貼付材は、従来の貼付材が十分に備えていなかった皮膚の縮みの抑制効果にも優れている。本発明者らは、貼付材の10%引張荷重が18N/25mm以上であると皮膚の伸びを十分抑制でき、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上であると皮膚の縮みを十分抑制できることを見出したものである。 The invention made in order to solve the above-mentioned problems is that the 10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the bending resistance (mm) and basis weight (by the cantilever method) g / m 2 ) is a patch for wound covering or postoperative wound protection having a product of 3000 or more. The patch of the present invention can suppress both stretching and shrinkage of the skin, and is excellent in followability to the skin and can be applied for a long time. The patch of the present invention is also excellent in the effect of suppressing the shrinkage of the skin that the conventional patch has not sufficiently provided. The present inventors can sufficiently suppress the elongation of the skin when the 10% tensile load of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method. It has been found that the shrinkage of the skin can be sufficiently suppressed when the ratio is 3000 or more.
 即ち、本発明の要旨は以下の通りである。なお、本発明において、「10%引張荷重」とは、日本工業規格のJIS K 7113に従って測定したものである。「カンチレバー法による剛軟度(mm)」はJIS L 1096に従って測定することができる。「坪量(g/m)」とは、1平方メートル当たりのグラム数で表された貼付材単位面積当たりの重量(g)である。 That is, the gist of the present invention is as follows. In the present invention, “10% tensile load” is measured according to JIS K 7113 of Japanese Industrial Standard. The “bending softness by cantilever method (mm)” can be measured according to JIS L 1096. The “basis weight (g / m 2 )” is the weight (g) per unit area of the patch expressed in grams per square meter.
<1>支持体と、前記支持体の片面に設けられた粘着剤層とを備える貼付材において、
 前記貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上である、創傷被覆用又は術後創保護用の貼付材。
<1> In a patch comprising a support and an adhesive layer provided on one side of the support,
10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more. A patch for wound covering or protecting a wound after surgery.
<2>カンチレバー法による剛軟度(mm)と見かけ密度(g/cm)との積が25以上である、<1>に記載の貼付材。 <2> The patch according to <1>, wherein the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is 25 or more.
<3>透湿度が700g/m・24h以上である、<1>又は<2>に記載の貼付材。 <3> The patch according to <1> or <2>, wherein the moisture permeability is 700 g / m 2 · 24 h or more.
<4>前記貼付材の長手方向又は短手方向の少なくとも一方の応力緩和時間が10s以上である、<1>~<3>のいずれかに記載の貼付材。 <4> The patch according to any one of <1> to <3>, wherein the stress relaxation time in at least one of the longitudinal direction and the short direction of the patch is 10 s or more.
<5>長手方向及び短手方向の10%引張荷重が18N/25mm以上である、<1>~<4>のいずれかに記載の貼付材。 <5> The adhesive material according to any one of <1> to <4>, wherein the 10% tensile load in the longitudinal direction and the lateral direction is 18 N / 25 mm or more.
<6>前記粘着剤層がウレタン系粘着剤又は発泡したアクリル系粘着剤を含む、<1>~<5>のいずれかに記載の貼付材。 <6> The patch according to any one of <1> to <5>, wherein the pressure-sensitive adhesive layer contains a urethane-based pressure-sensitive adhesive or a foamed acrylic pressure-sensitive adhesive.
<7>前記支持体が織布又は不織布を含む、<1>~<6>のいずれかに記載の貼付材。 <7> The patch according to any one of <1> to <6>, wherein the support comprises a woven fabric or a nonwoven fabric.
<8>前記支持体が微小孔を含む、<1>~<7>のいずれかに記載の貼付材。 <8> The patch according to any one of <1> to <7>, wherein the support includes micropores.
<9>創傷の治癒用、傷跡の治療用又は瘢痕・ケロイド形成予防用である<1>~<8>のいずれかに記載の貼付材。 <9> The patch according to any one of <1> to <8>, which is used for wound healing, scar treatment, or scar / keloid formation prevention.
<10>外科手術による創部の創傷の治癒用、傷跡の治療用又は瘢痕・ケロイド形成予防用である、<9>に記載の貼付材。 <10> The patch according to <9>, which is used for healing a wound of a wound by surgery, treating a scar, or preventing scar / keloid formation.
<11>前記外科手術が帝王切開、胸骨正中切開又は腹腔鏡手術である<10>に記載の貼付材。 <11> The patch according to <10>, wherein the surgical operation is caesarean section, median sternotomy, or laparoscopic surgery.
<12>支持体と、前記支持体の片面に設けられた接着剤層とを備える貼付材において、前記貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上であり、
 前記粘着剤層がウレタン系粘着剤又は発泡したアクリル系粘着剤を含む貼付材。
<12> In a patch comprising a support and an adhesive layer provided on one side of the support, at least one 10% tensile load in the longitudinal direction or the short direction of the patch is 18 N / 25 mm or more. Yes, the product of the bending resistance (mm) by the cantilever method and the basis weight (g / m 2 ) is 3000 or more,
A patch comprising the pressure-sensitive adhesive layer containing a urethane-based pressure-sensitive adhesive or a foamed acrylic pressure-sensitive adhesive.
<13>支持体と、前記支持体の片面に設けられた粘着剤層とを備える貼付材において、
前記貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上であり、カンチレバー法による剛軟度(mm)と見かけ密度(g/cm)との積が25以上である貼付材。
In a patch comprising a <13> support and an adhesive layer provided on one side of the support,
10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more. A patch material in which the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is 25 or more.
<14>前記粘着剤層が、瘢痕、ケロイド形成を抑制する薬剤をさらに含む<1>~<13>に記載の貼付材。 <14> The patch according to <1> to <13>, wherein the pressure-sensitive adhesive layer further contains an agent that suppresses scarring and keloid formation.
 本発明の貼付材によると、皮膚の伸びだけでなく縮みも抑制することができるため、外傷や手術による傷を有する皮膚にかかる外力を十分に減じることができる。また、皮膚への追従性、透湿性、付着性等にも優れ、長時間貼付することも可能である。従って、本発明の貼付材によると、外傷、手術後の創部等についての創傷の治癒、傷跡の治療を促進し、瘢痕やケロイドの形成を効果的に予防することができる。 According to the patch of the present invention, not only the stretch of the skin but also the shrinkage can be suppressed, so that the external force applied to the skin having a wound due to an injury or an operation can be sufficiently reduced. In addition, it is excellent in followability to skin, moisture permeability, adhesion, etc., and can be applied for a long time. Therefore, according to the patch of the present invention, it is possible to promote the healing of wounds and the treatment of scars on wounds and wounds after surgery, and to effectively prevent the formation of scars and keloids.
 以下、本発明について詳細に説明する。 Hereinafter, the present invention will be described in detail.
<貼付材>
 本発明の貼付材(以下、「当該貼付材」ともいう)は、支持体と、前記支持体の片面に設けられた粘着剤層とを備える。さらに、当該貼付材は、必要に応じて剥離体及び/又は担持体を備える。また、担持体と支持体との間、支持体と粘着剤層との間、及び/又は粘着剤層と剥離体との間に、その他の層を一層以上介在させてもよい。支持体、粘着剤層、剥離体、担持体、その他の層については後述する。なお、貼付材の長い方向を長手方向、短い方向を短手方向とする。例えば、長方形状の貼付材においては、長辺に対応する方向を長手方向、短辺に対応する方向を短手方向とし、正方形の場合は、その一方を長手方向、もう一方を短手方向とする。ロール形状の場合には、カットした場合に長い方向を長手方向、短い方向を短手方向とする。
<Patch material>
The patch of the present invention (hereinafter also referred to as “the patch”) includes a support and an adhesive layer provided on one side of the support. Further, the patch material includes a peeler and / or a carrier as necessary. One or more other layers may be interposed between the support and the support, between the support and the pressure-sensitive adhesive layer, and / or between the pressure-sensitive adhesive layer and the release body. A support body, an adhesive layer, a peeling body, a support body, and other layers will be described later. In addition, let the long direction of a sticking material be a longitudinal direction, and let a short direction be a transversal direction. For example, in a rectangular patch, the direction corresponding to the long side is the longitudinal direction, the direction corresponding to the short side is the short direction, and in the case of a square, one is the longitudinal direction and the other is the short direction. To do. In the case of a roll shape, the longer direction when cut is the longer direction, and the shorter direction is the shorter direction.
 当該貼付材は、その長手方向又は短手方向の少なくとも一方の10%引張荷重が、18N/25mm以上である。当該貼付材は、このような物理的特性を備えていることにより、外力や瘢痕組織の伸展等によって変形し難く、皮膚の伸びを十分に抑制することができる。前記引張荷重は、18N/25mm以上500N/25mm以下であることが好ましく、18N/25mm以上300N/25mm以下であることがより好ましく、20N/25mm以上200N/25mm以下であることがさらに好ましく、25N/25mm以上150N/25mm以下であることが特に好ましく、30N/25mm以上150N/25mm以下が最も好ましい。当該貼付材は、前記引張荷重が18N/25mm未満であると、外力等により変形し易くなり、皮膚の伸びの抑制効果が不十分となるおそれがある。また、前記引張荷重が500N/25mmを超えると、皮膚の伸びは抑制できるものの、当該貼付材を貼付した状態では貼付材の皮膚への追従が低下したり、通常の動作が行い難くなる場合がある。また、当該貼付材は、長手方向又は短手方向の少なくとも一方が前記条件を満たしていればよいが、皮膚への外力を十分に減じ、皮膚の伸びを効果的に抑制するためには、長手方向及び短手方向の両方が前記条件を満たすことが好ましい。なお、本発明における引張荷重の測定は、JIS K 7113に準じて引張試験を行い、10%引張荷重の測定を実施した。 The adhesive material has a 10% tensile load of 18 N / 25 mm or more in at least one of the longitudinal direction and the short direction. Since the patch has such physical properties, it is difficult to be deformed by external force, scar tissue extension, or the like, and can sufficiently suppress the elongation of the skin. The tensile load is preferably 18 N / 25 mm or more and 500 N / 25 mm or less, more preferably 18 N / 25 mm or more and 300 N / 25 mm or less, further preferably 20 N / 25 mm or more and 200 N / 25 mm or less, more preferably 25 N / 25 mm or more and 150 N / 25 mm or less is particularly preferable, and 30 N / 25 mm or more and 150 N / 25 mm or less is most preferable. When the tensile load is less than 18 N / 25 mm, the patch is likely to be deformed by an external force or the like, and the effect of suppressing the elongation of the skin may be insufficient. Further, when the tensile load exceeds 500 N / 25 mm, the elongation of the skin can be suppressed. However, in the state where the adhesive material is applied, the follow-up of the adhesive material to the skin may be reduced or normal operation may be difficult to perform. is there. In addition, the adhesive material only needs to satisfy at least one of the longitudinal direction and the short-side direction, but in order to sufficiently reduce the external force on the skin and effectively suppress the elongation of the skin, It is preferable that both the direction and the short direction satisfy the above conditions. In addition, the measurement of the tensile load in this invention performed the tensile test according to JISK7113, and measured the 10% tensile load.
 当該貼付材は、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上である。発明者らは、貼付材においては、前記剛軟度と坪量との積の値が、その貼付材を皮膚に貼付した際の皮膚の伸び及び縮み抑制効果、特に皮膚の縮み抑制効果と関連があることを見出した。すなわち、前記剛軟度と坪量の積が大きいほど皮膚の縮み抑制効果が高く、この積の値が小さいほど皮膚の縮み抑制効果が低くなる。この積の値が3000以上である本発明の貼付材は、皮膚の縮みを十分に抑制でき、創傷の治癒、傷跡の治療を促進し、瘢痕やケロイドの形成を効果的に抑制することができる。しかし、この値が大き過ぎると、皮膚の縮み抑制効果は得られるものの、貼付材の皮膚への追従性が低下したり、皮膚に貼付した状態では通常の動作が行い難くなる場合がある。そのため、当該貼付材において、前記剛軟度と坪量との積は3000以上70000以下であることが好ましく、3300以上20000以下であることがより好ましく、3500以上10000以下であることがさらに好ましく、3500以上8000以下であることが特に好ましく、4000以上8000以下であることが最も好ましい。 The patch has a product of bending resistance (mm) and basis weight (g / m 2 ) by the cantilever method of 3000 or more. In the patch, the value of the product of the bending resistance and the basis weight is related to the effect of suppressing the stretch and contraction of the skin when the patch is applied to the skin, particularly the effect of suppressing the contraction of the skin. Found that there is. That is, the larger the product of the bending resistance and the basis weight, the higher the effect of suppressing skin shrinkage, and the smaller the product, the lower the effect of suppressing skin shrinkage. The patch of the present invention having a product value of 3000 or more can sufficiently suppress the shrinkage of the skin, promote the healing of wounds and the treatment of scars, and can effectively suppress the formation of scars and keloids. . However, if this value is too large, the effect of suppressing the shrinkage of the skin can be obtained, but the followability of the patch to the skin may be reduced, or normal operation may be difficult to perform when the patch is stuck to the skin. Therefore, in the patch, the product of the bending resistance and the basis weight is preferably 3000 or more and 70000 or less, more preferably 3300 or more and 20000 or less, and further preferably 3500 or more and 10,000 or less, It is particularly preferably 3500 or more and 8000 or less, and most preferably 4000 or more and 8000 or less.
