CN107854453A - A kind of medical aquogel eyeshield dressing - Google Patents
A kind of medical aquogel eyeshield dressing Download PDFInfo
- Publication number
- CN107854453A CN107854453A CN201711366806.2A CN201711366806A CN107854453A CN 107854453 A CN107854453 A CN 107854453A CN 201711366806 A CN201711366806 A CN 201711366806A CN 107854453 A CN107854453 A CN 107854453A
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- CN
- China
- Prior art keywords
- dressing
- eyeshield
- water
- biological fiber
- medical aquogel
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- 239000000017 hydrogel Substances 0.000 claims abstract description 38
- 239000000835 fiber Substances 0.000 claims abstract description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000000463 material Substances 0.000 claims abstract description 24
- 239000000499 gel Substances 0.000 claims abstract description 19
- 239000012528 membrane Substances 0.000 claims abstract description 17
- 238000000926 separation method Methods 0.000 claims abstract description 14
- 230000001954 sterilising effect Effects 0.000 claims abstract description 11
- 238000004132 cross linking Methods 0.000 claims abstract description 10
- 239000008213 purified water Substances 0.000 claims abstract description 8
- 230000005855 radiation Effects 0.000 claims abstract description 8
- 238000004806 packaging method and process Methods 0.000 claims abstract description 7
- 239000003292 glue Substances 0.000 claims abstract description 6
- 229920003169 water-soluble polymer Polymers 0.000 claims abstract description 6
- 238000000034 method Methods 0.000 claims description 20
- -1 polyethylene Polymers 0.000 claims description 8
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 7
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 5
- 239000004698 Polyethylene Substances 0.000 claims description 5
- 239000004743 Polypropylene Substances 0.000 claims description 5
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- 229920001155 polypropylene Polymers 0.000 claims description 5
- SVTBMSDMJJWYQN-UHFFFAOYSA-N 2-methylpentane-2,4-diol Chemical compound CC(O)CC(C)(C)O SVTBMSDMJJWYQN-UHFFFAOYSA-N 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- CDQSJQSWAWPGKG-UHFFFAOYSA-N butane-1,1-diol Chemical compound CCCC(O)O CDQSJQSWAWPGKG-UHFFFAOYSA-N 0.000 claims description 3
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- 244000005700 microbiome Species 0.000 claims description 3
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- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 3
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
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- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical class CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 claims description 2
- 238000001179 sorption measurement Methods 0.000 claims description 2
- KKEYFWRCBNTPAC-UHFFFAOYSA-N Terephthalic acid Chemical compound OC(=O)C1=CC=C(C(O)=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-N 0.000 claims 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- 229910052708 sodium Inorganic materials 0.000 claims 2
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- 238000002695 general anesthesia Methods 0.000 abstract description 12
- 201000009819 exposure keratitis Diseases 0.000 abstract description 7
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- 239000004744 fabric Substances 0.000 description 4
- 239000010409 thin film Substances 0.000 description 4
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 3
- 229920001661 Chitosan Polymers 0.000 description 3
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 3
- 206010013082 Discomfort Diseases 0.000 description 3
- ZSBXGIUJOOQZMP-UHFFFAOYSA-N Isomatrine Natural products C1CCC2CN3C(=O)CCCC3C3C2N1CCC3 ZSBXGIUJOOQZMP-UHFFFAOYSA-N 0.000 description 3
- ZSBXGIUJOOQZMP-JLNYLFASSA-N Matrine Chemical compound C1CC[C@H]2CN3C(=O)CCC[C@@H]3[C@@H]3[C@H]2N1CCC3 ZSBXGIUJOOQZMP-JLNYLFASSA-N 0.000 description 3
- 206010047513 Vision blurred Diseases 0.000 description 3
- 210000000744 eyelid Anatomy 0.000 description 3
- 206010023332 keratitis Diseases 0.000 description 3
- 229930014456 matrine Natural products 0.000 description 3
- 229940041616 menthol Drugs 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 239000000523 sample Substances 0.000 description 3
- 230000035807 sensation Effects 0.000 description 3
- 230000008961 swelling Effects 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 206010051625 Conjunctival hyperaemia Diseases 0.000 description 2
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
- 206010015946 Eye irritation Diseases 0.000 description 2
- 229920002385 Sodium hyaluronate Polymers 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
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- 238000001356 surgical procedure Methods 0.000 description 2
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 description 1
