WO2009087877A1 - 皮膚用粘着剤、皮膚用粘着シート及びオストミー装具面板 - Google Patents
皮膚用粘着剤、皮膚用粘着シート及びオストミー装具面板 Download PDFInfo
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- WO2009087877A1 WO2009087877A1 PCT/JP2008/073065 JP2008073065W WO2009087877A1 WO 2009087877 A1 WO2009087877 A1 WO 2009087877A1 JP 2008073065 W JP2008073065 W JP 2008073065W WO 2009087877 A1 WO2009087877 A1 WO 2009087877A1
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- skin
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- adhesive
- adhesive sheet
- sensitive adhesive
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- 239000002699 waste material Substances 0.000 description 1
- 229940100445 wheat starch Drugs 0.000 description 1
- 239000002759 woven fabric Substances 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- FJHBOVDFOQMZRV-XQIHNALSSA-N xanthophyll Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C=C(C)C(O)CC2(C)C FJHBOVDFOQMZRV-XQIHNALSSA-N 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/58—Adhesives
- A61L15/585—Mixtures of macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0253—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0256—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the parametric properties of the adhesive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/44—Medicaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0015—Medicaments; Biocides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/043—Mixtures of macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/22—Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/14—Adhesives for ostomy devices
Definitions
- the present invention relates to an adhesive for skin, an adhesive sheet for skin, and an ostomy appliance face plate. More specifically, the present invention includes a skin pressure-sensitive adhesive used for skin protection around the stoma, ostomy appliance face plate, wound dressing, etc., a skin pressure-sensitive adhesive sheet having the skin pressure-sensitive adhesive layer, and the skin pressure-sensitive adhesive sheet.
- the ostomy appliance face plate is a skin pressure-sensitive adhesive used for skin protection around the stoma, ostomy appliance face plate, wound dressing, etc.
- a skin pressure-sensitive adhesive sheet having the skin pressure-sensitive adhesive layer
- the skin pressure-sensitive adhesive sheet The ostomy appliance face plate.
- stoma owner For those who cannot control the excretion of stool and urine by their own will, and those with diseases of the digestive system or urinary organs, perform surgical operation to bring the intestinal tract and urinary tract to the body surface and stoma on the body surface It is done to create a so-called aperture.
- the person who constructed the stoma (hereinafter, sometimes referred to as “stoma owner”) needs to wear an ostomy appliance that can temporarily store the waste from the stoma around the stoma.
- This ostomy appliance is composed of a pouch for storing excrement and an adhesive sheet called a face plate, and this face plate is used by being adhesively fixed around the stoma.
- a so-called hydrocolloid skin pressure-sensitive adhesive containing a hydrophilic polymer compound is generally used so that moisture from the skin and excrement can be absorbed even when applied to the skin for a long time.
- Patent Documents 1 to 9 For example, Patent Documents 1 to 9).
- Some conventional face plates can absorb a large amount of moisture, but they are not sufficiently cohesive, and the adhesive for skin may melt from the outer periphery of the face plate after water absorption, or adhesive residue may be generated at the time of peeling. .
- those with increased cohesiveness and shape retention may have poor water absorption characteristics and adaptability to the skin, and long-time application may cause the faceplate to peel off or cause discomfort during application. It was.
- stoma holders will use ostomy appliances for a long period of time, so the skin's physiological function (skin barrier function) decreases and the dermatitis is likely to occur while repeatedly applying and peeling the face plate. Become.
- skin adhesives or adhesive sheets used for wound dressings, etc. when applied for a long time, blood, exudate, etc. are quickly absorbed, and the adaptability to the affected area is good. What is not required.
- the problem of the present invention is that the skin is not adversely affected by moisture from excrement even when applied to the skin for a long time, has good shape retention and skin adaptability, and has no adhesive residue when peeled off. It is to provide a pressure-sensitive adhesive. Moreover, the other subject of this invention is providing the adhesive for skin which can hold
- thermoplastic elastomer 25 to 60% by weight of hydrophilic polymer compound, 16 to 40% by weight of softening agent and 0.01 to 4.8% by weight of bioactive agent are contained.
- a skin pressure-sensitive adhesive having a water absorption rate after 3 hours and a water absorption rate after 24 hours of 55 to 240% and 240 to 450%, respectively, is provided.
- the bioactive agent is preferably a hydrophilic bioactive agent.
- the bioactive agent is preferably a sphingolipid.
- the thermoplastic elastomer is preferably a hydrogenated styrene-butadiene rubber.
- the skin pressure-sensitive adhesive of the present invention preferably further comprises 1 to 30% by weight of oil.
- the skin pressure-sensitive adhesive of the present invention preferably further comprises 1 to 25% by weight of a tackifying resin.
- the skin adhesive of the present invention is preferably 2 to 35% by weight of a styrenic thermoplastic elastomer; at least one hydrophilic polymer compound 25 selected from the group consisting of sodium carboxymethylcellulose, pectin, karaya gum and gelatin.
- At least one softener selected from the group consisting of polyisobutylene, polyisoprene, polybutadiene, polybutene, styrene-isoprene rubber, ethylene-propylene rubber, styrene-ethylene-propylene rubber and derivatives thereof 16-40 Containing 0.01 to 4.8% by weight of bioactive agent; 1 to 30% by weight of oil; and 1 to 25% by weight of tackifying resin, and water absorption after 3 hours and water absorption after 24 hours The rates are 55-240% and 240-450%, respectively.
- thermoplastic elastomer 25 to 60% by weight of a hydrophilic polymer compound, 16 to 40% by weight of a softening agent, and a bioactive agent 0.
- a skin adhesive layer containing 01 to 4.8% by weight, and has a water absorption rate of 55 to 240% and 240 to 450% after 3 hours and 24 hours, respectively.
- An adhesive sheet is provided.
- the bioactive agent is preferably a hydrophilic bioactive agent.
- the bioactive agent is preferably a sphingolipid.
- the thermoplastic elastomer is preferably hydrogenated styrene-butadiene rubber.
- the pressure-sensitive adhesive sheet for skin of the present invention preferably further contains 1 to 30% by weight of oil.
- the skin pressure-sensitive adhesive sheet of the present invention preferably further comprises 1 to 25% by weight of a tackifying resin.
- the skin pressure-sensitive adhesive sheet of the present invention is preferably at least selected from the group consisting of a base material and a thermoplastic elastomer of 2 to 35% by weight formed on one side thereof; sodium carboxymethylcellulose, pectin, karaya gum and gelatin.
- one hydrophilic polymer compound selected from the group consisting of polyisobutylene, polyisoprene, polybutadiene, polybutene, styrene-isoprene rubber, ethylene-propylene rubber, styrene-ethylene-propylene rubber and derivatives thereof
- Skin pressure-sensitive adhesive comprising at least one softening agent of 16 to 40% by weight; bioactive agent 0.01 to 4.8% by weight; oil 1 to 30% by weight; and tackifying resin 1 to 25% by weight
- the water absorption after 3 hours and 24 hours was 55 to 240%, respectively. Beauty is a 240 to 450 percent.
- the adhesive sheet for ostomy appliance face plates which consists of an adhesive sheet for skin of this invention.
- the pressure-sensitive adhesive sheet for ostomy appliance face plate of the present invention preferably has a convex surface on the skin pressure-sensitive adhesive surface of the skin pressure-sensitive adhesive layer.
- a hole for inserting a stoma is formed at the center, and no substrate is present around the hole.
- a hole for inserting a stoma is formed at the center, and the base material around the hole has a fragile part.
- the ostomy appliance faceplate provided with the adhesive sheet for ostomy appliance faceplates of this invention is provided.
- the adhesive for skin of the present invention has good adhesiveness and adaptability to the skin, and also maintains sufficient absorbability for moisture from sweat and excrement and shape retention after absorption. Moreover, at the time of peeling, there is no residue of the skin adhesive on the skin, and it can be peeled off without damaging the skin or wound surface. Therefore, the skin pressure-sensitive adhesive sheet using this skin pressure-sensitive adhesive and the ostomy faceplate provided with this skin pressure-sensitive adhesive sheet are less likely to cause skin irritation or discomfort even when applied to the skin for a long time. There is little peeling from the skin under the influence of objects and moisture.