 当該貼付材においては、カンチレバー法による剛軟度(mm)と見かけ密度(g/cm)との積が25以上であることが好ましい。発明者らは、貼付材においては、前記剛軟度と見かけ密度との積の値も、その貼付材を皮膚に貼付した際の皮膚の伸び及び縮み抑制効果、特に縮み抑制効果と深い関連があることを見出した。すなわち、前記剛軟度と見かけ密度の積が大きいほど皮膚の縮み抑制効果が高く、この積の値が小さいほど皮膚の縮み抑制効果が低くなる。この積の値が25以上である本発明の貼付材は、皮膚の縮みを十分に抑制でき、創傷の治癒、傷跡の治療を促進し、瘢痕やケロイドの形成を効果的に抑制することができる。しかし、この値が大き過ぎると、皮膚の縮み抑制効果は得られるものの、貼付材の皮膚への追従性が低下したり、貼付材を皮膚に貼付した状態では通常の動作が行い難くなるおそれがある。そのため、当該貼付材において、前記剛軟度と見かけ密度の積は25以上100以下であることが好ましく、25以上70以下であることがより好ましく、25以上50以下であることがさらに好ましく、30以上50以下であることが特に好ましい。なお、ここで、貼付材の見かけ密度(g/cm)とは、坪量(g/m)を厚さ(μm)で除した値である。 In the patch, the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is preferably 25 or more. In the patch, the value of the product of the bending resistance and the apparent density is also closely related to the effect of suppressing the elongation and contraction of the skin when the patch is applied to the skin, particularly the contraction suppressing effect. I found out. That is, the greater the product of the bending resistance and the apparent density, the higher the skin shrinkage suppressing effect, and the smaller the product value, the lower the skin shrinkage suppressing effect. The patch of the present invention having a product value of 25 or more can sufficiently suppress the shrinkage of the skin, promote the healing of wounds and the treatment of scars, and can effectively suppress the formation of scars and keloids. . However, if this value is too large, the effect of suppressing skin shrinkage can be obtained, but the followability of the patch to the skin may be reduced, or normal operation may be difficult to perform when the patch is applied to the skin. is there. Therefore, in the patch, the product of the bending resistance and the apparent density is preferably 25 or more and 100 or less, more preferably 25 or more and 70 or less, and further preferably 25 or more and 50 or less, 30 It is especially preferable that it is 50 or more. Here, the apparent density (g / cm 3 ) of the patch is a value obtained by dividing the basis weight (g / m 2 ) by the thickness (μm).
 当該貼付材においては、透湿度が700(g/m・24h)以上であることが好ましい。当該貼付材は、透湿度が700(g/m・24h)以上であることで、皮膚に貼付した際の蒸れが少ないため、長時間の貼付が可能となる。当該貼付材の透湿度は、900(g/m・24h)以上であることがより好ましく、1000(g/m・24h)以上であることがさらに好ましく、1500(g/m・24h)以上であることが特に好ましい。透湿度は高いほど好ましく、好ましい透湿度の上限は特にないが、通常30000(g/m・24h)以下である。なお、本発明において透湿度の測定は、JIS Z0208のB条件に従って、温度40℃、相対湿度90%で測定した。すなわち、貼付材の片面側を温度40℃、相対湿度90%に調節し、他面側には塩化カルシウム等の吸湿剤を置いて貼付材を通過した水分を吸収させ、吸湿剤の重量変化量を24時間、1m当たりに換算して算出した。 In the patch, the moisture permeability is preferably 700 (g / m 2 · 24 h) or more. Since the adhesive material has a water vapor transmission rate of 700 (g / m 2 · 24 h) or more, it can be applied for a long time because it has less stuffiness when applied to the skin. The moisture permeability of the patch is more preferably 900 (g / m 2 · 24 h) or more, further preferably 1000 (g / m 2 · 24 h) or more, and 1500 (g / m 2 · 24 h). ) Or more is particularly preferable. The higher the moisture permeability, the better. The upper limit of the preferable moisture permeability is not particularly limited, but is usually 30000 (g / m 2 · 24 h) or less. In the present invention, the moisture permeability was measured at a temperature of 40 ° C. and a relative humidity of 90% according to the B condition of JIS Z0208. That is, one side of the patch is adjusted to a temperature of 40 ° C. and a relative humidity of 90%, and a moisture absorbent such as calcium chloride is placed on the other side to absorb the moisture that has passed through the patch, and the weight change of the moisture absorbent Was calculated by converting per 1 m 2 for 24 hours.
 当該貼付材においては、その長手方向又は短手方向の少なくとも一方の応力緩和時間が10(s)以上であることが好ましい。当該貼付材は、応力緩和時間が10(s)以上であることで、貼付材が外力等により伸びた場合にも、伸び切ってしまうことなく、元の状態に戻ることができるため、外傷、手術後の創部等について創傷の治癒、傷跡の治療を促進し、瘢痕やケロイドの形成を効果的に予防することができる。当該貼付材の応力緩和時間は、30(s)以上であることがより好ましく、70(s)以上であることがさらに好ましく、100(s)以上であることが特に好ましい。応力緩和時間は高い数値であるほど好ましいが、通常1000(s)以下である。また、当該貼付材は、長手方向又は短手方向の少なくとも一方が前記条件を満たしていればよいが、貼付材が外力等により伸びた場合にも、伸び切ってしまうことなく、元の状態に戻ることができるためには、長手方向及び短手方向の両方が前記条件を満たすことが好ましい。本発明において、応力緩和時間の測定は、各貼付材の短手(CD)方向、長手(MD)方向それぞれについて、幅25mm、長さ80mmの短冊を用い、チャック間が50mmになるように両端にニチバン株式会社製カートンテープNo.660を貼付して前記引張荷重の測定と同様の方法にて行った。25Nまで300mm/minの速度で引っ張った後、荷重が25Nになった時点で180秒間停止させ、荷重が20Nまで低下した時間(秒)を応力緩和時間とした。 In the patch, it is preferable that the stress relaxation time of at least one of the longitudinal direction and the short direction is 10 (s) or more. Since the patch material has a stress relaxation time of 10 (s) or longer, even when the patch material is stretched by an external force or the like, it can return to its original state without being stretched. It can promote wound healing and scar treatment for wounds and the like after surgery, and can effectively prevent the formation of scars and keloids. The stress relaxation time of the patch is more preferably 30 (s) or more, further preferably 70 (s) or more, and particularly preferably 100 (s) or more. The stress relaxation time is preferably as high as possible, but is usually 1000 (s) or less. In addition, the adhesive material only needs to satisfy the above condition in at least one of the longitudinal direction and the lateral direction, but even when the adhesive material is extended by an external force or the like, the original material is not stretched. In order to be able to return, it is preferable that both the longitudinal direction and the lateral direction satisfy the above conditions. In the present invention, the stress relaxation time is measured by using a strip with a width of 25 mm and a length of 80 mm in each of the short side (CD) direction and the long side (MD) direction of each adhesive material, so that the gap between the chucks is 50 mm. Nichiban Co., Ltd. Carton Tape No. 660 was attached, and the same method as the measurement of the tensile load was performed. After pulling at a speed of 300 mm / min up to 25 N, the load was stopped for 180 seconds when the load became 25 N, and the time (second) when the load decreased to 20 N was defined as the stress relaxation time.
 当該貼付材は、10%引張荷重と、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が、前記規定の範囲内であることで、皮膚の伸びを抑制すると共に、縮みをも抑制することができる。すなわち、10%引張荷重の大きさが主に皮膚の伸びの抑制に寄与するのに対し、剛軟度(mm)と坪量(g/m)との積が主に皮膚の縮みの抑制に寄与し、これらの値が所定の数値以上か、好ましくは所定の範囲内である場合に上記所望の作用効果を発揮するという発見に基づくものである。これにより、外傷や手術により傷を負った皮膚が、外力や瘢痕組織の伸縮等の力学的作用によって変形することを効果的に防ぐことができるので、創傷の治癒用、傷跡の治療用、瘢痕・ケロイド形成予防用として有効である。また、当該貼付材は皮膚への追従性にも優れている。また、カンチレバー法による剛軟度(mm)と見かけ密度(g/cm)の積を25以上とすることで、皮膚の縮みを抑制する効果をさらに向上させることができる。また、当該貼付材は透湿性にも優れるため、皮膚に貼付した際に蒸れを起こしにくく、長時間の貼付が可能となる。 The patch has a 10% tensile load, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is within the specified range, thereby suppressing skin elongation. At the same time, shrinkage can be suppressed. That is, the magnitude of 10% tensile load mainly contributes to the suppression of skin elongation, whereas the product of bending resistance (mm) and basis weight (g / m 2 ) mainly suppresses skin shrinkage. This is based on the discovery that these desired effects are exhibited when these values are equal to or greater than a predetermined numerical value, preferably within a predetermined range. As a result, it is possible to effectively prevent the skin damaged by trauma or surgery from being deformed by mechanical action such as external force or scar tissue expansion / contraction. -Effective for preventing keloid formation. In addition, the patch is excellent in followability to the skin. Moreover, the effect of suppressing the shrinkage of the skin can be further improved by setting the product of the bending resistance (mm) and the apparent density (g / cm 3 ) by the cantilever method to 25 or more. In addition, since the patch is excellent in moisture permeability, it is difficult to cause stuffiness when it is applied to the skin, and it can be applied for a long time.
 当該貼付材の厚みは、特に限定されないが、取り扱い易さの観点から6μm以上6mm以下であり、50μm以上2mm以下であることが好ましく、60μm以上1mm以下であることがより好ましく、80μm以上0.5mm以下であることがさらに好ましい。 The thickness of the patch is not particularly limited, but is 6 μm or more and 6 mm or less, preferably 50 μm or more and 2 mm or less, more preferably 60 μm or more and 1 mm or less, and more preferably 80 μm or more and 0. More preferably, it is 5 mm or less.
 当該貼付材の形態は、前記支持体と粘着層とを備えていれば特に限定されないが、例えば長方形、正方形、ひし形などの四角形や、多角形、これらの形状を適宜組み合わせたシート状の形態、特定の方向に連続的に形成したテープ状、ロール状の形態等、目的に合わせて自由な形態とすることができる。周囲に角部を有する貼付材においては、周囲の角部に適宜Rを設けてもよい。また、貼付する部位に合わせて立体的に形成したり、切り込みやスリット等を設けてもよい。これらの当該貼付材のサイズも、目的に合わせて自由に選択することができるが、瘢痕・ケロイド形成予防等のために、皮膚に負った傷に貼付する場合には、その傷を十分カバーできるサイズである必要がある。 The form of the patch is not particularly limited as long as it includes the support and the adhesive layer.For example, a rectangle, a square, a quadrangle such as a rhombus, a polygon, a sheet-like form appropriately combining these shapes, It can be made into a free form according to the purpose, such as a tape form or a roll form continuously formed in a specific direction. In a patch having corners around, R may be appropriately provided at the corners around. Moreover, you may form in three dimensions according to the site | part to stick, or may provide a notch | incision, a slit, etc. The size of these patch materials can also be freely selected according to the purpose, but when applying to wounds on the skin to prevent scarring and keloid formation, the wounds can be covered sufficiently. Must be size.
 当該貼付材を瘢痕・ケロイド予防等、皮膚に負った傷に貼付する等、医療的な目的で用いる場合には、細菌感染、ウイルス感染等を防ぐために、滅菌処理を施されていることが好ましい。前記滅菌処理の方法としては、一般に貼付材に広く用いられている方法を用いることができ、例えばγ線滅菌法、電子線滅菌法、高圧蒸気滅菌法、エチレンオキサイドガス滅菌法等が使用される。 When the patch is used for medical purposes, such as to prevent scars and keloids, and to be applied to wounds on the skin, it is preferably sterilized to prevent bacterial infection, viral infection, etc. . As the sterilization method, a method generally used for a patch can be used. For example, a γ-ray sterilization method, an electron beam sterilization method, a high-pressure steam sterilization method, an ethylene oxide gas sterilization method, or the like is used. .
 以下に、当該貼付材を構成する支持体、粘着剤層、剥離体、担持体、その他の層について詳述する。 Hereinafter, the support, the pressure-sensitive adhesive layer, the release body, the carrier, and other layers constituting the patch will be described in detail.
[支持体]
 本発明の貼付材の支持体(以下、「当該支持体」ともいう)としては、貼付材とした際に長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上となり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積を3000以上とすることができるものであれば特に限定されないが、例えば以下のような素材からなるものが挙げられる。
[Support]
As the support of the patch of the present invention (hereinafter also referred to as “the support”), when it is used as a patch, the 10% tensile load in at least one of the longitudinal direction and the short direction is 18 N / 25 mm or more, and the cantilever Although it will not specifically limit if the product of the bending resistance (mm) by a method and basic weight (g / m < 2 >) can be 3000 or more, For example, what consists of the following materials is mentioned.
 当該支持体の素材としては、
 ポリエチレンテレフタレート(PET)、ポリブチレンテレフタレート等のポリエステル;
 ナイロン(ナイロン6、ナイロン66)等のポリアミド;
 ポリプロピレン、ポリエチレン、低密度ポリエチレン(Low Density Polyethylene;LDPE)、高密度ポリエチレン(High Density Polyethylene;HDPE)等のポリオレフィン;
 エチレン・酢酸ビニル共重合体(EVA)、エチレン・エチルアクリレート共重合体(EEA)、エチレン・メチルアクリレート共重合体(EMA)、エチレン・メチルメタクリレート共重合体(EMMA)、エチレン・アクリル酸共重合体(EAA)等のオレフィン系共重合体;
 ポリビニルアルコール(PVA);
 ポリ塩化ビニル、ポリ塩化ビニリデン等のポリ塩化物;
 木材等を原料としたパルプ類;
 シリコーン類;
 ポリウレタン等、又はそれらの複合素材から選択することができる。また、単独では透湿性が低い素材については、炭酸カルシウム等を含ませて多孔質としたり、穿孔等をして加工して用いることもできる。
As a material of the support,
Polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate;
Polyamides such as nylon (nylon 6, nylon 66);
Polyolefins such as polypropylene, polyethylene, low density polyethylene (LDPE), and high density polyethylene (HDPE);
Ethylene / vinyl acetate copolymer (EVA), ethylene / ethyl acrylate copolymer (EEA), ethylene / methyl acrylate copolymer (EMA), ethylene / methyl methacrylate copolymer (EMMA), ethylene / acrylic acid copolymer Olefin copolymers such as coalescence (EAA);
Polyvinyl alcohol (PVA);
Polychlorides such as polyvinyl chloride and polyvinylidene chloride;
Pulp made from wood, etc .;
Silicones;
It can be selected from polyurethane and the like, or composite materials thereof. In addition, a material having low moisture permeability by itself can be made porous by containing calcium carbonate or the like, or can be processed by drilling.