- 206010010726 Conjunctival oedema Diseases 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
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- 206010020751 Hypersensitivity Diseases 0.000 description 1
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- 239000004820 Pressure-sensitive adhesive Substances 0.000 description 1
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- 229920002472 Starch Polymers 0.000 description 1
- 208000010513 Stupor Diseases 0.000 description 1
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- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
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- 208000030961 allergic reaction Diseases 0.000 description 1
- 150000001408 amides Chemical class 0.000 description 1
- 230000001775 anti-pathogenic effect Effects 0.000 description 1
- 230000000840 anti-viral effect Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000006399 behavior Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
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- 239000002674 ointment Substances 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 239000003507 refrigerant Substances 0.000 description 1
- 239000012266 salt solution Substances 0.000 description 1
- 230000008313 sensitization Effects 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 229940010747 sodium hyaluronate Drugs 0.000 description 1
- NGSFWBMYFKHRBD-UHFFFAOYSA-M sodium lactate Chemical class [Na+].CC(O)C([O-])=O NGSFWBMYFKHRBD-UHFFFAOYSA-M 0.000 description 1
- 239000001540 sodium lactate Substances 0.000 description 1
- 229940005581 sodium lactate Drugs 0.000 description 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical group [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 150000003503 terephthalic acid derivatives Chemical class 0.000 description 1
- 210000003684 theca cell Anatomy 0.000 description 1
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 1
- 229940033663 thimerosal Drugs 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
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- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Materials For Medical Uses (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a kind of medical aquogel eyeshield dressing, including basalis, biological fiber hydrogel layer and separation layer；The biological fiber hydrogel layer includes biological fiber membrane material and gel component.The gel component is by mass percentage：High molecular weight water soluble polymer 0.2%~10%, NMF 0.5%~10%, surplus purified water.Water-soluble high-molecular material, NMF and water are prepared into solution or gel in proportion during preparation, adsorb or be applied to biological fiber membrane material, after being covered with basalis, water-setting glue surface is put on separation layer, after packaging, cross-linking radiation sterilizing.Eyeshield dressing of the present invention can provide stable humidity to eye；Stick to sulci of skin, adhesiveness is splendid, is pasted without additional adhesive plaster, and soft not viscous damage hair skin, comfortableness are splendid when taking off.The present invention, which is applicable, to be pasted on outside the eye of general anesthesia or depth coma patient, prevents exposure keratitis.
Description
Technical field
The invention belongs to medical eyeshield dressing and its preparation field, and in particular to one kind is pasted on general anesthesia or depth domsiekte
Outside the eye of people, relatively closed moist environment is provided, prevents exposure keratitis medical aquogel eyeshield dressing.
Background technology
General anesthesia is clinically common surgery anesthesia mode, because the Muscle relaxation of medicine result in the closure of eyelid
It is bad, cause eyeball to expose, general anesthesia also results in eyelash reflex, winking reflex disappears, can not be by closing after tear film rupture
Eyelid function forms new tear film, so that cornea cannot be moistened and protected, further results in bitot's patches.Other Head And Face hand
Art thimerosal penetrate into patient's eyes in, shadowless lamp prolonged exposure, operation technique when friction, the wind speed of Cleaning operating room it is too fast and wet
Spend it is low can cause that exposed anterior corneal surface is dry, conjunctival congestion, then trigger exposure keratitis, photophobia, stream occur
The clinical symptoms such as tear, foreign body sensation and localized pain.
Annual millions of people carries out anesthesia surgery, along with the patient of depth stupor, facioplegia in art, these patients
There are about 70% general anesthesia patient eyes can not close completely, if not taking corresponding preventative corneal protection measure, expose
The ratio of property keratitis is high by 40%~60%, and severe patient can cause ulcer of the cornea, and extra pain is brought to patient with operation.
