CN1986001B - 生物护创膜 - Google Patents

生物护创膜 Download PDF

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CN1986001B
CN1986001B CN2005101207912A CN200510120791A CN1986001B CN 1986001 B CN1986001 B CN 1986001B CN 2005101207912 A CN2005101207912 A CN 2005101207912A CN 200510120791 A CN200510120791 A CN 200510120791A CN 1986001 B CN1986001 B CN 1986001B
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base material
wound
protecting film
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epoxide
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CN1986001A (zh
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徐国风
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Guan Hao biotech inc
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GUANGDONG SUMMIT LIFE SCIENCES CO Ltd
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Priority to CN2005101207912A priority Critical patent/CN1986001B/zh
Priority to US11/639,690 priority patent/US7820871B2/en
Priority to DE602006018365T priority patent/DE602006018365D1/de
Priority to PCT/CN2006/003443 priority patent/WO2007071168A1/en
Priority to AU2006329153A priority patent/AU2006329153B2/en
Priority to EP06828356A priority patent/EP1979010B1/en
Priority to JP2008546076A priority patent/JP5256044B2/ja
Priority to RU2008127981/15A priority patent/RU2438713C2/ru
Priority to CA2634316A priority patent/CA2634316C/en
Priority to AT06828356T priority patent/ATE488254T1/de
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F2013/00902—Plasters containing means
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
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    • A61F2013/00927—Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
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    • 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
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
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    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S602/00—Surgery: splint, brace, or bandage
    • Y10S602/90—Method of making bandage structure
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S602/00—Surgery: splint, brace, or bandage
    • Y10S602/901—Tubular bandage applicators

Abstract

本发明公开了一种生物型护创膜及其制备方法，它由经非醛类固定剂交联固定和去抗原处理过的动物肠膜为基材(1)而构成，在所述基材(1)的表面上设了含有可粘附细胞的纤连蛋白、层粘连蛋白或玻连蛋白的活性修饰层(2)，或含有抗菌药的抗菌缓释层(2)。本发明的优点是：它是用很薄而坚韧的动物肠膜制成，质量轻而柔软，使用方便。肠膜属于半透膜，微孔小而密，透气及透汽性好，但不透过细菌，又经多方位除抗原处理，有效去除免疫抗原性，再加上表面活性修饰，可征集上皮细胞及成纤维细胞，促进创面愈合；或能缓释抗菌药，增大抗感染作用，其使用性能及护创效果比猪皮制成的敷料或保护膜好。