 当該支持体の素材としては、これらのうち、ポリエステル、ポリアミド、ポリオレフェン、ポリウレタンが好ましく、中でもポリエチレンテレフタレート(PET)、ナイロン、ポリエチレン、パルプがより好ましく、ポリエチレンテレフタレート(PET)、ナイロン、低密度ポリエチレン(LDPE)がさらに好ましい。また、複合素材としては、ポリエチレンテレフタレート(PET)とパルプの複合素材が好ましい。 Of these, polyester, polyamide, polyolefin, and polyurethane are preferable as the material for the support. Among these, polyethylene terephthalate (PET), nylon, polyethylene, and pulp are more preferable. Polyethylene terephthalate (PET), nylon, low-density polyethylene ( LDPE) is more preferred. The composite material is preferably a composite material of polyethylene terephthalate (PET) and pulp.
 また、当該支持体は、前記素材からなる織布であってもよいし、不織布、編布、フィルム、発泡体等であってもよい。これらのうち、当該貼付材が十分な透湿性を備えるという観点から織布及び不織布が好ましい。 Further, the support may be a woven fabric made of the above-mentioned material, or may be a non-woven fabric, a knitted fabric, a film, a foam or the like. Among these, a woven fabric and a non-woven fabric are preferable from the viewpoint that the patch has sufficient moisture permeability.
 また、当該支持体は、前記素材からなる織布、不織布、編布、フィルム、発泡体等が、さらに加工されていてもよい。例えば、ポリウレタン樹脂、アクリル樹脂等でコーティングされていてもよく、ポリウレタンフィルム等でラミネートされていてもよい。コーティング又はラミネートする等、支持体と粘着剤層の間に、柔軟性のある層を設けることで、皮膚の微細な動きを妨げず、物理刺激を低減することができる。さらに、貼付材が外力等により伸びた場合にも、伸びきってしまうことなく、元の状態に戻ることができたり、貼付時の水などの浸入を防ぐことができる。 In addition, the support may be further processed from a woven fabric, a nonwoven fabric, a knitted fabric, a film, a foam, or the like made of the above material. For example, it may be coated with a polyurethane resin, an acrylic resin or the like, or may be laminated with a polyurethane film or the like. By providing a flexible layer between the support and the pressure-sensitive adhesive layer, such as coating or laminating, it is possible to reduce physical irritation without preventing fine skin movement. Furthermore, even when the patch is stretched by an external force or the like, it can return to its original state without being fully stretched, and can prevent intrusion of water or the like during sticking.
 当該支持体としては、ポリウレタンコーティングを施したPET織布、アクリルコーティングを施したPET織布、ポリウレタンフィルムでラミネートしたPET織布、エーテル系ポリウレタンフィルムでラミネートしたPET織布、PETとパルプの複合素材からなる不織布、LDPEフィルム、アクリルコーティングを施したナイロン織布、ポリウレタン発泡体が好ましい支持体として挙げられる。 The support includes: PET woven fabric with polyurethane coating, PET woven fabric with acrylic coating, PET woven fabric laminated with polyurethane film, PET woven fabric laminated with ether polyurethane film, and composite material of PET and pulp Nonwoven fabrics made of, LDPE film, nylon woven fabric with acrylic coating, and polyurethane foam are preferred supports.
 当該貼付材が有する特性は、当該支持体が備える物理的な特性に依存する部分が大きい。特に、皮膚の伸縮を抑制する効果を十分に奏するためには、当該支持体の長手方向又は短手方向の少なくとも一方の10%引張荷重も、18N/25mm以上であることが好ましい。長手方向と短手方向の組成や特性が異なる支持体を用いることで、長手方向と短手方向の強度の異なる支持体とすることができる。当該支持体は、このような物理的な強度を備えていることにより、得られる貼付材の物理的強度も向上し、外力や瘢痕組織の伸縮等によって変形し難く、皮膚の伸びを効果的に抑制することができる。なお、前記引張荷重は、18N/25mm以上500N/25mm以下であることが好ましく、18N/25mm以上300N/25mm以下であることがより好ましく、20N/25mm以上200N/25mm以下であることが更に好ましく、25N/25mm以上150N/25mm以下が特に好ましく、30N/25mm以上150N/25mm以下が最も好ましい。当該貼付材は、当該支持体の前記引張荷重が18N/25mm未満であると、外力等により変形し易くなり、皮膚の伸びの抑制効果が不十分となるおそれがある。また、前記引張荷重が500N/25mmを超えると、皮膚の伸びは抑制できるものの、当該貼付材を貼付した状態では通常の動作が行い難くなるおそれがある。また、当該支持体は、皮膚への外力を十分に減じ、皮膚の伸びを効果的に抑制するためには、長手方向及び短手方向の両方が前記条件を満たすことが好ましい。 The characteristics of the adhesive material largely depend on the physical characteristics of the support. In particular, in order to sufficiently exhibit the effect of suppressing the expansion and contraction of the skin, the 10% tensile load in at least one of the longitudinal direction and the short direction of the support is also preferably 18 N / 25 mm or more. By using a support having different compositions and characteristics in the longitudinal direction and the short direction, a support having different strengths in the longitudinal direction and the short direction can be obtained. Since the support has such physical strength, the physical strength of the obtained patch is also improved, and it is difficult to deform due to external force or the expansion and contraction of the scar tissue, effectively extending the skin. Can be suppressed. The tensile load is preferably 18 N / 25 mm or more and 500 N / 25 mm or less, more preferably 18 N / 25 mm or more and 300 N / 25 mm or less, and further preferably 20 N / 25 mm or more and 200 N / 25 mm or less. 25 N / 25 mm to 150 N / 25 mm is particularly preferable, and 30 N / 25 mm to 150 N / 25 mm is most preferable. If the tensile load of the support is less than 18 N / 25 mm, the patch is likely to be deformed by an external force or the like, and the effect of suppressing skin elongation may be insufficient. Further, when the tensile load exceeds 500 N / 25 mm, the elongation of the skin can be suppressed, but normal operation may be difficult to perform in a state where the patch is applied. Moreover, in order that the said support body fully reduces the external force to skin and suppresses the elongation of skin effectively, it is preferable that both the longitudinal direction and the transversal direction satisfy | fill the said conditions.
 当該支持体の破断強度は、18N/25mm以上であることが好ましく、50N/25mm以上であることがより好ましく、100N/25mm以上であることがさらに好ましい。 The breaking strength of the support is preferably 18 N / 25 mm or more, more preferably 50 N / 25 mm or more, and further preferably 100 N / 25 mm or more.
 当該支持体には、必要に応じて通常使用される添加剤を添加してもよい。前記添加剤としては、例えば紫外線吸収剤、老化防止剤、充填剤、顔料、着色剤、難燃剤、帯電防止剤等が挙げられる。これらの添加剤は、1種で、又は複数を組み合わせて用いてもよく、これら添加剤の含有量は、添加剤の種類によって最適な範囲を選定すればよいが、支持体層中において、通常0.001~30質量%、好ましくは0.01~25質量%、より好ましくは0.1~20質量%の範囲とすることが多い。当該支持体は、支持体層に紫外線吸収剤を添加したり、紫外線吸収剤を支持体層にコーティングするなど、紫外線の創傷部への照射を遮断することが創傷の治癒、傷跡の治療、瘢痕・ケロイド等の予防の観点から好ましい。 In the support, additives that are usually used may be added as necessary. Examples of the additive include an ultraviolet absorber, an anti-aging agent, a filler, a pigment, a colorant, a flame retardant, and an antistatic agent. These additives may be used alone or in combination, and the content of these additives may be selected in an optimum range depending on the type of the additive. In many cases, the amount is in the range of 0.001 to 30% by mass, preferably 0.01 to 25% by mass, more preferably 0.1 to 20% by mass. In the support, UV irradiation to the wound part is blocked by adding an ultraviolet absorber to the support layer or coating the ultraviolet ray absorber on the support layer, so that wound healing, scar treatment, scarring, etc. -It is preferable from the viewpoint of prevention of keloids and the like.
 当該支持体の厚みとしては、本発明の貼付材が皮膚の伸縮抑制効果を十分に奏すると共に、取り扱い性を高める観点から、5μm以上5mm以下であり、20μm以上3mm以下が好ましく、40μm以上1mm以下がより好ましく、50μm以上0.5mm以下がさらに好ましく、60μm以上0.15mm以下が特に好ましい。当該支持体の厚みが5μm未満であると、支持体の強度が不十分となり使用時に摩擦等により破れるおそれがある。また、取り扱い性も低減する可能性がある。一方、厚みが5mmを超えると嵩高になり皮膚に貼付した際に違和感が生じ、特に皮膚の曲面部位への追従性が悪くなったり、貼付材が覆っている衣類と接触しやすくなるため皮膚から剥がれやすくなる等のおそれがある。 The thickness of the support is 5 μm or more and 5 mm or less, preferably 20 μm or more and 3 mm or less, and preferably 40 μm or more and 1 mm or less from the viewpoint that the patch of the present invention sufficiently exhibits the effect of suppressing the stretching of the skin and improves the handleability. Is more preferably 50 μm or more and 0.5 mm or less, and particularly preferably 60 μm or more and 0.15 mm or less. If the thickness of the support is less than 5 μm, the strength of the support is insufficient, and the support may be broken due to friction or the like during use. In addition, handleability may be reduced. On the other hand, if the thickness exceeds 5 mm, it becomes bulky and uncomfortable when it is applied to the skin. In particular, the ability to follow the curved surface of the skin is poor, and it is easy to come into contact with the clothing covered by the adhesive material. There is a risk of peeling off easily.
 当該支持体は、貼付中に支持体の上から薬剤を含有した軟膏、クリーム剤、ゲル剤などを塗付するために、微小孔を設けることができる。例えばステロイド剤を含有した軟膏を、支持体の上から塗付することで、貼付材を剥離することなく、創傷部の炎症、かゆみを抑制することができる。微小孔の大きさは、軟膏、クリーム剤、ゲル剤が創傷部に浸透するような大きさであれば、特には限定されないが、0.01~30mmが好ましい。 The support can be provided with micropores in order to apply an ointment, cream, gel or the like containing a drug from the top of the support during application. For example, by applying an ointment containing a steroid agent from above the support, inflammation and itching of the wound can be suppressed without peeling off the patch. The size of the micropores is not particularly limited as long as the ointment, cream or gel penetrates into the wound part, but is preferably 0.01 to 30 mm 2 .
[粘着剤層]
 本発明の貼付材の粘着剤層(以下、「当該粘着剤層」ともいう)は、前記支持体の片面に設けられている。当該粘着剤層は、本発明の貼付材を皮膚に取り外し可能に固定する役割を果たす。当該粘着剤層は、少なくとも1種の粘着剤を含む。また、必要に応じて、軟化剤、粘着付与剤、pH調整剤、薬効成分、充填剤、酸化防止剤(抗酸化剤、防腐剤)、着色料、香料等の任意成分を含んでいてもよい。以下に、当該粘着剤層が含む粘着剤、前記任意成分について詳述する。
[Adhesive layer]
The pressure-sensitive adhesive layer of the patch of the present invention (hereinafter also referred to as “the pressure-sensitive adhesive layer”) is provided on one side of the support. The pressure-sensitive adhesive layer serves to removably fix the patch of the present invention to the skin. The pressure-sensitive adhesive layer contains at least one pressure-sensitive adhesive. Moreover, it may contain optional components such as a softener, a tackifier, a pH adjuster, a medicinal component, a filler, an antioxidant (antioxidant, antiseptic), a colorant, and a fragrance as necessary. . Below, the adhesive which the said adhesive layer contains and the said arbitrary component are explained in full detail.
 当該粘着剤層が含む粘着剤の種類は特に限定されないが、例えば、ウレタン系粘着剤、アクリル系粘着剤、ゴム系粘着剤、シリコーン系粘着剤等が挙げられる。 The type of pressure-sensitive adhesive contained in the pressure-sensitive adhesive layer is not particularly limited, and examples thereof include a urethane-based pressure-sensitive adhesive, an acrylic pressure-sensitive adhesive, a rubber-based pressure-sensitive adhesive, and a silicone-based pressure-sensitive adhesive.
 ウレタン系粘着剤としては、ポリオールとポリイソシアネート化合物を反応させて得られるウレタン樹脂からなるものが挙げられる。ポリオールとしては、例えば、ポリエーテルポリオール、ポリエステルポリオール、ポリカーボネートポリオール、ポリカプロラクトンポリオール等が挙げられる。ポリイソシアネート化合物としては、例えば、ジフェニルメタンジイソシアネート、トリレンジイソシアネート、ヘキサメチレンジイソシアネート等が挙げられる。 Examples of the urethane-based pressure-sensitive adhesive include those made of a urethane resin obtained by reacting a polyol and a polyisocyanate compound. Examples of the polyol include polyether polyol, polyester polyol, polycarbonate polyol, polycaprolactone polyol, and the like. Examples of the polyisocyanate compound include diphenylmethane diisocyanate, tolylene diisocyanate, hexamethylene diisocyanate, and the like.
 前記反応に用いるポリオールとポリイソシアネート化合物とのNCO/OHモル比は、反応におけるゲル化が抑えられ、粘着力が上昇するよう、0.7/1.00~1.00/1.00とすることが好ましい。 The NCO / OH molar ratio between the polyol and the polyisocyanate compound used in the reaction is 0.7 / 1.00 to 1.00 / 1.00 so that gelation in the reaction is suppressed and the adhesive strength is increased. It is preferable.
 ウレタン系粘着剤の製造は、例えば、溶融状態で反応させるバルク重合(固形反応)法、溶液重合法等の通常の方法を用いることができる。溶液重合法にて用いる溶剤としては、具体的には、メチルエチルケトン、メチルイソブチルケトン、シクロヘキサノン等のケトン系溶剤、酢酸エチル、酢酸ブチル等のエステル系溶剤、ジオキサン、テトラヒドロフラン等のエーテル系溶剤、セロソルブ、カルビトール等のグリコールエーテル系溶剤、セロソルブアセテート等の酢酸グリコールエーテル系溶剤、ジメチルアセトアミド、ジメチルホルムアミド等のアミド系溶剤、トルエン、キシレン等の芳香族炭化水素系溶剤、メタノール、エタノール、イソプロパノール等のアルコール系溶剤等、さらにこれらの混合溶剤が挙げられる。 For the production of the urethane pressure-sensitive adhesive, for example, a usual method such as a bulk polymerization (solid reaction) method in which the reaction is performed in a molten state, a solution polymerization method, or the like can be used. Specific examples of the solvent used in the solution polymerization method include ketone solvents such as methyl ethyl ketone, methyl isobutyl ketone, and cyclohexanone, ester solvents such as ethyl acetate and butyl acetate, ether solvents such as dioxane and tetrahydrofuran, cellosolve, Glycol ether solvents such as carbitol, glycol ether solvents such as cellosolve acetate, amide solvents such as dimethylacetamide and dimethylformamide, aromatic hydrocarbon solvents such as toluene and xylene, alcohols such as methanol, ethanol and isopropanol These solvents are further included such as system solvents.