- FIG. 1 is a graph showing the evaluation results of the ostomy appliance faceplate of the present invention by the stoma holder.
- the adhesive for skin of the present invention comprises a thermoplastic elastomer, a hydrophilic polymer compound, a softening agent and a bioactive agent.
- thermoplastic elastomer for constituting the adhesive for skin of the present invention
- thermoplastic elastomer for constituting the adhesive for skin of the present invention
- thermoplastic elastomer for constituting the adhesive for skin of the present invention
- thermoplastic elastomer for constituting the adhesive for skin of the present invention
- thermoplastic elastomer for constituting the adhesive for skin of the present invention
- styrene thermoplastic elastomer examples include hydrogenated styrene-butadiene rubber (HSBR), styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), and styrene-ethylene.
- HSBR hydrogenated styrene-butadiene rubber
- SIS styrene-isoprene-styrene block copolymer
- SBS styrene-butadiene-styrene block copolymer
- styrene-ethylene examples include hydrogenated styrene-butadiene rubber (HSBR), styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), and sty
- SEPS Propylene-styrene block copolymer
- SEBS butylene-styrene block copolymer
- SEEPS styrene-ethylene / ethylene / propylene-styrene block copolymer
- SEBC olefin crystal block copolymer
- HBR hydrogenated styrene-butadiene rubber
- SIS styrene-isoprene-styrene block copolymer
- HBR hydrogenated styrene-butadiene rubber
- SIS hydrogenated styrene-butadiene rubber
- HSBR hydrogenated styrene-butadiene rubber
- SIS hydrogenated styrene-butadiene rubber
- the thermoplastic elastomer may be used alone or in combination of two or more.
- the blending amount of the thermoplastic elastomer needs to be 2 to 35% by weight with respect to the total weight of the skin adhesive.
- the amount is preferably 5 to 20% by weight.
- hydrophilic polymer compound As the hydrophilic polymer compound for constituting the skin adhesive of the present invention, a natural, semi-synthetic or synthetic hydrophilic polymer compound can be used.
- natural hydrophilic polymer compounds include plant gums such as gum arabic, gum tragacanth, galactan, guar gum, carob gum, caraya gum, carrageenan, pectin, agar, starch (eg, rice, corn, potato and wheat starch). Molecules; microbial polymers such as xanthan gum, dextrin, dextran, succinoglucan, and pullulan; animal polymers such as casein, albumin, and gelatin;
- semi-synthetic hydrophilic polymer compounds include starch polymers (eg, carboxymethyl starch, methylhydroxypropyl starch, etc.); cellulosic polymers (eg, methylcellulose, ethylcellulose, methylhydroxypropylcellulose, hydroxyethylcellulose, Cellulose sodium sulfate, hydroxypropylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, etc.); alginic acid polymers (for example, sodium alginate, propylene glycol alginate, etc.); Specific examples of the synthetic hydrophilic polymer compound include vinyl polymers (eg, polyvinyl alcohol, polyvinyl methyl ether, polyvinyl pyrrolidone, carboxyvinyl polymer); acrylic polymers (eg, sodium polyacrylate, polyacrylamide, etc.) ); Polyethyleneimine; and the like.
- starch polymers eg, carboxymethyl starch, methylhydroxypropyl starch, etc.
- hydrophilic polymer compounds carboxymethylcellulose sodium, pectin, karaya gum and gelatin are preferable, and carboxymethylcellulose sodium is particularly preferable.
- the hydrophilic polymer compound may be used alone or in combination of two or more.
- the blending amount of the hydrophilic polymer compound needs to be 25 to 60% by weight based on the total weight of the skin adhesive. This blending amount is preferably 35 to 55% by weight.
- the blending amount of the hydrophilic polymer compound is within the above range, the absorption of moisture of sweat and excrement by the skin adhesive is improved, the skin irritation due to skin maceration and the like is reduced, and the skin adhesive Long-term skin application is possible.
- Softener As a softener for constituting the skin adhesive of the present invention, a liquid or semi-solid resin can be used.
- the softening agent include polyisobutylene, polyisoprene, polybutadiene, polybutene, styrene-isoprene rubber, ethylene-propylene rubber, styrene-ethylene-propylene rubber, and derivatives such as hydrogenated products thereof. Of these, polyisobutylene is particularly preferred.
- a softener may be used individually by 1 type, or may use 2 or more types together.
- the blending amount of the softener needs to be 16 to 40% by weight with respect to the total weight of the skin adhesive. This blending amount is preferably 20 to 40% by weight. When the blending amount of the softener is within the above range, the adhesive strength and flexibility of the skin adhesive are improved, thereby reducing the skin irritation and physical irritation caused by the hardness of the skin adhesive. Is done.
- the physiologically active agent for constituting the adhesive for skin of the present invention has a function of maintaining or improving the physiological function (skin barrier function, etc.) of the skin.
- the bioactive agent is not particularly limited, but preferably has a hydrophilic group such as a hydroxy group, a carboxy group, an amino group, a carbonyl group, or a sulfo group and exhibits hydrophilicity.
- hydrophilic bioactive agents include sphingolipids, urea, glycolic acid, amino acids (arginine, cysteine, glycine, lysine, proline, serine, etc.) and derivatives thereof, protein hydrolysates (collagen, elastin, keratin, etc.), Mucopolysaccharides (hyaluronic acid, chondroitin sulfate, heparin, etc.) and derivatives thereof, vitamin B group (thiamine, riboflavin, nicotinic acid, pyridoxine, pyridoxal, pyridoxamine, biotin, folic acid, cyanocobalamin, etc.), ascorbic acid (vitamin C and its derivatives) , Retinoids (vitamin A, retinal, retinoic acid, etc.), vitamin D (D2, D3, etc.), vitamin E and its derivatives, carotenoids (carotene, lycopene, xanthophyll
- sphingolipids are particularly preferred.
- ceramide in which sphingosine and a fatty acid are bonded and glycosphingolipid in which ceramide and a sugar are bonded are preferable.
- the ceramide either natural or synthetic ceramide may be used, and examples thereof include ceramides of types 1 to 7, and ceramides of types 2, 5, and 7 are particularly preferable.
- the sphingoglycolipid cerebroside, galactosylceramide, glucosylceramide and the like are preferable.
- the physiologically active agent may be used alone or in combination of two or more.
- the blending amount of the bioactive agent needs to be 0.01 to 4.8% by weight with respect to the total weight of the skin adhesive. This blending amount is preferably 0.05 to 3% by weight.
- the blending amount of the bioactive agent is within the above range, the effect of maintaining and improving the physiological function (skin barrier function, etc.) of the skin becomes excellent.
- the use of a hydrophilic bioactive agent provides good water absorption characteristics in a short time after application, and is suitable for use in combination with other components constituting the skin adhesive of the present invention. Excellent water absorption characteristics.
- the adhesive for skin of this invention contains oil other than the said essential component.
- the oil that can be used may be any of mineral oil, vegetable oil, animal oil and synthetic oil. Specific examples of the mineral oil include liquid paraffin, liquid isoparaffin, and naphthenic oil.
- vegetable oils include olive oil, olive squalane, macadamia nut oil, jojoba oil, castor oil, palm oil, palm oil, safflower oil, sunflower oil, hardened palm oil, hardened palm oil, almond oil, peanut oil, cottonseed oil , avocado oil, apricot oil, grape seed oil, peppermint oil, mint oil, spearmint oil, lavender oil, tea tree oil, eucalyptus oil, peppermint oil, clove oil, cinnamon oil, rosemary oil, orange oil, lemongrass oil, Examples include lemon oil, yuzu oil, lime oil, grapefruit oil, and hinoki oil.
- animal oils include lanolin, turtle oil, beeswax, squalene, pristane and the like.
