WO2012075658A1 - 一种医用敷料的制备方法 - Google Patents

一种医用敷料的制备方法 Download PDF

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Publication number
WO2012075658A1
WO2012075658A1 PCT/CN2010/080482 CN2010080482W WO2012075658A1 WO 2012075658 A1 WO2012075658 A1 WO 2012075658A1 CN 2010080482 W CN2010080482 W CN 2010080482W WO 2012075658 A1 WO2012075658 A1 WO 2012075658A1
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chitosan fiber
woven fabric
ethanol
solution
succinic anhydride
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PCT/CN2010/080482
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English (en)
French (fr)
Inventor
黄聿华
杨为东
衣宏君
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青岛即发新材料有限公司
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Publication of WO2012075658A1 publication Critical patent/WO2012075658A1/zh

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    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • the invention relates to a method for preparing a medical dressing, in particular to a method for preparing a medical dressing which can be swollen after liquid absorption.
  • Traumatic wounds are characterized by the exposure of intradermal tissue, which is susceptible to bacterial infection, slow healing of the wound, and more susceptible to repeated infections, especially on the surface of chronic wounds with large amounts of blood or effluent. Therefore, in the treatment, a dressing is needed to absorb the effluent on the surface of the wound, and has the functions of inhibiting bacteria, stopping bleeding, and promoting wound healing.
  • liquid-absorbent dressings include alginate fibers and carboxymethylcellulose fiber nonwovens, but these two nonwoven fabrics only have a liquid absorbing function and absorb only 15 times their own weight.
  • chitosan fiber nonwoven fabrics have been gradually used as medical dressings. Because it is a biological material, it has good compatibility with human skin, and because of its special molecular structure, it has natural bacteriostasis, hemostasis, anti-inflammatory, promote wound healing, and reduce the function of wound scar. However, the chitosan fiber nonwoven fabric does not have the function of aspirating.
  • the published invention patent introduces a method for producing carboxymethyl chitosan fiber.
  • the non-woven fabric produced by the method has the characteristics of liquid absorption in addition to the original function of chitosan, but the method has the characteristics of liquid absorption.
  • Chloroacetic acid is used as a reaction reagent in the production process. Chloroacetic acid is highly toxic. It needs to be cleaned with a large amount of organic solvent in production. The production cost is high, it brings pollution to the environment, and it is easy to produce. Residue.
  • the pH of the product is greater than 8, deviating from the pH of the healthy human PH5-7.
  • Chinese patent application CN200910162382.7 discloses a method for producing super absorbent chitosan fiber, which is to modify chitosan fiber, and if modified chitosan fiber is used as medical dressing, it needs to be used.
  • the fiber is spun into a spunlace nonwoven fabric or a needlepunched nonwoven fabric, but the modified chitosan fiber is swollen with water and cannot be processed into a spunlace nonwoven fabric, and the elongation at break and fracture of the fiber after modification The elongation strength is lowered, and the consumption of the needle-punched nonwoven fabric is large, and the production cost is high.
  • the present invention is different in that the modification process and the mass ratio between the materials used are optimized, and the chitosan fiber non-woven fabric is modified to avoid the above problems, and the technology is more perfect. Summary of the invention
  • the present invention provides a method for preparing a bacteriostatic medical dressing having good liquid absorption and high swelling, comprising the following steps:
  • it is an aqueous ethanol solution
  • step 2) adding hydrochloric acid solution to the mixture prepared in step 2), the mass ratio of pure hydrochloric acid to chitosan fiber non-woven fabric is 0.01 - 0.11: 1;
  • the chitosan fiber non-woven fabric is immersed in the mixed solution prepared in the step 3), the temperature is controlled at 30 - 60 ° C; the treatment time is 20 min - 2 hr, the chitosan fiber non-woven fabric is taken out, and the anhydrous ethanol is used. Dip for 20min - 40min, dehydration, and obtain medical dressings.
  • the monomer nano silver solution having a concentration of 50000 ppm is mixed with absolute ethanol in a ratio of 0.18 - 0.24 m 1: 1 L, and the mixture is uniformly stirred.
  • the obtained medical dressing was completely immersed for 20-30 min, taken out, dehydrated, and air-dried.
  • the chitosan fiber non-woven fabric may be selected from a needle-punched nonwoven fabric or a spunlace nonwoven fabric.
