WO2022126628A1 - 一种液体创可贴及其制备方法 - Google Patents
一种液体创可贴及其制备方法 Download PDFInfo
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- WO2022126628A1 WO2022126628A1 PCT/CN2020/137697 CN2020137697W WO2022126628A1 WO 2022126628 A1 WO2022126628 A1 WO 2022126628A1 CN 2020137697 W CN2020137697 W CN 2020137697W WO 2022126628 A1 WO2022126628 A1 WO 2022126628A1
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- parts
- film
- ethyl cellulose
- carboxymethyl chitosan
- ethanol
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- 239000007788 liquid Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims description 13
- 239000000853 adhesive Substances 0.000 title abstract 2
- 230000001070 adhesive effect Effects 0.000 title abstract 2
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims abstract description 76
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 57
- 239000001856 Ethyl cellulose Substances 0.000 claims abstract description 47
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims abstract description 47
- 229920001249 ethyl cellulose Polymers 0.000 claims abstract description 47
- 235000019325 ethyl cellulose Nutrition 0.000 claims abstract description 47
- 229920001661 Chitosan Polymers 0.000 claims abstract description 37
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract description 32
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 31
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000012153 distilled water Substances 0.000 claims abstract description 22
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 20
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 20
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 20
- 239000002131 composite material Substances 0.000 claims abstract description 11
- 239000004014 plasticizer Substances 0.000 claims abstract description 8
- 239000011148 porous material Substances 0.000 claims abstract description 5
- 238000003756 stirring Methods 0.000 claims description 23
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical group CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 claims description 20
- 230000035699 permeability Effects 0.000 claims description 16
- 239000002904 solvent Substances 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 12
- 239000012528 membrane Substances 0.000 claims description 10
- 238000002955 isolation Methods 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 206010052428 Wound Diseases 0.000 abstract description 15
- 208000027418 Wounds and injury Diseases 0.000 abstract description 15
- 230000035876 healing Effects 0.000 abstract description 9
- 230000000844 anti-bacterial effect Effects 0.000 abstract description 7
- 230000023597 hemostasis Effects 0.000 abstract description 7
- -1 i.e. Substances 0.000 abstract description 4
- 102000010834 Extracellular Matrix Proteins Human genes 0.000 abstract description 3
- 108010037362 Extracellular Matrix Proteins Proteins 0.000 abstract description 3
- 230000000202 analgesic effect Effects 0.000 abstract description 3
- 210000004027 cell Anatomy 0.000 abstract description 3
- 210000002919 epithelial cell Anatomy 0.000 abstract description 3
- 210000002744 extracellular matrix Anatomy 0.000 abstract description 3
- 210000002950 fibroblast Anatomy 0.000 abstract description 3
- 230000029663 wound healing Effects 0.000 abstract description 3
- 230000036573 scar formation Effects 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 12
- 230000003110 anti-inflammatory effect Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- NIPNSKYNPDTRPC-UHFFFAOYSA-N N-[2-oxo-2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 NIPNSKYNPDTRPC-UHFFFAOYSA-N 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
- 238000011109 contamination Methods 0.000 description 4
- 230000002439 hemostatic effect Effects 0.000 description 4
- 230000001681 protective effect Effects 0.000 description 4
- BDAGIHXWWSANSR-UHFFFAOYSA-M Formate Chemical compound [O-]C=O BDAGIHXWWSANSR-UHFFFAOYSA-M 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 230000036592 analgesia Effects 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229920006254 polymer film Polymers 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- LDXJRKWFNNFDSA-UHFFFAOYSA-N 2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)-1-[4-[2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidin-5-yl]piperazin-1-yl]ethanone Chemical compound C1CN(CC2=NNN=C21)CC(=O)N3CCN(CC3)C4=CN=C(N=C4)NCC5=CC(=CC=C5)OC(F)(F)F LDXJRKWFNNFDSA-UHFFFAOYSA-N 0.000 description 1
- 208000032544 Cicatrix Diseases 0.000 description 1
- 241000779819 Syncarpia glomulifera Species 0.000 description 1
- FHKPLLOSJHHKNU-INIZCTEOSA-N [(3S)-3-[8-(1-ethyl-5-methylpyrazol-4-yl)-9-methylpurin-6-yl]oxypyrrolidin-1-yl]-(oxan-4-yl)methanone Chemical compound C(C)N1N=CC(=C1C)C=1N(C2=NC=NC(=C2N=1)O[C@@H]1CN(CC1)C(=O)C1CCOCC1)C FHKPLLOSJHHKNU-INIZCTEOSA-N 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 150000001338 aliphatic hydrocarbons Chemical class 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 230000001194 anti-hemostatic effect Effects 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 235000019606 astringent taste Nutrition 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000032823 cell division Effects 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 239000012847 fine chemical Substances 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 150000008282 halocarbons Chemical class 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 125000004971 nitroalkyl group Chemical group 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 231100000956 nontoxicity Toxicity 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000000614 phase inversion technique Methods 0.000 description 1
- 239000001739 pinus spp. Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920000867 polyelectrolyte Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 230000037390 scarring Effects 0.000 description 1
- 230000037387 scars Effects 0.000 description 1
- 230000037380 skin damage Effects 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229940036248 turpentine Drugs 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
-
- 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
- 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
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
-
- 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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
Definitions
- the invention belongs to the technical field of medical devices, and in particular relates to a liquid band-aid and a preparation method thereof.
