CN111729128A - 一种生物基医用辅料的制备方法 - Google Patents
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Abstract
本发明涉及医用辅料的制造方法，该方法使用聚羟基丁酸酯为原料，用氯仿作为溶剂，在一定的反应条件下制得用于预防手术粘连薄膜和人造皮肤、人工硬脑膜、可吸收手术缝合线等医用辅料。该产品与人体的组织相容性极好，不存在导致炎症反应的异物，本发明制备的薄膜等辅料生物活性好，能够促进表皮组织的生长，减少疤痕组织增生，其抗牵拉性能和柔韧性都满足医用辅料的要求。且该医用纤维的降解时间较长，可以很好的用于制造治疗难以愈合伤口的手术缝合线和医用辅料。而且该发明所使用的原料为生物基原料，它是一种安全环保的绿色原料，具有很广阔的生产前景。
Description
技术领域
本发明涉及医用辅料的制造方法，更确切地说，本发明涉及用于预防手术粘连薄膜和人造皮肤、人工硬脑膜、可吸收手术缝合线等医用辅料的制造方法。
背景技术
医用敷料是指盖在伤口上有保护作用的覆盖物，其作用是协助控制止血、保护伤口、减少感染、吸收分泌物、保持体温、促进伤口愈合。伤口很容易感染而不易愈合，这是由于伤口表面一般有一个温暖而且潮湿的环境，金黄色葡萄球菌、念珠菌和大肠杆菌等病原体在伤口上很快繁殖引起的。而生活中伤口随处可见，常常会引起皮肤和软组织的损伤，一旦引发，将给人们的生活和工作带来诸多不便，甚至威胁着人类的健康。尤其是烧烫伤，作为一种突发性的社会灾害，提高对其发病的认识和救治水平具有十分重要的临床和社会意义。医用敷料是用以覆盖伤口或其他损害的医用材料，传统方式对伤口的处理主要是用纱布覆盖来吸收创面的渗出液和防止脏东西的侵入而引起感染，但是这种方式因不能保湿和粘连创面，更换时易再次损伤创口而引起剧烈疼痛。现在已经出现了一些用新材料新方法制成的敷料，但还没有一种使用的是纯天然可吸收安全可靠的材料。
电纺纤维膜具有很大的比表面积及较高的孔隙率，因此赋予材料很强的吸附力以及良好的过滤性、阻隔性、黏合性和保温性等。纤维材料质轻柔软，便于手术操作，少量聚合物即能纺出所需面积的纤维膜，因此也降低了植入体内材料多而引起的副作用。纳米纤维构成的几何空间模拟细胞外基质结构具有仿生材料的性能。而通过纤维直径的可控性能够实现其降解速度的调控。因此电纺纳米纤维材料作为医用辅料在生物膜、伤口包覆、组织工程、脑膜修复、术后防粘连等方面具有很广阔的应用。
聚羟基丁酸酯是一种聚羟基脂肪酸酯(PHA)，一种聚酯类聚合物，于1925年，法国微生物学家MauriceLemoigne首次分离取得。因其生物可降解、可生物合成，属于环境友好型材料逐渐被大众广泛研究，目前已超过90多种不同结构和不同性质的PHA被发现，但由于其脆性大、断裂伸长率低、热稳定性差，不易加工，一直未受到重视。但随着科技的发展，第四代PHA生物塑料被逐渐开发出来，此种材料成本更低，韧性更好而且是生物基材料。如本实验所用的聚-4-羟基丁酸酯是微生物在合适条件下在胞内积累的一种高分子聚合物，具有生物可降解性和生物相容性。可用于制作心脏瓣膜、血管等组织工程材料，也可用于制作支架、手术缝合线、骨板等医用植入材料。因此本实验将其与静电纺丝技术结合起来，制备实验所需的静电纺丝薄膜，进而发现其潜在的应用性能，使材料得到进一步的使用。
发明内容
本发明的目的是提供一种制备医用辅料的原材料以及提供用于术后防粘连薄膜和人造皮肤、人工硬脑膜、可吸收手术缝线、医用支架的医用辅料的制造方法，该方法使用生物基原料聚羟基丁酸酯，响应当前对环境友好型材料的开发研究，本发明还克服了现有技术的局限性，在一定反应条件下，制得各种医用辅料。制备的辅料不仅具有良好的生物相容性，还具有生物降解性能，其产品的抗牵拉性能和柔韧性都能满足医用材料的要求。
