WO2022133629A1 - 一种喷雾型液体创可贴及其制备方法 - Google Patents

一种喷雾型液体创可贴及其制备方法 Download PDF

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WO2022133629A1
WO2022133629A1 PCT/CN2020/137864 CN2020137864W WO2022133629A1 WO 2022133629 A1 WO2022133629 A1 WO 2022133629A1 CN 2020137864 W CN2020137864 W CN 2020137864W WO 2022133629 A1 WO2022133629 A1 WO 2022133629A1
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parts
film
spray
container
type liquid
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PCT/CN2020/137864
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English (en)
French (fr)
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吴克
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江苏奇力康皮肤药业有限公司
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Priority to PCT/CN2020/137864 priority Critical patent/WO2022133629A1/zh
Publication of WO2022133629A1 publication Critical patent/WO2022133629A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • 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
    • 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, in particular to a spray-type liquid band-aid and a preparation method thereof.
  • the tensile strength of the film body is poor, and it cannot be well attached to the wound; the viscosity and surface tension of the spray stock solution are high, and it is laborious to use the spray device to spray, and due to the high viscosity and high surface tension, some spray stock solution is easy to adhere to the spray nozzle and block the nozzle , unsanitary and prevent the spray liquid from spraying out; the liquid Band-Aid film is dry after the solvent is fully evaporated, which affects the wound healing speed. The wound healing speed in the wet state is much faster than that in the dry state.
  • the main purpose of the present invention is to provide a spray-type liquid Band-Aid, which is combined with ethyl cellulose, carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer as a
  • the film-forming material adopts a combination of volatile solvents and co-volatile agents, and uses sodium lauryl sulfate and Tween as surface tension modifiers, so that the formed film has good flexibility and elasticity, low adhesion, and surface tension. Low, good moisturizing.
  • the present invention provides the following technical solutions:
  • a spray-type liquid Band-Aid comprising the following components by weight:
  • ethyl cellulose 20-30 parts of ethyl cellulose, 6-10 parts of carboxymethyl chitosan, 3-5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 15-25 parts of ethanol, 20-25 parts of ethyl acetate, diacetone 25-40 parts of alcohol, 5-15 parts of isooctane, 5-15 parts of n-hexane, 5-15 parts of n-heptane, 1-5 parts of sodium lauryl sulfate, 1-5 parts of Tween, glycerol 0.5-1.5 parts, distilled water 25-35 parts;
  • ethyl cellulose, carboxymethyl chitosan, and polyvinyl pyrrolidone-vinyl acetate copolymer are used as film-forming materials, ethyl cellulose improves the elasticity of the film, and carboxymethyl chitosan and glycerin synergize It can improve the moisturizing property of the film.
  • the synergistic effect of ethanol, ethyl acetate, diacetone alcohol and isooctane, n-hexane and n-heptane reduces the viscosity of the film.
  • the surface tension modifier sodium lauryl sulfate and Tween reduce the film's viscosity. Surface Tension.
  • the present invention also provides a method for preparing a spray-type liquid Band-Aid, comprising the following steps:
  • the present invention adopts ethyl cellulose, carboxymethyl chitosan, polyvinylpyrrolidone-vinyl acetate copolymer as film-forming material, adopts volatile solvent combination and co-volatile agent combination, and adopts sodium lauryl sulfate And Tween as a surface tension modifier, so that the formed film has good flexibility and elasticity, low adhesion, low surface tension and good moisture retention.
  • Ethyl cellulose improves the elasticity of the film
  • the synergistic effect of carboxymethyl chitosan and glycerol improves the moisture retention of the film
  • the synergistic effect of ethanol, ethyl acetate, diacetone alcohol and isooctane, n-hexane and n-heptane reduces Film viscosity
  • surface tension modifiers sodium dodecyl sulfate and Tween reduce the surface tension of the film.