- Liquid Band-Aids can quickly dry and form a breathable, waterproof and elastic protective film, which can fit wounds of various sizes and shapes.
- the common biofilm-forming material of liquid Band-Aid products on the market is chitosan. Chitosan-like substances have good film-forming properties and are commonly used biofilm-forming materials. At the same time, it has the functions of antibacterial, hemostasis, healing and analgesia.
- chitosan as a film-forming agent has the following drawbacks: pure chitosan film has poor tensile strength and elasticity, resulting in brittleness of the film, inability to adhere well to wounds, and inconvenience to patients.
- the main purpose of the present invention is to provide a liquid Band-Aid, which uses ethyl cellulose and carboxymethyl chitosan in combination as a film-forming agent, so that the film-forming body is elastic, It has good tensile strength, and has the functions of antibacterial, hemostasis, healing and analgesia to wounds.
- the present invention provides the following technical solutions:
- a liquid Band-Aid comprising the following components in parts by weight: 10-20 parts of main film-forming agent ethyl cellulose, 6-15 parts of auxiliary film-forming agent carboxymethyl chitosan, and 3-15 parts of air permeability improver polyvinylpyrrolidone 5 parts, 1-8 parts of plasticizer, 25-30 parts of ethanol, 30-40 parts of ethyl acetate, and 20-30 parts of distilled water; Solvent, the distilled water is used as the solvent of carboxymethyl chitosan, the ethyl cellulose dissolved in ethanol and ethyl acetate forms an isolation waterproof film on the wound, and the carboxymethyl chitosan dissolved in distilled water is embedded in the ethyl cellulose A composite membrane is formed in the nanoscale pores of the membrane.
- the plasticizer is dibutyl phthalate.
- a preparation method of a liquid Band-Aid comprising the following steps:
- the main film-forming agent ethyl cellulose is slowly added in the described first container containing solvent ethanol and ethyl acetate, until complete wetting and dissolving, to obtain the first solution;
- the main film-forming agent ethyl cellulose is dissolved in ethanol and ethyl acetate to form a uniform ethyl cellulose film.
- the ethyl cellulose film is a porous polymer film with many small nano-scale holes.
- the water-soluble carboxymethyl chitosan is embedded in the nano-scale holes of the ethyl cellulose film to form a composite film.
- the ethyl cellulose film can prevent the contamination of the wound by external bacteria, and the carboxymethyl chitosan plays an anti-inflammatory role. , Hemostatic effect, to promote rapid wound healing.
- the composite membrane combines the advantages of ethyl cellulose and carboxymethyl chitosan, has strong tensile strength and flexibility, is elastic, and has good antibacterial, hemostasis, healing and analgesic functions It can promote the division of epithelial cells, fibroblasts and other cells and the growth of extracellular matrix, which can significantly accelerate the healing of wounds and reduce the formation of scars.
- Water-soluble polyvinylpyrrolidone is used as the air permeability improver, and the polyvinylpyrrolidone is embedded in the nano-scale holes of the ethyl cellulose film to form through holes, which play a good role in air permeability.