本发明提供的用于预防手术粘连薄膜和人造皮肤的医用辅料的制造方法，其特征是该方法包括以下步骤：
将聚酯材料按5wt％-30wt％的配比溶解于有机溶剂中，于磁力搅拌器上搅拌均匀得到透明的高分子溶液：将所述高分子溶液进行静电纺丝处理，得到静电纺丝薄膜。所述静电纺丝的电压为10-20Kv，接收距离为5-30cm，电纺丝溶液的进料速度为5-20μl/min，环境空气流速为0-10m2/min，环境温度为15-45℃。将锡箔纸置于收集器上，开启高压电源，开启注射器泵，将静电纺丝溶液喷射流喷射到锡箔纸上。在锡箔纸上得到聚合物静电纺丝纤维膜层，小心取下即得到静电纺丝成纤维膜；将所述静电纺丝薄膜在真空干燥箱中30-45℃退火干燥处理，直至有机溶剂挥发至国家标准要求之下。根据不同需求，可制成不同厚度的薄膜，用于预防手术粘连的薄膜，厚度为0.02-0.1mm，用于人造皮肤的薄膜，其厚度为0.05-0.3mm。对于厚度为0.2mm的薄膜而言，侧得其机械强度大于2.5MPa。
用于人工硬脑膜的医用辅料制造方法，其特征是该方法包括以下步骤：
将聚酯材料按5wt％-30wt％的配比溶解于有机溶剂中，于磁力搅拌器上搅拌均匀得到透明的高分子溶液：将所述高分子溶液进行静电纺丝处理，得到静电纺丝薄膜。所述静电纺丝的电压为10-20Kv，接收距离为5-30cm，电纺丝溶液的进料速度为5-20μl/min，环境空气流速为0-10m2/min，环境温度为15-45℃。将锡箔纸置于收集器上，开启高压电源，开启注射器泵，将静电纺丝溶液喷射流喷射到锡箔纸上。在锡箔纸上得到聚合物静电纺丝纤维膜层，小心取下即得到静电纺丝成纤维膜；将所述静电纺丝薄膜在真空干燥箱中30-45℃退火干燥处理。
用于可吸收手术缝合线的医用辅料的制造方法，其特征是该方法包括以下步骤：
将聚酯材料按5wt％-30wt％的配比溶解于有机溶剂中，于磁力搅拌器上搅拌均匀得到透明的高分子溶液，在高压下喷丝，将丝取下，浸入95％的乙醇中脱水灭菌，取出于真空干燥箱中退火风干，再用0.5Mol，pH为7.0+0.5的含10—20％甘油的磷酸缓冲液浸泡纺丝1-6小时，然后拉伸、风干。控制该丝的直径为0.05-0.15mm。
用于医用支架的医用辅料的制造方法，其特征是该方法包括如下步骤：
将聚酯材料于双螺杆挤压机内挤压拉伸并剪切成粒料，于干燥箱中25-35℃干燥6-12小时，然后通过单螺杆将其拉伸成合适尺寸的线材，再于3D打印机上打印所需支架材料。对支架材料进行必要的除菌消毒。
按本发明制备的医用辅料其生物活性和生物相容性都是极好的，且用途广泛，可以预防腹腔、盆腔、胸腔脏器、腱鞘、神经鞘等组织手术后发生粘连和皮肤瘢痕所带来的后遗症；对皮肤、硬脑膜及相关组织缺损具有修复、缝合、支撑作用。经体外细胞实验和动物实验验证，其生物活性和生物组织相容性良好，不会产生炎症反应。
附图说明
图1为实施例制备的纳米纤维膜的扫描电镜图
图2为实施例制备的纳米纤维膜的力学性能图
图3为实施例制备的纳米纤维膜上细胞贴壁和活力检测结果示意图
图4为实施例制备的纳米纤维膜上细胞增殖示意图
图5为实施例制备的纳米纤维膜上细胞增殖数量曲线图
图6为实施例制备的纳米纤维膜上细胞存活/死亡对比图
图7为实施例制备的纳米纤维膜皮下植入切片结果示意图
具体实施例
为了进一步理解本发明，下面结合实施例对本发明优选实施方案进行描述，但是应当理解，这些描述只是为进一步说明本发明的特征和优点，而不是对本发明权利要求的限制。
实施例1