  • the ethyl cellulose film has good flexibility and elasticity, and can prevent the contamination of the wound by external bacteria;
  • Carboxymethyl chitosan has anti-inflammatory and hemostatic effects, which promotes rapid wound healing; water-soluble carboxymethyl chitosan makes the liquid Band-Aid have good moisturizing properties; glycerin makes the film have good softness and can moisturize Skin, moisturizing wounds and accelerating wound healing; carboxymethyl chitosan and glycerol synergize to improve the moisturizing properties of spray-type liquid band-aids;
  • Ethanol, ethyl acetate, and diacetone alcohol, and diacetone alcohol is a low-viscosity solvent, and the combination of the above-mentioned volatile solvents is beneficial to reduce the viscosity of the spray-type liquid Band-Aid;
  • Isooctane, n-hexane and n-heptane are used as co-volatile agents, and the three synergistic effects promote solvent volatilization and reduce the viscosity of spray-type liquid Band-Aid;
  • Sodium lauryl sulfate and Tween are used as surface tension modifiers, and the two act synergistically to reduce the surface tension of spray-type liquid Band-Aids.
  • a spray-type liquid Band-Aid comprising the following components by weight: 20 parts of ethyl cellulose, 6 parts of carboxymethyl chitosan, 3 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 15 parts of ethanol, ethyl acetate 20 parts, 25 parts of diacetone alcohol, 5 parts of isooctane, 5 parts of n-hexane, 5 parts of n-heptane, 1 part of sodium lauryl sulfate, 1 part of Tween, 0.5 part of glycerol, and 25 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid comprises the following steps:
  • 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 antibacterial, hemostasis, healing, analgesia, and moisturizing, and can promote the division of epithelial cells, fibroblasts and other cells. and extracellular matrix growth, significantly accelerate wound healing, and reduce 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.
  • Polyvinylpyrrolidone-vinyl acetate copolymer is a very ideal film-forming material with alcohol solubility. It has good non-toxic and tasteless, no irritation to the skin, no pollution, close contact with the skin, easy to degrade naturally and other excellent properties. nature. Polyvinylpyrrolidone-vinyl acetate copolymer is completely soluble in water, also soluble in ethanol, isopropanol, propylene glycol, glycerol, low molecular weight polyethylene glycol and other solvents as well as ester and ketone solvents, slightly soluble in ether and Hydrocarbon solvents. Polyvinylpyrrolidone-vinyl acetate copolymer is a highly cross-linked polymer material with a three-dimensional network structure, which can be used as a porogen.
  • the film-forming agent ethyl cellulose is dissolved in the solvent ethanol, ethyl acetate and diacetone alcohol to form a uniform ethyl cellulose film
  • the ethyl cellulose film is a porous polymer film with many small nano-scale pores
  • water-soluble carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer are embedded in the nano-scale pores of 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 exerts anti-inflammatory, hemostasis and good moisturizing effects to promote 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, so it is not only a film-forming material but also a good porogen.
  • Glycerol is glycerin, which is colorless, odorless, sweet in taste, and has a clear and viscous liquid appearance. It is an organic substance that can absorb moisture from the air, as well as hydrogen sulfide, hydrogen cyanide and sulfur dioxide. It is miscible with water and ethanol, 1 part can be dissolved in 11 parts of ethyl acetate, about 500 parts of ether, insoluble in benzene, carbon disulfide, chloroform, carbon tetrachloride, petroleum ether, chloroform, oil. Glycerol is a commonly used plasticizer, which gives the film good softness, moisturizing the skin, moisturizing the wound, and accelerating wound healing.
  • both a plasticizer and an auxiliary moisturizing agent works synergistically with water-soluble carboxymethyl chitosan to improve the moisturizing property of the spray-type liquid Band-Aid to improve its wetting effect on the wound; at the same time, because of its plasticizing effect Therefore, reducing its dosage is beneficial to reduce the viscosity of the spray-type liquid Band-Aid.
  • Ethyl acetate, ethanol, and diacetone alcohol are all good volatile solvents, and ethyl acetate has a fruity fragrance and is also used as a fragrance for spray-type liquid Band-Aids.
  • diacetone alcohol is a medium boiling point solvent with low viscosity and little influence by temperature, and can dissolve resin, nitrocellulose, cellulose acetate, ethyl cellulose, plexiglass, polystyrene and polyvinyl acetate.
  • Diacetone alcohol also known as diacetone alcohol, methyl pentanol, 2-methyl-4-oxopentanol, or DAA for short, is a colorless liquid with a slight mint smell.
