CN109078215A - 一种可吸收抗菌缝合线的制备方法 - Google Patents
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Abstract
本发明涉及一种可吸收抗菌缝合线的制备方法，属于医用生物材料领域。本发明所制备的可降解抗菌缝合线采用可降解的壳聚糖和胶原蛋白作为缝合线主材料，壳聚糖有优良的生物相容性及抗菌防腐、止血、促进细胞生长和伤口愈合、抑制溃疡等功能，成膜性好，机械强度高，具有生物可降解性，猪皮中富含胶原蛋白，胶原蛋白在等电点以上带负电，可与带正电的壳聚糖复合形成聚两性电解质，实现性能互补和协同效应，呈现两种材料本身所不具有的良好性能，同时调整两种组分的比例又可以调控材料的性能，提高缝合线的机械性能；配以仙人掌提取液达到抗菌消炎的效果，猪皮的胶原蛋白能够提高缝合线与人体的相容性，具有良好的可降解性和抗菌性。
Description
技术领域
本发明涉及一种可吸收抗菌缝合线的制备方法，属于医用生物材料领域。
背景技术
随着医疗技术和纺织工程的不断进步，纺织品材料在医疗行业的应用越来越广。医用手术缝合线是最常见的外科移植类生物医用纺织品，广泛应用于各类外科手术中，用以缝合伤口，联结组织和结扎血管。近年来其他伤口闭合技术，如夹子、钉子或组织粘合剂等也在不断发展，但缝合线仍然是大多数手术中伤口闭合的主要选择。
缝合线根据生物降解性能可分为可吸收缝合线和不可吸收缝合线。可吸收缝合线一般应用于腹部、眼科等手术切口的缝合，是由于其在生物组织中支撑强度优良，吸收时间合适，缝合后能慢慢和组织相溶，此过程不影响伤口的正常愈合，在身体组织内可以降解成为可溶性产物，通常在2-6个月后消失，支撑时间较短，比如天然的羊肠线，胶原线，合成材料的有聚乙烯醇纤维、聚乙交酯纤维、聚对二氧环己酯纤维、聚己内酯纤维、聚乳酸纤维等。
不可吸收缝合线在体内不降解，支撑时间较长，但长时间作为身体异物留在组织中，容易引起组织感染，此类线有丝、聚酰胺、聚酯、聚丙烯及金属缝合线等。经缝合的伤口很容易受到机体周围环境中细菌的感染，表现为切口处出现或渗出脓性分泌物，或出现蜂窝组织炎的红斑区域，患者的伤口处会出现有不同程度的疼痛感或是在碰触的情况下存在有压痛感，同时伴随有组织水肿，红斑区域扩大趋势等现象。
随着医学的发展和进步，人们对医疗服务的安全性越来越关注。手术切口缝合的周围环境中常常存在有各种各样的细菌，而普通的外科手术缝合线对细菌又没有抑菌作用，这直接影响了伤口的有效愈合，进而威胁人类的健康。理想的生物可吸收缝合线应满足以下一些条件：纤维柔韧性好，打结强度高，结扎时操作方便，持结性能良好；在体内能保持一定时间的强度，在体液环境中不会变形，伤口愈合后被吸收；生物相容性好，不致因异物反应而发生炎症；产品质量稳定可靠、保存方便，能够对其进行彻底的消毒杀菌处理。
目前的抗菌缝合线普遍存在或分别存在价格昂贵、抗菌谱不广、抗菌持续时间短、操作复杂、有毒对人体有害、与组织不相容等问题。因此，研发具有抗菌性能且生物相容性良好的医用缝合线具有十分重要的社会意义和经济价值。
发明内容
本发明所要解决的技术问题：针对现今缝合线相容性较差抗菌能力弱的的问题，提出了一种可吸收抗菌缝合线的制备方法。
为解决上述技术问题，本发明采用的技术方案是：
（1）取六氟异丙醇和三氟乙酸混合均匀，得到溶液A；
（2）取新鲜仙人掌，将表面的刺带皮削去，得到无刺仙人掌，将无刺仙人掌切碎后置入去离子水中，蒸煮1h，过滤去除滤渣，得到溶液B；
