CN114558163B - 一种负载中药微球纳米纤维敷料的制备方法和应用 - Google Patents

一种负载中药微球纳米纤维敷料的制备方法和应用 Download PDF

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CN114558163B
CN114558163B CN202210216658.0A CN202210216658A CN114558163B CN 114558163 B CN114558163 B CN 114558163B CN 202210216658 A CN202210216658 A CN 202210216658A CN 114558163 B CN114558163 B CN 114558163B
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CN114558163A (zh
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周武艺
万美玲
曹庆云
付先军
童荣标
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Guangdong Yun Zhao Medical Technology Co ltd
South China Agricultural University
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South China Agricultural University
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Abstract

本发明公开了一种负载中药微球纳米纤维敷料的制备方法，所得纳米纤维敷料由聚合物为载体和中药微球颗粒通过静电纺丝的双喷头技术电纺制备而成。本发明所得纳米纤维敷料具有多孔纳米结构，与中药微球颗粒形成双重药物缓释效应，且具有良好的透气性、生物相容性优点，其纳米尺寸的孔径能够促进细胞的增殖和伤口的愈合。

Description

一种负载中药微球纳米纤维敷料的制备方法和应用
技术领域
本发明属于生物医用材料技术领域，具体涉及一种负载中药微球纳米纤维敷料的制备方法和应用，所得纳米纤维敷料适用于创伤、烧伤、急性或慢性损伤等伤口，吸收分泌物的同时还可减少创面感染、促进细胞的增殖和伤口的愈合。
背景技术
皮肤是人体最大的器官和第一道生理防线，对保障人体正常的生理活动起着极其重要的作用。在日常生活中，人们会因创伤、烧伤、急性或慢性损伤等造成皮肤破损而形成伤口，随着对创面愈合过程病理生理的深入研究，人们对创面愈合过程的理解也越来越深刻，促进了医用创面敷料的不断改进与发展。医用敷料是用以覆盖疮、伤口或其他损害的医用材料，其中的纳米纤维敷料具有高吸湿性、高通透性，载药纳米纤维敷料更是可定点、长效给药，具有有效的抑菌性能，安全无毒，能促进伤口愈合和减少局部疼痛。
石决明和海螵蛸广泛存在于海洋生物的硬质壳中，有研究表明，二者具有清热、镇静、降血压、抗感染、收湿敛疮、止血消疹，促进骨缺损修复等作用。基于石决明和海螵蛸的生理功能，在医用敷料中具有巨大的潜在应用价值。目前，石决明和海螵蛸大多用于煎汤内服，用于清热明目和除湿气。如何提高石决明和海螵蛸在其它领域如医用材料领域的有效应用，增加海洋生物壳的回收利用成为国内外专家的研究焦点之一。
发明内容
为改善中药在纳米纤维膜中的控释效应，本发明提供了一种负载中药微球纳米纤维敷料的制备方法。
为解决上述技术问题，本发明通过以下技术方案实现：
一种负载中药微球纳米纤维敷料的制备方法，包括以下步骤：
（1）将高分子聚合物与有机溶剂A混合制备聚合物静电纺丝前驱液；
（2）制备中药微球颗粒溶液；
（3）采用静电纺丝双喷头技术将步骤（1）和（2）制备的溶液同时进行电纺喷丝，获得负载中药微球纳米纤维敷料。
优选的，步骤（1）中的高分子聚合物为聚己内酯、聚丙烯腈、聚偏氟乙烯、聚丙烯、聚丙交酯和聚乳酸中的一种或一种以上；步骤（1）中的有机溶剂A为二氯甲烷、N, N-二甲基甲酰胺、N, N-二甲基乙酰胺、氯仿、六氟异丙醇和丙酮中的一种或一种以上；步骤（1）中聚合物静电纺丝前驱液中高分子聚合物的浓度为5-20wt%。
步骤（3）中静电纺丝的参数为：电压：8-30KV，流速：0.1-15mL/h，接收距离：4-15cm，纺丝量：5-30mL，喷射针头：18-23号，滚筒转速：10-30m/min，更优选为：电压：13KV，流速：0.7mL/h，接收距离：15cm，纺丝量：5mL，喷射针头：18号，滚筒转速：15m/min。
优选的，步骤（2）中的中药微球颗粒溶液的制备方法，包括以下步骤：
1）将中药溶解在水中，在40-60℃水浴条件下分散均匀，作为水相；
2）将聚己内酯溶解在二氯甲烷中，在常温水浴条件下分散均匀，作为油相；
3）将步骤1）所得水相缓慢加入步骤2）所得油相中，同时加入适量亲油性乳化剂，低速搅拌直至水相添加完全，然后进行中速搅拌，待水相完全被油相包住，得到油包水相，即为中药微球颗粒溶液。
步骤1）中所述中药为石决明、海螵蛸、黄连素、姜黄素、番茄素、桑螵蛸、黄芪和蒲公英中的一种或一种以上，优选石决明和海螵蛸中的至少一种。
步骤1）所述水相中中药的浓度为50-80wt%，优选60wt%；步骤2）所述油相中聚己内酯的浓度为10-30wt%，优选10wt%；步骤3）中所用油相与水相的体积比为（2-3）：1，优选7：3；所述亲油性乳化剂用量为所述水相重量的0.2-0.8倍，优选0.4倍。
步骤3）中的亲油性乳化剂是HLB值为2-7的表面活性剂，优选聚氧乙烯聚二甲基硅氧烷、硬脂酸酯、聚羟基硬脂酸葵二酸酯、脂肪酸酯、柠檬酸酯、PEG-10聚二甲基硅氧烷中的一种或一种以上，优选为脂肪酸酯。
步骤3）中的低速搅拌为30-250rpm，中速搅拌为300-1000rpm，优选低速搅拌为100rpm，中速搅拌为500rpm。