- a liquid Band-Aid comprising the following components in parts by weight: 10 parts of main film-forming agent ethyl cellulose, 6 parts of auxiliary film-forming agent carboxymethyl chitosan, 3 parts of air permeability improver polyvinylpyrrolidone, phthalate 1 part of dibutyl formate, 25 parts of ethanol, 30 parts of ethyl acetate, and 20 parts of distilled water; wherein, the ethanol and ethyl acetate are used as the solvent of the main film-forming agent ethyl cellulose, and the distilled water is used as the carboxymethyl shell
- the solvent of polysaccharide, ethyl cellulose dissolved in ethanol and ethyl acetate forms an isolation and waterproof membrane on the wound, and carboxymethyl chitosan dissolved in distilled water is embedded in the nano-scale holes of the ethyl cellulose membrane to form a composite membrane.
- the preparation method of the liquid Band-Aid comprises the following steps:
- the main film-forming agent ethyl cellulose is slowly added in the described first container containing solvent ethanol and ethyl acetate, until fully wetted and dissolved, to obtain the first solution;
- Ethyl cellulose is referred to as EC, generally insoluble in water, but soluble in different organic solvents, with good thermal stability, extremely low ash content when burning, little stickiness or astringency, and can form a tough film that remains stable at low temperatures. It can maintain flexibility, good flexibility, and the film-forming body is elastic and has good tensile strength. This product is safe and non-toxic, has strong anti-biological properties, and is metabolically inert. It is used as the main film-forming material. Ethyl cellulose (EC) has the advantages of no odor, no toxicity, good hydrophobicity and easy solubility in organic solvents, and is widely used in the field of pharmaceutical preparations.
- a uniform film with good protective properties can be formed by a phase inversion method.
- the EC was slowly added to the container containing solvent ethanol and ethyl acetate under stirring until it was completely wetted and dissolved.
- Chitosan has good film-forming properties and is a commonly used biofilm-forming material. It also has the functions of bacteriostatic, hemostasis, healing and pain relief, and can promote the division and cell division of epithelial cells, fibroblasts and other cells. The growth of extracellular matrix significantly accelerates wound healing and reduces scarring.
- Carboxymethyl chitosan is a water-soluble chitosan derivative with many properties, such as strong antibacterial properties, preservation of freshness, an amphoteric polyelectrolyte, etc. It has many applications in cosmetics, medicine, etc. One of the most studied chitosan derivatives in recent years, its stable properties, antibacterial and anti-infection, are of great significance in medicine and health care products.
- Polyvinyl pyrrolidone is an ideal film-forming material with alcohol solubility. The deepest and broadest range of fine chemicals. It has the effect of colloid protection, film-forming, cohesion, hygroscopicity, solubilization or cohesion, but its most distinctive feature is its excellent solubility and physiological compatibility. PVP is easily soluble in water and solvents containing halogenated hydrocarbons, alcohols, amines, nitroalkanes and low molecular fatty acids, etc. It is insoluble in a few solvents such as acetone, ether, turpentine, aliphatic hydrocarbons and alicyclic hydrocarbons. Compatible with inorganic acid salts and various resins.
- the main film-forming agent, ethyl cellulose is dissolved in ethanol and ethyl acetate to form a uniform ethyl cellulose film.
- the ethyl cellulose film is a porous polymer film with many small nano-scale pores.
- Carboxymethyl chitosan is embedded in the nano-scale pores of the ethyl cellulose membrane to form a composite membrane.
- the ethyl cellulose film can prevent the contamination of the wound by external bacteria, and the carboxymethyl chitosan plays the role of anti-inflammatory and hemostasis, and promotes the rapid healing of the wound.
- the water-soluble polyvinylpyrrolidone is embedded in the nano-scale holes of the ethyl cellulose film to form through holes, which play a good role in air permeability and are a good air permeability improver.
- the composite protective film formed after the solvent volatilizes has certain toughness, and has obvious waterproof, breathable and protective effects.
- a liquid Band-Aid comprising the following components by weight: 15 parts of main film-forming agent ethyl cellulose, 10 parts of auxiliary film-forming agent carboxymethyl chitosan, 4 parts of air permeability improver polyvinylpyrrolidone, phthalate 5 parts of dibutyl formate, 28 parts of ethanol, 35 parts of ethyl acetate, and 25 parts of distilled water.
