CN109130403A - 一种海藻酸盐粘合的复合型防粘连补片及其制备方法 - Google Patents

一种海藻酸盐粘合的复合型防粘连补片及其制备方法 Download PDF

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CN109130403A
CN109130403A CN201810953796.0A CN201810953796A CN109130403A CN 109130403 A CN109130403 A CN 109130403A CN 201810953796 A CN201810953796 A CN 201810953796A CN 109130403 A CN109130403 A CN 109130403A
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sticking patch
alginate
prevents adhesion
compound sticking
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王璐
毛迎
乔燕莎
赵新哲
王富军
李彦
高晶
陈南梁
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Donghua University
National Dong Hwa University
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Abstract

本发明公开了一种海藻酸盐粘合的复合型防粘连补片及其制备方法。所述复合型防粘连补片包括支撑层、粘合层及防粘连层，所述支撑层为聚丙烯网片，粘合层的材质为海藻酸钠，防粘连层为纳米纤维膜。制备方法为：将聚己内酯和聚丙交酯乙交酯混合，溶于溶剂，得到聚己内酯/聚丙交酯乙交酯的混合溶液，将混合溶液进行静电纺丝，得到纳米纤维膜；将海藻酸钠溶液涂于聚丙烯网片的一面，并将纳米纤维膜直接覆盖在该面上，得到复合型补片；将复合型补片浸泡于氯化钙溶液中取出，即得海藻酸盐粘合的复合型防粘连补片。本发明所制备的复合型防粘连补片结构可控、轻质柔软，纳米纤维膜替代传统防粘屏障，提升了材料的通透性，延长其防粘连时间，降低异物反应。