Prevention exposure keratitis method substantially has three kinds of methods at present：When covered with physiological saline gauze, but gauze
Easily dry, action time is short, need to frequently moisten, and increases medical personnel's workload, and gauze cotton thread wadding easily enters eye into foreign matter, salt solution
Also easily enter eye and cause discomfort.Second, medicine applies, medicine is not easy coating uniformly, and part conjunctiva is unprotected, causes to prevent in art
Failure, another medicine has minimal irritation in itself, easily cause it is furious, fear the symptoms such as light.Third, eyeshield application or hydrogel eye paste
Deng, it is pasted on outside eye, plays a part of physics covering to eye, eye is in the environment of relative air-tight moist, and then in advance
The generation of anti-exposure property keratitis.But many eye stickers are in order to closely stick, all tender and lovely with pressure-sensitive adhesive layer or adhesive plaster, eye part skin
Fragility, stick for a long time, easily cause periocualr skin allergy, when tearing adhesive plaster off, easily cause periocualr skin breakage.Some
Eye sticker, the number of plies is more, and gel is blocked up, easily causes eye compression, poor air permeability, causes to bear to eye.
Patent of invention CN 201410140068.X disclose a kind of hydrogel eyeshield sticking dressing and preparation method thereof, water-setting
Glue eyeshield sticking dressing is made up of adhesion layer, enhancement layer, gel layer and separation layer successively.Gel layer is by high molecular weight water soluble polymer
2%-15%, pseudoplastic behavior high molecular polymer 0.1%-5%, NMF 0.1%-10%, remaining is water, and each component sum is
100%.Each group lease making series of process is molten to be integrated, and solution is poured into a mould in a mold, is obtained after solidification through irradiation sterilization.The invention
The number of plies is more, complex process, and the eye paste made is thicker, is pasted onto circumference of eyes by adhesion layer, comfort is bad.
The patent of invention of application number 200910019954.6, a kind of medical moisturized eye paste and preparation method thereof is disclosed,
It is characterized in that it is by 8~25% hydrophilic high molecular materials and the mixing of 92~75% water, by -6~10 by weight percentage
DEG C place 10~24h, 10~60 DEG C place 48~72h solidification after use 15~120kGy of irradiation dose gamma-radiation or electron beam
Irradiation is made, and the thickness of obtained medical moisturized eye paste is 2.5~6.0 millimeters, meets the shape of human body circumference of eyes structure,
It can disposably operate, usage time length, relatively closed wet environment can be provided, there is good biocompatibility, nontoxic, nothing
Sensitization, have no toxic side effect, with rear noresidue, it is not necessary to patient skin and hair are cleaned, it is simple to operate.The inventive structure is single, glues
Attached power is poor, and poor water retention property, water loss is very fast, it is difficult to meet the needs of prolonged operationses.
A kind of medical hydrogel eye mask of the disclosure of the invention of application number 201510481326.5, including non-woven substrate and PE
Film, hydrogel is provided between non-woven substrate and the PE film, wherein, the hydrogel includes as follows by mass percentage
Component：18-25% starch, 50-55% polyvinylpyrrolidones, 25-30% sodium carboxymethylcelluloses and enough by other
The fully miscible solvent of component.Preparation process：(1) will claim for each component for preparing hydrogel according to corresponding mass percent
Take, it is standby；(2) each component in step (1) is substantially dissolved in medical purified water to formation solution, and is maintained at 90 DEG C
At a temperature of agitating solution, until solution becomes semigel state；(3) the semigel state solution prepared in step (2) is existed
Irradiated under the electron beam of 25kGy-35kGy dosage, so as to which hydrogel be made；(4) by obtained hydrogel and nonwoven in step (3)
Cloth layer and PE moulds are closed, so as to which the hydrogel with tridimensional network be made.The invention solid raw material proportion is too high, into
This height, water content is low, and water absorption rate is high, brittle friable, and lasting moist environment can not be provided to eye after closed.