（3）取新鲜猪皮，刮去猪毛和皮下油脂后置入40℃1mol/L碳酸钠溶液中，20min后将猪皮取出，用100g40℃去离子水冲洗3~5次，得到预处理猪皮；
（4）取冰醋酸、氢氧化钠和去离子水，混合均匀，得到溶液C，取氯化钠和0.1mol/L盐酸溶液混合得到溶液D；
（5）取蛋白酶和预处理猪皮并浸泡在60℃溶液C中，搅拌混合30min，得到混合液，将混合液过滤，除去滤液，得到处理猪皮，用溶液D清洗处理猪皮，然后再用100g去离子水冲去残留溶液D，得到处理后猪皮；
（6）取处理后猪皮和去离子水，混合后升温至60℃并搅拌30min，过滤，得到猪皮滤液；
（7）取猪皮滤液、壳聚糖、溶液A和溶液B，搅拌混合，得到纺丝液；
（8）将纺丝液通过静电纺丝得到初生态纤维，将初生态纤维进行假捻、交联、烘干，得到可降解抗菌缝合线。
步骤（1）所述六氟异丙醇和三氟乙酸的质量比为10:1。
步骤（2）所述新鲜仙人掌和去离子水的质量比为3:5。
步骤（3）所述新鲜猪皮和1mol/L碳酸钠溶液的质量比为1:2。
步骤（4）所述冰醋酸、氢氧化钠、去离子水、氯化钠和0.1mol/L盐酸溶液的质量比为8:4:100:1:10。
步骤（5）所述蛋白酶和预处理猪皮的质量比为1:15。
步骤（6）所述处理后猪皮与去离子水的质量比为2:5。
步骤（7）所述猪皮滤液、壳聚糖、溶液A和溶液B的质量比为1:1:15:3。
本发明与其他方法相比，有益技术效果是：
（1）壳聚糖有优良的生物相容性及抗菌防腐、止血、促进细胞生长和伤口愈合、抑制溃疡等功能，成膜性好，机械强度高，具有生物可降解性，猪皮中富含胶原蛋白，胶原蛋白在等电点以上带负电，可与带正电的壳聚糖复合形成聚两性电解质，实现性能互补和协同效应，呈现两种材料本身所不具有的良好性能，同时调整两种组分的比例又可以调控材料的性能，提高缝合线的机械性能；
（2）用仙人掌制成的提取液具有消炎抗菌的作用，抗菌谱广，抗菌效果好，而且制备成本较为低廉，同时仙人掌提取液对人体无毒无害，配合壳聚糖能够有效阻止缝合处发生感染以及炎症；
（3）本发明所制备的可降解抗菌缝合线采用可降解的壳聚糖和胶原蛋白作为缝合线主材料，配以仙人掌提取液达到抗菌消炎的效果，猪皮的胶原蛋白能够提高缝合线与人体的相容性，具有良好的可降解性和抗菌性。
具体实施方式
取250~500g六氟异丙醇和25~50g三氟乙酸混合均匀，得到溶液A；取30~60g新鲜仙人掌，将表面的刺带皮削去，得到无刺仙人掌，将无刺仙人掌切碎后置入50~100g去离子水中，蒸煮1h，过滤去除滤渣，得到溶液B；取50~100g新鲜猪皮，刮去猪毛和皮下油脂后置入100~200g40%1mol/L的碳酸钠溶液中，20min后将猪皮取出，用100g40℃去离子水冲洗3~5次，得到预处理猪皮；取80~160g冰醋酸、40~80g氢氧化钠和1000~2000g去离子水，混合均匀，得到溶液C，取10~20g氯化钠和100~200g0.1mol/L盐酸溶液混合得到溶液D；取2~4g蛋白酶和30~60g预处理猪皮并浸泡在60℃溶液C中，搅拌混合30min，得到混合液，将混合液过滤，除去滤液，得到处理猪皮，用溶液D清洗处理猪皮，然后再用100g去离子水冲去残留溶液D，得到处理后猪皮；取20~40g处理后猪皮和50~100g去离子水，混合后升温至60℃并搅拌30min，过滤，得到猪皮滤液；取10~20g猪皮滤液、10~20g壳聚糖、150~300g溶液A和30~60g溶液B，搅拌混合，得到纺丝液；将纺丝液通过静电纺丝得到初生态纤维，将初生态纤维进行假捻、交联、烘干，得到可降解抗菌缝合线。