- synthetic oils include fatty acid triglycerides such as glycerin tri-2-ethylhexanoate; silicone oils such as polymethylphenylsiloxane, polydimethylsiloxane, and aminosilicon; isopropyl myristate, octyldodecyl myristate, isononane And fatty acid esters such as isononyl acid, isopropyl palmitate, and ethylhexyl palmitate; Of these, mineral oil is preferred, and liquid paraffin is particularly preferred. In the present invention, the oil may be used alone or in combination of two or more.
- the amount of oil blended is preferably 1 to 30% by weight, more preferably 2 to 20% by weight, based on the total weight of the skin adhesive.
- the skin pressure-sensitive adhesive of the present invention preferably contains a tackifying resin in addition to the above essential components.
- tackifying resins that can be used include petroleum-based resins such as aliphatic copolymers, aromatic copolymers, aliphatic / aromatic copolymers, and alicyclic copolymers; coumarone-indene resins.
- the tackifying resin may be used alone or in combination of two or more.
- the compounding amount of the tackifying resin is preferably 1 to 25% by weight, more preferably 5 to 20% by weight, based on the total weight of the skin adhesive.
- a surfactant, powder, pH adjuster, antibacterial agent, and the like can be appropriately added to the skin pressure-sensitive adhesive of the present invention as long as the object of the present invention is not impaired.
- the adhesive for skin of the present invention needs to have a water absorption rate of 55 to 240% and 240 to 450% after 3 hours and 24 hours, respectively, and 60 to 200% and 250 to 420, respectively. % Is preferred.
- the water absorption rate is within the above range, sweat and excreta are absorbed quickly, and deformation and adhesive residue at the time of water absorption and peeling are prevented.
- skin troubles at the time of application are reduced, the physiological function (skin barrier function) of the skin is maintained or improved, and the application can be performed for a long time.
- the predetermined water absorption rate of the present invention closely related to such suitable characteristics includes the thermoplastic elastomer, hydrophilic polymer compound, softener, bioactive agent, oil, tackifying resin, etc. It can be expressed by combining at a ratio.
- the skin pressure-sensitive adhesive of the present invention preferably has a swelling rate of 135% or less after 3 hours and a swelling rate of 145% or less after 24 hours. When the swelling ratio is within this range, the skin pressure-sensitive adhesive can maintain its shape even after water absorption, and there is no adhesive residue even after peeling.
- the skin adhesive of the present invention preferably has a bending resistance of 10 to 50 mm / 20 mm. When the bending resistance is in this range, the skin is highly adaptable and less uncomfortable during application.
- the skin adhesive of the present invention preferably has a visible light transmittance of 2.5% or more, and more preferably has a visible light transmittance of 5.0% or more. Visible light transmittance in this range improves the aesthetics when skin adhesive is applied to the skin, and allows easy observation of water absorption and skin condition with the skin adhesive applied to the skin. be able to. Thereby, it is possible to confirm an appropriate replacement time without peeling off the affixed adhesive for skin, and it is possible to prevent moisture leakage and unnecessary replacement.
- At least one hydrophilic polymer compound 25 selected from the group consisting of 2 to 35% by weight of a styrenic thermoplastic elastomer; sodium carboxymethylcellulose, pectin, Karaya gum and gelatin.
- the bioactive agent is preferably hydrophilic.
- the bioactive agent is preferably a sphingolipid.
- the thermoplastic elastomer is preferably a hydrogenated styrene-butadiene rubber.
- the above skin adhesive of the present invention can be used in various forms. For example, in addition to a form including a base material such as a “skin adhesive sheet” described later, It can be used as a product molded into a ring shape or a stick shape, or filled into a tube or bottle.
- the adhesive sheet for skin of this invention consists of a base material and the layer of the adhesive for skin formed in the single side
- This skin adhesive layer can be composed of the same substances and blending ratio as the skin adhesive of the present invention.
- a film As the substrate, a film, foam (foam), fabric (nonwoven fabric, woven fabric, knitted fabric) or the like can be used. Among these, a film is preferable from the viewpoints of flexibility, stretchability, moderate water vapor permeability, fungus barrier property, ease of wiping off dirt, and the like. Specific examples of the film material include polyurethane, polyester, polyamide, polyethylene, polypropylene, acrylic polymer, olefin copolymer, and the like. Of these, polyurethane, polyester and polyamide are preferred.
- the thickness of the substrate is preferably 5 to 150 ⁇ m, particularly preferably 10 to 100 ⁇ m.
- the thickness of the adhesive layer for skin is preferably 0.1 to 2.5 mm, and more preferably 0.3 to 2 mm. When the thickness of the adhesive layer for skin is within this range, it exhibits moderate adhesive strength when a skin adhesive sheet is applied to the skin, and achieves excellent adaptability to the skin and suitable water absorption rate. Can do.
- the shape of the skin pressure-sensitive adhesive sheet of the present invention may be appropriately selected according to the purpose of use.
- Specific examples of the shape include a circle, an ellipse, a polygon such as a triangle, a rectangle, and a rhombus.
- the shape which combined these shapes suitably may be sufficient, and you may form in a roll shape.
- the method of forming the skin adhesive layer of the present invention on one side of the substrate is not particularly limited, but the adhesive is rolled into a sheet and the substrate is bonded to the substrate, the adhesive directly on the substrate.
- the method of extruding and pressing can be shown. Among these, a method in which the pressure-sensitive adhesive is rolled into a sheet and a base material is bonded thereto is preferable.
- the skin pressure-sensitive adhesive sheet of the present invention needs to have a water absorption rate of 55 to 240% and 240 to 450% after 3 hours and 24 hours, respectively, and 60 to 200% and 250 to 420, respectively. % Is preferred.
- the pressure-sensitive adhesive sheet for skin of the present invention preferably has a swelling rate of 110% or less after 3 hours and a swelling rate of 24% after 24 hours.
- the swelling ratio is within this range, the skin pressure-sensitive adhesive can maintain its shape even after water absorption, and there is no adhesive residue even after peeling.
- the skin adhesive sheet of the present invention preferably has a stiffness of 10 to 50 mm / 20 mm. When the bending resistance is within this range, the skin is highly adaptable and less uncomfortable during application.
- the skin pressure-sensitive adhesive sheet of the present invention preferably has a visible light transmittance of 2.5% or more, and more preferably has a visible light transmittance of 5.0% or more. Visible light transmittance within this range improves the aesthetics when the skin adhesive sheet is affixed to the skin, and allows easy observation of water absorption and skin condition while the skin adhesive sheet is affixed to the skin. be able to. Thereby, it is possible to confirm an appropriate replacement time without peeling off the affixed adhesive sheet for skin, and it is possible to prevent moisture leakage and unnecessary replacement.
- the skin pressure-sensitive adhesive sheet of the present invention comprising a substrate and a skin pressure-sensitive adhesive layer formed on one surface thereof is suitable as an ostomy appliance face plate pressure-sensitive adhesive sheet. That is, it is suitable as an adhesive sheet for adhesively fixing an ostomy appliance face plate (ostomy pouch) around the stoma.
- the face plate for an ostomy appliance according to the present invention includes the pressure-sensitive adhesive sheet for an ostomy appliance face plate.
- the pressure-sensitive adhesive sheet for ostomy appliance face plate of the present invention can be used for both one-piece type and two-piece type ostomy appliances, and the face plate can be constituted by a conventional method so as to be suitable for each type of appliance. That is, in the case of the one-piece type, the opening of the ostomy pouch only needs to be joined to the base material side of the skin pressure-sensitive adhesive sheet. It only has to be attached.
- the pressure-sensitive adhesive sheet for ostomy appliance faceplate of the present invention preferably has a convex surface on the skin pressure-sensitive adhesive surface (the surface opposite to the base material).
- the convex type ostomy appliance face plate that has a convex surface on the skin adhesive surface of the adhesive sheet increases the adhesion between the skin and the face plate when the stoma height is low or there are wrinkles or dents on the skin surrounding the stoma. It is possible to prevent the excrement from leaking.
- by combining the skin pressure-sensitive adhesive sheet having high adaptability and suitable water-absorbing properties of the present invention and this convex shape it is possible to ensure better adhesion to the skin.
- the convex surface preferably protrudes 1 to 15 mm outside the non-convex adhesive surface, and more preferably 2 to 10 mm outside.