 ウレタン系粘着剤を製造する際には、必要に応じて触媒及び添加剤等を用いることができる。触媒としては、トリエチルアミン、トリエチレンジアミン等の含窒素化合物、ジブチル錫ジラウレート、オクチル酸錫、ステアリン酸錫等の有機金属化合物等の一般的なウレタン化触媒が挙げられる。添加剤としては、例えば、置換ベンゾトリアゾール類等の紫外線吸収剤、フェノール誘導体等の酸化防止剤、及び加水分解防止剤等が挙げられる。 When producing a urethane-based pressure-sensitive adhesive, a catalyst, an additive, and the like can be used as necessary. Examples of the catalyst include general urethanization catalysts such as nitrogen-containing compounds such as triethylamine and triethylenediamine, and organometallic compounds such as dibutyltin dilaurate, tin octylate and tin stearate. Examples of the additive include ultraviolet absorbers such as substituted benzotriazoles, antioxidants such as phenol derivatives, and hydrolysis inhibitors.
 ウレタン系粘着剤の凝集力をアップし、糊残り等の問題を回避するために、前記ウレタン系粘着剤の製造に鎖延長剤を使用することができる。さらに、ウレタン系粘着剤は、ポリイソシアネート硬化剤を併用し、粘着特性を変化させることが可能である。ポリイソシアネート硬化剤の併用による凝集力のアップは、糊残り等の不具合の改善に有効である。硬化剤として用いられるポリイソシアネートとしては、前記反応に用いたポリイソシアネートも使用することができるが、これらと2官能以上のポリオールの反応で得られるイソシアネートのポリオールアダクトが好ましく、また、ポリメリックポリイソシアネート、イソシアヌレート変性体、カルボジイミド変性体も好ましい。具体的には、日本ポリウレタン工業製のコロネートL、コロネートHL、コロネート3041、コロネート2030、コロネート2031、コロネートHX、ミリオネートMTL、ミリオネートMR等が挙げられる。 In order to increase the cohesive strength of the urethane adhesive and avoid problems such as adhesive residue, a chain extender can be used in the production of the urethane adhesive. Furthermore, the urethane-based adhesive can be used in combination with a polyisocyanate curing agent to change the adhesive properties. Increasing the cohesive strength by the combined use of a polyisocyanate curing agent is effective in improving problems such as adhesive residue. As the polyisocyanate used as the curing agent, the polyisocyanate used in the above reaction can also be used, but a polyol adduct of isocyanate obtained by reaction of these with a bifunctional or higher polyol is preferable, and polymeric polyisocyanate, Isocyanurate modified products and carbodiimide modified products are also preferable. Specific examples include Coronate L, Coronate HL, Coronate 3041, Coronate 2030, Coronate 2031, Coronate HX, Millionate MTL, Millionate MR, and the like manufactured by Nippon Polyurethane Industry.
 ウレタン系粘着剤は安全性が高く、医療用高分子材料として実用されている。透湿度が高く皮膚に対して密着性がよく、柔軟で馴染みが良く、低刺激性の粘着剤となる。従って、人体に貼付する用途に適しており、医療用貼付材用の粘着剤として好適である。また、粘着性、安全性、材料としての安定性、経済性等全てを充足する。 Urethane adhesives are highly safe and are practically used as medical polymer materials. High moisture permeability, good adhesion to the skin, flexible, familiar, and low-irritant adhesive. Therefore, it is suitable for an application to be applied to a human body, and is suitable as an adhesive for a medical patch. Moreover, all of adhesiveness, safety, stability as a material, economy, etc. are satisfied.
 アクリル系粘着剤としては、例えば、ブチルアクリレート、イソノニルアクリレート、2-エチルヘキシルアクリレート、2-ヒドロキシエチルアクリレート、イソオクチルアクリレート、n-オクチルアクリレート等の炭素数4~12のアルキル基を有するアクリル酸エステルまたはメタアクリル酸エステルの単独重合体;これらの(メタ)アクリル酸エステルを主成分とし、他のモノマーとして(メタ)アクリル酸、酢酸ビニル、ビニルピロリドン、アクリルアミド、ヒドロキシエチルアクリレート、ヒドロキシプロピルアクリレート等の共重合可能な他のモノマーの1種以上と共重合してなる共重合体等が挙げられる。他のモノマーは、通常2~50質量%の範囲で用いられる。 Examples of the acrylic pressure-sensitive adhesive include acrylic acid esters having an alkyl group having 4 to 12 carbon atoms, such as butyl acrylate, isononyl acrylate, 2-ethylhexyl acrylate, 2-hydroxyethyl acrylate, isooctyl acrylate, n-octyl acrylate, and the like. Or homopolymers of methacrylic acid esters; these (meth) acrylic acid esters as the main component, and other monomers such as (meth) acrylic acid, vinyl acetate, vinylpyrrolidone, acrylamide, hydroxyethyl acrylate, hydroxypropyl acrylate, etc. Examples thereof include a copolymer obtained by copolymerizing with one or more other copolymerizable monomers. Other monomers are usually used in the range of 2 to 50% by mass.
 アクリル系粘着剤は、トルエン、ヘキサン、酢酸エチル等の有機溶剤中で、過酸化ベンゾイル等の過酸化物等を開始剤として使用し、モノマーを窒素雰囲気下で重合することにより得ることができる。この方法により得られるアクリル系粘着剤は、溶剤型アクリル系粘着剤と呼ばれている。また、モノマーを水中で乳化剤にて乳化分散後、重合して得られるエマルジョン型アクリル系粘着剤も使用することができる。 The acrylic pressure-sensitive adhesive can be obtained by polymerizing a monomer in a nitrogen atmosphere using a peroxide such as benzoyl peroxide as an initiator in an organic solvent such as toluene, hexane, or ethyl acetate. The acrylic pressure-sensitive adhesive obtained by this method is called a solvent-type acrylic pressure-sensitive adhesive. An emulsion acrylic pressure-sensitive adhesive obtained by emulsifying and dispersing the monomer in water with an emulsifier and then polymerizing can also be used.
 アクリル系粘着剤を架橋するには、重合後、アクリル系粘着剤を多価イソシアネート系架橋剤、多価エポキシ樹脂系架橋剤、多価金属系架橋剤等の架橋剤を用いて架橋する。具体的には、例えばTetrad-X(三菱ガス化学社製)、ナーセム(日本化学産業社製)、コロネートHL、コロネートL、コロネートEH(日本ポリウレタン工業株式会社製)等が用いられる。これらの架橋剤は、通常、粘着剤組成物を調製する際に、その中に添加する。 In order to crosslink the acrylic pressure-sensitive adhesive, after polymerization, the acrylic pressure-sensitive adhesive is cross-linked using a cross-linking agent such as a polyvalent isocyanate-based cross-linking agent, a polyvalent epoxy resin-based cross-linking agent, or a polyvalent metal-based cross-linking agent. Specifically, for example, Tetrad-X (manufactured by Mitsubishi Gas Chemical Co., Inc.), nursem (manufactured by Nippon Chemical Industry Co., Ltd.), coronate HL, coronate L, coronate EH (manufactured by Nippon Polyurethane Industry Co., Ltd.) and the like are used. These crosslinking agents are usually added to the pressure-sensitive adhesive composition when it is prepared.
 アクリル系粘着剤を架橋して凝集性を付与することにより、皮膚表面に対する適度な粘着力を保持しつつ、皮膚からの剥離の際にも糊残りがない構成とすることができる。架橋剤は、アクリル系粘着剤(アクリル系重合体成分)100質量部に対して、通常0.01~5質量部、好ましくは0.05~2質量部の範囲で用いられる。すなわち、架橋剤の使用量は、前記の範囲内から、粘着特性、凝集性、薬効成分のブリード性等を考慮して適宜選ばれる。アクリル系粘着剤には、必要に応じて、軟化剤のような液状成分を配合することもできる。また、粘着剤を発泡させたものを用いると、通気性を良好にし、クッション性を良くすることもできて、一層好ましい。粘着剤を発泡させるには、通常の方法で行うことができ、発泡剤を用いることや、水溶液や有機溶剤を加熱する際に生じる気化作用を利用する方法などが挙げられる。 By cross-linking the acrylic pressure-sensitive adhesive to impart cohesiveness, it is possible to obtain a structure in which no adhesive residue remains even when peeling from the skin while maintaining an appropriate adhesive force to the skin surface. The crosslinking agent is generally used in an amount of 0.01 to 5 parts by mass, preferably 0.05 to 2 parts by mass with respect to 100 parts by mass of the acrylic pressure-sensitive adhesive (acrylic polymer component). That is, the amount of the crosslinking agent used is appropriately selected from the above range in consideration of adhesive properties, cohesiveness, bleeding properties of medicinal components, and the like. If necessary, a liquid component such as a softening agent can be blended in the acrylic pressure-sensitive adhesive. Further, it is more preferable to use a foamed pressure-sensitive adhesive because air permeability can be improved and cushioning properties can be improved. Foaming of the pressure-sensitive adhesive can be performed by a usual method, and examples thereof include a method of using a foaming agent and a method of using a vaporizing action generated when an aqueous solution or an organic solvent is heated.
 ゴム系粘着剤としては、例えば、天然ゴム、スチレン-イソプレン-スチレンブロック共重合体、ポリイソブチレン、ポリブテン、ポリイソプレン、これらの2種以上の混合物等のゴム状弾性体に、ロジン系樹脂、テルペン系樹脂、クマロンーインデン樹脂、石油系樹脂等の粘着付与剤を添加したものを挙げることができる。ゴム系粘着剤には、必要に応じて、液状ポリブテン、液状ポリイソブチレン、鉱油等の軟化剤;酸化チタン、酸化亜鉛等の充填剤;ブチルヒドロキシトルエン等の酸化防止剤等を添加することができる。これらの中でも、粘着性の観点から、スチレン-イソプレン-スチレンブロック共重合体を主基剤としたものが好ましい。 Examples of the rubber-based adhesive include rubber-like elastic bodies such as natural rubber, styrene-isoprene-styrene block copolymer, polyisobutylene, polybutene, polyisoprene, and a mixture of two or more thereof, rosin resin, terpene And the like, to which a tackifier such as a resin, a coumarone-indene resin, or a petroleum resin is added. If necessary, the rubber-based pressure-sensitive adhesive can be added with softening agents such as liquid polybutene, liquid polyisobutylene and mineral oil; fillers such as titanium oxide and zinc oxide; antioxidants such as butylhydroxytoluene and the like. . Among these, those having a styrene-isoprene-styrene block copolymer as a main base are preferable from the viewpoint of adhesiveness.
 シリコーン系粘着剤としては、例えば、シリコーンゴムとシリコーンレジンの混合物又は部分縮合物が挙げられる。シリコーンゴムとしては、両末端にシラノール基のようなケイ素官能基を有する高分子量の直鎖状ポリジオルガノシロキサンが挙げられ、シリコーンレジンとしては、1官能性シロキサン単位と4官能性シロキサン単位を含み、分子中にシラノール基又はメトキシ基のようなケイ素官能基を有する分岐状もしくは網状構造を有するポリオルガノシロキサンが挙げられる。より具体的には、このようなシリコーンゴムとしては、ポリジメチルシロキサンの長鎖の共重合体を、シリコーンレジンとしては、MQレジン(M単位((CH)SiO1/2)とQ単位(SiO)からなる3次元構造のシリコーンレジン)を挙げることができる。 Examples of the silicone pressure-sensitive adhesive include a mixture or partial condensate of silicone rubber and silicone resin. Examples of the silicone rubber include a high molecular weight linear polydiorganosiloxane having a silicon functional group such as a silanol group at both ends, and the silicone resin includes a monofunctional siloxane unit and a tetrafunctional siloxane unit, Examples thereof include polyorganosiloxanes having a branched or network structure having a silicon functional group such as a silanol group or a methoxy group in the molecule. More specifically, such a silicone rubber is a long-chain copolymer of polydimethylsiloxane, and the silicone resin is an MQ resin (M units ((CH 3 ) 3 SiO 1/2 ) and Q units). (Silicone resin having a three-dimensional structure made of (SiO 2 )).
 シリコーン系粘着剤を構成するシリコーンゴム/シリコーンレジンの構成比は特に限定されるものではないが、好ましくは30:70~60:40、より好ましくは35:65~45:55である(質量比)。本発明において特に好ましいシリコーンゴム/シリコーンレジンの構成比としては、40/60(w/w)(BIO-PSA4501、ダウコーニング社)、45/55(w/w)(BIO-PSA4601、ダウコーニング社)等を挙げることができる。 The composition ratio of the silicone rubber / silicone resin constituting the silicone pressure-sensitive adhesive is not particularly limited, but is preferably 30:70 to 60:40, more preferably 35:65 to 45:55 (mass ratio). ). The composition ratio of silicone rubber / silicone resin particularly preferred in the present invention is 40/60 (w / w) (BIO-PSA4501, Dow Corning), 45/55 (w / w) (BIO-PSA4601, Dow Corning) And the like.
 シリコーン系粘着剤は、分子中に存在するケイ素官能基によって、感圧接着性を有する粘着剤である。ケイ素原子に結合した有機基としては、メチル、エチル、ビニル、フェニル等各種の1価の炭化水素基が挙げられ、置換基の種類を選ぶことによって粘着性を調節することができる。シリコーン系粘着剤は、その主成分であるポリオルガノシロキサンの分子間距離が大きいので、通気性及び透湿性に富む。 A silicone-based pressure-sensitive adhesive is a pressure-sensitive adhesive having pressure-sensitive adhesive properties due to silicon functional groups present in the molecule. Examples of the organic group bonded to the silicon atom include various monovalent hydrocarbon groups such as methyl, ethyl, vinyl, and phenyl, and the adhesiveness can be adjusted by selecting the type of substituent. The silicone-based pressure-sensitive adhesive is rich in air permeability and moisture permeability because the intermolecular distance of the polyorganosiloxane that is the main component thereof is large.
