CN1094374C - 创伤被覆材料 - Google Patents

创伤被覆材料 Download PDF

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CN1094374C
CN1094374C CN97190147A CN97190147A CN1094374C CN 1094374 C CN1094374 C CN 1094374C CN 97190147 A CN97190147 A CN 97190147A CN 97190147 A CN97190147 A CN 97190147A CN 1094374 C CN1094374 C CN 1094374C
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fibroin
thin film
wound covering
covering material
aqueous solution
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CN1181707A (zh
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坪内纮三
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Japan Represented By National Inst Of Sericultural And Entomological Science M
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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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • 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
    • A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

提供在能圆滑地促进缺损皮肤再生的同时，在从皮肤剥离时也不剥下再生皮肤的创伤被覆材料。由非结晶性丝纤朊薄膜构成的创伤被覆材料。

Description

创伤被覆材料
技术领域
本发明是关于创伤被覆材料。
背景技术
作为人工皮肤适用于皮肤缺损部的被覆材料称为创伤被覆材料。已开发出猪的皮肤和壳质等。但是，它们存在在治疗中若想要将其剥下，也将在该人工皮肤下正在形成的新皮肤剥下的缺点。另外，最近正在开发叫做デイオアクチブCGF的创伤被覆材料，该创伤被覆材料虽然剥下在人工皮肤下正在形成的新皮肤少，但是在被覆材料下成形新皮肤的形成速度比猪的皮肤的场合慢。
发明的公开
本发明的课题在于提供在圆滑地促进缺损皮肤再生的同时，在从皮肤剥离时不剥下其再生皮肤的创伤被覆材料。
本发明人应为解决上述课题向反复进行深入研究，结果完成了本发明。
即，按照本发明，提供含非结晶性丝纤朊薄膜的创伤被覆材料。
本发明的创伤被覆材料(以下，也简单称为被覆材料)，以丝纤朊水溶液作为原料使用，可以通过使该水溶液加工成薄膜来制造。
为了得到丝纤朊水溶液，将丝物质提纯，除去丝胶。作为丝物质，可举出蚕茧壳、茧丝、生丝、丝织品、它们的废物等。丝物质的提纯可以通过将丝物质在酶和碳酸钠、碳酸氢钠等的碱水溶液中煮沸，接着水洗后，浸渍在热水中，溶出而除去像丝胶和耐酸钠等的化学物质来进行。另外，如此得到的提纯丝物质最好用环氧乙烷气体或高压釜等进行杀菌。
像上述那样得到的提纯丝物质溶解在包含助溶剂的纯水中。作为此场合的助溶剂使用酸和中性盐的氯化钙、溴化锂等或乙醇等。
溶丝物质的水溶液用半透膜管等进行透析，得到除去助溶剂的丝纤朊水溶液。
丝纤朊水溶液中的丝纤朊浓度是2％(重量)以上，最好是5％(重量)以上，通常以5～20％(重量)使用。另外，该丝纤朊水溶液中的丝纤朊以外的杂质成分的含量是0.001％(重量)以下，最好是0.0001％(重量)以下。在此场合下，在杂质成分中有可能包含丝胶和氯等。
可以通过将丝纤朊水溶液流延在平滑的固体元件表面上，蒸发除去水进行丝纤朊水溶液的薄膜化。在此场合，抑制可得到的丝纤朊薄膜的结晶化，形成实质上非结晶性薄膜是重要的。为此，在上述薄膜化时，可以调整水的蒸发去除速度，通过使水的蒸发去除速度加快，可以防止薄膜的结晶化。丝纤朊薄膜的结晶化，在丝纤朊水溶液的干燥过程中，在干燥中需要时间以达到丝纤朊水溶液的浓度在30％以上时发生。为了防止薄膜的结晶化，在减压下进行丝纤朊水溶液的干燥时，可以是0.5气压以下，最好是0.1气压以下。在大气压下进行时，有必要分别变化干燥室内的空气或者不活性气体(氮气等)等气体的温度、湿度和风速。薄膜化的温度是0～50℃，最好是10～30℃。空气或不活性气体等的相对湿度RH是40～90％，最好是50～80％。丝纤朊水溶液的薄膜化，对于流延在固体表面上形成的丝纤朊水溶液膜，以5cm/S以上的风速、最好10～30cm/s的风速使0～50℃，最好10～30℃的空气或不活性气体(氮气等)流通接触。在得到厚度30μm以上，特别是40～60μm的丝纤朊薄膜的场合，上述空气或不活性气体的流通风速规定10cm/s或更高，而可以使相对湿度在约10cm/s或更低的风速下，置于约30％RH，由此防止薄膜的结晶化。水对该薄膜的溶解度是60％以上。
在本发明作为被覆材料使用的丝纤朊薄膜中，其厚度可以规定在10～100μm的范围内。另外，该薄膜中的水分量是3～16％(重量)，通常是5～13％(重量)。根据需要，该薄膜也可以层叠在其他材料上使用。
在实际使用该被覆材料时，在使用前可以用环氧乙烷气体等进行杀菌。
下面按照实施例更详细地说明本发明。
实施例
(1)材料调制
将丝线在0.5％(重量)碳酸钠水溶液中煮沸1小时，水洗后在60℃的热水中浸渍30分钟，除去丝胶和碳酸钠并进行干燥。用高压釜将所得到的丝线杀菌，作为丝纤朊薄膜制造用的材料。
(2)丝线的溶解
将以(1)得到的提纯丝线溶解在由氯化钙、乙醇和水组成的水溶液(混合摩尔比＝1∶2∶8)中。此时，丝线和水溶液的重量比达到1∶7。该水溶液放入纤维素管(半透膜)中用纯水进行透析，从而得到丝纤朊水溶液。此时的丝纤朊水溶液的丝纤朊浓度约是7％(重量)。
(3)丝纤朊薄膜的制造
将上述的丝纤朊水溶液在平的塑料板上流成一定面积，在20℃、65％相对湿度的室内一边送风(20～40cm/s)，一边进行干燥。薄膜的厚度因丝纤朊水溶液的浓度和量及干燥面的面积不同而变化，但可制成厚10μm以上的薄膜。厚度越变厚，丝纤朊薄膜越容易结晶化，因此要迅速送风。
(4)丝纤朊薄膜的性质。
观察所得到的丝纤朊薄膜的X射线衍射照片，在该X射线衍射照片上显示非晶态晕圈，证实丝纤朊是非结晶性的。另外，观察水(室温)对该丝纤朊的溶解性时，在数分钟内几乎完全溶解。因此，证实该丝纤朊薄膜实质上是非结晶性的。
另外，为了观察血液与丝纤朊薄膜的相互作用，在薄膜上滴上一滴血液，薄膜在1分钟以内吸收血液而膨润。这显示该非结晶丝纤朊薄膜可以与体液相互作用，使体液很好地吸收在薄膜上，而薄膜水分迅速蒸发。
(5)作为创伤被覆材料的机能
为了观察作为创伤被覆材料的非结晶丝纤朊薄膜的机能，用环氧乙烷气体杀菌后，将该薄膜接触在火伤的患部，吸收从体内出来的液体，因为水分从薄膜表面蒸发，可以患部保持干燥状态，即使一周后不更换薄膜，从患部下也形成新皮肤。由此证实，丝纤朊薄膜充分完成作为人工皮肤的机能。
本发明的创伤被覆材料，在已缺损(创伤)的皮肤表面作为人工皮肤进行被覆，在促进该缺损皮肤再生和新皮肤的形成的同时，在将其剥离时，也不会将该被覆材料下的再生皮肤和新形成的皮肤剥下。另外，在将本发明的创伤被覆材料使用于缺损皮肤的场合，有经过长时间不要更换的优点。