Application number 201610503255.9 discloses a kind of hydrogel eye plaster of medical heat-clearing antibacterial, by polypropylene liner plate,
Hydrogel, non-woven fabrics and polyvinyl chloride film composition, to imitate lens type appearance design.Wherein hydrogel is according to mass percent
Meter, including following components：5~20% polyvinyl alcohol, 0.5~5% polyacrylamide, 0.3~1.3% chitosan, 0.2
~1% matrine, 0.02~0.15% menthol and 80~90% purified water.The present invention is with polyvinyl alcohol and polypropylene
Acid amides is gel skeleton, to strengthen the Swelling Capacity of single polyvinyl alcohol hydrogel and gas permeability.Add chitosan, matrine and
The antipathogenic compositions such as menthol, strengthen the antibacterial ability of hydrogel.Wherein, traditional Chinese medicine ingredients matrine also has heat-clearing, antiviral work
With the addition of a small amount of menthol enhances the penetrating power of traditional Chinese medicinal components while hydrogel is had refrigerant sense of touch.The invention layer
More, the complex process of number, gel support force itself is weaker, introduces the support of polypropylene liner plate, but reduce the comfortableness of eye sticker.
In view of the high incidence of general anesthesia operation and deep coma patient's exposure keratitis, according to original of the prevention better than treatment
Then, the eye paste for taking safeguard measure is preferably to select.But at present still there is above-mentioned various deficiencies in eye paste.
The content of the invention
The purpose of the present invention be exactly overcome in existing operation eyeshield dressing technical matters is complicated, pliability is poor, sticking nature not
The deficiencies of humidity good, that stabilization can not be provided, there is provided a kind of new medical hydrogel eyeshield dressing, the present invention is with biological fiber mould
Material is skeleton, irradiated to be prepared with reference to water soluble polymer and NMF, is that a kind of technique is simple, the number of plies is few, frivolous
Gas, moisture retention are good, flexible adhesion is good but the eyeshield dressing of not viscous damage hair skin, good biocompatibility.
For achieving the above object, the present invention uses following technical scheme：
The medical aquogel eyeshield dressing of the present invention includes basalis, biological fiber hydrogel layer and separation layer.The life
Fibres hydrogel layer includes biological fiber membrane material and gel component.The gel component is by mass percentage：It is water-soluble high
Molecularly Imprinted Polymer 0.2%~10%, NMF 0.5%~10%, surplus purified water.
The biological fiber membrane material refers to the tunica fibrosa generated through microbial fermentation, and described microorganism includes acetic acid bacteria
Category, Agrobacterium, rhizobium, the one or more of Sarcina；The mode of the fermentation generation tunica fibrosa is ability
Domain conventional method.
The high molecular weight water soluble polymer is Sodium Hyaluronate and its derivative, Chitosan-phospholipid complex, polyethylene
Pyrrolidones and its derivative, carbomer and its derivative, the one or more of polyvinyl alcohol and its derivative；
The NMF be glycerine, polyethylene glycol, sodium lactate, butanediol, propane diols, hexylene glycol, amino acid one kind or
It is several；
The biological fiber hydrogel layer thickness is 0.5~4.5mm, preferably 1~3mm；
The basalis is non-woven fabrics, polyurethane film, one kind of plastic foil；
The separation layer is macromolecule mould release membrance or the release liners such as polyethylene, polypropylene, poly terephthalic acid class；
The present invention medical aquogel eyeshield dressing by cross-linking radiation, sterilizing, radiation mode can be electron beam, ray,
60Co one kind, irradiation dose are 10~50KGy.
Preparation technology：Biological fiber membrane material according to Fig. 1-Fig. 3 shape design cut it is standby, by water soluble polymer material
Material, NMF and water prepare solution in proportion, by the immersion of biological fiber membrane material wherein, abundant adsorption saturation, after being covered with basalis,
Water-setting glue surface is put on separation layer, after packaging, cross-linking radiation, sterilizing.Also can be by water-soluble high-molecular material, NMF, water
Gel is configured to by proportioning, is brushed in biological fiber membrane material, after being covered with basalis, water-setting glue surface is put on separation layer, is wrapped
After dress, cross-linking radiation sterilizing.
