CN111298205A - 一种载药复合疝气补片 - Google Patents

一种载药复合疝气补片 Download PDF

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CN111298205A
CN111298205A CN202010243191.XA CN202010243191A CN111298205A CN 111298205 A CN111298205 A CN 111298205A CN 202010243191 A CN202010243191 A CN 202010243191A CN 111298205 A CN111298205 A CN 111298205A
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马学所
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Hangzhou Aiduo Biotechnology Co ltd
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Abstract

本发明公开了一种载药复合疝气补片及其制备方法，所述复合疝气补片包括聚乳酸/聚丙烯皮芯结构纤维基片和载药缓释层，两者通过热压结合在一起。本发明还提供了复合疝气补片的制备方法，包括以下步骤：1)制备掺杂显影剂的聚丙烯；2)聚乳酸/聚丙烯皮芯结构纤维并编织得到基片；3)制取抗菌药物、止血药物和麻醉药物的载药微球；4)通过静电纺丝制取载药缓释层；5)热压制取成品。本发明的载药复合疝气补片避免了聚丙烯材料与组织直接接触产生的粘连问题，同时载药缓释层根据需要可以增加不同的药物，促进手术愈合，聚乳酸材质可以在体内缓慢降解吸收，在愈合后降低补片的不适感。

Description

一种载药复合疝气补片
技术领域：
本发明涉及生物医用材料领域，具体涉及一种载药复合疝气补片及其制备方法。
背景技术
疝气是指支撑内脏器官的腹膜在某个位置由于外科损伤或者病化引起的断裂或者弱化，使的腹内内脏器官通过该断裂或弱化部位向体外突出，形成局部肿块。疝气一般发生在腹股沟，腰和肚脐等位置，可分为腹股沟疝、股疝、脐疝、切疝、腰疝等，疝气一般不能自愈，严重时影响患者的行走与正常活动，对人体健康和生命构成了严重的威胁，如不及时治疗，可导致肠管缺血坏死并危及生命。
目前治疗疝气的理想方法是疝补片修补术，即选用补片材料覆盖破损部位来修补疝环口，其术后复发率低、手术时间短且伤口愈合快。20世纪80年代美国外科医生首先提出并采用了无张力疝气修补手术来治疗疝气，发展至今，无张力疝气修补手术已经取得了广泛的临床治疗验证，被认为是最安全有效的治疗方法。
目前，临床中广泛使用的无张力补片材料主要为聚酯类、聚丙烯类、膨化聚四氟乙烯类以及其他生物修复材料。其中，聚丙烯经编织物是目前应用最广、最为成熟补片材料，聚丙烯修补网具备柔韧性好、化学性质稳定、价格相对便宜等优点。
然而，目前疝网产品仍然存在一些问题，需要进一步改进。在疝修补手术过程以及术后一段时间内，我们需要补片具备一定的刚性和挺度，来维持腹膜形状并隔离器官，聚丙烯补片可以很好的实现这种效果。然而随着缺口逐步愈合，聚丙烯良好的稳定性使的它在体内继续维持较高的挺度，这会导致患者较为严重的异物感或疼痛感，因此我们希望疝补片的刚性和强度可以在预期的时间内缓慢降低。
为了解决这些问题，公开号为US4652264和US6162962的美国专利公开了部分可降解疝网的制备研究，采用可降解材料和聚丙烯材料复合编织来实现疝网的物理性能，同时确保后期可降解部分被人体吸收后剩余材料的柔韧性。公开号为CN1950036A和CN104947305A的专利公开了可降解材料和不可降解材料共混纺丝或混合编织的技术，前者实现的裂片结构在技术上存在较大难度，后者提供了一种混合编织方法，可降解单丝和不可降解单丝通过编织结合形成疝网，但是这种编织方法无法确保可降解单丝降解的一致性或均匀性，可能会导致单丝剥落或局部降解，并导致其他问题。其他疝气补片所遵循的思路大都类似，利用可降解聚合物形成的丝、片、膜等来提高手术时的挺度和生物相容性，并在体内降解或吸收后降低补片强度以减少异物感。
同时，由于各种原因，疝气修补手术会在术后出现炎症、出血，并伴随疼痛感，严重可能导致其他术后问题，可降解材料包覆的药物缓释微球根据手术情况，可以很好地解决这个问题。
综上所述，虽然目前疝网补片已经被认为是治疗疝气最安全有效的办法，但是同样存在着很多问题，比如术后异物感较强，局部出血、炎症等。现有的专利或补片产品已经在尝试更多的材料选择、结构设计或者增加药物功能。可降解材料通过选择不同的分子量可以控制体内降解周期，通过控制与不可降解材料的比例可以控制部分降解后补片的柔韧性，从而降低术后异物感，乳酸基聚合物载药微球，通过各种方式结合在补片上，可以在术后愈合的较长时间内，有效解决术后出血、炎症等问题。