  • Isooctane is a colorless transparent liquid, volatile, almost insoluble in water, miscible in heptane, acetone, soluble in alcohol, benzene, toluene, xylene, chloroform, ether, carbon disulfide, carbon tetrachloride, diethyl ether Oils other than methylformamide and reduced castor oil can help volatilize and assist in reducing viscosity; n-hexane is volatile, almost insoluble in water, easily soluble in chloroform, ether, ethanol, and can help volatilize and assist in reducing viscosity The role of n-heptane; n-heptane is a colorless, volatile liquid, insoluble in water, soluble in alcohol, miscible in low polar solvents such as ether, chloroform, dichloromethane, etc., which can help volatilize and assist in reducing viscosity; The synergistic effect of isooc
  • Sodium lauryl sulfate is a white or light yellow micro-sticky substance, which is commonly used in the detergent and textile industries in industry. It is an anionic surface tension modifier. It is easily soluble in water, has good compatibility with anions and non-ions, has good emulsification, foaming, penetration, decontamination and dispersion properties, and can effectively reduce surface tension; Tween Tween (or polysorbate) is a non-ionic Type surface tension modifier, a series of partial fatty acid esters of polyoxyethylene sorbitan, widely used as emulsifier and solubilizer for oil substances, polysorbate is generally considered as a non-toxic and non-irritating material . Sodium lauryl sulfate and Tween are used as surface tension modifiers, and the two act synergistically to reduce the surface tension of spray-type liquid Band-Aids.
  • the present invention adopts ethyl cellulose, carboxymethyl chitosan, polyvinylpyrrolidone-vinyl acetate copolymer as film-forming material, adopts volatile solvent combination and co-volatile agent combination, and adopts sodium lauryl sulfate And Tween as a surface tension modifier, so that the formed film has good flexibility and elasticity, low adhesion, low surface tension and good moisture retention.
  • Ethyl cellulose improves the elasticity of the film
  • the synergistic effect of carboxymethyl chitosan and glycerol improves the moisture retention of the film
  • the synergistic effect of ethanol, ethyl acetate, diacetone alcohol and isooctane, n-hexane and n-heptane reduces Film viscosity
  • surface tension modifiers sodium dodecyl sulfate and Tween reduce the surface tension of the film.
  • a spray-type liquid Band-Aid comprising the following components by weight: 25 parts of ethyl cellulose, 8 parts of carboxymethyl chitosan, 4 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 20 parts of ethanol, ethyl acetate 22 parts, 35 parts of diacetone alcohol, 10 parts of isooctane, 8 parts of n-hexane, 9 parts of n-heptane, 3 parts of sodium lauryl sulfate, 4 parts of Tween, 1 part of glycerol, and 30 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid is as in Example 1.
  • a spray-type liquid band-aid comprising the following components by weight: 30 parts of ethyl cellulose, 10 parts of carboxymethyl chitosan, 5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 25 parts of ethanol, ethyl acetate 25 parts, 40 parts of diacetone alcohol, 15 parts of isooctane, 15 parts of n-hexane, 15 parts of n-heptane, 5 parts of sodium lauryl sulfate, 5 parts of Tween, 1.5 parts of glycerol, and 35 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid is as in Example 1.
  • Example 3 The difference between this comparative example and Example 3 is that it does not contain ethyl cellulose.
  • the plan is as follows:
  • a spray-type liquid Band-Aid comprising the following components by weight: 10 parts of carboxymethyl chitosan, 5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 25 parts of ethanol, 25 parts of ethyl acetate, and 40 parts of diacetone alcohol parts, 15 parts of isooctane, 15 parts of n-hexane, 15 parts of n-heptane, 5 parts of sodium lauryl sulfate, 5 parts of Tween, 1.5 parts of glycerol, and 35 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid comprises the following steps:
  • Example 3 The difference between this comparative example and Example 3 is that it does not contain carboxymethyl chitosan and glycerol.