The present invention takes separation layer off when using, and hydrogel aspect is applied in eye.
The principle of the present invention is as follows：Biological fiber membrane material be in itself formed by the nanofiber of hydrogeneous oxygen key it is complicated
Network structure, have natural retentiveness careful, pro-skin is docile, extremely strong and anti-tear power, hydrophilic absorbent water conservation, tensile strength high
Feature.In the present invention, biological fiber membrane material is as skeleton carrier, there is provided support force, with reference to water-soluble high-molecular material, enters one
Step strengthens its moisture holding capacity, and sample irradiation post-crosslinking forms flexible gel, tensile strength increase；It is simultaneously superior plus its own
Biological property, after high molecular polymer and NMF, moisture sustained release can be played a part of, the wet of stabilization is provided to eye
Degree；Stick to sulci of skin, adhesiveness is splendid, is pasted without additional adhesive plaster, soft not viscous damage hair skin, comfortableness pole when taking off
It is good.The present invention is pasted on outside the eye of general anesthesia or depth coma patient to be applicable, there is provided relatively closed moist environment, it is pre- anti-riot
The medical aquogel eyeshield dressing of dew property keratitis.
The beneficial effects of the invention are as follows：
1st, dressing of the invention is flexible intensity, and not easily broken, use is simple to operate, and the impact of performance is good.
2nd, dressing water content of the invention is higher than 85%, can be sustained moisture, there is provided stable eye humidity, keeps for a long time
The needs of average of operation periods.
3rd, dressing docile closure of the invention is good, can be pasted to sulci of skin, as shown in Figure 2 and Figure 3；Docile closure is good, takes off
When lower, not viscous damage skin hair, with rear noresidue, it need not clean；Comfort level is high.
4th, dressing of the invention is sterile nontoxic, no allergic reaction.The present invention does not add other additional sets such as any preservative
Point, diagonal theca cell and other ocular tissues have good biocompatibility without any toxicity and damaging action, safe,
It is very easy to use.
5th, present invention process process is relatively simple, and gel cross-linkage, formed product and product sterilizing can be achieved in once irradiation
Deng, technique it is simpler, prepare it is more convenient.
Brief description of the drawings
Fig. 1 is subject hydrogel eyeshield dressing pictorial diagram；Fig. 1 a are gel layer；Fig. 1 b are that complete structure (basalis, coagulates
Glue-line, separation layer) eyeshield dressing.
Fig. 2 is that subject hydrogel eyeshield dressing actually uses process real scene shooting figure.
Fig. 3 is to stick on the real scene shooting figure on skin；, can after visible subject hydrogel eyeshield dressing is applied to skin in figure
Deeply stick to sulci of skin.
Embodiment
The present invention is further elaborated with specific embodiment below in conjunction with the accompanying drawings, so that those skilled in the art know more about
The present invention, but and it is not so limited the present invention.It is not specified in the present invention, it is this area conventional method, it is raw materials used
It is commercial goods.
Embodiment 1
2g polyvinyl alcohol, 0.5g Sodium Hyaluronates are weighed, 3g polyethylene glycol 400s add purified water to be settled to 100g, and heating is stirred
Dissolving is mixed, biological fiber membrane material is immersed in 0.5h in solution, imbibition swelling, taking-up is placed on non-woven fabrics lining cloth, plus isolation
Layer, bagging and packaging, the crosslinking of 15kGY electron beam irradiations, sterilizing, thus obtaining the product hydrogel eyeshield dressing.Biological fiber hydrogel layer thickness is
2mm, water content 91%.
Embodiment 2
1g polyvinylpyrrolidones are weighed, 1.0g carboxymethyl chitosans, 2g glycerine, add purified water to be settled to 100g, are heated
Stirring and dissolving, biological fiber membrane material is immersed in 2h in solution, imbibition swelling, taking-up is placed on non-woven fabrics lining cloth, plus isolation
Layer, bagging and packaging, the crosslinking of 25kGY electron beam irradiations, sterilizing, thus obtaining the product hydrogel eyeshield dressing.Biological fiber hydrogel layer thickness is
3.5mm, water content 93%.
