CN112826811A - 一种医用冷敷凝胶眼贴及其制备方法 - Google Patents
一种医用冷敷凝胶眼贴及其制备方法 Download PDFInfo
- Publication number
- CN112826811A CN112826811A CN202110136605.3A CN202110136605A CN112826811A CN 112826811 A CN112826811 A CN 112826811A CN 202110136605 A CN202110136605 A CN 202110136605A CN 112826811 A CN112826811 A CN 112826811A
- Authority
- CN
- China
- Prior art keywords
- gel
- cold compress
- eye patch
- medical cold
- eye
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000002360 preparation method Methods 0.000 title abstract description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 35
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 23
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 17
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 17
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 16
- 239000011248 coating agent Substances 0.000 claims description 16
- 238000000576 coating method Methods 0.000 claims description 16
- 238000005520 cutting process Methods 0.000 claims description 16
- 235000010413 sodium alginate Nutrition 0.000 claims description 16
- 239000000661 sodium alginate Substances 0.000 claims description 16
- 229940005550 sodium alginate Drugs 0.000 claims description 16
- 229920002385 Sodium hyaluronate Polymers 0.000 claims description 12
- 235000011187 glycerol Nutrition 0.000 claims description 12
- 229940010747 sodium hyaluronate Drugs 0.000 claims description 12
- 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 compound [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 claims description 12
- 239000004745 nonwoven fabric Substances 0.000 claims description 11
- 239000004743 Polypropylene Substances 0.000 claims description 10
- 238000010438 heat treatment Methods 0.000 claims description 10
- -1 polypropylene Polymers 0.000 claims description 10
- 229920001155 polypropylene Polymers 0.000 claims description 10
- 238000003756 stirring Methods 0.000 claims description 10
- 238000001816 cooling Methods 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 8
- 239000011265 semifinished product Substances 0.000 claims description 8
- 230000001954 sterilising effect Effects 0.000 claims description 8
- 238000004659 sterilization and disinfection Methods 0.000 claims description 8
- 238000005303 weighing Methods 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 239000002562 thickening agent Substances 0.000 claims description 7
- LUEWUZLMQUOBSB-FSKGGBMCSA-N (2s,3s,4s,5s,6r)-2-[(2r,3s,4r,5r,6s)-6-[(2r,3s,4r,5s,6s)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2r,4r,5s,6r)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-4,5-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@@H](O[C@@H]2[C@H](O[C@@H](OC3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-FSKGGBMCSA-N 0.000 claims description 4