  • the plan is as follows:
  • a spray-type liquid Band-Aid comprising the following components by weight: 30 parts of ethyl cellulose, 5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 25 parts of ethanol, 25 parts of ethyl acetate, and 40 parts of diacetone alcohol, 15 parts of isooctane, 15 parts of n-hexane, 15 parts of n-heptane, 5 parts of sodium lauryl sulfate, 5 parts of Tween, and 35 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid comprises the following steps:
  • Example 3 The difference between this comparative example and Example 3 is that it does not contain isooctane, n-hexane and n-heptane.
  • the plan is as follows:
  • a spray-type liquid band-aid comprising the following components by weight: 30 parts of ethyl cellulose, 10 parts of carboxymethyl chitosan, 5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 25 parts of ethanol, ethyl acetate 25 parts, 40 parts of diacetone alcohol, 5 parts of sodium lauryl sulfate, 5 parts of Tween, 1.5 parts of glycerin, and 35 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid comprises the following steps:
  • Example 3 The difference between this comparative example and Example 3 is that it does not contain sodium dodecyl sulfate and Tween.
  • the plan is as follows:
  • a spray-type liquid band-aid comprising the following components by weight: 30 parts of ethyl cellulose, 10 parts of carboxymethyl chitosan, 5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 25 parts of ethanol, ethyl acetate 25 parts, 40 parts of diacetone alcohol, 15 parts of isooctane, 15 parts of n-hexane, 15 parts of n-heptane, 1.5 parts of glycerol, and 35 parts of distilled water.
  • the preparation method of the spray-type liquid Band-Aid comprises the following steps:
  • the spray-type liquid Band-Aids obtained by the solutions provided in Examples 1-3 and Comparative Examples 1-4 are compared from three aspects of film tensile strength, viscosity and aseptic effect, wherein the film tensile strength is based on GB13022-91 plastics.
  • Test method for film tensile properties the viscosity is measured with a Ping'an viscometer (Jiangsu Yangzhou Hongqi Glass Instrument Factory), and the measurement method is the first method of VIG viscosity measurement method in the second appendix of the "Chinese Pharmacopoeia" 2000 edition.
  • Examples 1-3 use ethyl cellulose, carboxymethyl chitosan, and polyvinylpyrrolidone-vinyl acetate copolymer as the film-forming material, and use volatile materials.
  • the combination of solvent and co-volatile agent, and the use of sodium lauryl sulfate and Tween as the surface tension modifier, the formed film has good flexibility and elasticity, low adhesion and low surface tension.
  • Ethyl cellulose improves the elasticity of the film
  • the surface tension modifier sodium lauryl sulfate and Tween reduce The surface tension of the film thereby reduces the viscosity.
  • test group used the liquid Band-Aid of Example 3
  • control group used the purchased liquid Band-Aid of Japan's Kobayashi Pharmaceutical Co., Ltd. to observe the curative effect. From the hemostatic effect, anti-inflammatory effect and isolation effect, the results are shown in Table 2.
  • the liquid Band-Aid of Example 3 has better hemostatic effect, anti-inflammatory effect and moisturizing effect.
  • the present invention adopts ethyl cellulose, carboxymethyl chitosan, polyvinyl pyrrolidone-vinyl acetate copolymer as film-forming material, adopts volatile solvent combination and co-volatile agent combination, and adopts dodecyl Sodium sulfate and Tween are used as surface tension modifiers, so that the formed film has good flexibility and elasticity, low adhesion, low surface tension, good moisture retention, and is convenient for spraying.