- the convex surface is preferably formed in a circular range with a diameter of 25 to 120 mm, and more preferably formed in a circular range with a diameter of 50 to 90 mm.
- the method of forming a convex surface on the skin adhesive surface of the adhesive sheet is not particularly limited, and a method of pressing a plastic ring on the adhesive sheet for the ostomy appliance face plate from the side opposite to the adhesive surface, in the adhesive layer for skin Conventional methods such as a method of embedding a plastic ring and a method of making the center portion of the face plate convex by a press using a die can be used.
- the ostomy appliance face plate pressure-sensitive adhesive sheet of the present invention preferably has a stoma insertion hole formed at the center, and no substrate is present around the hole.
- the region where the substrate is not provided is preferably within 40 mm, preferably within 25 mm from the outer periphery of the stoma insertion hole.
- the shape and size of the hole can be easily changed with your finger without using scissors, and the face plate hole fits perfectly with the stoma shape. Can be adjusted.
- the adhesive for skin of the present invention is soft, the pore diameter can be easily adjusted by hand, and high adhesion to the skin can be obtained after application.
- the method for forming the stoma insertion hole is not particularly limited.
- the ostomy appliance face plate pressure-sensitive adhesive sheet of the present invention may have a stoma insertion hole formed at the center, and the base material around the hole may have a fragile portion.
- the fragile portion is a portion having a physical strength weaker than that of the base portion other than the fragile portion, and is a flexible portion that is more easily deformed than the portion other than the fragile portion.
- the region of the fragile portion is preferably within 40 mm from the outer peripheral edge of the stoma insertion hole, and more preferably within 25 mm.
- the shape and size of the hole can be easily changed with fingers without using scissors, and the face plate fits perfectly with the stoma shape
- the hole can be adjusted. Since the adhesive for skin of the present invention is soft, the pore diameter can be easily adjusted by hand, and high adhesion to the skin can be obtained after application.
- the mode in which the weak part is provided in the base material around the hole for stoma insertion is less in the flow of the adhesive for skin around the hole than the mode in which the base material is not provided around the hole for stoma insertion, and the inside of the pouch and the face plate Adhesion with can be prevented.
- a method of providing a fragile portion on the base material around the hole for stoma insertion a method of partially providing a slit or hole in the base material around the hole, a method of embossing (such as embossing) on the base material around the hole, Examples include a method in which the base material around the hole is made of a material that is more flexible than other parts. Further, a face plate having a convex surface on the skin adhesive surface and having no base material around the hole or having a fragile portion around the hole is compatible with the excellent adhesive property of the skin adhesive of the present invention. As a result, the adhesiveness is higher and there is no leakage of excrement.
- the test piece is gently slid in the direction of the slope, and the position of the other end of the test piece is read by the scale when the center point of one end of the test piece contacts the slope of the horizontal table.
- the bending resistance is indicated by the length (mm) of the movement of the test piece, and measurement is performed on three front and back surfaces, and an average value is calculated.
- the thickness of a test piece shall be 1.5 mm.
- the light transmittance at a wavelength of 550 nm is measured with a spectrophotometer.
- the thickness of a test piece shall be 1.5 mm.
- Example 1A Hydrogenated styrene-butadiene rubber (manufactured by JSR) as a thermoplastic elastomer, polyisobutylene (manufactured by Nippon Oil Co., Ltd., trade name “Himor 6H”) as a softener, liquid paraffin as oil are charged into a pressure kneader. Mix under pressure until uniform.
- JSR Hydrogenated styrene-butadiene rubber
- polyisobutylene manufactured by Nippon Oil Co., Ltd., trade name “Himor 6H”
- Example 1B A polyurethane film substrate (weight per unit area: 15 g / m 2 , thickness: 15 ⁇ m) was laminated on the skin pressure-sensitive adhesive obtained in Example 1 to obtain a pressure-sensitive adhesive sheet for skin 1B. The characteristics of the adhesive sheet for skin were evaluated. The results are shown in Table 1.
- Example 2B-4B Skin adhesives 2A to 4A were obtained in the same manner as in Example 1 except that the amount of each component was changed as shown in Table 1. Using this skin adhesive, skin adhesive sheets 2B to 4B were obtained in the same manner as in Example 1B. The results of evaluating the characteristics are shown in Table 1 (here, the results of evaluation of water absorption rate, swelling rate, stiffness and skin adhesion evaluation shown in Table 1 are measured values as an adhesive sheet for skin).
- the polyethylene film was used in Example 2B and 3B, and the polyurethane film was used in Example 4B.
- a skin pressure-sensitive adhesive sheet C1B was prepared by using an EMA (ethylene-methyl acrylate copolymer) film as a base material and using a pressure-sensitive adhesive having the composition shown in Table 1. Evaluated. In addition, the characteristics of the adhesive sheets C2B and C3B for skin used for the commercially available face plates for ostomy appliances were evaluated (Comparative Example C2B: “Varicare Treatmenta Flange” manufactured by Combatech Co., Ltd., Comparative Example C3B: “Ashura Self Plate” manufactured by Coloplast Co., Ltd. clear”).
- EMA ethylene-methyl acrylate copolymer
- the adhesive sheet for skin of the present invention has almost no irritation or discomfort at the time of application, almost no occurrence of wrinkling or peeling of the test piece, and no flow of the adhesive for skin, and shape retention.
- the skin adhesive did not remain on the skin at the time of peeling.
- the composition balance of the skin pressure-sensitive adhesive of the present invention provides characteristic cohesiveness, flexibility and water absorption characteristics of the skin pressure-sensitive adhesive, and these characteristics are suitable for skin adaptability and adhesiveness. Etc.
- the skin pressure-sensitive adhesive sheet of the comparative example there was deformation and flow of the skin pressure-sensitive adhesive, and the skin pressure-sensitive adhesive once absorbed was dried and hardened, resulting in irritation and discomfort during application.
- Example 1C A substantially circular ostomy appliance face plate 1C was cut out from the skin adhesive sheet obtained in Example 1B, and a two-piece fitting type ostomy appliance using this face plate 1C was produced by a conventional method.
- Various characteristics were evaluated by 38 stoma holders when the ostomy appliance face plate 1C was used in place of a conventional product. The result is shown in FIG.
- the numbers in FIG. 1 are the number of stoma holders determined to be in a satisfactory level for each characteristic of the ostomy appliance faceplate 1C according to the present invention among the 38 stoma holders who participated in the evaluation.
- the conventional product used by 38 stoma holders is a two-piece fitting type ostomy appliance, and the adhesive sheet of the face plate has the following composition and water absorption characteristics.
- Composition of conventional adhesive 51% by weight of hydrophilic polymer compound consisting of karaya gum, pectin, alginate, gelatin and guar gum, 36% by weight of softening agent consisting of polyisobutylene, 4.4% by weight of tackifying resin consisting of alicyclic saturated hydrocarbon resin, etc. Butyl rubber 4.4% by weight and silica 4.2% by weight as modifiers.
- Water absorption of conventional products Water absorption 153% after 3 hours, water absorption 541% after 24 hours.
- the ostomy appliance faceplate of the present invention has an adhesiveness (initial adhesiveness) when the faceplate is first applied to the skin, adhesiveness during wearing, sticking feeling, It is excellent in durability, etc., and has no adhesive residue on the skin (glue residue) at the time of peeling, and can be peeled off without damaging the skin. there were. Therefore, it can be said that the ostomy appliance faceplate of the present invention has very little skin irritation even when used for a long period of time, and can maintain or improve the physiological function (skin barrier function) of the skin.