取250g六氟异丙醇和25g三氟乙酸混合均匀，得到溶液A；取30g新鲜仙人掌，将表面的刺带皮削去，得到无刺仙人掌，将无刺仙人掌切碎后置入50g去离子水中，蒸煮1h，过滤去除滤渣，得到溶液B；取50g新鲜猪皮，刮去猪毛和皮下油脂后置入100g40%1mol/L的碳酸钠溶液中，20min后将猪皮取出，用100g40℃去离子水冲洗3次，得到预处理猪皮；取80g冰醋酸、40g氢氧化钠和1000g去离子水，混合均匀，得到溶液C，取10g氯化钠和100g0.1mol/L盐酸溶液混合得到溶液D；取2g蛋白酶和30g预处理猪皮并浸泡在60℃溶液C中，搅拌混合30min，得到混合液，将混合液过滤，除去滤液，得到处理猪皮，用溶液D清洗处理猪皮，然后再用100g去离子水冲去残留溶液D，得到处理后猪皮；取20g处理后猪皮和50g去离子水，混合后升温至60℃并搅拌30min，过滤，得到猪皮滤液；取10g猪皮滤液、10g壳聚糖、150g溶液A和30g溶液B，搅拌混合，得到纺丝液；将纺丝液通过静电纺丝得到初生态纤维，将初生态纤维进行假捻、交联、烘干，得到可降解抗菌缝合线。
取375g六氟异丙醇和35g三氟乙酸混合均匀，得到溶液A；取45g新鲜仙人掌，将表面的刺带皮削去，得到无刺仙人掌，将无刺仙人掌切碎后置入75g去离子水中，蒸煮1h，过滤去除滤渣，得到溶液B；取75g新鲜猪皮，刮去猪毛和皮下油脂后置入150g40%1mol/L的碳酸钠溶液中，20min后将猪皮取出，用100g40℃去离子水冲洗4次，得到预处理猪皮；取120g冰醋酸、60g氢氧化钠和1500g去离子水，混合均匀，得到溶液C，取15g氯化钠和150g0.1mol/L盐酸溶液混合得到溶液D；取3g蛋白酶和45g预处理猪皮并浸泡在60℃溶液C中，搅拌混合30min，得到混合液，将混合液过滤，除去滤液，得到处理猪皮，用溶液D清洗处理猪皮，然后再用100g去离子水冲去残留溶液D，得到处理后猪皮；取30g处理后猪皮和75g去离子水，混合后升温至60℃并搅拌30min，过滤，得到猪皮滤液；取15g猪皮滤液、15g壳聚糖、225g溶液A和45g溶液B，搅拌混合，得到纺丝液；将纺丝液通过静电纺丝得到初生态纤维，将初生态纤维进行假捻、交联、烘干，得到可降解抗菌缝合线。
取500g六氟异丙醇和50g三氟乙酸混合均匀，得到溶液A；取60g新鲜仙人掌，将表面的刺带皮削去，得到无刺仙人掌，将无刺仙人掌切碎后置入100g去离子水中，蒸煮1h，过滤去除滤渣，得到溶液B；取100g新鲜猪皮，刮去猪毛和皮下油脂后置入200g40%1mol/L的碳酸钠溶液中，20min后将猪皮取出，用100g40℃去离子水冲洗5次，得到预处理猪皮；取160g冰醋酸、80g氢氧化钠和2000g去离子水，混合均匀，得到溶液C，取20g氯化钠和200g0.1mol/L盐酸溶液混合得到溶液D；取4g蛋白酶和60g预处理猪皮并浸泡在60℃溶液C中，搅拌混合30min，得到混合液，将混合液过滤，除去滤液，得到处理猪皮，用溶液D清洗处理猪皮，然后再用100g去离子水冲去残留溶液D，得到处理后猪皮；取40g处理后猪皮和100g去离子水，混合后升温至60℃并搅拌30min，过滤，得到猪皮滤液；取20g猪皮滤液、20g壳聚糖、300g溶液A和60g溶液B，搅拌混合，得到纺丝液；将纺丝液通过静电纺丝得到初生态纤维，将初生态纤维进行假捻、交联、烘干，得到可降解抗菌缝合线。