- a liquid Band-Aid comprising the following components by weight: 20 parts of main film-forming agent ethyl cellulose, 15 parts of auxiliary film-forming agent carboxymethyl chitosan, 5 parts of air permeability improver polyvinylpyrrolidone, phthalate 8 parts of dibutyl formate, 30 parts of ethanol, 40 parts of ethyl acetate, and 30 parts of distilled water.
- Example 3 The difference between this comparative example and Example 3 is that it does not contain the auxiliary film-forming agent carboxymethyl chitosan.
- the plan is as follows:
- a liquid Band-Aid comprising the following components by weight: 20 parts of main film-forming agent ethyl cellulose, 5 parts of air permeability improver polyvinylpyrrolidone, 8 parts of dibutyl phthalate, 30 parts of ethanol, ethyl acetate 40 parts of ester, 30 parts of distilled water.
- the preparation method of the liquid Band-Aid comprises the following steps:
- the main film-forming agent ethyl cellulose is slowly added into the first container containing solvent ethanol and ethyl acetate under stirring until it is completely wetted and dissolved to obtain the first solution;
- Example 3 The difference between this comparative example and Example 3 is that it does not contain the air permeability improver polyvinylpyrrolidone.
- the plan is as follows:
- a liquid Band-Aid comprising the following components by weight: 20 parts of main film-forming agent ethyl cellulose, 15 parts of auxiliary film-forming agent carboxymethyl chitosan, 8 parts of dibutyl phthalate, and 30 parts of ethanol , 40 parts of ethyl acetate and 30 parts of distilled water.
- the preparation method of the liquid Band-Aid comprises the following steps:
- the main film-forming agent ethyl cellulose is slowly added in the described first container containing solvent ethanol and ethyl acetate, until fully wetted and dissolved, to obtain the first solution;
- Example 3 The difference between this comparative example and Example 3 is that it does not contain the main film-forming agent ethyl cellulose and the air permeability improver polyvinylpyrrolidone.
- the plan is as follows:
- a liquid Band-Aid comprises the following components in parts by weight: 15 parts of auxiliary film-forming agent carboxymethyl chitosan, 8 parts of dibutyl phthalate, 30 parts of ethanol, 40 parts of ethyl acetate and 30 parts of distilled water.
- the preparation method of the liquid Band-Aid comprises the following steps:
- Example 1-3 adopts the main film-forming agent ethyl cellulose and carboxymethyl chitosan to form a composite film.
- the composite film has high tensile strength through ethyl cellulose and can prevent the contamination of the wound by external bacteria, and exerts anti-inflammatory and hemostatic effects through carboxymethyl chitosan, which promotes the rapid healing of the wound.
- Polyvinylpyrrolidone plays a good role in air permeability and is a good air permeability improver.
- the 200 cases of volunteers with skin damage were randomly divided into two groups, namely the test group and the control group, with 100 people in each group. Evaluation was made from hemostatic effect, anti-inflammatory effect and isolation effect, and the results are shown in Table 2.
- the liquid Band-Aid of Example 3 has better hemostatic effect, anti-inflammatory effect and isolation effect.
- ethyl cellulose and carboxymethyl chitosan is used as a film-forming agent, which makes the film-forming body rich in elasticity and good in tensile strength, which can prevent the contamination of the wound by external bacteria, and has antibacterial and hemostasis on the wound. , promoting healing, analgesic function.
- Polyvinylpyrrolidone plays a good role in air permeability and is a good air permeability improver.