  • the medical dressing prepared by the invention covers the surface of the wound, can quickly absorb the effluent on the surface, and after being swollen, "locks, and moisture, can keep the wound surface moist for a long time, promote wound healing, and has hemostasis, bacteriostasis, and scar reduction. It has no curative effect and does not adhere to the wound when it is replaced.
  • the medical dressing can be widely used for destructive wounds, burns, burns and other chronic wounds.
  • the medical dressing prepared by the invention has strong liquid absorption property, absorbs quickly after experiencing liquid, expands, and can absorb more than 25 times its own weight.
  • the medical dressing prepared by the invention is further processed by using nano silver, has stronger antibacterial property against the infected wound, can be quickly infiltrated into the subcutaneous 2 leg, and is caused by common bacteria, stubborn bacteria, resistant bacteria and fungi. Deeper tissue infections have a good bactericidal effect.
  • the preparation method of the liquid swellable medical dressing provided by the invention comprises the following steps:
  • Succinic anhydride (C 4 H 4 0 3 , City Chemical Company, Foshan, Guangdong, China) is dissolved in an aqueous solution of ethanol or acetone in a volume ratio greater than 70%.
  • the amount of succinic anhydride used is not based on chitosan fibers.
  • the mass ratio of succinic anhydride to chitosan fiber non-woven fabric (Qingdao Xinfa New Material Co., Ltd., China) is 0. 3 _ 0. 79: 1.
  • the volume of the aqueous solution of ethanol or acetone is controlled so that the chitosan fiber nonwoven fabric can be completely immersed.
  • step 3 Immerse the chitosan fiber non-woven fabric into the mixed solution prepared in step 2, place it in a constant temperature water bath vibration tank, keep the water temperature constant, and control the temperature at 30 - 60 °C. Processing time is 20min - 2hr, The chitosan fiber non-woven fabric was taken out, immersed in absolute ethanol for 20 min - 40 min, and dehydrated to obtain a medical material with good liquid absorption and high swelling.
  • the invention can further treat the above medical dressing to improve the sterilization effect.
  • the monomer nano silver solution (Shanghai Huzheng Nano Technology Co., Ltd.) having a concentration of 50000 ppra was mixed with absolute ethanol in a ratio of 0.18 - 0.24 ml: 1 L, stirred uniformly, and the medical dressing obtained above was completely immersed in standing. 25min, remove, dehydrate, and dry.
  • the dried chitosan fiber non-woven fabric is cut into pieces of different sizes and shapes, and then packaged.
  • succinic anhydride 50 g is dissolved in 5000 ml of 90% ethanol solution, and stirred at room temperature until all of the succinic anhydride is dissolved to form a mixed solution of succinic anhydride.
  • the dried chitosan fiber non-woven fabric is cut into pieces of different sizes and shapes, and then Packaging.
  • the above-mentioned medical dressing treated with nano silver was used as a bacteriostatic test of Candida albicans and Neisseria gonorrhoeae.
  • Candida albicans is disinfected by the Academy of Military Medical Sciences
  • test center It is provided by the test center and can also be obtained by other methods.
  • Bacteriostatic test strains Pre-oscillation colonies After shaking, colonies, bacteriostasis, pre-oscillation, colonies, shaking, colonies, bacteriostasis
  • Rate difference (cfu/ml) number (cfu/ml) rate (%) number (cfu/ml) number (cfu/ml) rate (%) binary white nymph
  • Neisseria gonorrhoeae bacteriostasis test Neisseria gonorrhoeae bacteriostasis test:
  • Test purpose The antibacterial effect of the liquid-swellable medical dressing of the present invention on Neisseria gonorrhoeae.
  • Test materials 4 gonococcal medium, liquid swell bacteriostatic dressing l cm 2 several pieces, temperature control box, microscope
  • Test methods and observations The test was divided into four groups of A, B, C, and D. The dressings were soaked in 0.9% physiological saline for 1 hour in advance.
  • Group A Randomly implant the secretion of gonococcal infection patients into the culture medium, a total of 5 points.
  • Group B 1. Place the prepared dressing directly into the medium at 5 points.
  • Group C 1. The secretion of the gonococcal infection patient was evenly spread on the test dressing, and then the medium was implanted at 5 points.