Embodiment 3
8g polyvinyl alcohol, 2g butanediols are weighed, 0.5g sodium lactates add purified water to be settled to 100g, and heating stirring is dissolved into
Clear gel, gel is applied in biological fiber membrane material, puts polyurethane film lining cloth, plus separation layer, bagging and packaging,
The crosslinking of 45kGY electron beam irradiations, sterilizing, thus obtaining the product hydrogel eyeshield dressing.Biological fiber hydrogel layer thickness is 1.5mm, water content
88%.
Test example 1
Performance detection is carried out to hydrogel eyeshield dressing prepared by embodiment 1~3：
1st, water content：According to《Pharmacopoeia of People's Republic of China》(version four in 2015) 0831 " dry weightless mensuration " enters
Row measure, water content are more than 85%.
2nd, dressing pH value：Dressing sample is taken to be extracted in 0.1g/ml ratios, according to《Pharmacopoeia of People's Republic of China》
(version four in 2015) 0631 " pH value determination method " is carried out, and pH value is 6.0~8.0.
3rd, tensile strength：Method determines according to specified in GB/T17928, and tensile strength is 200~600g/cm2。
4th, moisture-vapor transmission：Determined according to method as defined in YY/T0471.2, moisture-vapor transmission is 300~2000g/
m2.24h。
5th, it is sterile：Tested according to " method is direct plungeed into " specified in GB/T 14233.2-2005, eyeshield dressing without
Bacterium.
6th, Eye irritation and skin irritatin：Examined according to method specified in GB/T16886.10, eyeshield dressing is without Eye irritation
And skin irritatin.
The eye moistening effect simulated test of test example 2
Simulate operating room temperature and humidity conditions, temperature (25 ± 1) DEG C, relative humidity (50 ± 5) % constant temperature test box in,
With the humidity change in the lower relative confined space of electronics moisture probe measurement covering, the test period is 8 hours, in 0.5h, 1h,
3h、5h、8h.Record data is as shown in table 1：
Table 1
Test example 3 sticks closure experiment
In order to verify the clinical effectiveness of present invention prevention Balance anesthesia exposure keratitis, choose 60 general anesthesia operations and suffer from
Person, is randomly divided into 4 groups, 3 experimental groups and 1 control group, every group 15.Embodiment 1,2 is used respectively in 3 experimental group operations
With the 3 eyeshield dressing prepared, pasted in control group operation using erythromycin ophthalmic ointment joint aseptic thin-film, observe postoperative 4 groups respectively
The incidence of the malaise symptoms such as patients conjunctival's redness, foreign body sensation, viscid sense, blurred vision.
Experiment process is as follows：
Experimental group 1：Male 6, women 4,22~75 years old age, average age 48.5 years old, anesthesia duration 2~8 hours,
It is average 3.2 hours；
Experimental group 2：Male 5, women 5,25~73 years old age, average age 47.2 years old, anesthesia duration 2~9 hours,
It is average 3.6 hours；
Experimental group 3：Male 4, women 6,20~75 years old age, average age 49.3 years old, anesthesia duration 1.5~9 are small
When, it is average 3.7 hours；
Control group：Male 6, women 4,23~72 years old age, average age 48.7 years old, anesthesia duration 2~8 hours,
It is average 3.3 hours；
The age of control group and each experimental group patient, sex and operating time no difference of science of statistics.
Experimental group, after patient implements general anesthesia, medical aquogel eyeshield dressing is pasted on eye, operation terminates, gently
Light throw off can (such as Fig. 2 modes).
Control group, after patient implements general anesthesia, patient's eyelid is separated, erythromycin ointment is slowly squeezed into the upper palpebra inferior knot of patient
In membrane vesicle, being sticked at by eyes closed, then with aseptic thin-film on eyes, it is ensured that eyes close, and operation terminates, and tear aseptic thin-film off,
And with physiological saline gauze by wiped clean around eyes.
