CN101361751B - 吸湿自粘型防术后粘连隔离膜及其制备方法 - Google Patents
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Abstract
本发明公开的吸湿自粘型防术后粘连隔离膜,其成分及其重量百分比含量为:羧化壳聚糖65~99%,甘油1~10%,柠檬酸0~5%,余量为水。其制备步骤为:按重量百分比含量取各成分,先将羧化壳聚糖加入到水中,搅拌至溶解,再加入其它成分,搅拌成混合溶液;将上述混合液倒入玻璃模具中自流平,干燥成膜,冷却至室温;从模具中揭下膜,即可。本发明的膜无菌,植入体内时,膜与组织创面接触时会立即吸收组织液而具有粘性,自动黏附在需要隔离的创面上,临床使用简单方便,具有促进创面愈合防止组织之间粘连的功效。
Description
技术领域
本发明涉及吸湿自粘型防术后粘连隔离膜及其制备方法。
背景技术
术后粘连是困扰外科医生的一个世界性难题。据统计60-95%的腹部手术病人会产生程度不一的粘连,严重的术后粘连可以使一个成功的手术归于失败,因此对手术后粘连的防治研究一直是人们关注的热点之一。对术后粘连的防治大体可分为两类:药物性制剂和暂时机械隔离。药物性制剂一般是根据粘连的形成机制,用药物介入的方法,抑制粘连的形成,如临床中常用的抗炎类制剂、抗组胺类制剂、纤维蛋白溶解类制剂等。但是,由于粘连形成的机制十分复杂,且形成粘连的病因和形成粘连的机制具有极大的个体差异。因此,药物性制剂防粘连的效果一直差强人意。国际上现有预防术后粘连的措施大多采用暂时机械隔离的方法将受损组织与邻近组织暂时隔离,形成生物屏障,避免创面修复时组织间纤维蛋白的机化沉积,从而有效防止粘连的形成。早期的防术后粘连的阻隔膜材料主要是非降解性的合成高分子材料,如硅橡胶膜、聚四氟乙烯膜等,需二次手术取出。目前,国内外研究的暂时阻隔材料多采用可降解的天然生物高分子材料,如明胶海绵、透明质酸、自体脂肪。但研究表明:明胶海绵会使成纤维细胞顺其蔓延或阻碍脂肪成活而疤痕粘连更为广泛,自体脂肪会发生液化坏死而诱发疤痕生成,透明质酸有较好的防粘连效果,但以水凝胶形式使用,易造成涂布不匀,易流失,有效利用率不高。
发明内容
本发明的目的是要提供一种具有植入体内吸湿自粘型防术后粘连隔离膜及其制备方法。
本发明的吸湿自粘型防术后粘连隔离膜,它的成分及其重量百分比含量为:
羧化壳聚糖 65~99%
甘油 1~10%
柠檬酸 0~5%
余量为水 上述成分之和为100%。
吸湿自粘型防术后粘连隔离膜的制备方法,包括以下步骤:
1)按重量百分比含量取各成分,先将羧化壳聚糖加入到水中,搅拌至羧化壳聚糖溶解,配成质量浓度2%~6%的溶液,再加入其它成分,搅拌均匀,制得混合溶液;
2)将上述混合液倒入玻璃模具中自流平,然后在40~60℃下干燥成膜,冷却至室温,从模具中揭下膜,即可。
吸湿自粘型防术后粘连隔离膜的膜厚由模具面积大小和混合溶液的用量决定。
本发明中,所说的羧化壳聚糖可以是羧甲基壳聚糖或羧丙酰壳聚糖。
本发明的吸湿自粘型防术后粘连隔离膜的理化性能:吸湿自粘型防术后粘连隔离膜表观均匀、无色透明、膜厚60±30μm,含水率≤20%,有一定抗张强度和断裂伸长率;膜的pH值6.5~7,膜灰分质量百分比≤2%,膜中不溶物(质量百分比)≤1.5%,膜中重金属总含量(以Pb计)≤10ppm。
本发明的有益效果在于:
临床试验表明,本发明的防术后粘连隔离膜无菌,植入体内时,无非感染性炎症反应,无皮肤致敏反应,无细胞毒性反应,无热源和刺激致敏反应,无遗传毒性。本发明的吸湿自粘型防粘连隔离膜具有良好的术后防粘连作用,当吸湿自粘型防术后粘连隔离膜与体液或组织液接触时会立即吸收水分而形成凝胶,具有粘性,自行粘贴在组织的创面处,羧化壳聚糖具有促进创面愈合的功效和与周边组织起到隔离的作用。临床使用简单方便,无需缝合固定,对任何形状,任何位置的创面都可有效的保护而防止术后粘连的形成。
具体实施方式
以下结合实施例进一步说明本发明。
实施例1
吸湿自粘型防术后粘连隔离膜含有(按重量):