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Abstract
Description
更に詳しくは、本発明は、ストーマ周囲の皮膚保護、オストミー装具面板、創傷包帯等に使用する皮膚用粘着剤、この皮膚用粘着剤の層を有する皮膚用粘着シート及びこの皮膚用粘着シートを備えてなるオストミー装具面板に関する。
このオストミー装具の面板には、長時間皮膚に貼付しても皮膚や***物からの水分を吸収できるように、親水性高分子化合物が配合された所謂ハイドロコロイド皮膚用粘着剤が一般に使用されている(例えば、特許文献1~9)。
このオストミー装具の面板は、上記吸水特性を満足する他に、更に、凝集性、保形性及び皮膚への順応性のバランスを保つことが重要となる。
従来の面板は、多くの水分を吸収できるものもあるが、凝集性が十分でなく、吸水後に面板外周縁から皮膚用粘着剤が溶け出したり、剥離時に糊残りを起こしたりする場合があった。また、凝集性や保形性を高めたものは、吸水特性や皮膚への順応性が劣る場合があり、長時間の貼付により、面板が剥離したり、貼付時に違和感を生じたりする場合があった。
また、ストーマ保有者は、オストミー装具を長期に亘り使用することになるので、面板の貼付と剥離とを繰り返すうちに、皮膚の生理機能(皮膚バリア機能)が低下し、皮膚炎等を引き起こしやすくなる。
また、創傷包帯等に使用する皮膚用粘着剤又は粘着シートにおいても、長時間貼付した場合に、血液、滲出液等を速やかに吸収し、患部への順応性が良好で、剥離時には糊残りがないものが求められる。
また、本発明の他の課題は、皮膚の生理機能(皮膚バリア機能)を保持又は向上させ得る皮膚用粘着剤を提供することにある。
更に本発明の他の課題は、基材と前記皮膚用粘着剤の層とからなる皮膚用粘着シートを提供することにある。
更に本発明の他の課題は、前記皮膚用粘着シートを備えてなるオストミー装具面板を提供することにある。
本発明の皮膚用粘着剤において、生理活性剤が親水性生理活性剤であることが好ましい。
また、本発明の皮膚用粘着剤において、生理活性剤がスフィンゴ脂質であることが好ましい。
更に、本発明の皮膚用粘着剤において、熱可塑性エラストマーが水添スチレン-ブタジエンゴムであることが好ましい。
本発明の皮膚用粘着剤は、更に、油1~30重量%を含有してなるものであることが好ましい。
また、本発明の皮膚用粘着剤は、更に、粘着付与樹脂1~25重量%を含有してなるものであることが好ましい。
本発明のこのような特定の配合とそれに基づく所定の吸水特性が相俟って、皮膚への良好な接着性や順応性が奏され、糊残りや剥離刺激を防ぎ、皮膚の生理機能を保持又は向上させることが可能となる。
本発明の皮膚用粘着シートにおいて、生理活性剤が親水性生理活性剤であることが好ましい。
また、本発明の皮膚用粘着シートにおいて、生理活性剤がスフィンゴ脂質であることが好ましい。
更に、本発明の皮膚用粘着シートにおいて、熱可塑性エラストマーが水添スチレン-ブタジエンゴムであることが好ましい。
本発明の皮膚用粘着シートは、更に、油1~30重量%を含有してなるものであることが好ましい。
また、本発明の皮膚用粘着シートは、更に、粘着付与樹脂1~25重量%を含有してなるものであることが好ましい。
本発明のオストミー装具面板用粘着シートは、その皮膚用粘着剤層の皮膚粘着面に凸面を有するものであることが好ましい。
また、本発明のオストミー装具面板用粘着シートにおいて、中央部にストーマ挿入用の孔が形成されており、この孔周囲には基材が存在しないことが好ましい。
また、本発明のオストミー装具面板用粘着シートにおいて、中央部にストーマ挿入用の孔が形成されており、この孔周囲の基材が脆弱部を有することが好ましい。
また、本発明によれば、本発明のオストミー装具面板用粘着シートを備えてなるオストミー装具面板が提供される。
従って、この皮膚用粘着剤を用いた皮膚用粘着シート及びこの皮膚用粘着シートを備えてなるオストミー用面板は、これを長時間皮膚に貼付しておいても、皮膚刺激や違和感が少なく、***物や水分の影響で皮膚から剥離することも少ない。
本発明の皮膚用粘着剤は、熱可塑性エラストマー、親水性高分子化合物、軟化剤及び生理活性剤を含有してなる。
本発明の皮膚用粘着剤を構成するための熱可塑性エラストマーの具体例としては、スチレン系熱可塑性エラストマー、オレフィン系熱可塑性エラストマー、ポリエステル系熱可塑性エラストマー、ポリアミド系熱可塑性エラストマー、ウレタン系熱可塑性エラストマー、塩化ビニル系熱可塑性エラストマー、ジエン系熱可塑性エラストマー等が挙げられる。
これらのうち、特にスチレン系熱可塑性エラストマーが好適である。
スチレン系熱可塑性エラストマーの具体例としては、水添スチレン-ブタジエンゴム(HSBR)、スチレン-イソプレン-スチレンブロック共重合体(SIS)、スチレン-ブタジエン-スチレンブロック共重合体(SBS)、スチレン-エチレン/プロピレン-スチレンブロック共重合体(SEPS)、スチレン-エチレン/ブチレン-スチレンブロック共重合体(SEBS)、スチレン-エチレン/エチレン/プロピレン-スチレンブロック共重合体(SEEPS)、スチレン-エチレン/ブチレン-オレフィン結晶ブロック共重合体(SEBC)等が挙げられる。
これらのうち、水添スチレン-ブタジエンゴム(HSBR)、スチレン-イソプレン-スチレンブロック共重合体(SIS)が好ましく、水添スチレン-ブタジエンゴム(HSBR)が特に好ましい。
熱可塑性エラストマーの配合量は、皮膚用粘着剤の全重量に対して、2~35重量%であることが必要である。この配合量は、好ましくは、5~20重量%である。
熱可塑性エラストマーの配合量が上記範囲内にあることにより、皮膚用粘着剤の凝集性及び形状保持性が向上し、吸水後における皮膚用粘着剤の過度な膨潤、皮膚用粘着剤のフロー(崩壊)及び剥離時の糊残りを防止することができる。
本発明の皮膚用粘着剤を構成するための親水性高分子化合物としては、天然、半合成又は合成の親水性高分子化合物を使用できる。
天然親水性高分子化合物の具体例としては、アラビアガム、トラガカントガム、ガラクタン、グアガム、キャロブガム、カラヤガム、カラギーナン、ペクチン、カンテン、デンプン(例えば、コメ、トウモロコシ、バレイショ及びコムギのデンプン)等の植物系高分子;キサンタンガム、デキストリン、デキストラン、サクシノグルカン、プルラン等の微生物系高分子;カゼイン、アルブミン、ゼラチン等の動物系高分子;等が挙げられる。
合成親水性高分子化合物の具体例としては、ビニル系高分子(例えば、ポリビニルアルコール、ポリビニルメチルエーテル、ポリビニルピロリドン、カルボキシビニルポリマー等);アクリル系高分子(例えば、ポリアクリル酸ナトリウム、ポリアクリルアミド等);ポリエチレンイミン;等が挙げられる。
本発明において、親水性高分子化合物は、1種類を単独で使用しても、2種類以上を併用してもよい。
親水性高分子化合物の配合量は、皮膚用粘着剤の全重量に対して、25~60重量%であることが必要である。この配合量は、好ましくは、35~55重量%である。
親水性高分子化合物の配合量が上記範囲内にあることにより、皮膚用粘着剤による汗や***物の水分の吸収が良好となり、皮膚浸軟等による皮膚刺激を軽減し、皮膚用粘着剤の長時間の皮膚貼付が可能となる。
本発明の皮膚用粘着剤を構成するための軟化剤としては、液状又は半固体状の樹脂を使用することができる。軟化剤の具体例としては、ポリイソブチレン、ポリイソプレン、ポリブタジエン、ポリブテン、スチレン-イソプレンゴム、エチレン-プロピレンゴム、スチレン-エチレン-プロピレンゴム、及びこれらの水添物等の誘導体を挙げることができる。これらのうち、ポリイソブチレンが特に好適である。
本発明において、軟化剤は、1種類を単独で使用しても、2種類以上を併用してもよい。
軟化剤の配合量が上記範囲内にあることにより、皮膚用粘着剤の粘着力や柔軟性が向上し、それにより、皮膚の引きつれや、皮膚用粘着剤の硬さによる物理刺激等が緩和される。
本発明の皮膚用粘着剤を構成するための生理活性剤は、皮膚の生理機能(皮膚バリア機能等)を保持又は向上する機能を有するものである。生理活性剤は特に限定されないが、ヒドロキシ基、カルボキシ基、アミノ基、カルボニル基、スルホ基等の親水基を有し、親水性を発揮するものが好ましい。