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Abstract

一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素20-30份、羧甲基壳聚糖6-10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物3-5份、乙醇15-25份，乙酸乙酯20-25份，二丙酮醇25-40份，异辛烷5-15份，正己烷5-15份，正庚烷5-15份，十二烷基硫酸钠1-5份，吐温1-5份，丙三醇0.5-1.5份，蒸馏水25-35份，采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，采用易挥发的溶剂组合和助挥发剂组合，并采用十二烷基硫酸钠及吐温作为表面张力改良剂，使得形成的膜形成柔韧性和弹性良好、粘结低、表面张力低、保湿性好。

Description

一种喷雾型液体创可贴及其制备方法 技术领域
本发明属于医疗器械技术领域，具体涉及一种喷雾型液体创可贴及其制备方法。
背景技术
皮肤受损后形成的创面一般采用创可贴护理，但是近关节的伤口，因为关节部位活动度大，受摩擦的机会多，使伤口难以愈合，且有些伤口形状不规则贴创可贴无法覆盖创口。因此，为了克服传统的创可贴的缺点，方便使用的液体创可贴应运而生。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有涂抹和喷涂两种施用方式。喷雾型液体创可贴选用喷雾的方法迅速喷射在伤口处，快速在伤口表面形成膜体，起到保护伤口免受外界因素的影响，且膜体轻薄，无刺激，与皮肤的粘附性好不脱落，吸收组织渗透液的作用。发明人发现现有技术中喷雾型液体创可贴存在以下缺点：
膜体拉伸强度差，不能很好地贴附伤口；喷雾原液粘度和表面张力较高，采用喷雾装置喷涂费力，且由于粘度大且表面张力高，因此有些喷雾原液容易附在喷涂口堵塞喷头，不卫生且防止喷雾原液喷出；液体创可贴在溶剂充分挥发后膜体偏干燥，影响伤口愈合速度，伤口在润湿状态下的愈合速度比在干燥状态下快得多。
鉴于现有技术中存在的不足之处，有必要提供一种喷雾型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，提供一种喷雾 型液体创可贴，用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，采用易挥发的溶剂组合和助挥发剂组合，并采用十二烷基硫酸钠及吐温作为表面张力改良剂，使得形成的膜形成柔韧性和弹性良好、粘接低、表面张力低、保湿性好。
为了实现本发明的上述目的，本发明提供如下技术方案：
一种喷雾型液体创可贴，包括如下重量份的组分：
乙基纤维素20-30份、羧甲基壳聚糖6-10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物3-5份、乙醇15-25份，乙酸乙酯20-25份，二丙酮醇25-40份，异辛烷5-15份，正己烷5-15份，正庚烷5-15份，十二烷基硫酸钠1-5份，吐温1-5份，丙三醇0.5-1.5份，蒸馏水25-35份；
其中，采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，乙基纤维素提高膜的弹性，羧甲基壳聚糖与丙三醇协同作用提高膜的保湿性，乙醇、乙酸乙酯、二丙酮醇及异辛烷、正己烷、正庚烷协同作用降低膜的粘度，表面张力改良剂十二烷基硫酸钠及吐温降低膜的表面张力。
本发明还提供一种喷雾型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、二丙酮醇、异辛烷、正己烷、正庚烷置于第一容器中混合均匀；
2)在第一容器的上述混合物中加入配方量的丙三醇搅拌溶解；
3)然后在搅拌状态下将乙基纤维素慢慢加入所述第一容器内，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，称取配方量的十二烷基硫酸钠、吐温置于第二容器中混合均匀；
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喷雾型液体创可贴。
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：
本发明采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，采用易挥发的溶剂组合和助挥发剂组合，并采用十二烷基硫酸钠及吐温作为表面张力改良剂，使得形成的膜形成柔韧性和弹性良好、粘接低、表面张力低、保湿性好。乙基纤维素提高膜的弹性，羧甲基壳聚糖与丙三醇协同作用提高膜的保湿性，乙醇、乙酸乙酯、二丙酮醇及异辛烷、正己烷、正庚烷协同作用降低膜的粘度，表面张力改良剂十二烷基硫酸钠及吐温降低膜的表面张力。
所述乙基纤维素膜柔韧性好，富有弹性，可以防止外界细菌对创口的污染；
