CN112472872A - 一种医用神经嫁接修复膜及其制备方法 - Google Patents

一种医用神经嫁接修复膜及其制备方法 Download PDF

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CN112472872A
CN112472872A CN202011422894.5A CN202011422894A CN112472872A CN 112472872 A CN112472872 A CN 112472872A CN 202011422894 A CN202011422894 A CN 202011422894A CN 112472872 A CN112472872 A CN 112472872A
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chitosan
nerve
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王桂发
王亚群
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Shandong Kanglida Medical Products Co ltd
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Abstract

本发明公开了一种医用神经嫁接修复膜及其制备方法，制备方法包括选材、祛除杂蛋白、病毒灭活、胶原蛋白脱脂、肠衣延展、壳聚糖雾化、敷料定型、敷料固化、裁切和检验、包装和灭菌等步骤；本发明中的壳聚糖具有抑菌性，能抗微生物感染，诱导组织再生，加快神经纤维的生长愈合，在组织内不会引起任何炎性反应；胶原蛋白具有止血与修补功能，并具有生物吸收性及细胞粘附性，促新细胞形成，促神经细胞形成；产品的抗原性低、与人体组织相容性好，通过酶和体液自动协调吸收，吸收期稳定，最终被人本完全吸收；采用本发明方法制备烧烫伤修复膜具有质地均匀、弹性佳，透明度高，透气性能良，生物相容性好、敷料可被机体吸收和毒副作用小等特点。