親水性生理活性剤の具体例としてはスフィンゴ脂質、尿素、グリコール酸、アミノ酸(アルギニン、システイン、グリシン、リシン、プロリン、セリン等)及びその誘導体、タンパク質加水分解物(コラーゲン、エラスチン、ケラチン等)、ムコ多糖(ヒアルロン酸、コンドロイチン硫酸、ヘパリン等)及びその誘導体、ビタミンB群(チアミン、リボフラビン、ニコチン酸、ピリドキシン、ピリドキサール、ピリドキサミン、ビオチン、葉酸、シアノコバラミン等)、アスコルビン酸(ビタミンC及びその誘導体)、レチノイド(ビタミンA、レチナール、レチノイン酸等)、ビタミンD(D2、D3等)、ビタミンE及びその誘導体、カロチノイド(カロチン、リコピン、キサントフィル等)、酵素、補酵素、γ―オリザノール等を挙げることができる。これらのうち、スフィンゴ脂質が特に好ましい。
スフィンゴ脂質としては、スフィンゴシンと脂肪酸とが結合したセラミド及びセラミドと糖とが結合したスフィンゴ糖脂質が好ましい。
セラミドは、天然、合成いずれのものを使用してもよく、タイプ1~7のセラミドを挙げることができるが、タイプ2、5、7のセラミドが特に好ましい。
スフィンゴ糖脂質としては、セレブロシド、ガラクトシルセラミド、グルコシルセラミド等が好ましい。
本発明において、生理活性剤は、1種類を単独で使用しても、2種類以上を併用してもよい。
生理活性剤の配合量が上記範囲内にあることにより、皮膚の生理機能(皮膚バリア機能等)の保持及び向上効果が優れたものとなる。
特に親水性生理活性剤を使用することにより、貼付後短時間での吸水特性が良好なものとなり、また、本発明の皮膚用粘着剤を構成する他の成分と相俟って本発明の好適な吸水特性が発揮される。
本発明の皮膚用粘着剤は、上記必須成分のほかに、油を含有してなるものであることが好ましい。
使用し得る油は、鉱油、植物油、動物油及び合成油のいずれであってもよい。
鉱油の具体例としては、流動パラフィン、流動イソパラフィン、ナフテン油等を挙げることができる。
植物油の具体例としては、オリーブ油、オリーブスクワラン、マカデミアナッツ油、ホホバ油、ひまし油、やし油、パーム油、サフラワー油、ひまわり油、硬化やし油、硬化パーム油、アーモンド油、落花生油、綿実油、アボガド油、杏仁油、グレープシード油、ペパーミント油、ミント油、スペアミント油、ラベンダー油、ティーツリー油、ユーカリ油、ハッカ油、チョウジ油、ケイヒ油、ローズマリー油、オレンジ油、レモングラス油、レモン油、ユズ油、ライム油、グレープフルーツ油、ヒノキ油等を挙げることができる。
動物油の具体例としては、ラノリン、タートル油、ミツロウ、スクワレン、プリスタン等を挙げることができる。
また、合成油の具体例としては、グリセリントリ-2-エチルヘキサノエート等の脂肪酸トリグリセライド;ポリメチルフェニルシロキサン、ポリジメチルシロキサン、アミノシリコン等のシリコーンオイル;ミリスチン酸イソプロピル、ミリスチン酸オクチルドデシル、イソノナン酸イソノニル、パルミチン酸イソプロピル、パルミチン酸エチルヘキシル等の脂肪酸エステル類;等を挙げることができる。
これらのうち、鉱油が好ましく、流動パラフィンが特に好ましい。
本発明において、油は、1種類を単独で使用しても、2種類以上を併用してもよい。
皮膚用粘着剤に油を配合することにより、柔軟性や使用感を向上し、剥離刺激を軽減することができる。
本発明の皮膚用粘着剤は、上記必須成分のほかに、粘着付与樹脂を含有してなるものであることが好ましい。
使用し得る粘着付与樹脂の具体例としては、脂肪族共重合体、芳香族共重合体、脂肪族・芳香族共重合体、脂環式共重合体等の石油系樹脂;クマロン-インデン系樹脂;テルぺン系樹脂;テルぺン-フェノール系樹脂;重合ロジン等のロジン系樹脂;(アルキル)フェノール系樹脂;キシレン系樹脂;これらの水添物;等を挙げることができる。
本発明において、粘着付与樹脂は、1種類を単独で使用しても、2種類以上を併用してもよい。
皮膚用粘着剤に粘着付与樹脂を配合することにより、皮膚に皮膚用粘着剤を長時間貼付した場合でも、***物等に含まれる水分による剥離を低減でき、皮膚への密着性が向上する。
また、本発明の皮膚用粘着剤には、上記の成分以外に、界面活性剤、粉体、pH調整剤、抗菌剤等を本発明の目的を損なわない程度において適宜配合することができる。
また、本発明の皮膚用粘着剤は、3時間後の膨潤率が135%以下であり、且つ、24時間後の膨潤率が145%以下であることが好ましい。膨潤率がこの範囲にあることにより、皮膚用粘着剤は、吸水後でも形状を保つことができ、剥離時にも糊残りがない。
以上の本発明の皮膚用粘着剤は、様々な形態で用いることができ、例えば、後述する「皮膚用粘着シート」のような基材を備える形態のほか、基材を用いずに、板状、リング状、スティック状等に成型したものや、チューブやボトルに充填したもの等として、用いることができる。
本発明の皮膚用粘着シートは、基材とその片面に形成された皮膚用粘着剤の層とからなる。
この皮膚用粘着剤の層は、上記本発明の皮膚用粘着剤と同様の物質、配合比で構成できる。
基材としては、フィルム、フォーム(発泡体)、布帛(不織布、織布、編布)等を使用することができる。これらのうち、柔軟性、伸縮性、適度の水蒸気透過性、菌バリヤー性、汚れの拭き取りやすさ等の観点からフィルムが好ましい。
フィルム材質の具体例としては、ポリウレタン、ポリエステル、ポリアミド、ポリエチレン、ポリプロピレン、アクリル系重合体、オレフィン系共重合体等を挙げることができる。これらのうち、ポリウレタン、ポリエステル及びポリアミドが好ましい。
基材の厚さは、5~150μmであることが好ましく、10~100μmであることが特に好ましい。
また、本発明の皮膚用粘着シートは、3時間後の膨潤率が110%以下であり、且つ、24時間後の膨潤率が130%以下であることが好ましい。膨潤率がこの範囲にあることにより、皮膚用粘着剤は、吸水後でも形状を保つことができ、剥離時にも糊残りがない。
基材とその片面に形成された皮膚用粘着剤の層とからなる、本発明の皮膚用粘着シートは、オストミー装具面板用粘着シートとして好適である。即ち、オストミー装具面板(オストミーパウチ)をストーマ周囲に粘着固定するための粘着シートとして好適である。
本発明のオストミー装具用面板は、このオストミー装具面板用粘着シートを備えてなる。
粘着シートの皮膚粘着面に凸面を有する、いわゆるコンベックスタイプのオストミー装具面板は、ストーマの高さが低い場合や、ストーマ周囲皮膚に皺や窪みがある場合に、皮膚と面板との密着性を高めることができ、***物の漏れを防止することができる。特に、本発明の高い順応性及び好適な吸水特性を有する皮膚用粘着シートと、この凸面形状と、を組み合わせることにより、より優れた皮膚との密着性を確保できる。
凸面は、凸になっていない粘着面より1~15mm外側に出っ張っていることが好ましく、2~10mm外側に出っ張っていることが更に好ましい。また、凸面は、直径25~120mmの円形範囲で凸面を形成していることが好ましく、直径50~90mmの円形範囲で凸面を形成していることが更に好ましい。
粘着シートの皮膚粘着面に凸面を形成する方法は、特に限定されず、オストミー装具面板用粘着シートにプラスチック製リングを、粘着面とは反対側から、押し当てる方法、皮膚用粘着剤層中にプラスチック製リングを埋め込む方法、型によるプレスで面板中央部を凸面にする方法等、従来からの方法を利用することができる。
基材を設けない領域は、ストーマ挿入用孔の外周縁から40mm以内、好ましくは25mm以内とすることが好ましい。このように、ストーマ挿入用孔の周囲に基材を設けないことにより、ハサミを使わずに指で簡単に、孔の形や大きさを変えることができ、ストーマの形にぴったりと合う面板孔を調整することができる。本発明の皮膚用粘着剤は柔らかいので、手による孔径の調整が容易であり、貼付後は皮膚への高い密着性を得ることができる。
なお、ストーマ挿入用の孔を形成する方法は、特に限定されない。
脆弱部の領域は、ストーマ挿入用の孔の外周縁から40mm以内とすることが好ましく、25mm以内とすることがより好ましい。このように、ストーマ挿入用の孔周囲の基材に脆弱部を設けることにより、ハサミを使わずに指で簡単に孔の形や大きさを変えることができ、ストーマの形にぴったりと合う面板孔を調整することができる。本発明の皮膚用粘着剤は柔らかいので、手による孔径の調整が容易であり、貼付後は皮膚への高い密着性を得ることができる。