- 241001312219 Amorphophallus konjac Species 0.000 claims description 4
- 235000001206 Amorphophallus rivieri Nutrition 0.000 claims description 4
- 229920002581 Glucomannan Polymers 0.000 claims description 4
- 229920002752 Konjac Polymers 0.000 claims description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 235000010418 carrageenan Nutrition 0.000 claims description 4
- 239000000679 carrageenan Substances 0.000 claims description 4
- 229920001525 carrageenan Polymers 0.000 claims description 4
- 229940113118 carrageenan Drugs 0.000 claims description 4
- 229940046240 glucomannan Drugs 0.000 claims description 4
- 239000000252 konjac Substances 0.000 claims description 4
- 235000010485 konjac Nutrition 0.000 claims description 4
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 4
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 4
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims description 4
- PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 claims description 2
- 229920001661 Chitosan Polymers 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 2
- 229920001495 poly(sodium acrylate) polymer Polymers 0.000 claims description 2
- 239000002994 raw material Substances 0.000 claims description 2
- NNMHYFLPFNGQFZ-UHFFFAOYSA-M sodium polyacrylate Chemical compound [Na+].[O-]C(=O)C=C NNMHYFLPFNGQFZ-UHFFFAOYSA-M 0.000 claims description 2
- 239000000230 xanthan gum Substances 0.000 claims description 2
- 235000010493 xanthan gum Nutrition 0.000 claims description 2
- 229920001285 xanthan gum Polymers 0.000 claims description 2
- 229940082509 xanthan gum Drugs 0.000 claims description 2
- 210000001508 eye Anatomy 0.000 abstract description 57
- 238000002695 general anesthesia Methods 0.000 abstract description 11
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 206010010071 Coma Diseases 0.000 abstract description 3
- 230000000638 stimulation Effects 0.000 abstract description 3
- 239000000499 gel Substances 0.000 description 79
- 229940068984 polyvinyl alcohol Drugs 0.000 description 15
- 238000012360 testing method Methods 0.000 description 11
- 230000000052 comparative effect Effects 0.000 description 9
- 239000003885 eye ointment Substances 0.000 description 8
- 206010070834 Sensitisation Diseases 0.000 description 7
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 7
- 230000008313 sensitization Effects 0.000 description 7
- 206010002091 Anaesthesia Diseases 0.000 description 6
- 239000004098 Tetracycline Substances 0.000 description 6
- 230000037005 anaesthesia Effects 0.000 description 6
- 238000011085 pressure filtration Methods 0.000 description 6
- 208000024891 symptom Diseases 0.000 description 6
- 229960002180 tetracycline Drugs 0.000 description 6
- 229930101283 tetracycline Natural products 0.000 description 6