Postoperative 24h observations are paid a return visit：
Experimental group 1, postoperative 1 there is blurred vision symptom, and remaining patient does not have found other discomforts；
Experimental group 2, postoperative all patients do not have found other discomforts；
Experimental group 3, postoperative 1 occur conjunctiva redness, 1 there is blurred vision symptom, remaining patient do not find it is other not
It is suitable；
Control group 1, postoperative 2 there is chemosis, and 3 viscous sense occur, and 1 foreign body sensation occurs, and 1 appearance regards thing mould
Symptom is pasted, remaining patient does not have found other discomforts；
Statistical result is as shown in table 2：
Table 2
Experimental result shows that postoperative 24h is paid a return visit, and the postoperative discomfort of hydrogel eyeshield dressing is used during patient's general anesthesia operation
Far below erythromycin ophthalmic ointment combination aseptic thin-film is used, using the hydrogel eyeshield dressing of the present invention, operation side is not used only in sense
Just, and the sense of discomfort of postoperative general anesthesia operation eye can be reduced, effectively prevents the generation of Balance anesthesia exposure keratitis,
With extraordinary Clinical practice meaning.
Claims (10)
1. a kind of medical aquogel eyeshield dressing, it is characterized in that, including basalis, biological fiber hydrogel layer and separation layer；Institute
Stating biological fiber hydrogel layer includes biological fiber membrane material and gel component；The gel component is by mass percentage：It is water-soluble
Property high molecular polymer 0.2%~10%, NMF 0.5%~10%, surplus purified water.
2. medical aquogel eyeshield dressing as claimed in claim 1, it is characterized in that, the biological fiber membrane material refers to through microorganism
Ferment the tunica fibrosa generated, and described microorganism is acetic acid Pseudomonas, Agrobacterium, rhizobium, one kind of Sarcina
It is or several.
3. medical aquogel eyeshield dressing as claimed in claim 1, it is characterized in that, the high molecular weight water soluble polymer is transparent
Matter acid sodium and its derivative, Chitosan-phospholipid complex, polyvinylpyrrolidone and its derivative, carbomer and its derivative,
The one or more of polyvinyl alcohol and its derivative.
4. medical aquogel eyeshield dressing as claimed in claim 1, it is characterized in that, the NMF is glycerine, polyethylene glycol, breast
Sour sodium, butanediol, propane diols, hexylene glycol, the one or more of amino acid.
5. medical aquogel eyeshield dressing as claimed in claim 1, it is characterized in that, the biological fiber hydrogel layer thickness is
0.5~4.5mm.
6. medical aquogel eyeshield dressing as claimed in claim 1, it is characterized in that, the basalis is non-woven fabrics, thin polyurethane
One kind of film, plastic foil.
7. medical aquogel eyeshield dressing as claimed in claim 1, it is characterized in that, the separation layer is polyethylene, polypropylene, gathered
Terephthalic acid (TPA) family macromolecule mould release membrance or release liners.
8. the method for the medical aquogel eyeshield dressing described in claim 1 is prepared, it is characterized in that, step is：Will be water-soluble high
Molecular material, NMF and water are configured to solution, by the immersion of biological fiber membrane material wherein, abundant adsorption saturation, are covered with basalis
Afterwards, water-setting glue surface is put on separation layer, after packaging, cross-linking radiation sterilizing.
9. the method for the medical aquogel eyeshield dressing described in claim 1 is prepared, it is characterized in that, step is：Will be water-soluble high
Molecular material, NMF, water are configured to gel by proportioning, brush in biological fiber membrane material, after being covered with basalis, by hydrogel
Face is put on separation layer, after packaging, cross-linking radiation sterilizing.
10. the method for preparing medical aquogel eyeshield dressing as claimed in claim 8 or 9, it is characterized in that, radiation mode is electricity
Beamlet, ray, 60Co one kind, irradiation dose are 10~50KGy.
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Application publication date: 20180330 |