羧甲基壳聚糖发挥消炎、止血作用，促使创口快速愈合；且水溶性的羧甲基壳聚糖使得液体创可贴具有良好的保湿性；丙三醇使膜具有很好的柔软性，可滋润皮肤，对伤口保湿，加速伤口愈合；羧甲基壳聚糖与丙三醇协同作用提高喷雾型液体创可贴的保湿性；
乙醇、乙酸乙酯、二丙酮醇，且二丙酮醇为低粘度溶剂，采用上述挥发性溶剂组合有利于降低喷雾型液体创可贴的粘度；
异辛烷，正己烷，正庚烷作为助挥发剂，三者协同作用促进溶剂挥发，降低喷雾型液体创可贴的粘度；
通过降低甘油的比例以降低喷雾型液体创可贴的粘度；
十二烷基硫酸钠及吐温作为表面张力改良剂，二者协同作用降低喷雾型液体创可贴的表面张力。
具体实施方式
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
一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素20份、羧甲基壳聚糖6份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物3份、乙醇15份，乙酸乙酯20份，二丙酮醇25份，异辛烷5份，正己烷5份，正庚烷5份，十二烷基硫酸钠1份，吐温1份，丙三醇0.5份，蒸馏水25份。
所述喷雾型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、二丙酮醇、异辛烷、正己烷、正庚烷置于第一容器中混合均匀；
2)在第一容器的上述混合物中加入配方量的丙三醇搅拌溶解；
3)然后在搅拌状态下将乙基纤维素慢慢加入所述第一容器内，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，称取配方量的十二烷基硫酸钠、吐温置于第二容器中混合均匀；
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喷雾型液体创可贴。
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、保湿的功能，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，无任何毒副作用，且可生物降解，与生物组织具有良好相容性，在医药、保健品方面等都有重要的意义。
聚乙烯吡咯烷酮-醋酸乙烯酯共聚物是一种醇溶性的非常理想的成膜材料，具有很好的无毒无味，对皮肤没有刺激、不被污染、与皮肤接触紧密、容易自然降解等优秀的性质。聚乙烯吡咯烷酮-醋酸乙烯酯共聚物完全溶于水，也溶于乙醇、异丙醇、丙二醇、甘油、低分子量聚乙二醇等类溶剂及酯类、酮类溶剂中，微溶于乙醚及烃类溶剂。聚乙烯吡咯烷酮-醋酸乙烯酯共聚物为具有立体网状结构的高度交联的高分子材料，可作为致孔剂。
成膜剂乙基纤维素溶于溶剂乙醇、乙酸乙酯、二丙酮醇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和聚乙烯吡咯烷酮-醋酸乙烯酯共聚物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、止血及良好的保湿作用，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，因此其既作为成膜材料同时也作为良好的致孔剂。
丙三醇即甘油，其无色、无臭、味甜，外观呈澄明黏稠液态，是一种有机物，能从空气中吸收潮气，也能吸收硫化氢、氰化氢和二氧化硫。能与水、乙醇混溶，1份能溶于11份乙酸乙酯、约500份乙醚，不溶于苯、二硫化碳、三氯甲烷、四氯化碳、石油醚、氯仿、油类。丙三醇是常用的增塑剂，使膜具有良好的柔软性，可滋润皮肤，对伤口保湿，加速伤口愈合。其既作为增塑剂，也作为辅助保湿剂，与水溶性的羧甲基壳聚糖协同作用提高喷雾型液体创可贴的保湿性以提高其对伤口的润湿作用；同时由于其为增塑作用，因 此降低其用量有利于降低喷雾型液体创可贴的粘度。
乙酸乙酯、乙醇、二丙酮醇都是很好的挥发性溶剂，且其中乙酸乙酯具有水果香味，同时作为喷雾型液体创可贴的芳香剂。其中，二丙酮醇是中沸点溶剂，粘度低，受温度的影响小，能溶解树脂、硝酸纤维素、醋酸纤维素、乙基纤维素、有机玻璃、聚苯乙烯、聚醋酸乙烯酯。二丙酮醇，又称双丙酮醇、甲基戊酮醇、2-甲-4-氧代戊醇，简称DAA，是无色液体，稍有薄荷气味。能与水、醇、醚、芳烃和卤代烃混溶，但不与高级脂肪烃混溶。采用二丙酮醇作为溶剂有利于降低喷雾型液体创可贴的粘度，提高其在溶剂中的比例也有助于降低喷雾型液体创可贴的粘度。
异辛烷是一种无色透明液体，易挥发，几乎不溶于水，混溶于庚烷、丙酮，溶于醇、苯、甲苯、二甲苯、氯仿、乙醚、二硫化碳、四氯化碳、二甲基甲酰胺和降蓖麻油以外的油类，有助挥发和辅助降低粘度的作用；正己烷具有挥发性，几乎不溶于水，易溶于氯仿、乙醚、乙醇，有助挥发和辅助降低粘度的作用；正庚烷是无色、易挥发液体，难溶于水，溶于醇，可混溶于乙醚、氯仿、二氯甲烷等低极性溶剂，有助挥发和辅助降低粘度的作用；通过异辛烷，正己烷，正庚烷的协同作用促进溶剂挥发，进一步降低喷雾型液体创可贴的粘度。