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Abstract
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素10-20份、辅成膜剂羧甲基壳聚糖6-15份、透气性改良剂聚乙烯吡咯烷酮3-5份、增塑剂1-8份、乙醇25-30份，乙酸乙酯30-40份，蒸馏水20-30份；溶解于乙醇和乙酸乙酯的乙基纤维素在创口形成隔离防水膜，溶解于蒸馏水的羧甲基壳聚糖镶嵌于乙基纤维素膜的纳米级孔洞中形成复合膜；该复合膜集合了乙基纤维素和羧甲基壳聚糖的优点，具有较强的拉伸强度和柔韧性，富有弹性，且具有较好的抑菌、止血、促愈、镇痛的功能，能促进上皮细胞、成纤维细胞等多种细胞分裂和胞外基质生长，明显加速创面的愈合、并减少疤痕形成。
Description
本发明属于医疗器械技术领域，具体涉及一种液体创可贴及其制备方法。
近年来出现了加便捷实用的液体制剂创可贴，液体创可贴可快速干燥并形成透气、防水且有弹性的保护膜，可以贴合各种大小、形状的伤口。市面上常见的液体创可贴产品的生物成膜材料有壳聚糖，壳聚糖类物质具良好的成膜性，是常用的生物成膜材料。同时具有抑菌、止血、促愈、镇痛的功能。发明人发现壳聚糖作为成膜剂具有以下缺陷：纯壳聚糖膜有较差的拉伸强度和弹性，导致膜脆，不能很好地贴附创口，给患者带来不便。
鉴于现有技术中存在的不足之处，有必要提供一种液体创可贴及其制备方法。
发明内容
针对现有技术中存在的不足之处，本发明的主要目的是，提供一种液体创可贴，采用乙基纤维素和羧甲基壳聚糖联合作为成膜剂，使得所成膜体富有弹性，拉伸强度好，且对创口具有抑菌、止血、促愈、镇痛的功能。
为了实现本发明的上述目的，本发明提供如下技术方案：
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素10-20份、辅成膜剂羧甲基壳聚糖6-15份、透气性改良剂聚乙烯吡咯烷酮3-5份、增塑剂1-8份、乙醇25-30份，乙酸乙酯30-40份，蒸馏水20-30份；其中，所述乙醇和乙酸乙酯作为主成膜剂乙基纤维素的溶剂，所述蒸馏水作为羧甲基壳聚糖的溶剂，溶解于乙醇和乙酸乙酯的乙基纤维素在创口形成隔离防水膜，溶解于蒸馏水的羧甲基壳聚糖镶嵌于乙基纤维素膜的纳米级孔洞中形成 复合膜。
所述增塑剂为邻苯二甲酸二丁酯。
一种液体创可贴的制备方法，包括以下步骤：
1)称取配方量的乙醇、乙酸乙酯置于第一容器中混合均匀；
2)在上述混合物中加入配方量的增塑剂搅拌溶解；
3)然后在搅拌状态下将主成膜剂乙基纤维素慢慢加入所述盛有溶剂乙醇和乙酸乙酯的第一容器内，直到完全润湿溶解，得到第一溶液；
4)加配方量的蒸馏水于第二容器中；
5)称取配方量的羧甲基壳聚糖和聚乙烯吡咯烷酮于第二容器中搅拌至溶解得到第二溶液；
6)将所述第一溶液和第二溶液混合后搅拌均匀得到液体创可贴。
上述技术方案中的一个技术方案具有如下优点或有益效果：
本发明采用主成膜剂乙基纤维素溶于乙醇和乙酸乙酯后形成均匀的乙基纤维素膜，所述乙基纤维素膜是具有许多小的纳米级孔洞的多孔高聚物膜，水溶性的羧甲基壳聚糖镶嵌于乙基纤维素膜的纳米级孔洞中形成复合膜，所述乙基纤维素膜可以防止外界细菌对创口的污染，由羧甲基壳聚糖发挥消炎、止血作用，促使创口快速愈合。该复合膜集合了乙基纤维素和羧甲基壳聚糖的优点，具有较强的拉伸强度和柔韧性，富有弹性，且具有较好的抑菌、止血、促愈、镇痛的功能，能促进上皮细胞、成纤维细胞等多种细胞分裂和胞外基质生长，明显加速创面的愈合、并减少疤痕形成。