Claims (3)

1.含非结晶性丝纤朊薄膜的创伤被覆材料，其特征在于，所述非结晶性丝纤朊是水溶性的，所述非晶性丝纤朊薄膜的含水量为3～16重量％。
2.权利要求1所述的创伤被覆材料，其中，该非结晶性丝纤朊薄膜的含水量是5～13重量％。
3.权利要求1或2所述的创伤被覆材料，其中，该非结晶性丝纤朊薄膜的厚度是10～100μm。
CN97190147A 1996-01-23 1997-01-23 创伤被覆材料 Expired - Fee Related CN1094374C (zh)

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JP28559/96 1996-01-23
JP8028559A JP2997758B2 (ja) 1996-01-23 1996-01-23 創傷被覆材

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EP (1) EP0823258A4 (zh)
JP (1) JP2997758B2 (zh)
KR (1) KR100334486B1 (zh)
CN (1) CN1094374C (zh)
BR (1) BR9702038A (zh)
IN (1) IN191981B (zh)
WO (1) WO1997026927A1 (zh)

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KR19980703243A (ko) 1998-10-15
BR9702038A (pt) 1998-05-26
JPH09192210A (ja) 1997-07-29
WO1997026927A1 (fr) 1997-07-31
US5951506A (en) 1999-09-14
EP0823258A4 (en) 2002-11-06
EP0823258A1 (en) 1998-02-11
KR100334486B1 (ko) 2002-06-20
CN1181707A (zh) 1998-05-13
JP2997758B2 (ja) 2000-01-11
IN191981B (zh) 2004-01-31

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