- 235000019364 tetracycline Nutrition 0.000 description 6
- 150000003522 tetracyclines Chemical class 0.000 description 6
- 210000000744 eyelid Anatomy 0.000 description 5
- 206010023332 keratitis Diseases 0.000 description 5
- 206010020751 Hypersensitivity Diseases 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 229960005150 glycerol Drugs 0.000 description 4
- 230000002980 postoperative effect Effects 0.000 description 4
- 241000700198 Cavia Species 0.000 description 3
- VYZAHLCBVHPDDF-UHFFFAOYSA-N Dinitrochlorobenzene Chemical compound [O-][N+](=O)C1=CC=C(Cl)C([N+]([O-])=O)=C1 VYZAHLCBVHPDDF-UHFFFAOYSA-N 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 208000030961 allergic reaction Diseases 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 230000009467 reduction Effects 0.000 description 3
- 230000035807 sensation Effects 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 239000003106 tissue adhesive Substances 0.000 description 3
- 206010051625 Conjunctival hyperaemia Diseases 0.000 description 2
- 206010010726 Conjunctival oedema Diseases 0.000 description 2
- 206010023644 Lacrimation increased Diseases 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- 206010034960 Photophobia Diseases 0.000 description 2
- 206010070835 Skin sensitisation Diseases 0.000 description 2
- 206010047513 Vision blurred Diseases 0.000 description 2
- 238000001949 anaesthesia Methods 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 210000005252 bulbus oculi Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 210000000795 conjunctiva Anatomy 0.000 description 2
- 210000004087 cornea Anatomy 0.000 description 2
- 230000002951 depilatory effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000004317 lacrimation Effects 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000000474 nursing effect Effects 0.000 description 2
- 230000036407 pain Effects 0.000 description 2
- 239000013641 positive control Substances 0.000 description 2
- 231100000370 skin sensitisation Toxicity 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- KIUKXJAPPMFGSW-YXBJCWEESA-N (2s,4s,5r,6s)-6-[(2s,3r,5s,6r)-3-acetamido-2-[(3s,4r,5r,6r)-6-[(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-carboxylic acid Chemical compound CC(=O)N[C@H]1C(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(O[C@@H]3[C@@H]([C@@H](O)C(O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)C(C(O)=O)O1 KIUKXJAPPMFGSW-YXBJCWEESA-N 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 241001474374 Blennius Species 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 241000700199 Cavia porcellus Species 0.000 description 1
- 208000009043 Chemical Burns Diseases 0.000 description 1
- 206010010741 Conjunctivitis Diseases 0.000 description 1