  • Group D 1. Spread the secretion of gonococcal infection patients evenly on the test dressing (the test dressing is 3 times the amount of the C group, and the gonococcal secretion is the same as the C group)
  • the dried chitosan fiber non-woven fabric is cut into pieces of different sizes and shapes, and then packaged.
  • the non-woven fabric was taken out, immersed in absolute ethanol for 40 minutes, dehydrated, and dried;
  • the dried chitosan fiber non-woven fabric is cut into pieces of different sizes and shapes, and then packaged.
  • the dried chitosan fiber non-woven fabric is cut into pieces of different sizes and shapes, and then packaged.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Description

一种医用敷料的制备方法 技术领域
本发明涉及一种医用敷料的制备方法， 具体涉及一种吸液后可以溶胀 的医用敷料制备方法。
背景技术
一直以来， 外伤用医用敷料一般采用脱脂棉或棉制纱布。 近年来， 有 在使用时直接敷到伤口上， 通过按压起到止血和覆盖伤口的作用， 但是随 着伤口慢慢的愈合， 敷料表面的纤维会与伤口发生粘连， 不宜伤口愈合， 并且取下敷料时给伤口带来二次破坏， 给患者带来痛苦。
外伤伤口的特点是皮内组织曝露在外， 容易被细菌感染， 伤口愈合慢， 更易被重复感染， 尤其是慢性伤口表面会有大量的血液或流出液。 因此在 治疗时， 需要一种敷料即可以吸收伤口表面的流出液， 又具有抑菌， 止血， 促进伤口愈合的功能。
目前公布的可吸液的敷料有海藻酸钠纤维和羧甲基纤维素纤维非织 布， 但这两种非织布仅具有吸液的功能， 且吸液量仅有自身重量的 15倍。
近几年， 壳聚糖纤维非织布逐渐被用作医用敷料。 因为其本身是一种 生物材料， 与人体皮肤具有良好的相溶性， 且由于其具有特殊的分子结构， 具有天然抑菌， 止血， 消炎， 促进伤口愈合， 减小伤口疤痕的功能。 但壳 聚糖纤维非织布不具有吸液的功能。
已公布的发明专利， 介绍了一种羧曱基壳聚糖纤维的生产方法， 该方 法生产的非织布除了具有壳聚糖本来的功能外， 还具有了吸液的特点， 但 此方法的生产过程中使用氯乙酸作为反应试剂， 氯乙酸的毒性比较强， 生 产中需使用大量的有机溶剂清洗， 生产成本高， 给环境带来污染， 且易产 生残留。 产品的 PH值大于 8, 偏离于健康人体 PH5- 7的 PH值。
中国专利申请 CN200910162382.7公开了一种高吸水性壳聚糖纤维的生 产方法， 该方法是对壳聚糖纤维进行改性， 如果将改性后的壳聚糖纤维用 作医用敷料， 需要用该纤维纺成水刺无纺布或针刺无纺布， 但改性后的壳 聚糖纤维遇水溶胀， 不能加工成水刺无纺布， 同时纤维经改性后断裂伸长 率和断裂伸长强力降低， 在制造针刺无纺布时消耗大， 生产成本高。 与现 有技术相比， 本发明的不同之处是优化改性过程和各使用物质之间的质量 配比， 对壳聚糖纤维非织布进行改性， 避免了上述问题， 技术更加完善。 发明内容
为了解决现有技术中存在的技术问题， 提供一种吸液溶胀的医用敷料， 本发明提供一种吸液性好、 高溶胀的抑菌医用敷料的制备方法， 包括以下 步骤：
1 ) 准备壳聚糖纤维非织布；