ストーマ挿入用の孔周囲の基材に脆弱部を設ける態様は、ストーマ挿入用の孔周囲に基材を設けない態様に比べて、孔周囲の皮膚用粘着剤の流出が少なく、パウチ内部と面板との粘着を防ぐことができる。
ストーマ挿入用の孔周囲の基材に脆弱部を設ける方法としては、孔周囲の基材に部分的にスリットや孔を設ける方法、孔周囲の基材に型押し加工(エンボス等)する方法、孔周囲の基材を他の部分より柔軟な材料で構成する方法等が挙げられる。
また、皮膚粘着表面に凸面を有し、且つ、孔周囲に基材が存在しないか又は孔周囲の基材が脆弱部を有する面板は、本発明の皮膚用粘着剤の優れた粘着特性とも相俟って、より一層密着性が高く、***物の漏れのないものとなる。
皮膚用粘着剤又は皮膚用粘着シートから直径30mmの試験片を採取し、この試験片の重量を測定する。試験片を生理食塩水(0.9%NaCl水溶液)に浸漬し、37℃恒温槽中に静置する。浸漬3時間後及び24時間後に試験片の重量を測定し、下式により吸水率を求める。
なお、皮膚用粘着剤については、試験片の厚さを1.5mmとする。
吸水率(%)=[(浸漬後の試験片重量-浸漬前の試験片重量)/浸漬前の試験片重量]×100
皮膚用粘着剤又は皮膚用粘着シートから直径30mmの試験片を採取し、この試験片を生理食塩水(0.9%NaCl水溶液)に浸漬し、37℃恒温槽中に静置する。浸漬3時間後及び24時間後に試験片の直交する2方向についての最大直径を測定し、その平均値を吸水後の直径とし、下式により膨潤率を求める。
なお、皮膚用粘着剤については、試験片の厚さを1.5mmとする。
膨潤率(%)=(吸水後の試験片直径(mm)/吸水前の試験片直径(30mm))×100
JIS L 1096「剛軟性 A法(45°カンチレバー法)」に準じて、皮膚用粘着剤及び皮膚用粘着シートの剛軟性を測定する。具体的には、次のとおりである。
皮膚用粘着剤又は皮膚用粘着シートから20mm×80mmの試験片を3枚用意し、23℃、湿度65%の環境下で1時間静置する。その後、一端が45度の斜面を持つ表面の滑らかな水平台の上に試験片の短辺をスケール基線に合わせて置く。次に、試験片を斜面の方向に緩やかに滑らせて、試験片の一端の中央点が水平台の斜面と接したときに試験片の他端の位置をスケールによって読む。
剛軟度は、試験片が移動した長さ(mm)で示し、3枚の表裏について測定を行ない、平均値を算出する。
なお、皮膚用粘着剤については、試験片の厚さを1.5mmとする。
波長550nmにおける光の透過率を分光光度計で測定する。
なお、皮膚用粘着剤については、試験片の厚さを1.5mmとする。
〔(1):貼付感〕
皮膚用粘着剤又は皮膚用粘着シートから幅25mm×長さ50mmの試験片を採取し、これを被験者の下腹部に貼付し、貼付してから24時間後までに被験者が感じる刺激及び違和感の程度によって3段階の基準(○:刺激や違和感がほとんどない、△:刺激や違和感が多少ある、×:刺激や違和感が強い)に従って評価する。
〔(2):貼付後の状況〕
貼付24時間経過後の、試験片の状況を観察して、試験片の変形や皺、剥がれや浮き、皮膚用粘着剤のフローの程度によって、3段階の基準(○:発生がほとんどない、△:多少発生する、×:顕著に発生する)に従って評価する。
熱可塑性エラストマーとして水添スチレン-ブタジエンゴム(JSR社製)、軟化剤としてポリイソブチレン(新日本石油社製、商品名「ハイモール6H」)、油として流動パラフィンを、加圧ニーダーに仕込み、十分均一になるまで加圧混合する。
次に、親水性高分子化合物としてカルボキシメチルセルロース・ナトリウム(日本製紙ケミカル社製)及びペクチン、生理活性剤としてタイプ2のセラミド、並びに粘着付与剤として脂環族飽和炭化水素樹脂(荒川化学工業社製、商品名「アルコンP-100」)を加え、均等になるまで混合し、厚さ1.5mmに圧延し、皮膚用粘着剤1Aを得た。各成分の配合量を表1に示す。
実施例1で得られた皮膚用粘着剤に、ポリウレタンフィルム基材(単位面積当りの重さは15g/m2、厚さ15μm)を積層し、皮膚用粘着シート1Bを得た。
この皮膚用粘着シートの特性を評価した。結果を表1に示す。
各成分の量を表1に示すように変更したほかは、実施例1と同様にして皮膚用粘着剤2A~4Aを得た。この皮膚用粘着剤を用いて、実施例1Bと同様にして、皮膚用粘着シート2B~4Bを得た。その特性を評価した結果を表1に示す(ここで、表1に示した吸水率、膨潤率、剛軟性及び皮膚貼付評価の評価結果は、皮膚用粘着シートとしての測定値である。)。なお、基材としては、実施例2B及び3Bではポリエチレンフィルムを用い、実施例4Bではポリウレタンフィルムを用いた。
本発明の皮膚用粘着シートに代えて、EMA(エチレン-メチルアクリレ-ト共重合体)フィルムを基材とし、表1に示す組成の粘着剤を用いて皮膚用粘着シートC1Bを作成し、その特性を評価した。
また、市販のオストミー装具用面板に用いられている皮膚用粘着シートC2B及びC3Bの特性を評価した(比較例C2B:コンバテック社製 「バリケアナチュラフランジ」、比較例C3B:コロプラスト社製 「アシュラセルフプレートクリアー」)。
一方、比較例の皮膚用粘着シートでは、皮膚用粘着剤の変形やフローがあり、更にいったん吸水した皮膚用粘着剤が乾燥して硬くなり、貼付中に刺激や違和感が生じた。
実施例1Bで得られた皮膚用粘着シートから略円形のオストミー装具面板1Cを切り出し、この面板1Cを用いた2ピース嵌合タイプのオストミー装具を従来からの方法により作製した。このオストミー装具面板1Cを従来品に代えて使用したときの各種特性の評価をストーマ保有者38名により行なった。その結果を図1に示す。図1中の数字は、評価に参加したストーマ保有者38名中、本発明に係るオストミー装具面板1Cの各特性について、満足すべき水準にあると判定したストーマ保有者の数である。
〔従来品の粘着剤の組成〕
カラヤガム、ペクチン、アルギン酸塩、ゼラチン及びグアガムからなる親水性高分子化合物51重量%、ポリイソブチレンからなる軟化剤36重量%、脂環族飽和炭化水素樹脂からなる粘着付与樹脂4.4重量%、その他調整剤としてブチルゴム4.4重量%及びシリカ4.2重量%。
〔従来品の吸水率〕
3時間後の吸水率153%、24時間後の吸水率541%。
Claims (19)
- 熱可塑性エラストマー2~35重量%、親水性高分子化合物25~60重量%、軟化剤16~40重量%及び生理活性剤0.01~4.8重量%を含有してなり、3時間後の吸水率及び24時間後の吸水率が、それぞれ、55~240%及び240~450%である皮膚用粘着剤。
- 生理活性剤が親水性生理活性剤である請求の範囲第1項に記載の皮膚用粘着剤。
- 生理活性剤がスフィンゴ脂質である請求の範囲第1項又は第2項に記載の皮膚用粘着剤。
- 熱可塑性エラストマーが水添スチレン-ブタジエンゴムである請求の範囲第1項~第3項のいずれか1項に記載の皮膚用粘着剤。
- 更に、油1~30重量%を含有してなるものである請求の範囲第1項~第4項のいずれか1項に記載の皮膚用粘着剤。
- 更に、粘着付与樹脂1~25重量%を含有してなるものである請求の範囲第1項~第5項のいずれか1項に記載の皮膚用粘着剤。
- スチレン系熱可塑性エラストマー2~35重量%;カルボキシメチルセルロース・ナトリウム、ペクチン、カラヤガム及びゼラチンからなる群から選ばれる少なくとも1種の親水性高分子化合物25~60重量%;ポリイソブチレン、ポリイソプレン、ポリブタジエン、ポリブテン、スチレン-イソプレンゴム、エチレン-プロピレンゴム、スチレン-エチレン-プロピレンゴム及びこれらの誘導体からなる群から選ばれる少なくとも1種の軟化剤16~40重量%;生理活性剤0.01~4.8重量%;油1~30重量%;並びに粘着付与樹脂1~25重量%を含有してなり、3時間後の吸水率及び24時間後の吸水率が、それぞれ、55~240%及び240~450%である皮膚用粘着剤。
- 基材と、その片面に形成された、熱可塑性エラストマー2~35重量%、親水性高分子化合物25~60重量%、軟化剤16~40重量%及び生理活性剤0.01~4.8重量%を含有してなる皮膚用粘着剤の層と、からなり、3時間後及び24時間後の吸水率が、それぞれ、55~240%及び240~450%である皮膚用粘着シート。