Description

一种医用神经嫁接修复膜及其制备方法
技术领域
本发明涉及生物医学技术领域，具体的说，尤其涉及一种医用神经嫁接修复膜及其制备方法。
背景技术
神经系统是人体中最重要的器官，由中枢神经和周围神经两大部分组成，中枢神经是指脑和脊髓，周围神经则是指离开脑和脊髓的神经纤维由结缔组织连接、包裹组成粗细不等的神经束的基础上，再由结缔组织进一步包裹而形成的（肉眼可见的）神经束的集合体。周围神经损伤表现为各种原因引起的受该神经支配的区域出现感觉障碍、运动障碍和营养障碍，只有在受损神经得到修复的情况下，器官的正常功能才能得到完全的恢复。
周围神经离断损伤后，能以约1毫米/天的速度从近端向远端生长，临床上常通过对离断神经吻合的方法就行修复，然而神经吻合后仍然会存在如下问题：局部缺乏良好的促进神经纤维生长的微环境，难以形成有利于神经纤维再生的“再生室”效应；吻合口暴露，神经生长因子外流，亦会降低神经的修复效果；纤维组织侵入吻合口形成瘢痕，阻碍再生纤维通过吻合口长入神经远端；生长受阻的再生纤维极易在局部形成神经纤维瘤子。寻找一种有效的修复材料，提高神经再生的速度和质量，是当前急需解决的问题。
发明内容
本发明的目的在于提供一种医用神经嫁接修复膜及其制备方法，以解决上述背景技术中提出的问题。
为实现上述目的，本发明提供如下技术方案：一种医用神经嫁接修复膜的制备方法，该制备方法按如下步骤进行：
（1）选材：精选经检疫合格的肠衣，截取小肠部位；
（2）祛除杂蛋白：将小肠肠衣内壁洗净，将肠衣中的肠绒毛膜、粘膜、浆膜使用专用器具使其分离和脱落；
（3）病毒灭活：将祛除杂蛋白的肠衣浸泡在食用过氧化氢溶液中并清洗；
（4）胶原蛋白脱脂：将上述肠衣用清水清理后放入氯化钠溶液中浸泡，然后分离切除肠衣胶原蛋白中的脂肪，得到较为纯净的胶原蛋白组织；
（5）肠衣延展：将肠衣剖开成片后，用延展设备延展至设定的长度和宽度；
（6）壳聚糖雾化：将过量壳聚糖加入醋酸溶液中，充分搅拌配成壳聚糖饱和溶液，将壳聚糖饱和溶液均匀的喷涂在上述肠衣表面后静置后再重复喷涂、静置操作多次；
（7）敷料定型：经延展后的肠衣片，用平整的夹具覆合使其定型；
（8）敷料固化：在温控室内采用温度逐步升高、湿度逐渐降低的条件下使其脱水固化；
（9）裁切和检验：在显微镜操作台下，检验敷料的透明度、均匀度和有无杂质，并把经上述过程处理过的肠衣片根据神经修复需要的尺寸和厚度裁剪成半成品；
（10）包装和灭菌：在不低于10万级的洁净车间内将上述医用神经嫁接修复膜真空包装后放入灭菌室中经钴-60伽马射线辐射灭菌。
优选的，所述病毒灭活的具体操作为：将祛除杂蛋白的肠衣浸泡在水温为35-37℃、浓度为6-8%的食用过氧化氢溶液中10-12小时后用纯化水清洗4-6遍。
优选的，所述胶原蛋白脱脂过程中氯化钠溶液的浓度为13-15%，浸泡时间为70-76分钟。
优选的，所述壳聚糖雾化具体操作为：将温度32-38摄氏度的壳聚糖饱和溶液均匀的喷涂在肠衣表面，静置34-56分钟后，再进行喷涂、静置，如此反复进行5-7遍。
优选的，所述敷料固化中温度升高的速率为0.5-0.7℃/h，湿度每小时降低3-5%，温度最高升至55℃，湿度最低降至8%。
上述方法制备的医用神经嫁接修复膜的厚度为0.02-0.08mm。
有益效果：与现有技术相比，本发明中的壳聚糖具有抑菌性，能抗微生物感染，诱导组织再生，加快神经纤维的生长愈合，在组织内不会引起任何炎性反应；胶原蛋白具有止血与修补功能，并具有生物吸收性及细胞粘附性，促新细胞形成，促神经细胞形成；由于壳聚糖与胶原蛋白材质本身的优良生物兼容性特性，决定了产品的抗原性低、与人体组织相容性好，通过酶和体液自动协调吸收，吸收期稳定，最终被人本完全吸收。
采用本发明方法制备的医用神经嫁接修复膜具有质地均匀、弹性佳，透明度高，透气性能良，生物相容性好、敷料可被机体吸收和毒副作用小等特点。本发明修复膜吸收完全，组织不良反应小，可特异性引导损伤神经的再生，不易沾染细菌，可避免感染。
具体实施方式
为了能够更清楚地理解本发明的上述目的、特征和优点，下面结合实施例对本发明做进一步说明。需要说明的是，在不冲突的情况下，本申请的实施例及实施例中的特征可以相互组合。
在下面的描述中阐述了很多具体细节以便于充分理解本发明，但是，本发明还可以采用不同于在此描述的其他方式来实施，因此，本发明并不限于下面公开说明书的具体实施例的限制。
实施例1
本实施例的一种医用神经嫁接修复膜的制备方法，该制备方法按如下步骤进行：
（1）精选经检疫合格的肠衣，截取小肠部位；
（2）祛除杂蛋白：将小肠肠衣内壁洗净，将肠衣中的肠绒毛膜、粘膜、浆膜使用专用器具使其分离和脱落；
（3）病毒灭活：将祛除杂蛋白的肠衣浸泡在水温为35℃、浓度为6%的食用过氧化氢溶液中10小时后用纯化水清洗4遍。
(4）胶原蛋白脱脂：将上述肠衣用清水清理后放入13%浓度的氯化钠溶液中浸泡70分钟，然后分离切除肠衣胶原蛋白中的脂肪，得到较为纯净的胶原蛋白组织；