- 206010011409 Cross infection Diseases 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010013774 Dry eye Diseases 0.000 description 1
- 206010029803 Nosocomial infection Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 208000003443 Unconsciousness Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000002390 adhesive tape Substances 0.000 description 1
- 230000003444 anaesthetic effect Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000002567 autonomic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000024245 cell differentiation Effects 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229940045110 chitosan Drugs 0.000 description 1
- 230000007012 clinical effect Effects 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 208000027744 congestion Diseases 0.000 description 1
- 210000000399 corneal endothelial cell Anatomy 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 239000003906 humectant Substances 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 229920001477 hydrophilic polymer Polymers 0.000 description 1
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 229920005684 linear copolymer Polymers 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000003020 moisturizing effect Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000001328 optic nerve Anatomy 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000011514 reflex Effects 0.000 description 1
- 238000007761 roller coating Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 230000037380 skin damage Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
- 208000005494 xerophthalmia Diseases 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
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Ophthalmology & Optometry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明公开了一种医用冷敷凝胶眼贴及其制备方法，所述眼贴从下至上依次为无纺布层、凝胶层和聚丙烯膜，所述凝胶层中的凝胶由聚乙烯醇、甘油、增稠剂、透明质酸钠、海藻酸钠和水制备而成。眼贴用于贴敷全麻手术病人或深度昏迷病人的眼外部，给病人提供相对密闭的潮湿环境，保护眼睛免受外界刺激且容易揭贴。本发明提供的制备方法能够缩短生产时间，提高生产效率。
Description
技术领域
本发明属于医用敷料技术领域，具体涉及一种医用冷敷凝胶眼贴及其制备方法。
背景技术
全麻手术病人、深昏迷病人由于麻醉药物的作用，手术患者中枢神经系统受到抑制，处于无意识状态，肌肉松弛无力，保护性反射作用消失或减弱，基本上失去了自主调节能力，导致了眼睑的闭合不良，发生以下合并症：眼部受压，造成视神经缺氧，视力下降；眼球暴露、角膜干燥、结膜充血继而引发暴露性角膜炎；眼内化学性烧伤等，出现畏光、流泪、异物感和局限性疼痛等临床症状。据相关临床文献报道，其发生率高达50％。全麻患者术中眼睛护理是手术患者护理工作不可忽视的重要环节，能有效预防和减轻患者术后眼部并发症。
为了避免以上合并症的发生，目前最常用的在手术中对病人眼部进行了防护。具体方法为：在全麻完成后，先在眼内结膜囊处涂上四环素眼膏，然后将病人双眼闭合，用手术贴膜分别把每只眼睛的上下眼睑贴合在一起，以防术中眼睛睁开，造成眼角膜干燥等眼部损伤。四环素眼膏黏性大，涂抹时不易均匀，部分结膜未被保护，导致术中预防失效；涂抹过程中挤压眼球也可能导致角结膜损伤，眼膏重复使用容易导致交叉感染；而手术贴膜可能引起眼周皮肤过敏，撕去胶布时，容易造成眼周皮肤破损等。
聚乙烯醇(Polyvinyl alcohol，PVA)是聚醋酸乙烯酯水解得到的亲水性聚合物。PVA水凝胶易于成型，含水量高，无毒副作用，和人体组织有良好的相容性，具有多微孔结构和渗透性，还具有良好的机械性，能够传导力学刺激，以促进细胞定位和基质合成。海藻酸钠(Sodium alginate，SA)是来源于海藻的天然高分子材料，是由M和G片段形成的线性共聚物。通过二价阳离子(如钙离子)交联能使海藻酸钠水溶液变成凝胶。该凝胶具有独特的pH敏感性和凝血效果，且能支持细胞的分化和生长，因此在生物医学领域获得广泛的应用。
发明内容
针对现有技术中的问题，本发明提供了一种医用冷敷凝胶眼贴，用于贴敷全麻手术病人或深度昏迷病人的眼外部，给患者提供相对密闭的潮湿环境，可以预防暴露性角膜炎等合并症。