2)将丁二酸酐溶于体积比浓度大于 70%的乙醇或丙酮的水溶液里， 丁 二酸酐与壳聚糖纤维非织布的质量比为 0.3-0.79: 1; 乙醇或丙酮的水溶 液的体积控制在能够把壳聚糖纤维非织布完全浸没为准； 常温下， 充分搅 拌至丁二酸酐完全溶解；
优选为乙醇水溶液；
3)将盐酸溶液加入步驟 2) 制备的混合液中， 純盐酸的质量与壳聚糖 纤维非织布的质量比为 0.01 - 0.11: 1;
4)将壳聚糖纤维非织布浸入步骤 3)制备的混合溶液中， 温度控制在 30 - 60°C; 处理时间为 20min-2hr, 将壳聚糖纤维非织布取出， 用无水乙 醇浸洗 20min- 40min， 脱水， 获得医用敷料。
为了进一步提高医用敷料的杀菌效果， 将浓度为 50000ppm的单体纳米 银溶液与无水乙醇按照 0.18 - 0.24m 1： 1 L的比例混合， 搅拌均匀， 将上述 获得的医用敷料完全浸没静置 20 - 30min, 取出， 脱水， 晾干。
壳聚糖纤维非织布可以选用针刺无纺布或水刺无纺布。 技术效果：
本发明制备的医用敷料覆盖在伤口表面 , 能迅速吸收表面的流出液， 溶胀后 "锁住，， 水分， 可长时间保持伤口表面湿润， 促进伤口愈合， 并且 具有止血、 抑菌、 减小疤痕等疗效， 更换时不与伤口粘连。 该医用敷料可 广泛用于体表破坏性伤口、 烧伤、 烫伤及其它慢性伤口等。
本发明制备的医用敷料， 具有很强的吸液性， 遇到液体后迅速吸收， 膨胀， 可吸收自身重量 25倍以上。
本发明制备的医用敷料， 用纳米银做进一步处理， 针对已感染的伤口， 具有更强的抗菌性， 可迅速渗入皮下 2腿处杀菌，对普通细菌、 顽固细菌、 耐药细菌以及真菌引起的较深处的组织感染均有很好的杀菌作用。
具体实施方式
本发明提供的吸液溶胀医用敷料的制备方法， 包括如下步驟：
1、 将丁二酸酐（C4H403， 城化工公司， 中国广东佛山）溶于体积比浓度 大于 70%的乙醇或丙酮的水溶液里，丁二酸酐的使用量依壳聚糖纤维非织布 的处理量而定， 丁二酸酐质量与壳聚糖纤维非织布（青岛即发新材料有限公 司， 中国）的质量比为 0. 3 _ 0. 79: 1。 乙醇或丙酮的水溶液的体积控制在可 以把壳聚糖纤维非织布完全浸没为准。
常温下， 充分搅拌至丁二酸酐完全溶解。
2、 将盐酸溶液加入步骤 1制备的混合液中， 搅拌至混合均匀。 纯盐酸 的质量与壳聚糖纤维非织布的质量比为 0. 01 - 0. 11： 1。
3、 将壳聚糖纤维非织布浸入步骤 2制备的混合溶液中， 置于恒温水浴 振动槽中， 保持水温恒定， 温度控制在 30 - 60°C。 处理时间为 20min - 2hr , 将壳聚糖纤维非织布取出， 用无水乙醇浸洗 20min - 40min, 脱水， 获得吸 液好、 高溶胀的医用教料。
本发明还可将上述的医用敷料进一步处理， 提高杀菌效果。 将浓度为 50000ppra的单体纳米银溶液（上海沪正纳米科技有限公司） 与无水乙醇按 照 0. 18 - 0. 24ml : 1L的比例混合， 搅拌均匀， 将上述获得的医用敷料完全 浸入静置 25min, 取出， 脱水， 晾干， 即可。
实施例 1 :
1、 取 10g丁二酸酐溶于 1000ml 85%的乙醇溶液中， 常温下， 搅拌至 丁二酸酐全部溶解， 形成丁二酸酐的混合溶液。
2、 加入 2mol / l的盐酸溶液 ½1， 搅拌均匀。
3、将 30g壳聚糖纤维非织布浸入以上溶液中，保持恒温振荡水浴 30 °C， 1. 5hr后将非织布取出， 用无水乙醇浸洗 30min, 脱水， 晾干。
4、 将晾干后的壳聚糖纤维非织布分切成大小和形状不同的片状， 然后 包装。
精确称取 = 0. 1275g制得的壳聚糖纤维非织布放入 Oral蒸馏水中， 20min后取出， 悬空， 待不滴水后称重， 非织布湿重 G2 = 3. 9942g , 吸水倍 数 Q = ( G -d ) I d = 30. 3。 实施例 2
1、 取 50g丁二酸酐溶于 5000ml 90%的乙醇溶液中， 常温下， 搅拌至 丁二酸酐全部溶解， 形成丁二酸酐的混合溶液。