十二烷基硫酸钠是一种白色或淡黄色微粘物，工业上常用于洗涤剂和纺织工业。属阴离子表面张力改良剂。易溶于水，与阴离子、非离子复配伍性好，具有良好的乳化、发泡、渗透、去污和分散性能，能有效减少表面张力；吐温吐温(或聚山梨酯)为非离子型表面张力改良剂，系一系列聚氧乙烯去水山梨醇的部分脂肪酸酯，广泛用作乳化剂和油类物质的增溶剂，聚山梨酯通常被认为是无毒、无刺激性的材料。十二烷基硫酸钠及吐温作为表面张力改良剂，二者协同作用降低喷雾型液体创可贴的表面张力。
本发明采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，采用易挥发的溶剂组合和助挥发剂组合，并采用十 二烷基硫酸钠及吐温作为表面张力改良剂，使得形成的膜形成柔韧性和弹性良好、粘接低、表面张力低、保湿性好。乙基纤维素提高膜的弹性，羧甲基壳聚糖与丙三醇协同作用提高膜的保湿性，乙醇、乙酸乙酯、二丙酮醇及异辛烷、正己烷、正庚烷协同作用降低膜的粘度，表面张力改良剂十二烷基硫酸钠及吐温降低膜的表面张力。
实施例2
一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素25份、羧甲基壳聚糖8份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物4份、乙醇20份，乙酸乙酯22份，二丙酮醇35份，异辛烷10份，正己烷8份，正庚烷9份，十二烷基硫酸钠3份，吐温4份，丙三醇1份，蒸馏水30份。
所述喷雾型液体创可贴的制备方法如实施例1。
实施例3
一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素30份、羧甲基壳聚糖10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物5份、乙醇25份，乙酸乙酯25份，二丙酮醇40份，异辛烷15份，正己烷15份，正庚烷15份，十二烷基硫酸钠5份，吐温5份，丙三醇1.5份，蒸馏水35份。
所述喷雾型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，不含乙基纤维素。方案如下：
一种喷雾型液体创可贴，包括如下重量份的组分：羧甲基壳聚糖10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物5份、乙醇25份，乙酸乙酯25份，二丙酮醇40份，异辛烷15份，正己烷15份，正庚烷15份，十二烷基硫酸钠5份，吐温5份，丙三醇1.5份，蒸馏水35份。
所述喷雾型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、二丙酮醇、异辛烷、正己烷、正庚烷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丙三醇搅拌溶解，得到第一溶液；
3)加配方量的蒸馏水于第二容器中，称取配方量的十二烷基硫酸钠、吐温置于第二容器中混合均匀；
4)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；
5)将所述第一溶液和第二溶液混合后搅拌均匀得到喷雾型液体创可贴。
对比例2
本对比例与实施例3不同的是，不含羧甲基壳聚糖和丙三醇。方案如下：
一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素30份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物5份、乙醇25份，乙酸乙酯25份，二丙酮醇40份，异辛烷15份，正己烷15份，正庚烷15份，十二烷基硫酸钠5份，吐温5份，蒸馏水35份。
所述喷雾型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、二丙酮醇、异辛烷、正己烷、正庚烷置于第一容器中混合均匀；
2)然后在搅拌状态下将乙基纤维素慢慢加入所述第一容器内，直到完全润湿溶解，得到第一溶液；
3)加配方量的蒸馏水于第二容器中，称取配方量的十二烷基硫酸钠、吐温置于第二容器中混合均匀；
4)称取配方量的聚乙烯吡咯烷酮于第二容器中搅拌至溶解得到第二溶液；
5)将所述第一溶液和第二溶液混合后搅拌均匀得到喷雾型液体创可贴。
对比例3
本对比例与实施例3不同的是，不含异辛烷、正己烷、正庚烷。方案如下：
一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素30份、羧 甲基壳聚糖10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物5份、乙醇25份，乙酸乙酯25份，二丙酮醇40份，十二烷基硫酸钠5份，吐温5份，丙三醇1.5份，蒸馏水35份。
所述喷雾型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、二丙酮醇置于第一容器中混合均匀；
2)在第一容器的上述混合物中加入配方量的丙三醇搅拌溶解；
3)然后在搅拌状态下将乙基纤维素慢慢加入所述第一容器内，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，称取配方量的十二烷基硫酸钠、吐温置于第二容器中混合均匀；