采用水溶性的聚乙烯吡咯烷酮作为透气性改良剂，所述聚乙烯吡咯烷酮镶嵌于乙基纤维素膜的纳米级孔洞中形成通孔起到良好的透气作用。
应当理解，本文所使用的诸如“具有”、“包含”以及“包括”术语并不配出一个或多个组合的存在或添加。
实施例1
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素10份、辅成膜剂羧甲基壳聚糖6份、透气性改良剂聚乙烯吡咯烷酮3份、邻苯二甲酸二丁酯1份、乙醇25份，乙酸乙酯30份，蒸馏水20份；其中，所述乙醇和乙酸乙酯作为主成膜剂乙基纤维素的溶剂，所述蒸馏水作为羧甲基壳聚糖的溶剂，溶解于乙醇和乙酸乙酯的乙基纤维素在创口形成隔离防水膜，溶解于蒸馏水的羧甲基壳聚糖镶嵌于乙基纤维素膜的纳米级孔洞中形成复合膜。
所述液体创可贴的制备方法，包括以下步骤：
1)称取配方量的乙醇、乙酸乙酯置于第一容器中混合均匀；
2)在上述混合物中加入配方量的邻苯二甲酸二丁酯搅拌溶解；
3)然后在搅拌状态下将主成膜剂乙基纤维素慢慢加入所述盛有溶剂乙醇和乙酸乙酯的第一容器内，直到完全润湿溶解，得到第一溶液；
4)加配方量的蒸馏水于第二容器中；
5)称取配方量的羧甲基壳聚糖和聚乙烯吡咯烷酮于第二容器中搅拌至溶解得到第二溶液；
6)将所述第一溶液和第二溶液混合后搅拌均匀得到液体创可贴。
乙基纤维素简称EC，一般不溶于水，而溶于不同的有机溶剂，热稳定性好，燃烧时灰份极低，很少有粘着感或发涩，能生成坚韧薄膜，在低温时仍能保持挠曲性，柔韧性好，所成膜体富有弹性，拉伸强度好，本品安全无毒，有极强的抗生物性能，代谢惰性，用于主要成膜的材料。乙基纤维素(EC)具有无异味、无毒性、良好的疏水性和易溶于有机溶剂等优点，广泛地应用于药物制剂领域。EC作为成膜材料溶于有机溶剂后，通过相转换法可以形成具有良好防护性能的均匀的薄膜。将EC在搅拌状态下慢慢加入至盛有溶剂乙醇和乙酸乙酯的容器内，直到完全润湿溶解为止。
壳聚糖类物质具良好的成膜性，是常用的生物成膜材料，同时具有抑菌、止血、促愈、镇痛的功能，能促进上皮细胞、成纤维细胞等多种细胞分裂和 胞外基质生长，明显加速创面的愈合、并减少疤痕形成。羧甲基壳聚糖是一种水溶性壳聚糖衍生物，有许多特性，如抗菌性强，具有保鲜作用，是一种两性聚电解质等，在化妆品、医药等方面有多种应用，也是近年来研究得较多的壳聚糖衍生物之一，其性质稳定，抗菌抗感染，在医药、保健品方面等都有重要的意义。
聚乙烯吡咯烷酮(polyvinyl pyrrolidone)简称PVP，一种醇溶性的非常理想的成膜材料，是一种非离子型高分子化合物，是N-乙烯基酰胺类聚合物中最具特色，且被研究得最深、广泛的精细化学品品种。具有胶体保护作用、成膜性、粘结性、吸湿性、增溶或凝聚作用，但其最具特色，因而受到人们重视的是其优异的溶解性能及生理相容性。PVP极易溶于水及含卤代烃类溶剂、醇类、胺类、硝基烷烃及低分子脂肪酸等，不溶于丙酮、乙醚、松节油、脂肪烃和脂环烃等少数溶剂，能与多数无机酸盐、多种树脂相容。
主成膜剂乙基纤维素溶于乙醇和乙酸乙酯后形成均匀的乙基纤维素膜，所述乙基纤维素膜是具有许多小的纳米级孔洞的多孔高聚物膜，水溶性的羧甲基壳聚糖镶嵌于乙基纤维素膜的纳米级孔洞中形成复合膜。所述乙基纤维素膜可以防止外界细菌对创口的污染，由羧甲基壳聚糖发挥消炎、止血作用，促使创口快速愈合。水溶性的聚乙烯吡咯烷酮镶嵌于乙基纤维素膜的纳米级孔洞中形成通孔起到良好的透气作用，是良好的透气性改良剂。所述溶剂挥发后形成的复合保护膜具有一定的韧性，具有显著的防水透气及防护作用。
实施例2
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素15份、辅成膜剂羧甲基壳聚糖10份、透气性改良剂聚乙烯吡咯烷酮4份、邻苯二甲酸二丁酯5份、乙醇28份，乙酸乙酯35份，蒸馏水25份。