Description

生物护创膜
技术领域
本发明涉及一种用于创伤治疗中保护创面的医疗用品，属二类医疗器械。
背景技术
由于人体自身对创伤有完善的修复机制，许多中小创伤，只需要将创面保护好，使其不受感染，靠自身的修复机制就可自行愈合。一般的外伤治疗的首要措施是清洗、消毒创面，用护创敷料将创面保护起来，防止后发感染。所以，近年来护创敷料的发展很快，时有各种各样的护创膜推出。但大多是合成材料膜，如硅橡胶膜、聚氨酯膜、尼龙膜、涤纶膜、聚乙烯膜、聚丙稀膜等，经过一段时间应用后，人们逐渐发现，合成材料的组织相容性不好，治疗效果不尽人意，有人试图用天然生物材料如胶原来制造护创膜，但胶原力学性能差，还要用合成膜来增强，这种胶原合成材料复合膜虽可以改善其组织相容性，但厚度增加柔软性变差，透气性欠佳，使用性能不好。也有人用壳聚糖及壳聚糖胶原复合物制护创膜，但力学强度差，韧性及柔软性欠佳，未能推广应用，近年来有人用猪皮作护创膜，但只是用传统的戊二醛固定及铬鞣制处理技术，没有专门进行除抗原处理，有醛的残留毒性，去抗原不彻底存在弱排异反应，干态柔软性差，且干后毛孔增大，隔菌性变差，使用性能及治疗效果都不理想，影响其推广应用。
发明内容
本发明的目的是提供一种生物相容性好、柔软坚韧、透气不透菌、使用方便的生物护创膜及其制备方法。
本发明的技术解决方案是：生物型护创膜，它由经非醛类固定剂交联固定和去抗原处理过的动物肠膜为基材而构成。
动物组织易被微生物降解或分解，需用固定剂使之交联固定，传统上使用戊二醛作固定剂，有残留毒性，我们选用非醛类固定剂，如环氧化物、二酰二胺、二异氰酸酯、聚乙二醇或碳化二亚胺，就没有这一缺点。以环氧化物为例，当应用环氧化物来代替醛类作固定试剂时，由于环氧化物很不稳定，易发生开环交联反应，控制反应条件可以做到使其胶原蛋白的交联产物很稳定，不轻易降解，只有在再生组织生长增殖需对其蚕蚀时，分泌出激肽释放酶、纤溶酶、糖皮质激素协同胶原酶作用下，才能将其缓慢分解为多肽及氨基酸，并吸收利用。这样一种被动式降解与组织的再生是同步的，是最有利于组织的再生性修复的，而且无醛类的残留毒性；根据现代免疫学理论，动物组织的抗原性主要是由蛋白质中某些特殊位置的活性基团及特异构象引起的，这些活性基团主要是-OH，-NH2，-SH等，而特异构象则主要是由于胶原蛋白分子螺旋链的某些特殊氢键引起，在处理动物组织时，用一种或多种易与这些基团起反应的活泼试剂(如酸酐、酰氯、酰胺、环氧化物、卤甲烷等)与这些基团结合，将其封闭起来，从而有效的去除其抗原，同时，还应用强氢键试剂(如胍类化合物)，置换引起特异构象的氢键，改变其构象，就能有效的消除其抗原性。
作为一种优化方案，在基材表面上设有活性修饰层，其中或者含有可粘附细胞的纤连蛋白或层粘连蛋白或玻连蛋白，以提高护创膜对上皮细胞和成纤维细胞的粘附性，使能征集上皮细胞和成纤维细胞，促进创面修复、愈合；或者在活性修饰层内含有广谱抗菌药的缓释包膜，使护创膜具有抗菌、抗感染的作用。
本发明的生物型护创膜的制备方法包括以下步骤：
(1)、选料：收集新鲜动物小肠；
(2)、预处理：洗净，消毒，去除小肠粘膜及下层结缔组织，取坚韧薄膜并修剪平整干燥得基材；
(3)、脱脂：用有机溶剂抽提基材中的脂肪及脂溶性杂质；
(4)、交联固定：使用非醛类固定剂交联固定基材中的胶原蛋白分子；
(5)、去除抗原：使用活泼试剂封闭基材蛋白质中的特异活性基团-OH或-NH2或-SH，并用强氢键试剂置换基材蛋白质分子螺旋链中的特殊氢键，改变特异构象。
作为一种优化方案，它还设有在基材表面上设有活性修饰层的步骤，及用吸附、粘附法将纤连蛋白、层粘连蛋白或玻连蛋白粘附于基材表面，形成活性修饰层，或用生物粘胶剂与光谱抗菌药混合后涂布于基材表面，形成抗菌缓释层。
生物型护创膜的制备方法中所述的非醛类固定剂为易与蛋白质分子发生交联反应的试剂，如环氧化物、二酰二胺、二异氰酸酯、聚乙二醇或碳化二亚胺试剂中的一种或两种，这里的环氧化物可以是单环氧化物
Figure S051C0791220060116D000031
也可以是双环氧化物
Figure S051C0791220060116D000032
，这里R＝H，CnH2n+1—，n＝0-10；还可以是低聚环氧化物，如聚环氧丙烷。
生物型护创膜的制备方法中所述的活泼试剂可以是小分子有机酸酐、酰氯、酰胺或环氧化物；强氢键试剂为胍类化合物。
本发明的优点是：它是用很薄而坚韧的动物肠膜制成，质量轻而柔软，使用方便。肠膜属于半透膜，微孔小而密，透气及透汽性好，但不透过细菌，又经多方位除抗原处理，有效去除免疫原性，再加上表面活性修饰，可征集上皮细胞及成纤维细胞，促进创面愈合；或能缓释抗菌药，增大抗感染作用，其使用性能及护创效果比猪皮制成的敷料或保护膜好。
附图说明
附图1为本发明实施例的剖视图；
1、基材，2、活性修饰层或抗菌缓释层。
具体实施方式
实施例：如图1所示，生物型护创膜，由经非醛类固定剂交联固定和去抗原处理过的动物肠膜为基材1而构成，在基材1的表面上设置了含有可粘附细胞的纤连蛋白、层粘连蛋白或玻连蛋白的活性修饰层2或含抗菌药的抗菌缓释层2。
本发明的生物型护创膜的制备方法包括以下步骤：
(1)、选料：收集新鲜动物小肠；
(2)、预处理：洗净，消毒，用专用工具刮除小肠粘膜及下层结缔组织，取坚韧薄膜并修剪平整干燥得膜材；
(3)、脱脂：用有机溶剂抽提膜材中的脂肪及脂溶性杂质；
(4)、交联固定：室温下使用环氧化物交联固定膜材中的胶原蛋白分子；
(5)、去除抗原：使用活泼试剂丁酸酐封闭膜材胶原蛋白中的特异活性基团-OH或-NH2或-SH，并用盐酸胍的Tris溶液置换膜材胶原蛋白分子螺旋链中的特殊氢键，改变特异构象，即得基材1。
(6)、表面活性修饰：用吸附、粘附法将纤连蛋白、层粘连蛋白或玻连蛋白粘附于基材1表面，形成活性修饰层2，或用生物粘胶剂与光谱抗菌药混合后涂布于基材1表面，形成抗菌缓释层2。
(7)、后处理：真空干燥，定型，包装，用环氧化物或辐射灭菌，得到成品。