为实现上述目的，本发明采用如下技术方案：
一种医用冷敷凝胶眼贴，所述眼贴从下至上依次是无纺布层、凝胶层和聚丙烯膜，所述凝胶层中的凝胶由以下质量百分比的原料制成：聚乙烯醇3-10％，甘油7-15％，增稠剂0.2-0.5％，透明质酸钠0.01-3％，海藻酸钠0.1-5％，余量为水。
优选的，所述增稠剂为卡拉胶、魔芋胶、羧甲基纤维素钠、羟丙基纤维素、微晶纤维素、壳聚糖、聚丙烯酸钠、黄原胶中的一种或几种。
本发明还提供了一种制备医用冷敷凝胶眼贴的方法，具体包括以下步骤：
S1、按配方称取甘油，聚乙烯醇、海藻酸钠、增稠剂、透明质酸钠混合均匀，加入水后置于制胶罐中加热搅拌，冷却，得到凝胶膏体；
S2、将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，辐照杀菌。
优选的，加热温度为80-85℃，搅拌时间为90-120min。
本发明的有益效果为：
(1)聚乙烯醇水量高，无毒副作用，和人体组织有良好的相容性，与海藻酸钠钠形成凝胶，其结构致密，含水率下降慢，可使眼部保持一定的湿度，同时降低眼贴的更换频率。
(2)加入保湿剂甘油和透明质酸钠，使水分保持80％以上，具有良好的保湿性，且透明质酸钠主要用于眼干燥综合症，并有保护角膜内皮细胞及眼内组织，减少手术并发症。
(3)制备的复合凝胶具有良好的粘性和弹性，能与眼部良好的贴合，形成湿环境，防止体液挥，保护眼睛免受外界刺激，容易揭贴，不会产生残留，不会撕拉皮肤和毛发。
(4)本发明方法共混形成凝胶，直接用辊涂法生产凝胶涂布于无纺布上面，可以缩短生产时间时间，提高生产效率。
具体实施方式
下面结合实施例对本发明作进一步详细的描述，其描述较为具体和详细，但并不能因此而理解为对本发明范围的限制。
实施例1:
本实施例中，制备凝胶所需的各组分的质量百分比为如表1所示。
按配方称取甘油、聚乙烯醇、海藻酸钠、卡拉胶、透明质酸钠混合均匀，加入水后置于制胶罐中加热至85℃，搅拌90min，室温下冷却至40℃，得到凝胶膏体；将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，Co60辐照杀菌。
实施例2
本实施例中，制备凝胶所需的各组分的质量百分比为如表1所示。
按配方称取甘油、聚乙烯醇、海藻酸钠、魔芋胶、透明质酸钠混合均匀，加入水后置于制胶罐中加热至80℃，搅拌90min，室温下冷却至40℃，得到凝胶膏体；将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，Co60辐照杀菌。
实施例3
本实施例中，制备凝胶所需的各组分的质量百分比为如表1所示。
按配方称取甘油、聚乙烯醇、海藻酸钠、羧甲基纤维素钠、透明质酸钠混合均匀，加入水后置于制胶罐中加热至85℃，搅拌100min，室温下冷却至40℃，得到凝胶膏体；将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，Co60辐照杀菌。
实施例4
本实施例中，制备凝胶所需的各组分的质量百分比为如表1所示。
按配方称取甘油、聚乙烯醇、海藻酸钠、卡拉胶、透明质酸钠混合均匀，加入水后置于制胶罐中加热至85℃，搅拌120min，室温下冷却至40℃，得到凝胶膏体；将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，Co60辐照杀菌。
对比例1
本实施例中，制备凝胶所需的各组分的质量百分比为如表1所示。
按配方称取甘油、聚乙烯醇、魔芋胶、透明质酸钠混合均匀，加入水后置于制胶罐中加热至85℃，搅拌90min，室温下冷却至40℃，得到凝胶膏体；将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，Co60辐照杀菌。
对比例2
本实施例中，制备凝胶所需的各组分的质量百分比为如表1所示。
按配方称取甘油、聚乙烯醇、海藻酸钠、羧甲基纤维素钠混合均匀，加入水后置于制胶罐中加热至85℃，搅拌90min，室温下冷却至40℃，得到凝胶膏体；将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后再在凝胶层上覆盖聚丙烯膜，模切凝胶得到眼贴半成品后，Co60辐照杀菌。
表1(组分含量以质量百分数计)
| 组分 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 对比例1 | 对比例2 |
| 聚乙烯醇 | 3 | 5 | 6 | 10 | 5 | 6 |
| 海藻酸钠 | 0.2 | 2 | 5 | 1 | / | 5 |
| 甘油 | 12 | 10 | 8 | 7 | 10 | 8 |
| 增稠剂 | 0.2 | 0.3 | 0.2 | 0.5 | 0.3 | 0.2 |
| 透明质酸钠 | 3 | 1 | 0.2 | 0.02 | 1 | / |
| 水 | 81.6 | 81.7 | 80.6 | 81.5 | 83.7 | 80.8 |
对各实施例得到的样品分别进行检测，评价其质量：
(1)致敏性评价
试验选用普通级豚鼠，雌雄各半，500x400x250mm3豚鼠笼，饲养密度5只/笼。温度19.9-25.8C，相对湿度45.0-70.6％，换气次数:≥8次/h，动物照明时间:每日12h/12h交替照明。观察了医用冷敷凝胶眼贴的豚鼠主动皮肤过敏反应。选取白色豚鼠30只，雌雄各半，分为2组，分别为阳性对照组(2,4-二硝基氯苯)和医用冷敷凝胶眼贴组。在第0、第7天和第14天，将1％2,4-二硝基氯苯和医用冷敷凝胶眼贴(选实施例1获得产品进行试验)分别涂或贴在相应的动物左侧背部脱毛区，6h后用温水去掉药物。末次给受试物致敏后14天,在激发接触阶段，将0.1％2,4-二硝基氯苯和医用冷敷凝胶眼贴涂贴于相应的动物右侧脱毛区，6h后用温水去掉药物，即可比较观察皮肤过敏反应情况，然后于24h、48h、72h再次观察。
试验结果如表2和表3所示：阳性对照组过敏反应致敏反应率为100％(6h)、60％(24h)、20％(48h)和0％(72h)，皮肤致敏性评价分别为极度致敏性(6h)，中度致敏性(24h)、轻度致敏性(48h)和无致敏性(72h)；医用冷敷凝胶眼贴组过敏反应6h、24h、48h和72h致敏反应率均为0，皮肤致敏性评价均为无致敏性。
表2
表3
结论：在本试验条件下，医用冷敷凝胶眼贴对豚鼠未见明显主动皮肤过敏反应。
(2)含水量变化试验