- 生理活性剤が親水性生理活性剤である請求の範囲第8項に記載の皮膚用粘着シート。
- 生理活性剤がスフィンゴ脂質である請求の範囲第8項又は第9項に記載の皮膚用粘着シート。
- 熱可塑性エラストマーが水添スチレン-ブタジエンゴムである請求の範囲第8項~第10項のいずれか1項に記載の皮膚用粘着シート。
- 更に、油1~30重量%を含有してなるものである請求の範囲第8項~第11項のいずれか1項に記載の皮膚用粘着シート。
- 更に、粘着付与樹脂1~25重量%を含有してなるものである請求の範囲第8項~第12項のいずれか1項に記載の皮膚用粘着シート。
- 基材と、その片面に形成された、熱可塑性エラストマー2~35重量%;カルボキシメチルセルロース・ナトリウム、ペクチン、カラヤガム及びゼラチンからなる群から選ばれる少なくとも1種の親水性高分子化合物25~60重量%;ポリイソブチレン、ポリイソプレン、ポリブタジエン、ポリブテン、スチレン-イソプレンゴム、エチレン-プロピレンゴム、スチレン-エチレン-プロピレンゴム及びこれらの誘導体からなる群から選ばれる少なくとも1種の軟化剤16~40重量%;生理活性剤0.01~4.8重量%;油1~30重量%;並びに粘着付与樹脂1~25重量%を含有してなる皮膚用粘着剤の層と、からなり、3時間後及び24時間後の吸水率が、それぞれ、55~240%及び240~450%である皮膚用粘着シート。
- 請求の範囲第8項~第14項のいずれか1項に記載の皮膚用粘着シートからなるオストミー装具面板用粘着シート。
- 皮膚用粘着剤層の皮膚粘着面に凸面を有するものである請求の範囲第15項に記載のオストミー装具面板用粘着シート。
- 中央部にストーマ挿入用の孔が形成されており、この孔周囲には基材が存在しない請求の範囲第15項又は第16項に記載のオストミー装具面板用粘着シート。
- 中央部にストーマ挿入用の孔が形成されており、この孔周囲の基材が脆弱部を有する請求の範囲第15項又は第16項に記載のオストミー装具面板用粘着シート。
- 請求項請求の範囲第15項~第18項のいずれか1項に記載のオストミー装具面板用粘着シートを備えてなるオストミー装具面板。
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Application Number | Priority Date | Filing Date | Title |
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ES08869881.6T ES2521671T3 (es) | 2008-01-10 | 2008-12-18 | Agente adhesivo sensible a la presión para la piel, lámina adhesiva sensible a la presión para la piel y placa frontal de un dispositivo para ostomía |
CN200880124086.1A CN101909667B (zh) | 2008-01-10 | 2008-12-18 | 皮肤用粘合剂、皮肤用粘合片及造口术器具底板 |
EP08869881.6A EP2241340B1 (en) | 2008-01-10 | 2008-12-18 | Pressure-sensitive adhesive agent for skin, pressure-sensitive adhesive sheet for skin and face plate of ostomy appliance |
US12/808,593 US10335509B2 (en) | 2008-01-10 | 2008-12-18 | Pressure-sensitive adhesive agent for skin, pressure-sensitive adhesive sheet for skin, and face plate of ostomy appliance |
DK08869881.6T DK2241340T3 (da) | 2008-01-10 | 2008-12-18 | Tryk-følsomt klæbemiddel til hud, tryk-følsomt klæbefolie til hud og frontplade af stomi-indretning |
KR1020107016997A KR101322971B1 (ko) | 2008-01-10 | 2008-12-18 | 피부용 점착제, 피부용 점착시트 및 오스토미장구 면판 |
JP2009548876A JP5799371B2 (ja) | 2008-01-10 | 2008-12-18 | 皮膚用粘着剤、皮膚用粘着シート及びオストミー装具面板 |
US16/416,952 US20190269814A1 (en) | 2008-01-10 | 2019-05-20 | Pressure-sensitive adhesive agent for skin, pressure-sensitive adhesive sheet for skin, and face plate of ostomy appliance |
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JP2008-003200 | 2008-01-10 | ||
JP2008003200 | 2008-01-10 |
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US16/416,952 Continuation US20190269814A1 (en) | 2008-01-10 | 2019-05-20 | Pressure-sensitive adhesive agent for skin, pressure-sensitive adhesive sheet for skin, and face plate of ostomy appliance |
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EP (1) | EP2241340B1 (ja) |
JP (1) | JP5799371B2 (ja) |
KR (1) | KR101322971B1 (ja) |
CN (1) | CN101909667B (ja) |
DK (1) | DK2241340T3 (ja) |
ES (1) | ES2521671T3 (ja) |
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Also Published As
Publication number | Publication date |
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ES2521671T3 (es) | 2014-11-13 |
JP5799371B2 (ja) | 2015-10-21 |
EP2241340A1 (en) | 2010-10-20 |
EP2241340A4 (en) | 2013-02-13 |
JPWO2009087877A1 (ja) | 2011-05-26 |
DK2241340T3 (da) | 2014-08-25 |
US10335509B2 (en) | 2019-07-02 |
KR20100111284A (ko) | 2010-10-14 |
EP2241340B1 (en) | 2014-07-30 |
CN101909667B (zh) | 2015-04-22 |
US20110130698A1 (en) | 2011-06-02 |
CN101909667A (zh) | 2010-12-08 |
US20190269814A1 (en) | 2019-09-05 |
KR101322971B1 (ko) | 2013-10-29 |
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