2、 加入 2mol 的盐酸溶液 120ml , 搅拌均匀。
3、将 100g壳聚糖纤维非织布浸入上述溶液中，保持恒温振荡水浴 60°C , 20 min后^夺非织布取出， 用无水乙醇浸洗 20min, 脱水， 晾干；
4、 将晾干后的壳聚糖纤维非织布分切成大小和形状不同的片状， 然后 包装。
精确称取 = 0. 1 129g制得的壳聚糖纤维非织布放入 Oral蒸馏水中， 20min后取出， 悬空， 待不滴水后称重， 非织布湿重 G2 = 3. 1020g , 吸水倍 数0 = ( G ) I G! = 26. 50
5 将浓度为 50000ppm的单体纳米银溶液 0. 6ml加入到 3L无水乙醇中，
充分搅拌， 将上述获得的医用敷料完全浸入静置 25min，取出， 脱水， 晾干， 分切， 包装。
将上述用纳米银处理过的医用敷料作白色念珠菌和***的抑菌实 验。
10 对白色念珠菌的抑菌效果实验： 白色念珠菌由军事医学科学院消毒检
测中心提供， 也可由其它方法自培获得。
检验依据《消毒技术规范》 2002年版 第 2. 1. 8. 7项， GB15979- 2002 — 次性使用卫生用品卫生标准 附录 C。 试验温度 20- 22 °C， 相对湿度 48-56%， 试验重复三次。 在 20-22 °C条件下， 将三角烧瓶固定在振荡摇床上， 以 15 300r/min振荡 l h。
结果如下：
吸液溶胀医用敷料对白色念珠菌的抑菌效果
普通对照 本发明医用敷料
抑菌 实验菌株 振荡前菌落 振荡后菌落 抑菌 振荡前菌落 振荡后菌落 抑菌
率差 数（cfu/ml ) 数（cfu/ml ) 率（％ ) 数（ cfu/ml ) 数（ cfu/ml ) 率（％ ) 二 值 白色念株
2. 66 X 104 2. 60 X 104 2. 25 2. 76 X 104 2. 46 X 102 99. 10 96. 85 菌
结论： 依据 《消毒技术规范》 2002年版， 试验样片抑菌率和对照样片 抑菌率差值 >26% , 即可认定该产品有抗菌作用。 吸液溶胀抑菌敷料在 20-22 °C条件下， 以 300r/m in振荡 lh , 对白色念珠菌平均抑菌率差值为 96. 85% , 具有抗菌作用。
***抑菌性实验：
1. 试验目的： 本发明的吸液溶胀医用敷料对***的抑菌作用。
2. 试验材料： ***培养基 4个， 吸液溶胀抑菌敷料 l cm2若干块， 温 度控制箱， 显微镜
3. 试验方法和观察： 本试验共分 A、 B、 C、 D四组，将敷料提前用 0. 9% 的生理盐水浸泡 1小时备用。
A组： 1、 将***感染病人分泌物随机植入培养基， 共 5个点。
2、 每隔 12h、 24h、 36h、 48h观察一次。
B组： 1、 将备好的敷料分 5点直接植入培养基。
2、 每隔 12h、 24h、 36h、 48h观察一次。
C组： 1、 将***感染病人分泌物均匀涂在试验用敷料上， 然后分 5 个点植入培养基。
2、 每隔 12h、 24h、 36h、 48h观察一次。
D组： 1、 将***感染病人分泌物均匀涂在试验用敷料上（试验敷料 为 C组的 3倍量， ***分泌物与 C组同量）
2、 每隔 12h、 24h、 36h、 48h观察一次。
12h观察： A组， ***生长菌斑 2个， B、 C、 D组均无反应；
24h观察： A组， ***生长正常， 菌斑 2个， B、 C、 D组均无反应； 36h观察： A组， ***生长正常， B、 C、 D组均无反应；
48h观察： A组， ***生长正常， 菌斑均匀增大， B、 C、 D组均无反 应；
结果表明： A组， ***培养生长正常， 植入 5点， 有 3点生长。 B、 C、 D组， 均未见***。 本发明的吸液溶胀医用敷料对***有很好地抑 菌作用。 实施例 3
1、 取 420g丁二酸酐溶于 20L 85%的丙酮溶液中， 常温下， 搅拌至丁 二酸酐全部溶解， 形成丁二酸酐的混合溶液。
2、 加入 4mol/l的盐酸溶液 200ml, 搅拌均匀。