本发明与现有技术相比，具有以下有益效果：
1. 本发明方法操作简单，原材料安全无毒且廉价易得，制备耗时较少，可在短时间内获得含中药纳米微球的纳米纤维膜材料。
2. 本发明采用的两大主要中药为石决明和海螵蛸，提高了海洋生物硬质壳的再利用率，其有效成分的提取，生物相容性好，环境友好，没有添加过多的助剂、有机溶剂，对人体皮肤也无刺激性。
3. 本发明所得负载中药微球纳米纤维敷料具有一定的芳香气味，能够一定程度的遮盖伤口的血腥味和化脓产生的异味，进而缓解压力，舒缓心情，促进伤口愈合。
附图说明
为了进一步阐明本发明技术方案的优点和目的，下面将介绍实施例或现有技术描述中的相关附图。
图1为本发明制备方法的工艺流程图。
图2为中药微球颗粒（油包水）溶液。
图3为负载中药微球纳米纤维敷料的SEM图。
图4为负载中药微球的纤维膜与含中药纤维膜的药物缓释图。
具体实施方式
下面结合附图和实施例对本发明作进一步的描述，但本发明的实施例不限于此。
实施例1
一种负载中药微球纳米纤维敷料的制备方法，包括以下步骤：
（1）将聚丙烯腈与N, N-二甲基甲酰胺共混搅拌，使聚丙烯腈浓度为12wt%，制备聚合物静电纺丝前驱液；
（2）将石决明（水溶性）溶解在去离子水中（浓度为60wt%），在水浴锅40℃中搅拌2h，形成均一的溶液，作为水相；将聚己内酯溶解在二氯甲烷中（浓度为10wt%），在水浴锅常温中搅拌1h，分散均匀，作为油相；然后将水相多次缓慢加入油相中，同时加入脂肪酸酯（水相质量的0.4），并在常温下进行100rpm的低速搅拌，直至水相添加完全后，进行500rpm的中速搅拌，待水相全部被油相包住，得到中药微球颗粒溶液；
（3）采用静电纺丝双喷头技术将上述步骤（1）和（2）制备的溶液同时进行电纺喷丝，按照如下的静电纺丝参数进行电纺：电压：13KV，流速：0.7ml/h，接收距离：15cm，纺丝量：5ml，喷射针头：18号，滚筒转速：15m/min，获得含有药物控释微球的纳米纤维膜，即为负载中药微球纳米纤维敷料。
实施例2
一种负载中药微球纳米纤维敷料的制备方法，包括以下步骤：
（1）将聚乳酸与二氯甲烷共混搅拌，使聚乳酸浓度为12wt%，制备聚合物静电纺丝前驱液；
（2）将石决明（水溶性）溶解在去离子水中（浓度为60wt%），在水浴锅40℃中搅拌2h，形成均一的溶液，作为水相；将聚己内酯溶解在二氯甲烷中（浓度为10wt%），在水浴锅常温中搅拌1h，分散均匀，作为油相；然后将水相多次缓慢加入油相中，同时加入脂肪酸酯（水相质量的0.4），并在常温下进行100rpm的低速搅拌，直至水相添加完全后，进行500rpm的中速搅拌，待水相全部被油相包住，得到中药微球颗粒溶液；
（3）采用静电纺丝双喷头技术将上述步骤（1）和（2）制备的溶液同时进行电纺喷丝，按照如下的静电纺丝参数进行电纺：电压：12KV，流速：1.5ml/h，接收距离：6cm，纺丝量：5ml，喷射针头：20号，滚筒转速：17m/min，获得含有药物控释微球纳米纤维膜，即为负载中药微球纳米纤维敷料。
实施例3
一种负载中药微球纳米纤维敷料的制备方法，包括以下步骤：
（1）将聚丙烯腈与N, N-二甲基甲酰胺共混搅拌，使聚丙烯腈浓度为12wt%，制备聚合物静电纺丝前驱液；
（2）将海螵蛸（水溶性）溶解在去离子水中（浓度为60wt%），在水浴锅40℃中搅拌2h，形成均一的溶液，作为水相；将聚己内酯溶解在二氯甲烷中（浓度为10wt%），在水浴锅常温中搅拌1h，分散均匀，作为油相；然后将水相多次缓慢加入油相中，同时加入脂肪酸酯（水相质量的0.4），并在常温下进行100rpm的低速搅拌，直至水相添加完全后，进行500rpm的中速搅拌，待水相全部被油相包住，得到中药微球颗粒溶液；
（3）采用静电纺丝双喷头技术将上述步骤（1）和（2）制备的溶液同时进行电纺喷丝，按照如下的静电纺丝参数进行电纺：电压：12KV，流速：1.2ml/h，接收距离：10cm，纺丝量：5ml，喷射针头：21号，滚筒转速：18m/min，获得含有药物控释微球纳米纤维膜，即为负载中药微球纳米纤维敷料。
对比例1
一种含有中药纳米纤维敷料的制备方法，包括以下步骤：
（1）将聚丙烯腈与N, N-二甲基甲酰胺共混搅拌，聚丙烯腈浓度为12wt%，制备聚合物溶液；
（2）将石决明（水溶性，浓度为60%）逐步加入步骤（1）的聚合物溶液中，在水浴锅40℃中搅拌2h，搅拌速度为150rpm，形成均一的溶液，得到含有中药的静电纺丝前驱液；
（3）采用静电纺丝单喷头技术将上述步骤（2）制备的静电纺丝前驱液进行电纺喷丝，按照如下的静电纺丝参数进行电纺：电压：15KV，流速：2.0ml/h，接收距离：8cm，纺丝量：5ml，喷射针头：20号，滚筒转速：12m/min，获得负载中药微球纳米纤维敷料。
性能测试：采用静电纺丝技术将实施例1-3，以及对比例1中所制备的纳米复合纤维膜进行机械拉伸性能测试，参考GB 1040-2006；纳米复合纤维膜的抗菌性能和生物相容性测试分别参考GB/B 31402-2015和GB/T 16886.5-2003；生物毒性评分：无细胞毒性（0），轻微细胞毒性（1），中度细胞毒性（2），重度细胞毒性（3），上述实施方式所得样品的性能比较如表1所示。
表1 性能检测结果
Figure DEST_PATH_IMAGE001
由表1可知，本发明制备的负载中药微球纳米纤维敷料具有良好的抗菌性能和生物相容性。拉伸应力试验的实验结果表明，负载中药微球纳米纤维敷料比对比例含有中药的纤维膜具有更好的机械性能，中药微球能有效的提高纤维膜的机械性能。由图4可知，在一定时间内，负载中药微球纳米纤维敷料比对比例含有中药的纤维膜药物释放量少，具有较好的缓释作用。
上述实施案例仅仅表述了本发明几种具体的实施方案，而不是对本发明专利范围的限制，应当是，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图做出不同的改进获得其他的附图，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 (8)