Description

一种海藻酸盐粘合的复合型防粘连补片及其制备方法
技术领域
本发明涉及一种海藻酸盐粘合双组份纳米纤维膜与PP网片复合型防粘连补片及其制备方法，属于生物医用纺织材料领域。
背景技术
疝气是指任何脏器或组织离开了原来的部位，通过人体正常的及不正常的薄弱点或缺陷、孔隙进入另一部位。据统计，疝气已成为了普外科多发病，其在全球范围内的发病率为3％～5％，高于任何一种恶性肿瘤。目前临床上治疗疝气的主要方式为植入能够加强或替代薄弱受损筋膜组织的补片。随着腹腔镜腹膜内置网修补法(IPOM)技术的推广，补片放置位置由原腹膜外改为腹腔内。由于植入腹腔内进行修复的补片直接与腹腔内脏器接触，所以，用于IPOM修补的补片必须具备防粘连功能。
目前，防粘连补片商品主要为聚丙烯(PP)复合补片，由防粘层和PP基材构成，防粘连部分通过缝纫技术、编织技术或涂层技术实现与聚丙烯基材的结合。不可吸收补片的防粘层通常以膨化聚四氟乙烯浓缩聚四氟乙烯和聚偏二氟乙烯(IPOM)等永久性材料为主，该类补片的质量大(≥80g/m2)，病患术后异物反应强烈，因而可实现远期轻量化的部分可吸收补片是发展趋势。部分可吸收补片的防粘连层以多组分水凝胶(Biosurgical Composite)、氧化再生纤维素膜(Surgical mesh)和氧化胶原涂层(Composite)等可吸收材料为主。可吸收防粘连材料的结构多为结构致密的无孔膜或凝胶结构，通透性差且柔韧性不佳，不仅抑制了病损区域的组织正常愈合，还影响了补片的顺应性。同时，由于降解过程短，中远期再次粘连的可能性大。因此若选用可吸收合成聚合物为防粘连层材料，采用静电纺丝技术，有望得到一种兼具优异的通透性和长期防粘连性的复合补片。
现有关于静电纺丝复合补片的专利有：1、聚丙烯/聚偏氟乙烯复合型疝气补片，是利用静电纺丝技术将聚偏氟乙烯溶液喷于等离子体改性后的聚丙烯编织层上形成复合型补片，但是一方面纤维膜是不可吸收材料，异物反应引起的炎症反应较大，另一方面纤维膜与编织层没有粘合剂粘合，容易分离；2、功能性补片(公开号CN106581786A)，是将附有载药颗粒的纤维膜经热融合与不可降解高分子网片复合得到功能性补片，但是热融合温度较高(100-200℃)，不适用于功能层为低熔点的高分子材料，如聚己内酯；3、静电纺覆膜型复合盆底补片(公开号CN105708581A)，是将静电纺纳米纤维粘合于涂有粘合剂(质量百分浓度8％的氟橡胶-丙酮溶液)的聚丙烯补片的一侧形成复合补片，但是粘合剂的生物相容性和安全性不佳。因此，进一步设计优化纳米纤维膜复合PP网片的防粘连补片具有重要的意义。
发明内容
本发明所要解决的技术问题是：提供一种海藻酸盐粘合双组份纳米纤维膜与PP网片的复合型防粘连补片及其制备方法，该复合型防粘连补片轻质柔软，既具有长期的防粘连功能，又能确保纳米纤维膜防粘层与PP网片牢固结合。
为了解决上述问题，本发明提供了一种海藻酸盐粘合的复合型防粘连补片，其特征在于，包括依次复合的支撑层、粘合层及防粘连层，所述支撑层为聚丙烯网片，粘合层的材质为海藻酸钠，防粘连层为纳米纤维膜，纳米纤维膜采用聚己内酯与聚丙交酯乙交酯的共混膜。
优选地，所述纳米纤维膜中聚己内酯与聚丙交酯乙交酯的重量比为3:7～7:3。
优选地，所述纳米纤维膜的孔隙率为80～95％，孔径为2～5μm。
优选地，所述聚丙烯网片的孔径为2～5mm，克重小于25g/m2。
优选地，所述复合型防粘连补片的克重小于35g/m2，顶破强力大于100N。
本发明还提供了一种上述海藻酸盐粘合的复合型防粘连补片的制备方法，其特征在于，包括以下步骤：
步骤1)：将聚己内酯和聚丙交酯乙交酯混合，溶于溶剂，然后匀速搅拌，得到聚己内酯/聚丙交酯乙交酯的混合溶液，将混合溶液作为纺丝液进行静电纺丝，得到纳米纤维膜；
步骤2)：配制海藻酸钠溶液作为粘合剂，氯化钙溶液作为交联剂；
步骤3)：采用喷涂的方式将步骤2)所得的粘合剂涂于聚丙烯网片的一面，并将步骤1)所得的纳米纤维膜直接覆盖在该面上，得到海藻酸盐粘合的复合型补片；
步骤4)：将步骤3)所得的复合型补片浸泡于氯化钙溶液中3-10分钟后取出，清洗，干燥，抽真空包装后，消毒灭菌，即得海藻酸盐粘合的复合型防粘连补片。
优选地，所述步骤1)中聚己内酯的重均分子量为6-10万，聚丙交酯乙交酯的重均分子量为8-15万；溶剂采用二氯甲烷(DCM)和二甲基甲酰胺(DMF)以体积比为8:2～6:4的比例混合的混合溶液；聚己内酯和聚丙交酯乙交酯在溶剂中的总质量浓度为10～20％；得到的纳米纤维膜制备完成后置于真空烘箱中真空干燥去除残留溶剂。
优选地，所述步骤1)中静电纺丝的工艺参数为：纺丝环境的温度为20～30℃，相对湿度为20～50％，施加的电压为10～20kV，灌注速度为0.5～1.5mL/h，接收距离为10～20cm。
优选地，所述步骤2)中海藻酸钠溶液的质量浓度为2～4％，氯化钙溶液的质量浓度为1～10％。
优选地，所述步骤3)中为了保证聚丙烯网片与纳米纤维膜紧密贴合，两者贴合后，采用玻璃板以15-35N/m2的压力平压1-5分钟，静置固化。