所述液体创可贴的制备方法如实施例1。
实施例3
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素20份、 辅成膜剂羧甲基壳聚糖15份、透气性改良剂聚乙烯吡咯烷酮5份、邻苯二甲酸二丁酯8份、乙醇30份，乙酸乙酯40份，蒸馏水30份。
所述液体创可贴的制备方法如实施例1。
对比例1
本对比例与实施例3不同的是，不含辅成膜剂羧甲基壳聚糖。方案如下：
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素20份、透气性改良剂聚乙烯吡咯烷酮5份、邻苯二甲酸二丁酯8份、乙醇30份，乙酸乙酯40份，蒸馏水30份。
所述液体创可贴的制备方法，包括以下步骤：
称取配方量的乙醇、乙酸乙酯置于第一容器中混合均匀；
在上述混合物中加入配方量的邻苯二甲酸二丁酯搅拌溶解；
然后在搅拌状态下将主成膜剂乙基纤维素慢慢加入所述盛有溶剂乙醇和乙酸乙酯的第一容器内，直到完全润湿溶解，得到第一溶液；
加配方量的蒸馏水于第二容器中；
称取配方量聚乙烯吡咯烷酮于第二容器中搅拌至溶解得到第二溶液；
将所述第一溶液和第二溶液混合后搅拌均匀得到液体创可贴。
对比例2
本对比例与实施例3不同的是，不含透气性改良剂聚乙烯吡咯烷酮。方案如下：
一种液体创可贴，包括如下重量份的组分：主成膜剂乙基纤维素20份、辅成膜剂羧甲基壳聚糖15份、邻苯二甲酸二丁酯8份、乙醇30份，乙酸乙酯40份，蒸馏水30份。
所述液体创可贴的制备方法，包括以下步骤：
称取配方量的乙醇、乙酸乙酯置于第一容器中混合均匀；
在上述混合物中加入配方量的邻苯二甲酸二丁酯搅拌溶解；
然后在搅拌状态下将主成膜剂乙基纤维素慢慢加入所述盛有溶剂乙醇和 乙酸乙酯的第一容器内，直到完全润湿溶解，得到第一溶液；
加配方量的蒸馏水于第二容器中；
称取配方量的羧甲基壳聚糖于第二容器中搅拌至溶解得到第二溶液；
将所述第一溶液和第二溶液混合后搅拌均匀得到液体创可贴。
对比例3
本对比例与实施例3不同的是，不含主成膜剂乙基纤维素和透气性改良剂聚乙烯吡咯烷酮。方案如下：
一种液体创可贴，包括如下重量份的组分：辅成膜剂羧甲基壳聚糖15份、邻苯二甲酸二丁酯8份、乙醇30份，乙酸乙酯40份，蒸馏水30份。
所述液体创可贴的制备方法，包括以下步骤：
称取配方量的乙醇、乙酸乙酯置于第一容器中混合均匀；
在上述混合物中加入配方量的邻苯二甲酸二丁酯搅拌溶解得到第一溶液；
加配方量的蒸馏水于第二容器中；
称取配方量的羧甲基壳聚糖于第二容器中搅拌至溶解得到第二溶液；
将所述第一溶液和第二溶液混合后搅拌均匀得到液体创可贴。
测试例1
将实施例1-3、对比例1-3提供的方案获得的液体创可贴各取约3g，流延铺平，自然干燥，制备成薄膜，然后进行效果对比，从膜拉伸强度、水蒸气透过率和无菌效果三方面进行比较，其中，所述膜拉伸强度按GB13022-91塑料薄膜拉伸性能试验方法测试；水蒸气透过率按YY/T0471.2-2004接触性创面敷料试验方法水蒸气透过率操作测试，无菌按照《中国药典》2010年版二部附录XIH无菌检查法检查，结果如表1所示。
表1 实施例1-3、对比例1-3提供的液体创可贴的性能
| 膜拉伸强度 | 水蒸气透过 | 无菌 |
| (MPa) | 率(g/m 2/24h) | ||
| 实施例1 | 6 | 1600 | 符合规定 |
| 实施例2 | 8 | 1700 | 符合规定 |
| 实施例3 | 10 | 1900 | 符合规定 |
| 对比例1 | 9.5 | 1580 | 符合规定 |