（5）肠衣延展：将肠衣剖开成片后，用延展设备延展至设定的长度和宽度；
（6）壳聚糖雾化：将过量壳聚糖加入醋酸溶液中，充分搅拌配成壳聚糖的饱和溶液，将温度32摄氏度的壳聚糖的饱和溶液均匀的喷涂在上述肠衣表面，等待34分钟后，再进行喷涂，如此反复进行5遍；
（7）敷料定型：经延展后的肠衣片，用平整的夹具覆合使其定型。
（8）敷料固化：在温控室内采用温度逐步升高、湿度逐渐降低的条件下使其脱水固化，其中温度升高的速率为0.5℃/h，湿度每小时降低3%，温度最高升至55℃，湿度最低降至8%；
（9）裁切和检验：在显微镜操作台下，检验敷料的透明度、均匀度和有无杂质，并裁剪成不同尺寸和厚度的半成品；
（10）包装和灭菌：在不低于10万级的洁净车间内将上述医用神经嫁接修复膜真空包装后放入灭菌室中经钴-60伽马射线辐射灭菌。
实施例2
本实施例的一种医用神经嫁接修复膜的制备方法，该制备方法按如下步骤进行：
（1）精选经检疫合格的肠衣，截取小肠部位；
（2）祛除杂蛋白：将小肠肠衣内壁洗净，将肠衣中的肠绒毛膜、粘膜、浆膜使用专用器具使其分离和脱落；
（3）病毒灭活：将祛除杂蛋白的肠衣浸泡在水温为36℃、浓度为7%的食用过氧化氢溶液中11小时后用纯化水清洗5遍。
(4）胶原蛋白脱脂：将上述肠衣用清水清理后放入14%浓度的氯化钠溶液中浸泡73分钟，然后分离切除肠衣胶原蛋白中的脂肪，得到较为纯净的胶原蛋白组织；
（5）肠衣延展：将肠衣剖开成片后，用延展设备延展至设定的长度和宽度；
（6）壳聚糖雾化：将过量壳聚糖加入醋酸溶液中，充分搅拌配成壳聚糖的饱和溶液，将温度35摄氏度的壳聚糖的饱和溶液均匀的喷涂在上述肠衣表面，等待45分钟后，再进行喷涂，如此反复进行6遍；
（7）敷料定型：经延展后的肠衣片，用平整的夹具覆合使其定型。
（8）敷料固化：在温控室内采用温度逐步升高、湿度逐渐降低的条件下使其脱水固化，其中温度升高的速率为0.6℃/h，湿度每小时降低4%，温度最高升至55℃，湿度最低降至8%；
（9）裁切和检验：在显微镜操作台下，检验敷料的透明度、均匀度和有无杂质，并裁剪成不同尺寸和厚度的半成品；
（10）包装和灭菌：在不低于10万级的洁净车间内将上述医用神经嫁接修复膜真空包装后放入灭菌室中经钴-60伽马射线辐射灭菌。
实施例3
本实施例的一种医用神经嫁接修复膜的制备方法，该制备方法按如下步骤进行：
（1）精选经检疫合格的肠衣，截取小肠部位；
（2）祛除杂蛋白：将小肠肠衣内壁洗净，将肠衣中的肠绒毛膜、粘膜、浆膜使用专用器具使其分离和脱落；
（3）病毒灭活：将祛除杂蛋白的肠衣浸泡在水温为37℃、浓度为8%的食用过氧化氢溶液中12小时后用纯化水清洗6遍。
(4）胶原蛋白脱脂：将上述肠衣用清水清理后放入15%浓度的氯化钠溶液中浸泡76分钟，然后分离切除肠衣胶原蛋白中的脂肪，得到较为纯净的胶原蛋白组织；
（5）肠衣延展：将肠衣剖开成片后，用延展设备延展至设定的长度和宽度；
（6）壳聚糖雾化：将过量壳聚糖加入醋酸溶液中，充分搅拌配成壳聚糖的饱和溶液，将温度38摄氏度的壳聚糖的饱和溶液均匀的喷涂在上述肠衣表面，等待56分钟后，再进行喷涂，如此反复进行7遍；
（7）敷料定型：经延展后的肠衣片，用平整的夹具覆合使其定型。
（8）敷料固化：在温控室内采用温度逐步升高、湿度逐渐降低的条件下使其脱水固化，其中温度升高的速率为0.7℃/h，湿度每小时降低5%，温度最高升至55℃，湿度最低降至8%；
（9）裁切和检验：在显微镜操作台下，检验敷料的透明度、均匀度和有无杂质，并裁剪成不同尺寸和厚度的半成品；
（10）包装和灭菌：在不低于10万级的洁净车间内将上述医用神经嫁接修复膜真空包装后放入灭菌室中经钴-60伽马射线辐射灭菌。
应用以上实施例中的制备方法获得的医用神经嫁接修复膜厚度为0.02-0.08mm。
本发明提供的一种医用神经嫁接修复膜及其制备方法，使用的壳聚糖具有抑菌性，能抗微生物感染，诱导组织再生，加快神经纤维的生长愈合，在组织内不会引起任何炎性反应；胶原蛋白具有止血与修补功能，并具有生物吸收性及细胞粘附性，促新细胞形成，促神经细胞形成；由于壳聚糖与胶原蛋白材质本身的优良生物兼容性特性，决定了产品的抗原性低、与人体组织相容性好，通过酶和体液自动协调吸收，吸收期稳定，最终被人本完全吸收。
采用本发明方法制备的医用神经嫁接修复膜具有质地均匀、弹性佳，透明度高，透气性能良，生物相容性好、敷料可被机体吸收和毒副作用小等特点。本发明修复膜吸收完全，组织不良反应小，可特异性引导损伤神经的再生，不易沾染细菌，可避免感染。
以上所述，仅是本发明的较佳实施例而已，并非是对本发明作其它形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例应用于其它领域，但是凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型，仍属于本发明技术方案的保护范围。