与现有技术相比，本发明的有益效果在于：
本发明的方法用海藻酸钠粘合双组份纳米纤维膜与PP网片，固化后进一步进行钙离子交联，大大增加了双组份纳米纤维膜与PP网片的牢固性。
本发明所制备的海藻酸盐粘合双组份纳米纤维膜与PP网片的复合型防粘连补片结构可控、轻质柔软，双组分纳米纤维防粘层替代传统防粘屏障，提升了材料的通透性，延长其防粘连时间，降低异物反应。
附图说明
图1为本发明提供的复合型防粘连补片的结构示意图；
图2为聚丙烯网片的示意图；
图3为纳米纤维膜的示意图；
图4为聚丙烯网片与纳米纤维膜的粘合机理的示意图。
具体实施方式
为使本发明更明显易懂，兹以优选实施例，并配合附图作详细说明如下。
实施例1
一种海藻酸盐粘合的复合型防粘连补片的制备方法：
1.已定型的聚丙烯网片由常州市润源医疗用品科技有限公司定制提供，即由聚丙烯单丝编织的大孔轻质不可吸收材料，洗净晾干后备用。
2.静电纺丝溶液的配置
分别称取0.8g的聚己内酯颗粒和聚丙交酯已交酯颗粒放入带密封盖的罗口玻璃瓶中，将DMC和DMF溶液以体积比7:3混合均匀，抽取10mL的混合溶液注入玻璃瓶中。加入磁力转子，密封后匀速搅拌12h，获得清澈透明的纺丝液。
3.静电纺丝纳米纤维膜的制备
用10mL的注射器吸取6mL纺丝液，放置在推进器上。接收装置为接地线铝箔。分别打开推进器，高压电源的电压，设置电压15kV，灌注速度1mL/h，调节接收距离15cm。开启电压，纺丝液在高压电场的作用下均匀的收集于铝箔上，收集时间为1h。结束后，关闭电源，取下负载纳米纤维膜的铝箔纸，40℃下真空干燥24h，以便溶剂挥发完全。
为了使静电纺纳米纤维膜与PP网片牢固地结合，采用海藻酸钠溶液作为粘合剂，氯化钙溶液作为离子交联剂。称取3g的海藻酸钠粉末加入盛有97mL去离子水的烧杯中，加入转子，磁力搅拌12小时，获得均匀透明的海藻酸钠溶液；称取5g的氯化钙颗粒加入盛有95mL去离子水的烧杯中，用玻璃棒搅拌至溶液均匀澄清。
4.海藻酸钙粘合的复合型防粘连补片
将海藻酸钠溶液喷涂于聚丙烯网片的一侧，并将纳米纤维膜平整地覆盖其上，为了保证两者紧密贴合，用玻璃板以25N/m2的压力平压1min，得到海藻酸钠粘合的复合补片，并将其浸泡在氯化钙水溶液中，5min后取出。清洗，干燥，抽真空包装后，消毒灭菌，即得海藻酸钙粘合的复合型防粘连补片。
表1实施例1中纳米纤维膜的结构参数
纤维直径/nm 纤维膜孔径/μm 厚度/μm 克重/(g·m<sup>2</sup>)
539±114 4.0±0.8 22.6±1.2 3.87±0.14
表2实施例1制得的的复合型防粘连补片的结构参数与力学性能
厚度/mm 克重/(g·m<sup>2</sup>) 顶破强力/(N) 粘合力/(N/mm)
0.446±0.010 26.76±0.08 131±5 1.5±0.3
实施例2
一种海藻酸盐粘合的复合型防粘连补片的制备方法：
1.定型的聚丙烯网片由常州市润源医疗用品科技有限公司定制提供。即由聚丙烯单丝编织的大孔轻质不可吸收材料，洗净晾干后备用。
2.静电纺丝溶液的配置
分别称取0.8g的聚己内酯颗粒和聚丙交酯已交酯颗粒放入带密封盖的罗口玻璃瓶中，将DMC和DMF溶液以体积比7:3混合均匀，抽取10mL的混合溶液注入玻璃瓶中。加入磁力转子，密封后匀速搅拌12小时，获得清澈透明的纺丝液。
3.静电纺丝纳米纤维膜的制备
用10mL的注射器吸取3mL纺丝液，放置在推进器上。接收装置为接地线铝箔。分别打开推进器，高压电源的电压，设置电压15kV，灌注速度1mL/h，调节接收距离15cm。开启电压，纺丝液在高压电场的作用下均匀的收集于铝箔上，收集时间为3h。结束后，关闭电源，取下负载纳米纤维膜的铝箔纸，40℃下真空干燥24h，以便溶剂挥发完全。
为了使静电纺纳米纤维膜与PP网片牢固地结合，采用海藻酸钠溶液作为粘合剂，氯化钙溶液作为离子交联剂。称取4g的海藻酸钠粉末加入盛有96mL去离子水的烧杯中，加入转子，磁力搅拌12h，获得均匀透明的海藻酸钠溶液；称取5g的氯化钙颗粒加入盛有95mL去离子水的烧杯中，用玻璃棒搅拌至溶液均匀澄清。
4.海藻酸钙粘合的复合型防粘连补片
将海藻酸钠溶液喷涂于聚丙烯网片的一侧，并将纳米纤维膜平整地覆盖其上，为了保证两者紧密贴合，用玻璃板以25N/m2的压力平压1min，得到海藻酸钠粘合的复合补片，并将其浸泡在氯化钙水溶液中，5min后取出，清洗，干燥，抽真空包装后，消毒灭菌，即得海藻酸钙粘合的复合型防粘连补片。
表3实施例2中纳米纤维膜的结构参数
纤维直径/nm 纤维膜孔径/μm 厚度/μm 克重/(g·m<sup>2</sup>)
680±147 3.3±0.5 68.6±2.1 9.62±0.05
表4实施例2制得的复合型防粘连补片的结构参数与力学性能
厚度/μm 克重/(g·m<sup>2</sup>) 顶破强力/(N) 粘合力/(N/mm)
0.468±0.012 31.34±0.12 134±2 2.3±0.2
实施例1、2制得的复合型防粘连补片如图1-3所示，包括依次复合的支撑层1、粘合层2及防粘连层3，粘合机理如图4所示。