3、将 6 OOg壳聚糖纤维非织布浸入以上溶液中，保持恒温振荡水浴 45 °C , 2hr后将非织布取出， 用无水乙醇浸洗 30min, 脱水， 晾干；
4、 将晾干后的壳聚糖纤维非织布分切成大小和形状不同的片状， 然后 包装。
精确称取 = 0.1304g制得的壳聚糖纤维非织布放入 Oral蒸餾水中， 20min后取出， 悬空， 待不滴水后称重， 非织布湿重 G2 = 4.8705g， 吸水倍 数 Q= ( G ) I Gi= 36.3。 实施例 4
1、 取 480g丁二酸肝溶于 30L 90%的乙醇溶液中， 常温下， 搅拌至丁 二酸酐全部溶解， 形成丁二酸肝的混合溶液。
2、 加入 2mol/l的盐酸溶液 1000ml, 搅拌均匀。
3、将 800g壳聚糖纤维非织布浸入以上溶液中，保持恒温振荡水浴 40°C。
2hr后将非织布取出， 用无水乙醇浸洗 40min, 脱水， 晾干；
4、 将晾干后的壳聚糖纤维非织布分切成大小和形状不同的片状， 然后 包装。
精确称取 = 0.1157g制得的壳聚糖纤维非织布放入 5 Oral蒸馏水中， 20min后取出， 悬空， 待不滴水后称重， 非织布湿重 G2 = 4.6116g, 吸水倍 数 Q= (G2— GJ I G 38.9。 实施例 5
1、 取 650g丁二酸酐溶于 40L 85%的乙醇溶液中， 常温下， 搅拌至丁 二酸酐全部溶解， 形成丁二酸酐的混合溶液。
2、 加入 2mol / l的盐酸溶液 1200ml， 搅拌均匀。
3、 将 l OOOg 壳聚糖纤维非织布浸入以上溶液中， 保持恒温振荡水浴 45 °C , 2hr后将非织布取出， 用无水乙醇浸洗 40min, 脱水， 晾干；
4、 将晾干后的壳聚糖纤维非织布分切成大小和形状不同的片状， 然后 包装。
精确称取 = 0. 0997g制得的壳聚糖纤维非织布放入 Oral蒸馏水中， 20min后取出， 悬空， 待不滴水后称重， 非织布湿重 G2 = 4. 0948g, 吸水倍 数 (} = ( G -G, ) / G! = 40. 10

Claims

权利要求书
1、 一种医用敷料的制备方法， 其特征在于包括以下步驟：
1 ) 准备壳聚糖纤维非织布；
2)将丁二酸酐溶于体积比浓度大于 70%的乙醇或丙酮的水溶液里， 丁 二酸酐与壳聚糖纤维非织布的质量比为 0.3-0.79: 1; 乙醇或丙酮的水溶 液的体积控制在能够把壳聚糖纤维非织布完全浸没为准； 常温下， 充分搅 拌至丁二酸酐完全溶解；
3)将盐酸溶液加入步骤 2) 制备的混合液中， 纯盐酸的质量与壳聚糖 纤维非织布的质量比为 0.01 - 0.11： 1;
4)将壳聚糖纤维非织布浸入步骤 3)制备的混合溶液中， 温度控制在 30 - 60°C, 处理时间为 20min-2hr， 将壳聚糖纤维非织布取出， 用无水乙 醇浸洗 20min- 40min, 脱水， 获得医用敷料。
2、 如权利要求 1所述的方法， 其特征在于还进一步包括用纳米银处理 已获得的医用敷料的步驟， 将浓度为 5000 Op pm的单体纳米银溶液与无水乙 醇按照 0.18- 0.24ml: 1L的比例混合， 搅拌均匀， 将已获得的医用敷料完 全浸没静置 20 - 30min， 取出， 脱水， 晾干。
3、 如权利要求 1或 2任一所述的方法， 其特征在于步骤 2 ) 所述的水 溶液为乙醇水溶液。
4、 如权利要求 1或 2任一所述的方法， 其特征在于所述的壳聚糖纤维 非织布为针刺无纺布或水刺无纺布。
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EP2228078A1 (en) * 2009-03-09 2010-09-15 Pietrasanta Pharma S.p.A. Chitosan and polyurethane foam based medication, production process thereof and use thereof in the wound management
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