 当該粘着剤層が含む粘着剤としては、それぞれの粘着剤を1種単独で用いても、2種以上を用いてもよい。また、これらの粘着剤の形態としては、粘着剤のみで用いてもよいし、例えば、水を含むヒドロゲル、有機溶媒を含むオルガノゲルの形態としたもの、親水性高分子化合物を加えた、ハイドロコロイドの形態としたハイドロコロイド粘着剤として用いてもよい。粘着剤層は、単一の粘着剤として形成しても良いし、複数の粘着剤層を積層して形成してもよい。複数の粘着剤層を積層したものである場合は、種類の異なる複数の粘着剤を積層させたり、大きさの異なる粘着剤を積層させることができる。例えば支持体よりも小さなハイドロコロイド粘着剤を絆創膏のパッドの部分のように用いることができる。 As the pressure-sensitive adhesive contained in the pressure-sensitive adhesive layer, each pressure-sensitive adhesive may be used alone or in combination of two or more. In addition, these pressure-sensitive adhesives may be used only with pressure-sensitive adhesives. For example, hydrogels containing water, organogels containing organic solvents, hydrocolloids added with hydrophilic polymer compounds It may be used as a hydrocolloid adhesive in the form. The pressure-sensitive adhesive layer may be formed as a single pressure-sensitive adhesive, or may be formed by laminating a plurality of pressure-sensitive adhesive layers. When a plurality of pressure-sensitive adhesive layers are laminated, a plurality of different types of pressure-sensitive adhesives or different sizes of pressure-sensitive adhesives can be laminated. For example, a hydrocolloid adhesive smaller than the support can be used as a part of the bandage pad.
 これらの粘着剤のうち、透湿度、低刺激性、安全性、適度な粘着性等の面から、ウレタン系粘着剤又は、発泡したアクリル系粘着剤が好ましい。 Among these pressure-sensitive adhesives, urethane pressure-sensitive adhesives or foamed acrylic pressure-sensitive adhesives are preferable from the viewpoints of moisture permeability, low irritation, safety, moderate pressure-sensitive adhesiveness, and the like.
 当該粘着剤層は、任意成分として軟化剤、粘着付与剤、pH調整剤、薬効成分、充填剤、酸化防止剤(抗酸化剤、防腐剤)、着色料、香料を含有してもよい。 The adhesive layer may contain a softener, a tackifier, a pH adjuster, a medicinal component, a filler, an antioxidant (antioxidant, preservative), a colorant, and a fragrance as optional components.
 軟化剤は粘着剤の弾性を低下させて柔軟性を付与すると共に、粘着性を向上させることができるため、必要に応じて添加するとよい。軟化剤としては、例えば、流動パラフィン、流動イソパラフィン、ナフテン油等の鉱油;オリーブ油、オリーブスクワラン等の植物油;ラノリン、タートル油、ミツロウ等の動物油;脂肪酸トリグリセライド、シリコーンオイル等の合成油等が挙げられる。 A softener can reduce the elasticity of the pressure-sensitive adhesive to give flexibility and improve the pressure-sensitive adhesiveness. Examples of the softener include mineral oils such as liquid paraffin, liquid isoparaffin, and naphthenic oil; vegetable oils such as olive oil and olive squalane; animal oils such as lanolin, turtle oil, and beeswax; and synthetic oils such as fatty acid triglyceride and silicone oil. .
 粘着付与剤は粘着剤に適度な柔軟性を付与しつつ、凝集破壊しにくくすることができるため、必要に応じて添加するとよい。粘着付与剤としては、例えば、天然ロジン誘導体、クマロン-インデン樹脂、テルペンオリゴマー、脂肪族石油樹脂、アルキル変性フェノール樹脂、ポリテルペン樹脂、ガムロジン、ロジンエステル、油性フェノール樹脂、クマロンインデン樹脂、石油系炭化水素樹脂等が挙げられる。 The tackifier can be added as needed because it can make it difficult to cohesive failure while imparting appropriate flexibility to the adhesive. Examples of tackifiers include natural rosin derivatives, coumarone-indene resins, terpene oligomers, aliphatic petroleum resins, alkyl-modified phenol resins, polyterpene resins, gum rosins, rosin esters, oily phenol resins, coumarone indene resins, petroleum carbonization. A hydrogen resin etc. are mentioned.
 pH調整剤の種類は、本発明の目的を損なわなければ特に限定されず、例えば、カラヤガム、クエン酸、リン酸、リン酸水素ナトリウム、無水リン酸水素ナトリウム、ペクチン、無水クエン酸、アルカリ金属水酸化物、有機酸の緩衝液等が挙げられる。これらのpH調整剤を用いて、粘着剤層を正常な皮膚のpHに合わせ、pH4.0~6.0の範囲に調整することができる。 The type of the pH adjuster is not particularly limited as long as the object of the present invention is not impaired. For example, karaya gum, citric acid, phosphoric acid, sodium hydrogen phosphate, anhydrous sodium hydrogen phosphate, pectin, anhydrous citric acid, alkali metal water Examples thereof include oxides and buffer solutions of organic acids. Using these pH adjusters, the pressure-sensitive adhesive layer can be adjusted to a pH range of 4.0 to 6.0 by adjusting to the pH of normal skin.
 薬効成分としては、特に限定されないが、本発明の効果を向上させるものが好ましい。例えば、抗菌剤、消炎鎮痛剤、ステロイド剤、麻酔剤、抗真菌剤、ビタミン剤等が挙げられる。これらの薬剤は、経皮吸収により全身又は局所においてその効果を発揮したり、あるいは貼付された部位において、局所的に効果を発揮する。
 本発明の好ましい実施形態において、上記薬剤としては、瘢痕、ケロイドの形成を抑制する薬剤を含有することができる。そのような薬剤には、抗アレルギー剤、ステロイド剤、TGF-βシグナル阻害剤などが含まれる。瘢痕やケロイドの発生・進行やかゆみ、痛みなどの症状にはアレルギー反応が関与していることが知られている。また、副腎皮質ステロイドには多彩な作用があるが、皮膚においては炎症を抑制する効果、組織を萎縮させる効果などがある。TGF-βは、生体の恒常性維持に非常に重要な役割を持つが、TGF-βシグナルの異常によって強皮症や皮膚硬化症、種々の線維症等の様々な疾患を引き起こすことが知られている。これらの疾患に共通する原因としては、過度のTGF-βシグナルによって、過剰な組織の線維化が誘導されるためと考えられている。
Although it does not specifically limit as a medicinal component, What improves the effect of this invention is preferable. For example, antibacterial agents, anti-inflammatory analgesics, steroid agents, anesthetic agents, antifungal agents, vitamin agents and the like can be mentioned. These drugs exert their effects systemically or locally through percutaneous absorption, or exert their effects locally at the site where they are applied.
In a preferred embodiment of the present invention, the drug may contain a drug that suppresses the formation of scars and keloids. Such drugs include antiallergic agents, steroidal agents, TGF-β signal inhibitors and the like. It is known that allergic reactions are involved in symptoms such as the development / progress of scars and keloids, itching and pain. In addition, corticosteroids have a variety of actions, but in the skin, they have an effect of suppressing inflammation and an effect of atrophying tissue. TGF-β has a very important role in maintaining the homeostasis of the living body, but it is known that abnormalities in TGF-β signal cause various diseases such as scleroderma, scleroderma and various fibrosis. ing. A common cause of these diseases is thought to be excessive tissue fibrosis induced by excessive TGF-β signal.
 当該粘着剤層の厚みは特に限定されないが、皮膚への固定性を担保し、支持体の厚みとのバランスの観点から1μm以上1mm以下であることが好ましく、10μm以上0.5mm以下であることがより好ましく、20μm以上0.1μm以下であることがさらに好ましい。なお、当該粘着剤層の乾燥時の塗工重量(粘着剤厚)は、1g/m以上1000g/m以下が好ましく、10g/m以上200g/m以下がより好ましく、20g/m以上100g/m以下がさらに好ましい。当該粘着剤層の厚みや、塗工重量が前記上限以上であると、透湿性、取り扱い性が低下するおそれがある。一方前記下限未満であると、皮膚への固定性が担保できないおそれがある。 The thickness of the pressure-sensitive adhesive layer is not particularly limited, but it is preferably 1 μm or more and 1 mm or less, preferably 10 μm or more and 0.5 mm or less from the viewpoint of ensuring the fixation to the skin and the balance with the thickness of the support. Is more preferably 20 μm or more and 0.1 μm or less. In addition, the coating weight (adhesive thickness) at the time of drying of the pressure-sensitive adhesive layer is preferably 1 g / m 2 or more and 1000 g / m 2 or less, more preferably 10 g / m 2 or more and 200 g / m 2 or less, and 20 g / m. 2 or more and 100 g / m 2 or less are more preferable. If the thickness of the pressure-sensitive adhesive layer or the coating weight is equal to or more than the upper limit, moisture permeability and handleability may be deteriorated. On the other hand, if it is less than the lower limit, there is a possibility that the fixation to the skin cannot be secured.
 こうした一面に粘着剤層を設けた貼付材の粘着力は、粘着力が強すぎることもなく、また、弱すぎることもないものであり、対ベークライト粘着力において0.3~10N/25mm程度、好ましくは2.0~6.0N/25mmにすることが好ましい。なお、前記対ベークライト粘着力は、温度23℃、50%RHの雰囲気下で、ベークライトパネルに、長さ150mm及び幅25mmに切り出して調製したテープ試験片を貼付し、2kgのゴムロールを300mm/分の速度で1往復させて圧着する。この状態で20分間放置した後、剥離角度180度及び剥離速度300mm/分の条件で剥離力を測定し、試験片の対ベークライト粘着力を求める。測定は3回行い、その平均値を貼付材の対ベークライト粘着力(単位:N/25mm)とする。 The adhesive strength of the adhesive material provided with an adhesive layer on one side is neither too strong nor too weak, and the adhesive strength against bakelite is about 0.3 to 10 N / 25 mm. Preferably, the thickness is 2.0 to 6.0 N / 25 mm. The adhesive strength to bakelite was determined by attaching a tape test piece prepared by cutting to a length of 150 mm and a width of 25 mm on a bakelite panel in an atmosphere of 23 ° C. and 50% RH, and applying a 2 kg rubber roll to 300 mm / min. The pressure is reciprocated at a speed of 1 mm. After leaving in this state for 20 minutes, the peel force is measured under the conditions of a peel angle of 180 degrees and a peel speed of 300 mm / min to determine the test piece's bakelite adhesive strength. The measurement is performed three times, and the average value is defined as the adhesive strength of the patch to the bakelite (unit: N / 25 mm).
 また、支持体に設けた粘着剤層のタック性は、強すぎることもなく、また、弱すぎることもないものであり、プローブタックにおいて0.4~10(N/5mmφ)程度、好ましくは0.6~5.0(N/5mmφ)程度にすると良い。なお、上記プローブタックは、ニチバン株式会社製プローブタックテスタ-を使用し、JIS Z 0237に参考として記載されているプローブタック試験法に基づいて測定する。この測定は3回行い、その平均値を対プローブタック(単位=N/5mmφ)とする。 The tackiness of the pressure-sensitive adhesive layer provided on the support is neither too strong nor too weak, and is about 0.4 to 10 (N / 5 mmφ) in probe tack, preferably 0. About 6 to 5.0 (N / 5mmφ) is preferable. The probe tack is measured using a probe tack tester manufactured by Nichiban Co., Ltd. based on the probe tack test method described in JIS Z 0237 as a reference. This measurement is performed three times, and the average value is taken as a probe tack (unit = N / 5 mmφ).
[剥離体]
 本発明の貼付材に用いる剥離体(以下、「当該剥離体」ともいう)は、粘着剤層を保護する目的で、当該粘着剤層における支持体が設けられた面とは反対側の面に剥離可能な状態で設けられる。当該剥離体としては、貼付材の分野で慣用の、剥離紙、剥離フィルム等を用いることができる。例えば、シリコーン離型処理した上質紙、グラシン紙等の紙基材やポリエステルフィルム等を用いることができる。また、剥離体の厚みは、特に限定はされないが、通常、20μm以上、好ましくは、40μm以上であり、その上限値は500μm程度である。剥離体の略中心部に、その外形を分断する線状の剥離体分断部を1本もしくは2本以上設けることによって、一方の剥離体を剥がしても、他方の剥離体が残り、粘着面に触れることなく貼付作業ができるようになり、作業性が向上する。貼付材をロール状とした場合においては、特に剥離体を剥ぎ取りやすくし、取り扱い性を向上させるのに有効である。また、2枚以上の剥離体を粘着剤から剥離しやすいように、剥離体を一方に覆い被せるか又は折り返すように配置してもよい。
[Peeled body]
For the purpose of protecting the pressure-sensitive adhesive layer, the peel-off body used for the patch of the present invention (hereinafter also referred to as “the peel-off body”) is provided on the surface of the pressure-sensitive adhesive layer opposite to the surface provided with the support. It is provided in a peelable state. As the release body, release paper, release film and the like commonly used in the field of patch materials can be used. For example, a paper substrate such as high-quality paper or glassine paper subjected to silicone release treatment, a polyester film, or the like can be used. The thickness of the peeled body is not particularly limited, but is usually 20 μm or more, preferably 40 μm or more, and the upper limit is about 500 μm. By providing one or two or more linear peeled body dividing portions that divide the outer shape at substantially the center of the peeled body, even if one peeled body is peeled off, the other peeled body remains and the adhesive surface Attaching work can be performed without touching, and workability is improved. In the case where the patch is made into a roll, it is particularly effective for making it easy to peel off the peeled body and improving the handleability. Moreover, you may arrange | position so that a peeling body may be covered on one side or turned up so that two or more peeling bodies may be easily peeled from an adhesive.