将实例与现有缝合线进行检测，具体检测如下：
将实例缝合线和现有缝合线对革兰氏阴性大肠杆菌和革兰氏阳性金黄色葡萄球菌进行抗菌性能测试，其中单纯的细菌作为阴性对照组，84液加入至细菌中为阳性对照组。操作程序：先对材料和培养基进行灭菌，然后对试样接种，接种后立即洗脱，然后培养，再洗脱，测定菌落数，最后进行结果计算。
测定缝合线材料表面对人体血红蛋白的溶血率，其中生理盐水为阴性对照组，超纯水为阳性对照组。
具体检测结果如表1。
表1
由表1可知，本发明制备的可降解抗菌缝合线在除菌方面拥有良好的性能，且与人体相容性好，优于市场产品。
Claims (8)
1.一种可降解抗菌缝合线的制备方法，其特征在于，具体制作步骤为：
（1）取六氟异丙醇和三氟乙酸混合均匀，得到溶液A；
（2）取新鲜仙人掌，将表面的刺带皮削去，得到无刺仙人掌，将无刺仙人掌切碎后置入去离子水中，蒸煮1h，过滤去除滤渣，得到溶液B；
（3）取新鲜猪皮，刮去猪毛和皮下油脂后置入40℃1mol/L碳酸钠溶液中，20min后将猪皮取出，用100g40℃去离子水冲洗3~5次，得到预处理猪皮；
（4）取冰醋酸、氢氧化钠和去离子水，混合均匀，得到溶液C，取氯化钠和0.1mol/L盐酸溶液混合得到溶液D；
（5）取蛋白酶和预处理猪皮并浸泡在60℃溶液C中，搅拌混合30min，得到混合液，将混合液过滤，除去滤液，得到处理猪皮，用溶液D清洗处理猪皮，然后再用100g去离子水冲去残留溶液D，得到处理后猪皮；
（6）取处理后猪皮和去离子水，混合后升温至60℃并搅拌30min，过滤，得到猪皮滤液；
（7）取猪皮滤液、壳聚糖、溶液A和溶液B，搅拌混合，得到纺丝液；
（8）将纺丝液通过静电纺丝得到初生态纤维，将初生态纤维进行假捻、交联、烘干，得到可降解抗菌缝合线。
2.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（1）所述六氟异丙醇和三氟乙酸的质量比为10:1。
3.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（2）所述新鲜仙人掌和去离子水的质量比为3:5。
4.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（3）所述新鲜猪皮和1mol/L碳酸钠溶液的质量比为1:2。
5.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（4）所述冰醋酸、氢氧化钠、去离子水、氯化钠和0.1mol/L盐酸溶液的质量比为8:4:100:1:10。
6.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（6）所述蛋白酶和预处理猪皮的质量比为1:15。
7.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（6）所述处理后猪皮与去离子水的质量比为2:5。
8.如权利要求1所述的一种可降解抗菌缝合线的制备方法，其特征在于，步骤（7）所述猪皮滤液、壳聚糖、溶液A和溶液B的质量比为1:1:15:3。
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