| 对比例2 | 9.8 | 800 | 符合规定 |
| 对比例3 | 2 | 700 | 符合规定 |
由表1可知，相比于对比例1-3，实施例1-3采用主成膜剂乙基纤维素与羧甲基壳聚糖形成复合膜。通过乙基纤维素使得复合膜拉伸强度高且可以防止外界细菌对创口的污染，通过羧甲基壳聚糖发挥消炎、止血作用，促使创口快速愈合。聚乙烯吡咯烷酮起到良好的透气作用，是良好的透气性改良剂。
测试例2
将200例皮肤损伤的志愿者随机平均分成2组，即试验组和对照组，每组100人，试验组采用实施例3的液体创可贴，对照组采用购买的日本小林制药液体创可贴，观察疗效，从止血效果、消炎效果、隔离效果进行评价，结果见表2。
表2 试验组和对照组测试结果
| 组别 | 止血效果 | 消炎效果 | 隔离效果 |
| 试验组 | 95 | 92 | 96 |
| 对照组 | 85 | 80 | 86 |
从表2可以看出，本实施例3的液体创可贴的止血效果、消炎效果、隔离效果更好。
可见，采用乙基纤维素和羧甲基壳聚糖联合作为成膜剂，使得所成膜体富有弹性，拉伸强度好，可以防止外界细菌对创口的污染，且对创口具有抑菌、止血、促愈、镇痛的功能。聚乙烯吡咯烷酮起到良好的透气作用，是良 好的透气性改良剂。
尽管本发明的实施方案已公开如上，但其并不仅限于说明书和实施方式中所列运用，它完全可以被适用于各种适合本发明的领域，对于熟悉本领域的人员而言，可容易地实现另外的修改，因此在不背离权利要求及等同范围所限定的一般概念下，本发明并不限于特定的细节和这里示出与描述的具体实施方式。
Claims (4)
- 一种液体创可贴，其特征在于：包括如下重量份的组分：主成膜剂乙基纤维素10-20份、辅成膜剂羧甲基壳聚糖6-15份、透气性改良剂聚乙烯吡咯烷酮3-5份、增塑剂1-8份、乙醇25-30份，乙酸乙酯30-40份，蒸馏水20-30份；其中，所述乙醇和乙酸乙酯作为主成膜剂乙基纤维素的溶剂，所述蒸馏水作为羧甲基壳聚糖的溶剂，溶解于乙醇和乙酸乙酯的乙基纤维素在创口形成隔离防水膜，溶解于蒸馏水的羧甲基壳聚糖镶嵌于乙基纤维素膜的纳米级孔洞中形成复合膜。
- 如权利要求1所述的液体创可贴，其特征在于：所述增塑剂为邻苯二甲酸二丁酯。
- 一种如权利要求1所述的液体创可贴的制备方法，其特征在于，包括以下步骤：1)称取配方量的乙醇、乙酸乙酯置于第一容器中混合均匀；2)在上述混合物中加入配方量的增塑剂搅拌溶解；3)然后在搅拌状态下将主成膜剂乙基纤维素慢慢加入所述盛有溶剂乙醇和乙酸乙酯的第一容器内，直到完全润湿溶解，得到第一溶液；4)加配方量的蒸馏水于第二容器中；5)称取配方量的羧甲基壳聚糖和聚乙烯吡咯烷酮于第二容器中搅拌至溶解得到第二溶液；6)将所述第一溶液和第二溶液混合后搅拌均匀得到液体创可贴。
- 如权利要求3所述的制备方法，其特征在于：所述增塑剂为邻苯二甲酸二丁酯。
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| CN109820945A (zh) * | 2019-03-29 | 2019-05-31 | 广西师范大学 | 促进皮肤创伤愈合及毛发生长的组合药物及其制备方法 |
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| CN116271205A (zh) * | 2023-03-30 | 2023-06-23 | 福州大学 | 一种含黑磷纳米片成分的液体创可贴及其制备方法 |
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