发明内容
本发明所要解决的技术问题是提供一种载药复合疝气补片及其制备方法，使疝气补片在植入人体后一定时间内维持较高的力学性能，并在可控的降解周期内，逐步降解被人体吸收，降低刚性和挺度，降低患者的异物感并减少发生其他病症的可能。
本发明为解决上述技术问题而采用的技术方案是提供一种载药复合疝气补片，包括聚乳酸/聚丙烯皮芯结构纤维基片和载药缓释层，其中，基片由以聚乳酸为皮层，聚丙烯为芯层的纤维编织而成，载药缓释层由可降解聚合物和载药微球通过静电纺丝设备制得。
上述聚乳酸/聚丙烯皮芯结构，聚乳酸为皮层，聚丙烯为芯层，其中皮层和芯层的质量比为1:0.5～2，所述聚乳酸的分子量为10000～200000，聚丙烯芯层中掺杂有显影剂。
具体的，所述显影剂为硫酸钡、碘克酸、泛影酸中的一种。
载药缓释层中的可降解聚合物为聚乳酸、聚己内酯、壳聚糖中的一种；药物缓释微球为乳酸基聚合物载药微球；所述载药微球中包覆的药物包括抗菌药物、止血药物和麻醉药物中的一种或多种。
一种载药复合疝气补片的制备方法，包含以下步骤：
1)采用常规办法制备显影剂掺杂比例为0.05～0.5％的聚丙烯材料；
2)将聚乳酸和掺杂有显影剂的聚丙烯干燥后按配比通过皮芯复合喷丝组件进行纺丝，经进一步络纱、整经、编织后得到聚乳酸/聚丙烯皮芯结构纤维基片；
3)选取PLGA为包封材料，采用复乳-液中干燥法分别制取抗菌药物、止血药物和麻醉药物的载药微球；
4)将可降解聚合物、载药微球溶解在有机溶剂中，搅拌至混合均匀得到静电纺丝溶液；
5)将步骤3)得到的纺丝溶液加入静电纺丝设备中，设置纺丝参数，纺丝，得到载药缓释层；
6)将步骤1)所得聚乳酸/聚丙烯皮芯结构纤维基片和步骤4)所得载药缓释层贴合覆盖，热压状态下干燥，即得到载药复合疝气补片。
本发明对比现有技术有如下有益效果：本发明技术方案提供的载药复合疝气补片，采用可降解聚乳酸皮层和不可降解芯层聚丙烯为原料的皮芯结构纤维编织成的基片，皮芯结构纤维截面稳定均匀，皮层聚乳酸降解周期可以通过分子量控制，降解后的柔韧性可以通过皮芯结构质量比来控制，这种结构降解时更加均匀可控，可以满足不同手术情况的要求，提供更好的术后舒适感；聚乳酸皮层或部分降解后的残留/结合层具备良好的生物相容性，可以有效避免脏器粘连；载药层采用预先制备的乳酸基载药微球，再通过低分子量的可降解聚合物静电纺丝工艺进一步包覆，调整载药微球的种类和比例，即可获得不同功能倾向的疝气补片。本发明的可降解/不可降解皮芯结构基片生产工艺更为成熟、简单，静电纺丝载药层由于采用预先制备的不同的载药微球，使的药物含量、药物缓释时间更加精确可控，采用热压工艺结合，也进一步简化了生产工艺。
具体实施方式
下面对本发明的优选实施例进行详细阐述，以使本发明的优点和特征能更易于被本领域技术人员理解，从而对本发明的保护范围做出更为清楚明确的界定。
实施例1
一种载药复合疝气补片，它包括聚乳酸/聚丙烯皮芯结构纤维基片和载药缓释层，经热压结合制得，厚度0.2mm～3.5mm，具体制备方法如下：
步骤一：采用医用级聚丙烯原料加入0.1w％的显影剂，适当加入其它加工助剂后造粒，烘干备用；聚乳酸原料在105℃下烘干2h备用，选用聚乳酸分子量为50000-200000；
步骤二：以上述掺显影剂的聚丙烯为芯层，聚乳酸为皮层，通过复合纺丝箱体以复合喷丝组件进行纺丝，获得直径为0.1～0.25mm的纤维，经进一步络纱、整经、编织后得到聚乳酸/聚丙烯皮芯结构纤维基片；
步骤三：选取PLGA为包封材料，采用复乳-液中干燥法分别制取抗菌药物、止血药物和麻醉药物的载药微球，所述抗菌药物
步骤四：将可降解聚合物、载药微球溶解在有机溶剂中，搅拌至混合均匀得到6-15wt％静电纺丝溶液；其中所述可降解聚合物材料为聚乳酸，分子量5000-50000；载药微球包含一种或多种；有机溶剂是二氯甲烷、氯仿、N,N-二甲基甲酰胺中的一种或多种；
步骤五：将上述纺丝溶液加入静电纺丝设备中，设置纺丝参数，纺丝，其中纺丝电压为10-20kV，接收距离10-20cm，进样速度为0.5-2.0ml/h，最后在真空干燥箱中除去残留的溶剂，即得到载药缓释层；
步骤六：将所得聚乳酸/聚丙烯皮芯结构纤维基片和载药缓释层贴合覆盖，于热压机上110℃压10s，即得到载药复合疝气补片。该补片各层之间结合良好，裁剪不分层，在水溶液中浸泡不分层。
本发明提供的一种载药复合疝气补片的制备方法简单、成本低、重复性强，适于大规模量产，且本发明制备的载药复合疝气补片生物相容性好，可生物降解，且降解更均匀可控；亲水性好，适合组织生长；药物缓释层可以有效抑制术后出血、炎症等状况。
以上所述仅为本发明的较佳实施例，对本发明而言仅仅是说明性的，而非限制性的。本专业技术人员理解，在本发明权利要求所限定的精神和范围内可对其进行许多改变，修改，甚至等效，但都将落入本发明的保护范围内。

