CN106729924A - 一种医用胶原贴生物敷料及其制备方法 - Google Patents
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Abstract
本发明涉及生物医学材料技术领域，具体涉及一种医用胶原贴生物敷料及其制备方法，本发明的医用胶原贴生物敷料，由生物基质液和医用无纺布组成，其中生物基质液主要由胶原蛋白、硫酸软骨素、壳聚糖和聚乳酸组成，其中胶原蛋白具有促进创面修复的作用，硫酸软骨素作为细胞外基质主要成分，在创面愈合过程中促进细胞的增殖，促进创面愈合，防止创面粘连，壳聚糖为一种含氨基的葡聚糖，具有抑菌，止血，促进愈合的作用，聚乳酸用于创面具有止血，防粘连的作用。
Description
技术领域
本发明涉及生物医学材料技术领域，具体涉及一种医用胶原贴生物敷料及其制备方法。
背景技术
临床上，为了保护烧伤、外伤、手术、感染等原因引起的各种创面，控制创面感染，保持创面湿润，促进创面愈合，往往采用各种不同的治疗手段和产品，但现有的方法和产品在治疗效果上往往不尽人意。
现有的医用胶原贴敷料中，仅含有胶原蛋白成分，虽然可以促进创面愈合，但是其创面愈合时间较长，临床应用过程中需要额外的消毒处理，甚至出现敷料与创面的粘连的现象，在使用过程中容易对创面造成额外的损伤。
发明内容
本发明针对现有技术中存在的问题，提供一种医用胶原贴生物敷料及其制备方法。
本发明通过以下技术方案实现该目的：
一种医用胶原贴生物敷料，由生物基质液和医用无纺布组成，所述生物基质液包括以下质量比的组分：
作为优选的，所述生物基质液包括以下质量比的组分：
一种医用胶原贴生物敷料的制备方法，包括以下步骤：
1)将胶原蛋白加入纯化水中，在搅拌罐中至完全溶解，搅拌罐内的温度为2-27℃；
2)将硫酸软骨素和聚乳酸按照比例加入上述胶原液中，搅拌温度同上，继续搅拌待完全溶解；
3)将壳聚糖按照比例加入上述生物基质液中，搅拌温度同上，继续搅拌待完全溶解；
4)将无纺布按照要求折叠放入包装袋中，进行辐照灭菌，辐照灭菌剂量在15kGy-25kGy之间；
5)将完成步骤3)的生物基质液灌装到完成步骤4)的包装袋中；
6)将完成步骤5的包装袋进行封口，制得医用胶原贴生物敷料。
其中，所述纯化水的pH＝4.0-7.5。
其中，所述步骤1)-6)均在无菌环境下完成。
其中，所述步骤4)在十万级洁净车间完成组装后辐照灭菌。
与现有技术相比，本发明具有如下有益效果：本发明的医用胶原贴生物敷料，由生物基质液和医用无纺布组成，其中生物基质液主要由胶原蛋白、硫酸软骨素、壳聚糖和聚乳酸组成，其中胶原蛋白具有促进创面修复的作用，硫酸软骨素作为细胞外基质主要成分，在创面愈合过程中促进细胞的增殖，促进创面愈合，防止创面粘连，壳聚糖为一种含氨基的葡聚糖，具有抑菌，止血，促进愈合的作用，聚乳酸用于创面具有止血，防粘连的作用。
具体实施方式
以下结合具体实施例对本发明进行详细描述。
实施例1。
本实施例的一种医用胶原贴生物敷料由生物基质液和医用无纺布组成，其中生物基质液主要有胶原蛋白、硫酸软骨素，壳聚糖和聚乳酸等组成，生物基质液各组分的质量比为：
实施例2。
本实施例的一种医用胶原贴生物敷料由生物基质液和医用无纺布组成，其中生物基质液主要有胶原蛋白、硫酸软骨素，壳聚糖和聚乳酸等组成，生物基质液各组分的质量比为：
实施例3。
本实施例的一种医用胶原贴生物敷料由生物基质液和医用无纺布组成，其中生物基质液主要有胶原蛋白、硫酸软骨素，壳聚糖和聚乳酸等组成，生物基质液各组分的质量比为：
对比例。
现有技术中的胶原贴敷料配方，胶原蛋白含量0.5％，剩余成分为纯化水。
验证试验。
比较实施例1-3与对比例在试验过程中的创面愈合时间和创面感染及处理情况。
采用1只健康成年兔，背部剪毛，沿背部脊柱两侧选取8个位置，大小约1cm×1cm，编号，酒精消毒处理，模拟浅二度烧伤创面，分别使用实施例1-3和对比例的敷料进行创面覆盖，观察创面愈合情况。
按照正常换药方法给动物换药，观察试验开始后7天和14天创面愈合情况，创面愈合情况如表1所示。
表1
由以上试验结果可以发现，实施例1-3较对比例能有效预防感染，减少创面消毒护理，有效促进创面愈合。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。
Claims (6)
1.一种医用胶原贴生物敷料，由生物基质液和医用无纺布组成，其特征在于，所述生物基质液包括以下质量比的组分：
2.根据权利要求1所述的医用胶原贴生物敷料，其特征在于，所述生物基质液包括以下质量比的组分：
3.权利要求1或2所述的医用胶原贴生物敷料的制备方法，其特征在于，包括以下步骤：
1)将胶原蛋白加入纯化水中，在搅拌罐中至完全溶解，搅拌罐内的温度为2-27℃；
2)将硫酸软骨素和聚乳酸按照比例加入上述胶原液中，搅拌温度同上，继续搅拌待完全溶解；
3)将壳聚糖按照比例加入上述生物基质液中，搅拌温度同上，继续搅拌待完全溶解；
4)将无纺布按照要求折叠放入包装袋中，进行辐照灭菌，辐照灭菌剂量在15kGy-25kGy之间；
5)将完成步骤3)的生物基质液灌装到完成步骤4)的包装袋中；
6)将完成步骤5的包装袋进行封口，制得医用胶原贴生物敷料。
4.根据权利要求3所述的医用胶原贴生物敷料的制备方法，其特征在于，所述纯化水的pH＝4.0-7.5。
5.根据权利要求4所述的医用胶原贴生物敷料的制备方法，其特征在于，所述步骤1)-6)均在无菌环境下完成。
6.根据权利要求5所述的医用胶原贴生物敷料的制备方法，其特征在于，所述步骤4)在十万级洁净车间完成组装后辐照灭菌。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112336909A (zh) * | 2020-08-25 | 2021-02-09 | 江苏奥普莱医疗用品有限公司 | 一种医用胶原贴敷料及其制备方法 |
| CN113995882A (zh) * | 2021-12-13 | 2022-02-01 | 山东鑫珂海洋生物技术股份有限公司 | 一种甲壳素快速止血医用敷料的制备方法 |
-
2016
- 2016-12-22 CN CN201611199268.8A patent/CN106729924A/zh active Pending
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| 段久芳: "《天然高分子材料》", 30 September 2016, 华中科技大学出版社 * |
| 王璐等: "《生物医用纺织品》", 30 November 2011, 中国纺织出版社 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112336909A (zh) * | 2020-08-25 | 2021-02-09 | 江苏奥普莱医疗用品有限公司 | 一种医用胶原贴敷料及其制备方法 |
| CN113995882A (zh) * | 2021-12-13 | 2022-02-01 | 山东鑫珂海洋生物技术股份有限公司 | 一种甲壳素快速止血医用敷料的制备方法 |
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