Claims (5)

1.一种生物型护创膜的制备方法，其特征在于：它包括以下步骤：
a)、选料：收集新鲜动物小肠；
b)、预处理：洗净，消毒，去除小肠粘膜及下层结缔组织，取坚韧薄膜并修剪平整干燥得基材(1)；
c)、脱脂：用有机溶剂抽提膜材中的脂肪及脂溶性杂质；
d)、交联固定：使用环氧化物交联固定基材(1)中的胶原蛋白分子；
e)、去除抗原：使用活泼试剂封闭基材(1)蛋白质中的特异活性基团-OH或-NH2或-SH，并用强氢键试剂置换基材(1)蛋白质分子螺旋链中的特殊氢键，改变特异构象；
所述的活泼试剂是小分子有机酸酐、酰氯、酰胺、环氧化物或卤甲烷；强氢键试剂为胍类化合物。
2.根据权利要求1所述的制备方法，其特征在于：它还设有在基材(1)表面上进行活性修饰的步骤，即用吸附、粘附法将纤连蛋白、层粘连蛋白或玻连蛋白粘附于基材(1)表面，形成活性修饰层(2)；或用生物粘胶剂于广谱抗菌药物混合涂布于基材(1)表面，形成抗菌缓释层(2)。
3.根据权利要求1所述的制备方法，其特征在于：所述环氧化物是单环氧化物
Figure FSB00000233742100011
或者是双环氧化物
Figure FSB00000233742100012
这里R＝H，CnH2n+1-，n＝0-10，或者低聚环氧化物中的聚环氧丙烷。
4.一种使用权利要求1所述制备方法得到的生物型护创膜，其特征在于：它由经环氧化物交联固定，以及用活泼试剂封闭基材(1)蛋白质中的特异活性基团并用强氢键试剂置换基材(1)蛋白质分子螺旋链中的特殊氢键去抗原处理过的动物肠膜为基材(1)而构成，所述的活泼试剂是小分子有机酸酐、酰氯、酰胺、环氧化物或卤甲烷；强氢键试剂为胍类化合物。
5.一种使用权利要求2所述制备方法得到的生物型护创膜，其特征在于：在所述基材(1)的表面上设有含有可粘附细胞的纤连蛋白、层粘连蛋白或玻连蛋白的活性修饰层(2)，或含有抗菌药的抗菌缓释层(2)。
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