Claims (6)

1.一种载药复合疝气补片，其特征在于，包括聚乳酸/聚丙烯皮芯结构纤维基片和载药缓释层，其中，基片由以聚乳酸为皮层，聚丙烯为芯层的纤维编织而成，载药缓释层由可降解聚合物和载药微球通过静电纺丝设备制得。
2.根据权利要求1所述的一种载药复合疝气补片，其特征在于，所述聚乳酸/聚丙烯皮芯结构，聚乳酸为皮层，聚丙烯为芯层，其中皮层和芯层的质量比为1:0.5～2，所述聚乳酸的分子量为50000～200000。
3.根据权利要求1所述的一种载药复合疝气补片，其特征在于，所述皮芯结构中，聚丙烯芯层中掺杂有显影剂。
4.根据权利要求1所述的一种载药复合疝气补片，其特征在于，所述可降解聚合物为聚乳酸、聚己内酯、壳聚糖中的一种；所述药物缓释微球为乳酸基聚合物载药微球；所述载药微球中包覆的药物包括抗菌药物、止血药物和麻醉药物中的一种或多种。
5.根据权利要求1所述的一种载药复合疝气补片的制备方法，其特征在于，包含以下步骤：
1)采用常规办法制备显影剂掺杂比例为0.05～0.5％的聚丙烯材料；
2)将聚乳酸和掺杂有显影剂的聚丙烯干燥后按配比通过皮芯复合喷丝组件进行纺丝，经进一步络纱、整经、编织后得到聚乳酸/聚丙烯皮芯结构纤维基片；
3)选取PLGA为包封材料，采用复乳-液中干燥法分别制取抗菌药物、止血药物和麻醉药物的载药微球；
4)将可降解聚合物、载药微球溶解在有机溶剂中，搅拌至混合均匀得到静电纺丝溶液；
5)将步骤3)得到的纺丝溶液加入静电纺丝设备中，设置纺丝参数，纺丝，得到载药缓释层；
6)将步骤1)所得聚乳酸/聚丙烯皮芯结构纤维基片和步骤4)所得载药缓释层贴合覆盖，热压状态下干燥，即得到载药复合疝气补片。
6.根据权利要求5所述的一种载药复合疝气补片的制备方法，其特征在于，步骤1)所述显影剂为硫酸钡、碘克酸、泛影酸中的一种。
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111979599A (zh) * 2020-08-06 2020-11-24 南通大学 一种含钡可显影功能聚丙烯纤维的制备方法
CN112891638A (zh) * 2021-01-18 2021-06-04 河南农业大学 一种具有抗菌作用的疝气补片的制备方法
CN114377215A (zh) * 2020-10-16 2022-04-22 生物岛实验室 界面修饰的疝气片及其制备方法

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111979599A (zh) * 2020-08-06 2020-11-24 南通大学 一种含钡可显影功能聚丙烯纤维的制备方法
WO2022027927A1 (zh) * 2020-08-06 2022-02-10 南通大学 一种含钡可显影功能聚丙烯纤维的制备方法
CN114377215A (zh) * 2020-10-16 2022-04-22 生物岛实验室 界面修饰的疝气片及其制备方法
CN112891638A (zh) * 2021-01-18 2021-06-04 河南农业大学 一种具有抗菌作用的疝气补片的制备方法

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