Claims (7)

1.一种医用神经嫁接修复膜的制备方法，其特征在于，该制备方法按如下步骤进行：
(1)选材：精选经检疫合格的肠衣，截取小肠部位；
(2)祛除杂蛋白：将小肠肠衣内壁洗净，将肠衣中的肠绒毛膜、粘膜、浆膜使用专用器具使其分离和脱落；
(3)病毒灭活：将祛除杂蛋白的肠衣浸泡在食用过氧化氢溶液中并清洗；
(4)胶原蛋白脱脂：将上述肠衣用清水清理后放入氯化钠溶液中浸泡，然后分离切除肠衣胶原蛋白中的脂肪，得到较为纯净的胶原蛋白组织；
(5)肠衣延展：将肠衣剖开成片后，用延展设备延展至设定的长度和宽度；
(6)壳聚糖雾化：将过量壳聚糖加入醋酸溶液中，充分搅拌配成壳聚糖饱和溶液，将壳聚糖饱和溶液均匀的喷涂在上述肠衣表面后静置后再重复喷涂、静置操作多次；
(7)敷料定型：经延展后的肠衣片，用平整的夹具覆合使其定型；
(8)敷料固化：在温控室内采用温度逐步升高、湿度逐渐降低的条件下使其脱水固化；
(9)裁切和检验：在显微镜操作台下，检验敷料的透明度、均匀度和有无杂质，并把经上述过程处理过的肠衣片根据神经修复需要的尺寸和厚度裁剪成半成品；
(10)包装和灭菌：在不低于10万级的洁净车间内将上述医用神经嫁接修复膜真空包装后放入灭菌室中经钴-60伽马射线辐射灭菌。
2.根据权利要求1所述的一种医用神经嫁接修复膜的制备方法，其特征在于，所述病毒灭活的具体操作为：将祛除杂蛋白的肠衣浸泡在水温为35-37℃、浓度为6-8％的食用过氧化氢溶液中10-12小时后用纯化水清洗4-6遍。
3.根据权利要求1所述的一种医用神经嫁接修复膜的制备方法，其特征在于，所述胶原蛋白脱脂过程中氯化钠溶液的浓度为13-15％，浸泡时间为70-76分钟。
4.根据权利要求1所述的一种医用神经嫁接修复膜的制备方法，其特征在于，所述壳聚糖雾化具体操作为：将温度32-38摄氏度的壳聚糖饱和溶液均匀的喷涂在肠衣表面，静置34-56分钟后，再进行喷涂、静置，如此反复进行5-7遍。
5.根据权利要求1所述的一种医用神经嫁接修复膜的制备方法，其特征在于，所述敷料固化中温度升高的速率为0.5-0.7℃/h，湿度每小时降低3-5％，温度最高升至55℃，湿度最低降至8％。
6.一种医用神经嫁接修复膜，其特征在于，由权利要求1-5任一项所述的医用神经嫁接修复膜制备方法所获得。
7.根据权利要求6所述的一种医用神经嫁接修复膜，其特征在于，所述神经嫁接修复膜的厚度为0.02-0.08mm。
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