[担持体]
 本発明の貼付材に用いる担持体(以下、「当該担持体」ともいう)は、支持体の粘着剤層が設けられた面とは反対側の面に剥離可能な状態で設けられ、支持体を補強して、本発明の貼付材の製造性や操作性を向上させる役割を果たす。また、この担持体は貼付時に貼付部位が確認できるような視認性を考慮すると、透明もしくは半透明であることが望ましい。さらに、この担持体は、支持体に対して相対的に高い弾性率を有して、支持体に対し、3~20倍程度の弾性率であるものが好ましい。また、担持体を支持体に積層させる面には、支持体と適度な接着性を保って積層される必要があるため、各種処理を行っておくことが適切である。このような処理としては、例えばコロナ処理、プラズマ処理、紫外線処理、マット処理等が挙げられる。
[Support]
The carrier used for the patch of the present invention (hereinafter also referred to as “the carrier”) is provided in a peelable state on the surface of the support opposite to the surface on which the pressure-sensitive adhesive layer is provided. It plays the role which improves the manufacturability and operativity of the patch of this invention. In addition, it is desirable that this carrier is transparent or translucent in view of visibility so that the application site can be confirmed at the time of application. Further, it is preferable that the carrier has a relatively high elastic modulus with respect to the support and has an elastic modulus of about 3 to 20 times that of the support. Moreover, since it is necessary to laminate | stack the support body on the surface which laminates | stacks a support body with a moderate adhesiveness with a support body, it is appropriate to perform various processes. Examples of such treatment include corona treatment, plasma treatment, ultraviolet treatment, and mat treatment.
 当該担持体が支持体から剥離しにくい場合は、担持体の中央部付近に切れ目を設けてもよく、担持体同士の切れ目間隔を空けて担持体を2枚としてもよい。また、さらに担持体の切れ目上部にテープ又はフィルムを積層して、掴み片として口取り部を設けてもよい。口取り部はフィルム、不織布、織布、又はそれらの積層体としてもよいし、粘着テープとしてもよく、着色も可能である。担持体の端部分は波形或いは複数の切り込みを入れた状態としても良く、支持体より大きく形成したものを使用してもよい。これらは、貼付材をロール状とした場合においても、担持体を剥ぎ取りやすくし、取り扱い性を向上させるのに有効である。 If the carrier is difficult to peel from the support, a cut may be provided near the center of the carrier, or two carriers may be provided with a gap between the carriers. Further, a tape or a film may be laminated on the upper part of the cut of the carrier, and a mouth portion may be provided as a gripping piece. The mouth portion may be a film, non-woven fabric, woven fabric, or a laminate thereof, may be an adhesive tape, and may be colored. The end portion of the carrier may be in the form of a waveform or a plurality of cuts, or may be formed larger than the support. These are effective in making the carrier easy to peel off and improving the handleability even when the patch is made into a roll.
 当該担持体として用いられるのは、例えば、ポリエチレン、ポリプロピレン等のポリオレフィン、ポリエチレンテフタレート等のポリエステル、ナイロン等のポリアミド、ポリ塩化ビニル、ポリ塩化ビニリデン等が挙げられる。また、これらの単体の担持体だけでなく、紙、不織布、織布、編布、金属箔と積層した複合体の担持体であっても差し支えないが、このような担持体には、視認性やコスト等の観点からポリオレフィン及びポリエステルフィルムが用いられることが好ましい。 Examples of the carrier used include polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polyamides such as nylon, polyvinyl chloride, and polyvinylidene chloride. In addition to these single carriers, it may be a composite carrier laminated with paper, non-woven fabric, woven fabric, knitted fabric, or metal foil. From the viewpoints of cost and cost, polyolefin and polyester films are preferably used.
 当該担持体の厚みは、特に限定はされないが、通常、20μm以上、好ましくは、40μm以上であり、その上限値は500μm程度である。 The thickness of the carrier is not particularly limited, but is usually 20 μm or more, preferably 40 μm or more, and the upper limit is about 500 μm.
 本発明の貼付材では、担持体と支持体との間、支持体と粘着剤層との間、及び/又は粘着剤層と剥離体との間に、他の層を一層以上介在させてもよい。例えば、接着性や剥離性を高めるため、下塗剤層や接着剤層、又は剥離剤層を設けてもよいし、あるいはフィルム、不織布、織布、又はそれらの積層体を介在させてもよい。 In the patch of the present invention, one or more other layers may be interposed between the carrier and the support, between the support and the pressure-sensitive adhesive layer, and / or between the pressure-sensitive adhesive layer and the release body. Good. For example, an undercoat layer, an adhesive layer, or a release agent layer may be provided in order to improve adhesiveness and peelability, or a film, a nonwoven fabric, a woven fabric, or a laminate thereof may be interposed.
<貼付材の製造方法>
 当該貼付材の製造方法は、特に限定されず、一般的な貼付材の製造方法に従って製造することができる。
<Manufacturing method of patch material>
The method for producing the patch is not particularly limited, and can be produced according to a general method for producing a patch.
 粘着剤層は、例えば、支持体又は剥離体の一方の上面に粘着剤をコーティング法、押出成形法などの方法により供給することによって形成することができる。また、支持体と剥離体の間に粘着剤を供給することによって形成することができる。さらに、支持体と粘着剤層を共押出成形することもできる。 The pressure-sensitive adhesive layer can be formed, for example, by supplying a pressure-sensitive adhesive to one upper surface of the support or release body by a method such as a coating method or an extrusion method. Moreover, it can form by supplying an adhesive between a support body and a peeling body. Furthermore, the support and the pressure-sensitive adhesive layer can be coextruded.
 安定した品質の貼付材を容易に製造することができる観点から、剥離体層の上面に粘着剤を塗工して粘着剤層を形成する工程を含む貼付材の製造方法であることが好ましい。粘着剤の塗工方法は、溶展塗工、ホットメルト塗工、エマルジョン塗工など特に限定はされないが、特に、厚み50μm以下の薄い粘着剤層を得る場合には溶展塗工方法が好ましい。具体的には、あらかじめ形成した剥離体を一方向に走行させながら、その上面に、粘着剤層を形成する粘着剤を塗工し、溶媒を乾燥除去して粘着剤層を形成する。次いで、粘着剤層が剥離体と対向するようにして、支持体を積層することにより、支持体、粘着剤層及び剥離体をこの順に積層して備えることを特徴とする貼付材を得ることができる。 From the viewpoint of easily producing a patch of stable quality, it is preferable that the method of manufacturing a patch includes a step of forming a pressure-sensitive adhesive layer by applying a pressure-sensitive adhesive to the upper surface of the release body layer. The pressure-sensitive adhesive coating method is not particularly limited, such as spread coating, hot melt coating, and emulsion coating, but the melt coating method is particularly preferable when a thin pressure-sensitive adhesive layer having a thickness of 50 μm or less is obtained. . Specifically, an adhesive that forms an adhesive layer is applied to the upper surface of a peeled body that is formed in advance in one direction, and the solvent is removed by drying to form an adhesive layer. Next, by laminating the support so that the pressure-sensitive adhesive layer faces the peelable body, a patch comprising the support, the pressure-sensitive adhesive layer, and the peelable body laminated in this order can be obtained. it can.
 当該粘着剤層の塗工パターンとしては、当該支持体の表面を全面的に被覆しても良いが、部分的に被覆することも可能である。部分的に被覆する場合は、格子状、ネット状、粒状、唐草模様等の任意の形態を選択できる。このように、当該支持体の片面に、部分的に当該粘着剤層を設けることにより、通気性、透湿性等をより向上させることもでき、また、皮膚からの剥離時の刺激をより軽減することもできる。 As the coating pattern of the pressure-sensitive adhesive layer, the surface of the support may be entirely covered, or may be partially covered. When covering partially, arbitrary forms, such as a grid | lattice form, a net form, a granular form, and an arabesque pattern, can be selected. Thus, by providing the pressure-sensitive adhesive layer partially on one side of the support, air permeability, moisture permeability, etc. can be further improved, and the irritation at the time of peeling from the skin is further reduced. You can also.
 当該貼付材の製造時においては、当該支持体と当該粘着剤層との接着性を向上させるために、当該支持体に表面処理又はプライマー処理を施してもよい。当該支持体の表面処理としては、例えば、エンボス加工、サンドマット加工、コロナ放電処理、プラズマ処理、アルカリ処理等、公知のあらゆる処理方法を採用することができる。プライマー処理としては、例えば、シランカップリング剤等からなるプライマーを用いる等、本発明に係る組成物に使用可能なプライマーであれば、公知のあらゆるプライマーを用いてプライマー処理を行うことが可能である。 In manufacturing the patch, the support may be subjected to surface treatment or primer treatment in order to improve the adhesion between the support and the pressure-sensitive adhesive layer. As the surface treatment of the support, for example, any known treatment methods such as embossing, sand matting, corona discharge treatment, plasma treatment, and alkali treatment can be employed. The primer treatment can be performed using any known primer as long as it is a primer that can be used in the composition according to the present invention, for example, using a primer composed of a silane coupling agent or the like. .
<貼付材の用途及び用法>
 当該貼付材は、以上説明したように、皮膚に貼付した際に、皮膚の伸びだけでなく縮みも抑制することができるため、外傷や手術による傷を有する皮膚にかかる外力を十分に減じることができる。また、皮膚への追従性、透湿性等にも優れるため、長時間貼付することも可能である。従って、本発明の貼付材によると、創傷の治癒、傷跡の治療を促進し、瘢痕やケロイドの形成を効果的に予防することができる。特に、瘢痕やケロイドの形成予防に効果的である。帝王切開や、胸骨正中切開、腹腔鏡手術等の外科手術による創部の傷跡の治療又は瘢痕・ケロイド形成予防に好適に用いられる。貼付する際の貼付材の方向(長手方向と短手方向)は、傷の大きさに応じて決めることが出来る。特に傷が直線状である場合には、傷と垂直になる方向(外力が掛かりやすい方向)の10%引張り荷重が高くなるように貼付することが好ましい。また、これらの用途以外であっても、本発明の効果を十分に奏することができる用途であれば特に限定されない。例えば湿疹、火傷、ニキビ、ピアス穴、BCG接種等を負った患部に貼付することもできる。
<Use and usage of patch material>
As described above, since the patch can suppress not only the expansion of the skin but also the shrinkage when applied to the skin, it can sufficiently reduce the external force applied to the skin having an injury or a wound caused by surgery. it can. Moreover, since it is excellent also in followability to skin, moisture permeability, etc., it can be applied for a long time. Therefore, according to the patch of the present invention, wound healing and scar treatment can be promoted, and scar and keloid formation can be effectively prevented. In particular, it is effective in preventing the formation of scars and keloids. It is suitably used for the treatment of wound scars or the prevention of scars and keloid formation by surgical operations such as caesarean section, median sternotomy, and laparoscopic surgery. The direction (longitudinal direction and transversal direction) of the sticking material when sticking can be determined according to the size of the wound. In particular, when the flaw is linear, it is preferable that the 10% tensile load in the direction perpendicular to the flaw (direction in which external force is easily applied) is increased. Moreover, even if it is except these uses, if it is a use which can fully show | play the effect of this invention, it will not specifically limit. For example, it can be affixed to the affected area suffering from eczema, burns, acne, pierced holes, BCG inoculation and the like.
 一般に創傷治癒過程は、その時間的経過から炎症期、増殖期及び組織再構築期の3つの時期に分けられる生体防御システムの一つであり、軽度な創傷では治療せずとも自然に治癒に至る。しかし、創傷部位に伸びや縮み等の機械的なひずみが生じると、特に増殖期初期におけるマクロファージによる壊死組織の消化除去や余分な細胞のアポトーシスを抑制し、コラーゲン線維の瘢痕化につながり、その結果組織の再構築が抑制され傷跡が肥大してケロイドが形成されると推測される。したがって、本発明に係る貼付材は、創傷治癒を促進するという視点において外傷や手術による傷跡の治療のために用いることができ、一方、瘢痕、ケロイドの形成を抑制する意味で、瘢痕、ケロイド形成の予防のために用いることができる。 In general, the wound healing process is one of the biological defense systems that are divided into three stages from the time course, the inflammatory phase, the proliferative phase and the tissue remodeling phase. . However, when mechanical strains such as stretching and contraction occur at the wound site, the digestion and removal of necrotic tissue by macrophages and the apoptosis of excess cells are suppressed, particularly in the early proliferative phase, leading to scarring of collagen fibers. It is presumed that the reconstruction of the tissue is suppressed and the scar is enlarged to form a keloid. Therefore, the patch according to the present invention can be used for the treatment of scars caused by trauma or surgery from the viewpoint of promoting wound healing, while scars and keloids are formed in the sense of suppressing the formation of scars and keloids. It can be used for prevention.
 当該貼付材の用法は、目的に応じて適宜選択されるが、例えば創部の瘢痕・ケロイド形成予防を目的とする場合には、3ヶ月~12ヶ月程度連続貼付することが好ましい。1枚の当該貼付材は、一旦貼付した後、それが剥がれるまで連続貼付することができる。この期間は、通常3日~7日間程度である。その後、新しい貼付材を貼付し、剥がれたらまた新しい貼付材を貼付することを繰り返し行うことが望ましい。 The usage of the patch is appropriately selected according to the purpose. For example, for the purpose of preventing scar and keloid formation in the wound, it is preferable to continuously apply for about 3 to 12 months. One sticking material can be stuck continuously after it is once stuck until it peels off. This period is usually about 3 to 7 days. After that, it is desirable to apply a new adhesive material, and repeatedly apply a new adhesive material when peeled off.
 当該貼付材は、防水及び長期付着のために、必要に応じて、ドレッシング材や医療用テープなどを当該貼付材の上から覆い使用することが出来る。 The adhesive material can be used by covering the adhesive material with a dressing material or medical tape as necessary for waterproofing and long-term adhesion.
 以下、実施例により本発明をより詳細に説明するが、本発明はこれらにより何ら限定されない。以下の実施例及び比較例中の部及び%は、特に断りのない限り、それぞれ質量部及び質量%を示す。 Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited thereto. Unless otherwise indicated, the part and% in a following example and a comparative example show a mass part and mass%, respectively.