1.一种负载中药微球纳米纤维敷料的制备方法，其特征在于，包括以下步骤：
（1）将高分子聚合物与有机溶剂A混合制备聚合物静电纺丝前驱液；
（2）制备中药微球颗粒溶液，包括以下步骤：
1）将中药溶解在水中，在40-60℃水浴条件下分散均匀，作为水相；
2）将聚己内酯溶解在二氯甲烷中，在常温水浴条件下分散均匀，作为油相；
3）将步骤1）所得水相缓慢加入步骤2）所得油相中，同时加入适量亲油性乳化剂，低速搅拌直至水相添加完全，然后进行中速搅拌，待水相完全被油相包住，得到油包水相，即为中药微球颗粒溶液；
（3）采用静电纺丝双喷头技术将步骤（1）和（2）制备的溶液同时进行电纺喷丝，获得负载中药微球纳米纤维敷料；
步骤1）中所述中药为石决明和海螵蛸中的一种或一种以上，步骤1）所述水相中中药的浓度为50-80wt%；
步骤3）中所用油相与水相的体积比为（2-3）：1。
2.根据权利要求1所述的制备方法，其特征在于：步骤（1）中的高分子聚合物为聚己内酯、聚丙烯腈、聚偏氟乙烯、聚丙烯、聚丙交酯和聚乳酸中的一种或一种以上，聚合物静电纺丝前驱液中高分子聚合物的浓度为5-20wt%。
3.根据权利要求1所述的制备方法，其特征在于：步骤（1）中的有机溶剂A为二氯甲烷、N, N-二甲基甲酰胺、N, N-二甲基乙酰胺、氯仿、六氟异丙醇和丙酮中的一种或一种以上。
4.根据权利要求1所述的制备方法，其特征在于：步骤（3）中静电纺丝的参数为：电压：8-30KV，流速：0.1-15mL/h，接收距离：4-15cm，纺丝量：5-30mL，喷射针头：18-23号，滚筒转速：10-30m/min。
5.根据权利要求1所述的制备方法，其特征在于：步骤2）所述油相中聚己内酯的浓度为10-30wt%。
6.根据权利要求1所述的制备方法，其特征在于：所述亲油性乳化剂用量为所述水相重量的0.2-0.8倍，亲油性乳化剂是HLB值为2-7的表面活性剂。
7.根据权利要求1所述的制备方法，其特征在于：步骤3）中的低速搅拌为30-250rpm，中速搅拌为300-1000rpm。
8.权利要求1-7任一项所述的制备方法 得到的负载中药微球纳米纤维敷料在制备创伤、烧伤、急性或慢性损伤的伤口敷料中的应用。
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