将医用冷敷凝胶眼贴放入25±2℃、相对湿度45±5％的恒温培养箱中，水分自然散失，在设定的8小时试验周期内，每隔一小时取出称重，定时测量医用冷敷凝胶眼贴的质量变化，计算减失重量即为自然散失水分，由初始含水量减去散失水分即为实际含水量，结果见表4。
表4
结论：在规定的试验条件下，在设定的8小时试验周期内，医用冷敷凝胶眼贴散失水分量对比例1>实施例1>实施例2>实施例4>对比例2>实施例3，试验证明聚乙烯醇单独形成弹性凝胶，加入海藻酸钠能够持续缓慢的释放水分，保持局部湿润环境，实施例1、实施例2、实施例3、实施例4和对比例2在试验结束时，其含水量仍在60％以上，能充分发挥眼部保湿功能，对比例1中缺少海藻酸钠，聚乙烯醇凝胶水分散失速度快，贴敷5小时以后，基本不散失水分，产生不了保护眼部的效果。
(3)预防全麻术后暴露性角膜炎的临床效果
将84例全麻患者随机分为6组，5个实验组和1个对照组，每组各14例。5个实验组术中分别使用实施例1、2、3、4和对比例2获得的医用冷敷凝胶眼贴，1个对照组术中使用四环素眼膏联合手术贴膜粘贴眼睛预防术后角膜炎的发生。术后分别观察比较两组患者结膜红肿、黏滞感、异物感、视物模糊等不适症状的发生率。
六组患者术前情况比较：对照组1男性9例，女性5例，年龄20-67岁，麻醉时间2-9小时，平均3.5小时；实验组1男性11例，女性3例，年龄22-76岁，麻醉时间2-8小时，平均3.7小时；实验组2男性6例，女性8例，年龄20-75岁，麻醉时间1-10小时，平均4.2小时；实验组3男性4例，女性10例，年龄15～57岁，麻醉时间2-9小时，平均3.8小时；实验组4男性9例，女性5例，年龄25-73岁，麻醉时间2-9小时，平均3.6小时，实验组5男性10例，女性4例，年龄25-70岁，麻醉时间2-9小时，平均3.6小时。
实验组在施行全麻插管，将医用冷敷凝胶眼贴敷于患者眼部。手术结束后，轻轻揭去护眼贴即可。对照组在施行全麻插管后，将四环素眼膏挤入患者下眼睑结膜囊内将眼睛闭合，再用手术贴膜粘于双眼睑上，确保双眼紧闭。手术结束后从上向下轻轻撕去手术贴膜，并用生理盐水纱布将双眼周围的污迹擦拭干净。术后24h对患者进行回访，观察患者双眼是否有充血、水肿、不适感、疼痛、畏光、流泪等结膜炎症状，询问患者是否有无黏滞感、视物模糊等症状，见表4。
表4
结论：临床结果显示，对照组使用四环素眼膏联合手术贴膜粘贴眼睛术后不适症状高于全麻期间采用医用冷敷凝胶眼贴，术后24h回访，57％的涂四环素眼膏患者有结膜红肿、黏滞感、异物感发生等症状产生。采取医用冷敷凝胶眼贴产生不适感为0％、0％、7.1％、14.3％、21.4％，对比例2减除透明质酸钠，可能增加眼睛干涩的风险，实施例1～4能有效预防全麻术后暴露性角膜炎的发生，降低患者眼部不适率的发生，具有较好的临床应用价值。
以上所述，仅是本发明的较佳实施例而已，并非对本发明的技术范围作任何限制，故凡是依据本发明的技术实质对以上实施例所做的细微修改、等同变化与修饰，仍然属于本发明技术方案的范围。
Claims (4)
1.一种医用冷敷凝胶眼贴，其特征在于，所述眼贴从下至上依次是无纺布层、凝胶层和聚丙烯膜，所述凝胶层中的凝胶由以下质量百分比的原料制成：聚乙烯醇3-10％、甘油7-15％、增稠剂0.2-0.5％、透明质酸钠0.01-3％、海藻酸钠0.1-5％、余量的水。
2.根据权利要求1所述的一种医用冷敷凝胶眼贴，其特征在于，所述增稠剂为卡拉胶、魔芋胶、羧甲基纤维素钠、羟丙基纤维素、微晶纤维素、壳聚糖、聚丙烯酸钠、黄原胶中的一种或几种。
3.一种如权利要求1或2所述的医用冷敷凝胶眼贴的制备方法，其特征在于，包括以下步骤：
S1、按配方称取甘油、聚乙烯醇、海藻酸钠、增稠剂、透明质酸钠混合均匀，加入水后置于制胶罐中加热搅拌，冷却，得到凝胶膏体；
S2、将制得的凝胶膏体压滤至涂布切割机上，再涂布于无纺布上，然后在凝胶上覆盖聚丙烯膜，模切得到眼贴半成品后，辐照杀菌。
4.根据权利要求3所述的一种医用冷敷凝胶眼贴的制备方法，其特征在于，所述S1中加热温度为80-85℃，搅拌时间为90-120min。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110136605.3A CN112826811A (zh) | 2021-02-01 | 2021-02-01 | 一种医用冷敷凝胶眼贴及其制备方法 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110136605.3A CN112826811A (zh) | 2021-02-01 | 2021-02-01 | 一种医用冷敷凝胶眼贴及其制备方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112826811A true CN112826811A (zh) | 2021-05-25 |
Family
ID=75931256
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110136605.3A Pending CN112826811A (zh) | 2021-02-01 | 2021-02-01 | 一种医用冷敷凝胶眼贴及其制备方法 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN112826811A (zh) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113274427A (zh) * | 2021-05-31 | 2021-08-20 | 上海林源医疗科技有限公司 | 一种具有近视防控功能的护眼贴 |
| CN113750179A (zh) * | 2021-10-20 | 2021-12-07 | 吉林农业科技学院 | 一种中药安神眼贴及其制备方法 |
| CN114028363A (zh) * | 2021-11-25 | 2022-02-11 | 上海婷伊美科技有限公司 | 一种用于干眼病的黄金眼贴及其制备方法 |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474169A (zh) * | 2008-01-04 | 2009-07-08 | 杨立群 | 一种全身麻醉患者专用的水凝胶眼贴 |
| KR20090081083A (ko) * | 2008-01-23 | 2009-07-28 | 주식회사태준제약 | 알긴산류 화합물을 포함하는 점안용 조성물 및 그의제조방법 |