<貼付材の作製>
1.粘着剤
 ウレタン粘着剤は、ポリエーテルポリオールA/ポリエーテルポリオールB/ポリエーテルモノオールC(質量比43/21/36)のモル比が活性水素化合物中の水酸基100に対してイソシアネートプレポリマー中のイソシアネート基の90となるようにヘキサメチレンジイソシアネートプレポリマーを添加したウレタン系粘着剤を使用した。
<Production of patch material>
1. Adhesive Urethane adhesive has a molar ratio of polyether polyol A / polyether polyol B / polyether monool C (mass ratio 43/21/36) in the isocyanate prepolymer with respect to hydroxyl group 100 in the active hydrogen compound. A urethane-based pressure-sensitive adhesive to which hexamethylene diisocyanate prepolymer was added so as to have an isocyanate group of 90 was used.
 アクリル粘着剤としては、アクリル粘着剤1、アクリル粘着剤2、アクリル粘着剤3を使用した。アクリル粘着剤1は、アクリル酸イソノニル/アクリル酸2-メトキシエチル/アクリル酸(質量比68/30/2)からなるアクリル酸アルキルエステル共重合体100質量部に対して、架橋剤としてコロネート(登録商標)HL0.3質量部(日本ポリウレタン工業株式会社製)を添加したアクリル系粘着剤である。アクリル粘着剤2は、アクリル酸イソノニル/アクリル酸(質量比98/2)からなるアクリル酸アルキルエステル共重合体100質量部に対して、架橋剤として、TETRAD(登録商標)X0.02質量部(三菱ガス化学株式会社製)、ナーセムアルミニウム0.1質量部(日本化学産業株式会社製)を添加したアクリル系粘着剤である。アクリル粘着剤3は、アクリル酸イソノニル/アクリル酸(質量比96/4)からなるアクリル酸アルキルエステル共重合体100質量部に対して、架橋剤として、TETRAD(登録商標)X0.03質量部(三菱ガス化学株式会社製)を添加したアクリル系粘着剤である。 As the acrylic adhesive, acrylic adhesive 1, acrylic adhesive 2, and acrylic adhesive 3 were used. The acrylic pressure-sensitive adhesive 1 is a coronate (registered as a cross-linking agent) with respect to 100 parts by mass of an alkyl acrylate copolymer comprising isononyl acrylate / 2-methoxyethyl acrylate / acrylic acid (mass ratio 68/30/2). Trademark) An acrylic pressure-sensitive adhesive to which 0.3 part by mass of HL (manufactured by Nippon Polyurethane Industry Co., Ltd.) is added. Acrylic pressure-sensitive adhesive 2 is TETRAD (registered trademark) X 0.02 parts by mass as a crosslinking agent with respect to 100 parts by mass of an acrylic acid alkyl ester copolymer consisting of isononyl acrylate / acrylic acid (mass ratio 98/2). It is an acrylic pressure-sensitive adhesive to which 0.1 part by mass of Nasem aluminum (manufactured by Nippon Chemical Industry Co., Ltd.) is added. The acrylic pressure-sensitive adhesive 3 was used as a crosslinking agent with respect to 100 parts by mass of an acrylic acid alkyl ester copolymer composed of isononyl acrylate / acrylic acid (mass ratio 96/4), and 0.03 parts by mass of TETRAD (registered trademark) X It is an acrylic adhesive with the addition of Mitsubishi Gas Chemical Co., Ltd.
2.基材(支持体)
 基材(支持体)としては、
 PET織布+PUコーティング(ポリエステル織布にポリウレタンコーティングを施したもの)、
 PET織布+PUフィルムラミ品(ポリエステル織布をポリウレタンフィルムでラミネートしたもの)、
 PET/パルプ不織布(ポリエステル及びパルプを含む不織布)、
 ナイロン織布+アクリルコーティング(ナイロン織布にアクリルコーティングを施したもの)、
 PET織布+アクリルコーティング(ポリエステル織布にアクリルコーティングを施したもの)、
 PET織布+エーテル系PUフィルムラミ品(ポリエステル織布をエーテル系ポリウレタンフィルムでラミネートしたもの)、
 ポリウレタンフィルム、
 PPスパンボンド不織布(ポリプロピレン長繊維不織布)、
 ポリウレタン不織布
を用いた。
2. Base material (support)
As a substrate (support),
PET woven fabric + PU coating (polyester woven fabric with polyurethane coating),
PET woven fabric + PU film laminated product (polyester woven fabric laminated with polyurethane film),
PET / pulp nonwoven fabric (nonwoven fabric containing polyester and pulp),
Nylon woven fabric + acrylic coating (Nylon woven fabric with acrylic coating),
PET woven fabric + acrylic coating (polyester woven fabric with acrylic coating),
PET woven fabric + ether PU film laminated product (polyester woven fabric laminated with ether polyurethane film),
Polyurethane film,
PP spunbond nonwoven fabric (polypropylene long fiber nonwoven fabric),
A polyurethane nonwoven fabric was used.
3.貼付材の作製
[実施例1]
 前記で調製されたウレタン粘着剤100部と、架橋剤であるコロネートL(日本ポリウレタン工業製)2部とを均一に混合したのち脱泡し、剥離処理を施したポリラミシリコーン処理グラシン紙上に乾燥時の粘着剤厚40g/mとなるように塗布し、次いで乾燥させ、粘着剤層を得た。得られた粘着剤層の上に、基材(支持体)としての、ポリウレタンコーティングを施したポリエステル織布(PET織布+PUコーティング)を貼り合わせ、貼付材を作製した。得られた貼付材の特性は、後述する方法を用いて測定し表2に示した。
3. Preparation of patch material
[Example 1]
100 parts of urethane adhesive prepared above and 2 parts of coronate L (manufactured by Nippon Polyurethane Industry), which is a cross-linking agent, are uniformly mixed, defoamed, and dried on a polyramie silicone treated glassine paper that has been subjected to a release treatment. It was applied so that the pressure-sensitive adhesive thickness was 40 g / m 2 and then dried to obtain a pressure-sensitive adhesive layer. On the obtained pressure-sensitive adhesive layer, a polyester woven fabric (PET woven fabric + PU coating) subjected to polyurethane coating as a base material (support) was bonded to prepare a patch. The properties of the obtained patch were measured using the method described later and are shown in Table 2.
[実施例2、5~7、及び比較例1]
 下記表1に記載した基材を用いたこと以外は実施例1と同様にして、実施例2、5~7、及び比較例1の貼付材を作製した。得られた各貼付材の粘着剤厚も表1に合わせて示した。各貼付材の特性は、同様に後述する方法を用いて測定し表2に示した。
[Examples 2, 5 to 7, and Comparative Example 1]
Except that the base material described in Table 1 below was used, the patch materials of Examples 2, 5 to 7 and Comparative Example 1 were prepared in the same manner as in Example 1. The adhesive thickness of each obtained patch was also shown in Table 1. The characteristics of each patch were similarly measured using the method described later and are shown in Table 2.
[実施例3]
 剥離体の片面に、アクリル粘着剤1の酢酸エチル溶液(全体の固形分は約40質量%)を、乾燥後の厚みが39g/m2になるように塗布し、次いで乾燥して、粘着剤層を形成し、支持体としてPET/パルプ不織布をラミネートし、貼付材を作成した。
[Example 3]
Apply an ethyl acetate solution of acrylic pressure-sensitive adhesive 1 (the total solid content is about 40% by mass) to one side of the peeled body so that the thickness after drying is 39 g / m 2 , and then dry, A layer was formed, and a PET / pulp nonwoven fabric was laminated as a support to prepare a patch.
[実施例4、及び比較例2~4]
 下記表1に記載した粘着剤及び基材を用いたこと以外は実施例3と同様にして、実施例4、及び比較例2~4の貼付材を作製した。得られた各貼付材の粘着剤厚も表1に合わせて示した。各貼付材の特性は、同様に後述する方法を用いて測定し表2に示した。
[Example 4 and Comparative Examples 2 to 4]
Except that the pressure-sensitive adhesive and the base material described in Table 1 below were used, patch materials of Example 4 and Comparative Examples 2 to 4 were prepared in the same manner as Example 3. The adhesive thickness of each obtained patch was also shown in Table 1. The characteristics of each patch were similarly measured using the method described later and are shown in Table 2.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
<貼付材の各特性の測定方法>
(引張荷重)
 実施例及び比較例の貼付材については、それぞれJIS K 7113に準じて引張試験を行い、10%引張荷重の測定を行った。各貼付材の試験片は、短手(CD)方向、長手(MD)方向それぞれについて、幅25mm、長さ100mmの短冊を裁断したものを用いた。チャック間が50mmになるように両端にニチバン株式会社製カートンテープNo.660を貼付し、引張強度測定用の試験片を作製し、テンシロン型引張試験機のクロスヘッドに前記50mmのつかみ間隔で取り付けた。上部クロスヘッドを300mm/minの速度で上げ、前記試験片を引っ張った。引張り長さが元の試験片を基準として、10%伸張に至ったときの荷重を10%引張荷重とした。引張荷重の単位は、ニュートン(N)/25mmで表した。各貼付材の短手(CD)方向、長手(MD)方向それぞれについて3枚ずつ試験片を裁断し、3枚全てについて前記測定を行った。3枚の平均値をCD方向、MD方向それぞれの引張荷重の測定値とした。測定の条件をまとめると以下の通りである。
 試験機:テンシロン型引張試験機
 試験片:幅25mm、長さ100mm
 つかみ間隔:50mm
 クロスヘッド移動速度(引張速度):300mm/min
 繰返し試験数:n=3
 測定雰囲気:23℃、50%RH
<Measuring method of each characteristic of patch material>
(Tensile load)
About the patch material of an Example and a comparative example, the tension test was performed according to JISK7113, and the 10% tensile load was measured, respectively. The test piece of each patch was obtained by cutting a strip having a width of 25 mm and a length of 100 mm in each of the short side (CD) direction and the long side (MD) direction. Nichiban Co., Ltd. Carton Tape No. 660 was affixed to prepare a test piece for measuring the tensile strength, and the test piece was attached to the crosshead of a Tensilon type tensile tester with the 50 mm grip interval. The upper crosshead was raised at a speed of 300 mm / min, and the test piece was pulled. The load when the tensile length reached 10% based on the original test piece was defined as a 10% tensile load. The unit of tensile load was expressed as Newton (N) / 25 mm. Three test pieces were cut in each of the short (CD) direction and the long (MD) direction of each patch, and the measurement was performed on all three sheets. The average value of the three sheets was taken as the measured value of the tensile load in each of the CD direction and MD direction. The measurement conditions are summarized as follows.
Tester: Tensilon type tensile tester Test piece: 25mm width, 100mm length
Grasp interval: 50mm
Crosshead moving speed (tensile speed): 300 mm / min
Number of repeated tests: n = 3
Measurement atmosphere: 23 ° C., 50% RH
(剛軟度)
 カンチレバー試験JIS L 1096による。各貼付材の試験片は、短手(CD)方向、長手(MD)方向それぞれについて、幅20mm、長さ150mmの短冊を裁断したものとした。45°の斜面をもつ、表面が滑らかな水平台の上にサンプルの短辺をスケール基線に合せて置き、適当な方法によって試験片を斜面の方向に緩やかに滑らせて20秒以内に試験片が倒れた時、水平台側の端の位置をスケールから読み取った。剛軟度は試験片が移動した長さ(mm)で示され、3枚の平均値を剛軟度の測定値とした。なお、測定は全て各貼付材の基材面を下にして行った。
(Flexibility)
Cantilever test according to JIS L 1096. The test piece of each patch was obtained by cutting a strip having a width of 20 mm and a length of 150 mm in each of the short side (CD) direction and the long side (MD) direction. Place the short side of the sample on a horizontal surface with a 45 ° slope and a smooth surface so that the short side of the sample matches the baseline of the scale, and slide the specimen gently in the direction of the slope by an appropriate method within 20 seconds. When the heel fell down, the position of the end on the horizontal platform side was read from the scale. The bending resistance is indicated by the length (mm) of the movement of the test piece, and the average value of the three pieces was taken as the measurement value of bending resistance. In addition, all measurements were performed with the base material surface of each patch material facing down.
(見かけ密度)
 各貼付材の坪量(g/m)をその厚さ(μm)で徐した値を算出し、見かけ密度(g/cm)とした。
(Apparent density)
A value obtained by gradually subtracting the basis weight (g / m 2 ) of each patch from its thickness (μm) was calculated and used as an apparent density (g / cm 3 ).
(透湿度)
 透湿度は、JIS Z 0208のB条件に従って、温度40℃、相対湿度90%で測定した。すなわち、各貼付材の片面側を温度40℃、相対湿度90%に調節し、他面側には約15gの吸湿剤(塩化カルシウム)を置いて、各貼付材を通過した水分を吸収させ、吸湿剤の質量変化量を1m、24時間当りに換算して、3枚の試験片の平均値を透湿度とした。
(Moisture permeability)
The moisture permeability was measured at a temperature of 40 ° C. and a relative humidity of 90% in accordance with B condition of JIS Z 0208. That is, one side of each patch is adjusted to a temperature of 40 ° C. and a relative humidity of 90%, and about 15 g of a hygroscopic agent (calcium chloride) is placed on the other side to absorb the moisture that has passed through each patch. The mass change amount of the hygroscopic agent was converted to 1 m 2 per 24 hours, and the average value of the three test pieces was defined as moisture permeability.
(応力緩和時間)
 各貼付材の試験片として、短手(CD)方向、長手(MD)方向それぞれについて、幅25mm、長さ80mmの短冊を3枚ずつ裁断したものを用いた。チャック間が50mmになるように両端にニチバン株式会社製カートンテープNo.660を貼付し、引張強度測定用の試験片を作製した。25Nまで300mm/minの速度で引っ張った後、荷重が25Nになった時点で180秒間停止させ、荷重が20Nまで低下した時間(秒)を応力緩和時間とした。測定の条件をまとめると以下の通りである。
 試験機:テンシロン型引張試験機
 試験片:幅25mm、長さ80mm
 チャック間:50mm
 クロスヘッド移動速度(引張速度):300mm/min
 繰返し試験数:n=3
 測定雰囲気:23℃、50%RH
(Stress relaxation time)
As the test piece of each patch, one obtained by cutting three strips each having a width of 25 mm and a length of 80 mm in each of the short side (CD) direction and the long side (MD) direction was used. Nichiban Co., Ltd. Carton Tape No. is attached to both ends so that the distance between chucks is 50 mm. A test piece for measuring tensile strength was prepared by attaching 660. After pulling at a speed of 300 mm / min up to 25 N, the load was stopped for 180 seconds when the load became 25 N, and the time (second) when the load decreased to 20 N was defined as the stress relaxation time. The measurement conditions are summarized as follows.