羧化壳聚糖 90%
甘油 2%
柠檬酸 2%
余量为水,上述成分之和为100%。
制备方法,步骤如下:
1)按所含成分的量称取羧甲基壳聚糖、甘油和柠檬酸,先将羧甲基壳聚糖加入到水中,配成4%的羧甲基壳聚糖溶液,再加入甘油和柠檬酸,搅拌均匀,制得混合溶液;
2)将上述混合液倒入玻璃模具中自流平,然后放入烘箱中在40℃下干燥8小时成膜,取出模具,冷却至室温;揭下膜,即为吸湿自粘型防术后粘连隔离膜。
制得的吸湿自粘型防术后粘连隔离膜的含水率为6%,膜的pH值6.7,膜灰分≤2%,膜中不溶物0.05%,膜中重金属总含量≤10ppm。
经动物体实验表明,当膜与组织液接触时立即自行粘贴在创面处,与周边组织起到了很好的隔离作用,与对照组相比具有明显防粘连的效果。
实施例2
吸湿自粘型防术后粘连隔离膜含有(按重量):
羧化壳聚糖 95%
甘油 1%
柠檬酸 0%
余量为水,上述成分之和为 100%。
1)按所含成分的量称取羧丙酰壳聚糖和甘油,先将羧丙酰壳聚糖加入到水中,配成6%的水溶液,再加入甘油,搅拌均匀,制得混合溶液;
2)将上述混合液倒入玻璃模具中自流平,然后放入烘箱中在50℃下干燥6小时成膜,取出模具,冷却至室温;揭下膜,即为吸湿自粘型防术后粘连隔离膜。
制得的吸湿自粘型防术后粘连隔离膜的含水率为4%,膜的pH值6.8,膜灰分≤2%,膜中不溶物0.05%,膜中重金属总含量≤10ppm。
经动物体实验表明,当膜与创面接触时立即自行粘贴在组织的创面处,并能吸收组织液,慢慢形成凝胶,与周边组织起到了很好的隔离作用。
实施例3
吸湿自粘型防术后粘连隔离膜含有(按重量):
羧化壳聚糖 65%
甘油 10%
柠檬酸 5%
余量为水,上述成分之和为100%。
1)按所含成分的量称取羧丙酰壳聚糖、甘油和柠檬酸,先将羧丙酰壳聚糖加入到水中,搅拌至羧化壳聚糖溶解,配成2%的羧化壳聚糖水溶液,再加入甘油和柠檬酸,搅拌均匀,制得混合溶液;
2)将上述混合液倒入玻璃模具中自流平,然后放入烘箱中在55℃下干燥5小时成膜,取出模具,冷却至室温;揭下膜,即为吸湿自粘型防术后粘连隔离膜。
制得的吸湿自粘型防术后粘连隔离膜的含水率为20%,膜的pH值6.5,膜灰分≤2%,膜中不溶物0.05%,膜中重金属总含量≤10ppm。
经动物体实验表明,当膜组织创面接触时立即自行粘贴在创面处,能吸收组织液与周边组织起到了很好的隔离作用。
实施例4
吸湿自粘型防术后粘连隔离膜含有(按重量):
羧化壳聚糖 99%
甘油 1%
柠檬酸 0%
余量为水,上述成分之和为100%。
1)按所含成分的量称取羧甲基壳聚糖和甘油,先将羧甲基壳聚糖加入到水中,配成6%的水溶液,再加入甘油,搅拌均匀,制得混合溶液;
2)将上述混合液倒入玻璃模具中自流平,然后放入烘箱中在50℃下干燥10小时除去水份成膜,取出模具,冷却至室温;揭下膜,即为吸湿自粘型防术后粘连隔离膜。
吸湿自粘型防术后粘连隔离膜的含水率为0,膜的pH值6.8,膜灰分≤2%,膜中不溶物0.05%,膜中重金属总含量≤10ppm。
经动物体实验表明,当膜与创面接触时立即自行粘贴在组织的创面处,并能吸收组织液,慢慢形成凝胶,与周边组织起到了很好的隔离作用。
Claims (2)
1.吸湿自粘型防术后粘连隔离膜,其特征是它的成分及其重量百分比含量为:
羧化壳聚糖 65~99%
甘油 1~10%
柠檬酸 0~5%
余量为水 上述成分之和为100%;
所说的羧化壳聚糖为羧甲基壳聚糖或羧丙酰壳聚糖。
2.根据权利要求1所述的吸湿自粘型防术后粘连隔离膜的制备方法,其特征是包括以下步骤:
1)按重量百分比含量取各成分,先将羧化壳聚糖加入到水中,搅拌至羧化壳聚糖溶解,配成质量浓度2%~6%的溶液,再加入其它成分,搅拌均匀,制得混合溶液,所说的羧化壳聚糖为羧甲基壳聚糖或羧丙酰壳聚糖;
2)将上述混合液倒入玻璃模具中自流平,然后在40~60℃下干燥成膜,冷却至室温,从模具中揭下膜,即可。
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