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喷雾型液体创可贴。
对比例4
本对比例与实施例3不同的是，不含十二烷基硫酸钠及吐温。方案如下：
一种喷雾型液体创可贴，包括如下重量份的组分：乙基纤维素30份、羧甲基壳聚糖10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物5份、乙醇25份，乙酸乙酯25份，二丙酮醇40份，异辛烷15份，正己烷15份，正庚烷15份，丙三醇1.5份，蒸馏水35份。
所述喷雾型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、二丙酮醇、异辛烷、正己烷、正庚烷置于第一容器中混合均匀；
2)在第一容器的上述混合物中加入配方量的丙三醇搅拌溶解；
3)然后在搅拌状态下将乙基纤维素慢慢加入所述第一容器内，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喷雾型液体创可贴。
测试例1
将实施例1-3、对比例1-4提供的方案获得的喷雾型液体创可贴从膜拉伸强度、粘度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；所述粘度用平氏粘度计(江苏扬州红旗玻璃仪器厂)测定，测定方法为《中国药典》2000版二部附录VIG粘度测定法第一法，灌装于喷雾瓶(标准喷雾泵0.05ml螺纹18/415德国Pfeiffer公司中国部)中，旋紧手动泵，在距离硅油纸10cm处喷雾，显微镜下观察、测量雾滴粒径，记录喷雾的指标，结果见表1；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1-4提供的喷雾液体创可贴的性能
Figure PCTCN2020137864-appb-000001
由表1可知，相比于对比例1-4，实施例1-3采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，采用易挥发的溶剂组合和助挥发剂组合，并采用十二烷基硫酸钠及吐温作为表面张力改良 剂，使得形成的膜形成柔韧性和弹性良好、粘接低、表面张力低。乙基纤维素提高膜的弹性，乙醇、乙酸乙酯、二丙酮醇及异辛烷、正己烷、正庚烷协同作用降低膜的粘度，表面张力改良剂十二烷基硫酸钠及吐温降低膜的表面张力从而降低粘度。
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 保湿效果
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、保湿效果更好。
可见，本发明采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，采用易挥发的溶剂组合和助挥发剂组合，并采用十二烷基硫酸钠及吐温作为表面张力改良剂，使得形成的膜形成柔韧性和弹性良好、粘接低、表面张力低、保湿性好，方便喷涂。
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 (2)

  1. 一种喷雾型液体创可贴，其特征在于，包括如下重量份的组分：乙基纤维素20-30份、羧甲基壳聚糖6-10份、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物3-5份、乙醇15-25份，乙酸乙酯20-25份，二丙酮醇25-40份，异辛烷5-15份，正己烷5-15份，正庚烷5-15份，十二烷基硫酸钠1-5份，吐温1-5份，丙三醇0.5-1.5份，蒸馏水25-35份；
    其中，采用乙基纤维素、羧甲基壳聚糖、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物联合作为成膜材料，乙基纤维素提高膜的弹性，羧甲基壳聚糖与丙三醇协同作用提高膜的保湿性，乙醇、乙酸乙酯、二丙酮醇及异辛烷、正己烷、正庚烷协同作用降低膜的粘度，表面张力改良剂十二烷基硫酸钠及吐温降低膜的表面张力。
  2. 一种如权利要求1所述的喷雾型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、二丙酮醇、异辛烷、正己烷、正庚烷置于第一容器中混合均匀；
    2)在第一容器的上述混合物中加入配方量的丙三醇搅拌溶解；
    3)然后在搅拌状态下将乙基纤维素慢慢加入所述第一容器内，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，称取配方量的十二烷基硫酸钠、吐温置于第二容器中混合均匀；
    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喷雾型液体创可贴。
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