Claims (10)

1.一种海藻酸盐粘合的复合型防粘连补片，其特征在于，包括依次复合的支撑层(1)、粘合层(2)及防粘连层(3)，所述支撑层(1)为聚丙烯网片，粘合层(2)的材质为海藻酸钠，防粘连层(3)为纳米纤维膜，纳米纤维膜采用聚己内酯与聚丙交酯乙交酯的共混膜。
2.如权利要求1所述的海藻酸盐粘合的复合型防粘连补片，其特征在于，所述纳米纤维膜中聚己内酯与聚丙交酯乙交酯的重量比为3:7～7:3。
3.如权利要求1所述的海藻酸盐粘合的复合型防粘连补片，其特征在于，所述纳米纤维膜的孔隙率为80～95％，孔径为2～5μm。
4.如权利要求1所述的海藻酸盐粘合的复合型防粘连补片，其特征在于，所述聚丙烯网片的孔径为2～5mm，克重小于25g/m2。
5.如权利要求1所述的海藻酸盐粘合的复合型防粘连补片，其特征在于，所述复合型防粘连补片的克重小于35g/m2，顶破强力大于100N。
6.一种权利要求1-5任意一项所述的海藻酸盐粘合的复合型防粘连补片的制备方法，其特征在于，包括以下步骤：
步骤1)：将聚己内酯和聚丙交酯乙交酯混合，溶于溶剂，然后匀速搅拌，得到聚己内酯/聚丙交酯乙交酯的混合溶液，将混合溶液作为纺丝液进行静电纺丝，得到纳米纤维膜；
步骤2)：配制海藻酸钠溶液作为粘合剂，氯化钙溶液作为交联剂；
步骤3)：采用喷涂的方式将步骤2)所得的粘合剂涂于聚丙烯网片的一面，并将步骤1)所得的纳米纤维膜直接覆盖在该面上，得到海藻酸盐粘合的复合型补片；
步骤4)：将步骤3)所得的复合型补片浸泡于氯化钙溶液中3-10分钟后取出，清洗，干燥，抽真空包装后，消毒灭菌，即得海藻酸盐粘合的复合型防粘连补片。
7.如权利要求6所述的海藻酸盐粘合的复合型防粘连补片的制备方法，其特征在于，所述步骤1)中聚己内酯的重均分子量为6-10万，聚丙交酯乙交酯的重均分子量为8-15万；溶剂采用二氯甲烷和二甲基甲酰胺以体积比为8:2～6:4的比例混合的混合溶液；聚己内酯和聚丙交酯乙交酯在溶剂中的总质量浓度为10～20％；得到的纳米纤维膜制备完成后置于真空烘箱中真空干燥去除残留溶剂。
8.如权利要求6所述的海藻酸盐粘合的复合型防粘连补片的制备方法，其特征在于，所述步骤1)中静电纺丝的工艺参数为：纺丝环境的温度为20～30℃，相对湿度为20～50％，施加的电压为10～20kV，灌注速度为0.5～1.5mL/h，接收距离为10～20cm。
9.如权利要求6所述的海藻酸盐粘合的复合型防粘连补片的制备方法，其特征在于，所述步骤2)中海藻酸钠溶液的质量浓度为2～4％，氯化钙溶液的质量浓度为1～10％。
10.如权利要求6所述的海藻酸盐粘合的复合型防粘连补片的制备方法，其特征在于，所述步骤3)中为了保证聚丙烯网片与纳米纤维膜紧密贴合，两者贴合后，采用玻璃板以15-35N/m2的压力平压1-5分钟，静置固化。
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