| CN105381496A (zh) * | 2015-10-21 | 2016-03-09 | 江苏华能药业有限公司 | 医用水凝胶护眼贴 |
| CN107854453A (zh) * | 2017-12-18 | 2018-03-30 | 济南格莱威医疗科技有限公司 | 一种医用水凝胶护眼敷料 |
| CN112089763A (zh) * | 2020-10-12 | 2020-12-18 | 滕智勇 | 一种医用薄荷凝胶护眼贴及其制备方法 |
-
2021
- 2021-02-01 CN CN202110136605.3A patent/CN112826811A/zh active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474169A (zh) * | 2008-01-04 | 2009-07-08 | 杨立群 | 一种全身麻醉患者专用的水凝胶眼贴 |
| KR20090081083A (ko) * | 2008-01-23 | 2009-07-28 | 주식회사태준제약 | 알긴산류 화합물을 포함하는 점안용 조성물 및 그의제조방법 |
| CN105381496A (zh) * | 2015-10-21 | 2016-03-09 | 江苏华能药业有限公司 | 医用水凝胶护眼贴 |
| CN107854453A (zh) * | 2017-12-18 | 2018-03-30 | 济南格莱威医疗科技有限公司 | 一种医用水凝胶护眼敷料 |
| CN112089763A (zh) * | 2020-10-12 | 2020-12-18 | 滕智勇 | 一种医用薄荷凝胶护眼贴及其制备方法 |
Non-Patent Citations (4)
| Title |
|---|
| 余啟聪等: "聚乙烯醇-海藻酸钙-透明质酸复合水凝胶材料的含水特性", 《中国组织工程研究与临床康复》, vol. 12, no. 23, 3 June 2008 (2008-06-03), pages 4445 - 4449 * |
| 刘恕: "常用保湿剂吸湿和保湿性能评价", 《上海医药》, vol. 39, no. 11, 10 June 2018 (2018-06-10), pages 60 - 63 * |
| 刘澜等: "Ca~(2+)交联处理对聚乙烯醇/海藻酸钠水凝胶吸水保水性能和溶蚀率的影响", 《中国科技论文》, vol. 13, no. 18, 23 September 2018 (2018-09-23), pages 2098 - 2103 * |
| 廉哲等: "聚乙烯醇/海藻酸钠互穿网络水凝胶结构与性能研究", 《高分子通报》, vol. 2014, no. 2, 15 February 2014 (2014-02-15), pages 156 - 161 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113274427A (zh) * | 2021-05-31 | 2021-08-20 | 上海林源医疗科技有限公司 | 一种具有近视防控功能的护眼贴 |
| CN113750179A (zh) * | 2021-10-20 | 2021-12-07 | 吉林农业科技学院 | 一种中药安神眼贴及其制备方法 |
| CN114028363A (zh) * | 2021-11-25 | 2022-02-11 | 上海婷伊美科技有限公司 | 一种用于干眼病的黄金眼贴及其制备方法 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105816911B (zh) | 一种含生长因子的修复凝胶及其制备方法 | |
| CN106822988B (zh) | 海藻纤维功能性敷料及其应用、海藻纤维功能性敷料贴 | |
| CN112826811A (zh) | 一种医用冷敷凝胶眼贴及其制备方法 | |
| DE69616514T2 (de) | Bio - erodierbares ophtalmisches schild | |
| CN103893157B (zh) | 水凝胶护眼贴敷料及其制备方法 | |
| CN107854453A (zh) | 一种医用水凝胶护眼敷料 | |
| CN109481148B (zh) | 一种吸湿透气型伤口敷料贴 | |
| CN105012235B (zh) | 一种含有盐酸特比萘芬的眼用抗真菌纳米胶束溶液 | |
| CN102038953A (zh) | 一种眼科手术前局部麻醉用组合物及其制备方法和用途 | |
| CN101530402A (zh) | 丝素蛋白复层膜及其制备方法 | |
| CN114376964B (zh) | 一种葛根素纳米粒成膜水凝胶制剂及其制备方法 | |
| CN105363062B (zh) | 医用水凝胶护眼贴 | |
| CN105381496A (zh) | 医用水凝胶护眼贴 | |
| CN115998940B (zh) | 一种修复敷料及其加工工艺 | |
| CN106265719A (zh) | 一种医用清热抗菌水凝胶眼贴及其制备方法 | |
| CN101543509A (zh) | 含有硫酸软骨素的眼用凝胶剂及其制备方法 | |
| CN102198087B (zh) | 一种不含防腐剂的眼用原位胶凝剂及其制备方法 | |
| CN111481731A (zh) | 一种胶原蛋白-壳聚糖静电纺丝膜复合海藻酸盐防海水浸泡敷贴及其制备方法 | |
| CN210904535U (zh) | 一种用于减少无创呼吸机使用过程中发生压疮的胶垫 | |
| CN113384742A (zh) | 一种高粘抗菌聚合物水凝胶复合敷料及其制备方法 | |
| CN203138827U (zh) | 医用聚氨酯水凝胶护眼装置 | |
| CN105816477A (zh) | 一种角膜表面保护剂在全麻手术中的应用 | |
| CN113499323A (zh) | 一种几丁质糖膜眼贴制作工艺 | |
| KR20220131018A (ko) | 무막줄기세포추출물을 포함하는 안구건조증 치료용 조성물 및 이에 의해 제조된 점안액 | |
| CN112957519A (zh) | 用于制备促进创口愈合的水凝胶的组合物、水凝胶及其制备方法 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20210525 |