Tester: Tensilon type tensile tester Test piece: 25mm width, 80mm length
Between chucks: 50 mm
Crosshead moving speed (tensile speed): 300 mm / min
Number of repeated tests: n = 3
Measurement atmosphere: 23 ° C., 50% RH
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
<貼付材の評価(ヒト皮膚での実用評価)方法>
 各貼付材をヒト皮膚の下記の各部位に貼付し、下記の方法に従って評価した。なお、各部位での評価には、短手(CD)方向、長手(MD)方向それぞれについて各貼付材を50mm四方のサイズに裁断した試験片を3枚ずつ用いた。
<Method of evaluation of patch (practical evaluation on human skin)>
Each patch was affixed to each of the following parts of human skin and evaluated according to the following method. Note that for each evaluation, three test pieces were used in which each patch was cut into a size of 50 mm square in each of the short side (CD) direction and the long side (MD) direction.
(へそ下部)
 へそ下部にマジックペンで50mm四方の正方形をマークした(50mm×50mmの4辺)。体の垂直(上下)方向をタテ、水平(左右)方向をヨコとした(胸部及び肩部も同様として行った)。両手を腰にあて、腰を後屈した状態(仰け反った状態)で停止し、その際のマークペンのタテの辺の長さを測定した(皮膚を伸ばす行為)。また、イスに腰深く座った状態で停止し、その際のマークペンのタテの辺の長さを測定した(皮膚を縮める行為)。これらの測定値を無貼付時(ブランク)の測定値とした。次に、マークした箇所に各貼付材の試験片を貼り、同様の動作を行い、テープのタテの長さを巻尺で測定し貼付時の測定値とした。各貼付材の試験片3枚について同様の測定を行った。無貼付時の測定値及び貼付時の測定値のそれぞれと、初期値(50mm)との差を算出し、無貼付時で伸びた又は縮んだ長さが、貼付時にどの程度抑制されたかを抑制率(%)として算出し、下記評価基準に従って評価した。タテ方向のみの評価結果を表2に示す。なお、表2に示した結果は、前記3枚の試験片についての平均値である。ここで、抑制率が100%とは、貼付材の貼付により、皮膚の伸び又は縮みが完全に抑えられたことを示す。
(Bottom of navel)
A 50 mm square was marked with a magic pen at the bottom of the navel (4 sides of 50 mm × 50 mm). The vertical (up and down) direction of the body was vertical and the horizontal (left and right) direction was horizontal (the same applies to the chest and shoulders). He put his hands on his hips, stopped in a state where his hips were bent backwards (backward state), and measured the length of the vertical side of the mark pen at that time (the act of stretching the skin). In addition, the patient stopped while sitting deeply on the chair, and measured the length of the vertical side of the mark pen at that time (the act of shrinking the skin). These measured values were taken as the measured values when not pasted (blank). Next, a test piece of each patch was pasted on the marked location, the same operation was performed, and the length of the tape was measured with a tape measure to obtain a measured value at the time of pasting. The same measurement was performed on three test pieces of each patch. Calculate the difference between the measured value when not pasted and the measured value when pasted, and the initial value (50 mm), and suppress how much the length stretched or shrunk when not pasted was suppressed when pasted It was calculated as a rate (%) and evaluated according to the following evaluation criteria. Table 2 shows the evaluation results only in the vertical direction. The results shown in Table 2 are average values for the three test pieces. Here, the inhibition rate of 100% indicates that the elongation or contraction of the skin was completely suppressed by applying the patch.
(胸部)
 胸部のよく動く箇所(胸部の中央)にマジックペンで50mm四方の正方形をマークした(50mm×50mmの4辺)。両手ともに拳を作り、胸を前に押し出すように胸を張ってその状態で停止し(皮膚を伸ばす行為)、その際のマークペンのタテ及びヨコの辺の長さを測定し、無貼付時(ブランク)の測定値とした。次に、マークした箇所に各貼付材の試験片を貼り、同様の動作を行い、テープのタテ及びヨコの辺の長さを巻尺で測定し貼付時の測定値とした。各貼付材の試験片の短手(CD)方向、長手(MD)方向それぞれ3枚について同様の測定を行った。抑制率の算出はへそ部の場合と同様に行い、下記評価基準に従って評価した。その結果を表3に示す。
(Chest)
A 50 mm square was marked with a magic pen (four sides of 50 mm × 50 mm) on the well-moving part of the chest (center of the chest). Make a fist with both hands, stretch the chest as if pushing it out forward, and stop in that state (the act of stretching the skin), measure the length of the mark pen's vertical and horizontal sides at that time, when not affixed The measured value was (blank). Next, a test piece of each patch was applied to the marked location, the same operation was performed, and the lengths of the vertical and horizontal sides of the tape were measured with a tape measure to obtain measurement values at the time of application. The same measurement was performed for each of the three test pieces of each patch material in the short (CD) direction and the long (MD) direction. The suppression rate was calculated in the same manner as in the navel, and evaluated according to the following evaluation criteria. The results are shown in Table 3.
(肩部)
 肩部のよく動く箇所にマジックペンで50mm四方の正方形をマークした(50mm×50mmの4辺)。腕を真上に出した状態で停止し、その際のマークペンのヨコ辺の長さを測定し、無貼付時(ブランク)の測定値とした。次に、マークした箇所に各貼付材の試験片を貼り、同様の動作を行い、テープのヨコの辺の長さを巻尺で測定し貼付時の測定値とした。各貼付材の試験片の短手(CD)方向、長手(MD)方向それぞれ3枚について同様の測定を行った。抑制率の算出はへそ部の場合と同様に行い、下記評価基準に従って評価した。ヨコ方向の評価結果を表3に示す。
(Shoulder)
A 50 mm square was marked with a magic pen on the shoulder that moved well (four sides of 50 mm × 50 mm). It stopped in the state which put out the arm right above, and measured the length of the side of a mark pen in that case, and made it the measurement value at the time of non-sticking (blank). Next, a test piece of each adhesive material was attached to the marked location, the same operation was performed, and the length of the side of the tape was measured with a tape measure to obtain a measured value at the time of application. The same measurement was performed for each of the three test pieces of each patch material in the short side (CD) direction and the long side (MD) direction. The suppression rate was calculated in the same manner as in the navel, and evaluated according to the following evaluation criteria. Table 3 shows the evaluation results in the horizontal direction.
(評価基準)
 皮膚を伸ばす行為について
  A:抑制率100%~90%
  B:抑制率89%~80%
  C:抑制率79%~70%
  D:抑制率69%以下
 皮膚を縮める行為について
  A:抑制率100%~90%
  B:抑制率89%~70%
  C:抑制率69%~60%
  D:抑制率59%以下
(Evaluation criteria)
Stretching skin A: 100% to 90% inhibition rate
B: Suppression rate 89% -80%
C: Inhibition rate 79% to 70%
D: Suppression rate of 69% or less Actions to shrink the skin A: Suppression rate of 100% to 90%
B: Suppression rate 89% to 70%
C: Suppression rate 69% -60%
D: Suppression rate of 59% or less
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
 <評価>
 前記表3に示される通り、実施例の貼付材は、比較例に比べて皮膚の伸び及び縮みを十分に抑制することがわかった。また、実施例の貼付材は、皮膚への追従性もよく、長期間の貼付に適していた。
<Evaluation>
As shown in Table 3, it was found that the patch materials of the examples sufficiently suppressed the elongation and contraction of the skin as compared with the comparative examples. Further, the patch materials of the examples had good followability to the skin and were suitable for long-term patching.
 本発明の創傷被覆用又は術後創保護用の貼付材によると、皮膚の伸びだけでなく縮みも抑制することができるため、外傷や手術による傷を有する皮膚にかかる外力を十分に減じることができる。また、皮膚への追従性、透湿性等にも優れるため、長時間貼付することも可能である。従って、本発明の創傷被覆用又は術後創保護用の貼付材は、創傷の治癒用、傷跡の治療用又は瘢痕やケロイドの形成予防用に好適である。 According to the patch for wound covering or post-operative wound protection of the present invention, not only the expansion of the skin but also the shrinkage can be suppressed, so that the external force applied to the skin having a wound due to trauma or surgery can be sufficiently reduced. it can. Moreover, since it is excellent also in followability to skin, moisture permeability, etc., it can be applied for a long time. Therefore, the patch for wound covering or protecting a postoperative wound according to the present invention is suitable for wound healing, scar treatment or prevention of scar or keloid formation.

Claims (14)

  1.  支持体と、前記支持体の片面に設けられた粘着剤層とを備える貼付材において、
     前記貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上である創傷被覆用又は術後創保護用の貼付材。
    In a patch comprising a support and an adhesive layer provided on one side of the support,
    10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more. A patch for wound covering or protecting a postoperative wound.
  2.  カンチレバー法による剛軟度(mm)と見かけ密度(g/cm)との積が25以上である、請求項1に記載の貼付材。 The patch according to claim 1, wherein the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is 25 or more.
  3.  透湿度が700g/m・24h以上である、請求項1又は2に記載の貼付材。 The patch according to claim 1 or 2, wherein the moisture permeability is 700 g / m 2 · 24h or more.
  4.  前記貼付材の長手方向又は短手方向の少なくとも一方の応力緩和時間が10s以上である、請求項1~3のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 3, wherein the stress relaxation time in at least one of the longitudinal direction and the short direction of the patch is 10 s or more.
  5.  長手方向及び短手方向の10%引張荷重が18N/25mm以上である、請求項1~4のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 4, wherein a 10% tensile load in the longitudinal direction and the short direction is 18 N / 25 mm or more.
  6.  前記粘着剤層がウレタン系粘着剤又は発泡したアクリル系粘着剤を含む、請求項1~5のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 5, wherein the pressure-sensitive adhesive layer contains a urethane-based pressure-sensitive adhesive or a foamed acrylic pressure-sensitive adhesive.
  7.  前記支持体が織布又は不織布を含む、請求項1~6のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 6, wherein the support comprises a woven fabric or a non-woven fabric.
  8.  前記支持体が微小孔を含む、請求項1~7のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 7, wherein the support comprises micropores.
  9.  創傷の治癒用、傷跡の治療用又は瘢痕・ケロイド形成予防用である請求項1~8のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 8, which is used for wound healing, scar treatment, or scar / keloid formation prevention.
  10.  外科手術による創部の創傷の治癒用、傷跡の治療用又は瘢痕・ケロイド形成予防用である、請求項9に記載の貼付材。 The patch according to claim 9, which is used for healing a wound of a wound by surgery, treating a scar, or preventing scar / keloid formation.
  11.  前記外科手術が帝王切開、胸骨正中切開又は腹腔鏡手術である、請求項10に記載の貼付材。 The patch according to claim 10, wherein the surgical operation is a caesarean section, a median sternotomy section, or a laparoscopic operation.
  12.  支持体と、前記支持体の片面に設けられた粘着剤層とを備える貼付材において、
     前記貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上であり、
     前記粘着剤層がウレタン系粘着剤又は発泡したアクリル系粘着剤を含む貼付材。
    In a patch comprising a support and an adhesive layer provided on one side of the support,
    10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more. And
    A patch comprising the pressure-sensitive adhesive layer containing a urethane-based pressure-sensitive adhesive or a foamed acrylic pressure-sensitive adhesive.
  13.  支持体と、前記支持体の片面に設けられた粘着剤層とを備える貼付材において、
     前記貼付材の長手方向又は短手方向の少なくとも一方の10%引張荷重が18N/25mm以上であり、カンチレバー法による剛軟度(mm)と坪量(g/m)との積が3000以上であり、カンチレバー法による剛軟度(mm)と見かけ密度(g/cm)との積が25以上である貼付材。
    In a patch comprising a support and an adhesive layer provided on one side of the support,
    10% tensile load in at least one of the longitudinal direction and the short direction of the patch is 18 N / 25 mm or more, and the product of the bending resistance (mm) and the basis weight (g / m 2 ) by the cantilever method is 3000 or more. A patch material in which the product of the bending resistance (mm) by the cantilever method and the apparent density (g / cm 3 ) is 25 or more.
  14.  前記粘着剤層が、瘢痕、ケロイド形成を抑制する薬剤をさらに含む請求項1~13のいずれか1項に記載の貼付材。 The patch according to any one of claims 1 to 13, wherein the pressure-sensitive adhesive layer further contains an agent that suppresses scarring and keloid formation.
PCT/JP2014/080079 2013-11-15 2014-11-13 Patch WO2015072517A1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017064083A (en) * 2015-09-30 2017-04-06 株式会社麻生 Umbilical hernia treatment material fixation patch
KR20190075578A (en) * 2017-12-21 2019-07-01 주식회사 엘지화학 Composition for antibacterial dressing film and antibacterial dressing film

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59183751A (en) * 1983-04-01 1984-10-18 冨士森 良輔 Medical bandage material
JP2007037562A (en) * 2005-07-29 2007-02-15 Sekisui Chem Co Ltd External adhesive skin patch for breast
JP2009545382A (en) * 2006-08-03 2009-12-24 ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー Device and bandage for the treatment or prevention of scars and / or keloids, and methods and kits therefor
JP2012135582A (en) * 2010-12-28 2012-07-19 Alcare Co Ltd Patch

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59183751A (en) * 1983-04-01 1984-10-18 冨士森 良輔 Medical bandage material
JP2007037562A (en) * 2005-07-29 2007-02-15 Sekisui Chem Co Ltd External adhesive skin patch for breast
JP2009545382A (en) * 2006-08-03 2009-12-24 ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー Device and bandage for the treatment or prevention of scars and / or keloids, and methods and kits therefor
JP2012135582A (en) * 2010-12-28 2012-07-19 Alcare Co Ltd Patch

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017064083A (en) * 2015-09-30 2017-04-06 株式会社麻生 Umbilical hernia treatment material fixation patch
KR20190075578A (en) * 2017-12-21 2019-07-01 주식회사 엘지화학 Composition for antibacterial dressing film and antibacterial dressing film
KR102224033B1 (en) 2017-12-21 2021-03-08 주식회사 엘지화학 Composition for antibacterial dressing film and antibacterial dressing film

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