膜的制备如下：室温下将聚酯材料溶于三氯甲烷中，得到20wt％的聚酯-三氯甲烷高分子混合液，将该混合液于磁力搅拌器上搅拌过夜从而得到均匀透明的高分子溶液；将高分子溶液置于静电纺丝设备的给料注射器内，以10μl/min的进料速度进料；调节注射器针尖与静止接地板之间的距离为20cm；调整纺丝的环境温度为30℃；开启高压电源以及给料注射器泵，调节电压至20kV，调整环境的空气流速为0-5m2/min，在静止接地板上覆盖锡铂纸，进而得到静电纺丝纤维薄膜，膜厚度为100-300μm。
将静电纺丝纤维薄膜从锡箔纸上小心取下，置于真空烘箱中退火干燥处理并保证有机溶剂彻底挥发，烘箱温度设置为40℃，干燥时间为24小时，得到成纤维膜，膜的SEM图像如图1所示。
为评估电纺丝膜的生物相容性，我们首先进行了体外细胞实验，首先将退火处理后的薄膜用75％的酒精浸泡5min，然后于真空干燥箱中干燥过夜，再于超净工作台中紫外灭菌2h，将薄膜剪成1cm2大小的正方形膜片，将膜片用灭菌的双面胶贴于24孔板板底，进而分别进行各种细胞实验包括：细胞贴壁和活力检测、细胞增殖实验、细胞毒性检测。细胞贴壁和活力检测实验采用鬼笔环肽染色法对细胞进行染色，检测结果如图3所示，细胞贴壁状态良好，也有细胞进入纤维丝孔隙中生长；细胞增殖实验采用AM染色法，染活细胞呈绿色，如图4所示，细胞增殖明显如图5所示；细胞毒性检测-Live/Dead实验，用AM染活细胞呈现绿色，Ethd染死细胞呈现红色，结果如图6所示。
为评估电纺丝膜在生物体内的生物相容性，我们将退火后的电纺丝薄膜按实施例5处理后再将其用环氧乙烷气体进行深层杀菌。将膜片密封在一个塑料袋中，放于环氧乙烷灭菌器中灭菌处理。使用300-450g的SD大鼠，分开饲养，实验前后喂食相同的水和食物。将大鼠注射麻药使其麻醉，将膜片剪成1cm2大小的正方形膜片，将膜片植入大鼠皮下，用缝合针缝合伤口。本次实验分为3组每组3个平行，分别于3d，7d，30d作为时间点进行取材，取材后对材料及其周围组织进行切片处理，结果如图7所示。
Claims (5)
1.一种生物基医用辅料的制备方法，其特征在于所使用的材料为生物基的聚酯材料，具体指聚羟基丁酸酯材料。
2.用于预防手术粘连薄膜和人造皮肤的医用辅料的制造方法，其特征是该方法包括以下步骤：
将聚酯材料按5wt％-30wt％的配比溶解于有机溶剂中，于磁力搅拌器上搅拌均匀得到透明的高分子溶液：将所述高分子溶液进行静电纺丝处理，得到静电纺丝薄膜。所述静电纺丝的电压为10-20Kv，接收距离为5-30cm，电纺丝溶液的进料速度为5-20μl/min，环境空气流速为0-10m2/min，环境温度为15-45℃。将锡箔纸置于收集器上，开启高压电源，开启注射器泵，将静电纺丝溶液喷射流喷射到锡箔纸上。在锡箔纸上得到聚合物静电纺丝纤维膜层，小心取下即得到静电纺丝成纤维膜；将所述静电纺丝薄膜在真空干燥箱中30-45℃退火干燥处理，直至有机溶剂挥发至国标之下。
3.用于人工硬脑膜的医用辅料制造方法，其特征是该方法包括以下步骤：
将聚酯材料按5wt％-30wt％的配比溶解于有机溶剂中，于磁力搅拌器上搅拌均匀得到透明的高分子溶液：将所述高分子溶液进行静电纺丝处理，得到静电纺丝薄膜。所述静电纺丝的电压为10-20Kv，接收距离为5-30cm，电纺丝溶液的进料速度为5-20μl/min，环境空气流速为0-10m2/min，环境温度为15-45℃。将锡箔纸置于收集器上，开启高压电源，开启注射器泵，将静电纺丝溶液喷射流喷射到锡箔纸上。在锡箔纸上得到聚合物静电纺丝纤维膜层，小心取下即得到静电纺丝成纤维膜；将所述静电纺丝薄膜在真空干燥箱中30-45℃退火干燥处理。
4.用于可吸收手术缝合线的医用辅料的制造方法，其特征是该方法包括以下步骤：
将聚酯材料按5wt％-30wt％的配比溶解于有机溶剂中，于磁力搅拌器上搅拌均匀得到透明的高分子溶液，在高压下喷丝，将丝取下，浸入95％的乙醇中脱水灭菌，取出于真空干燥箱中退火风干，再用0.5Mol，pH为7.0+0.5的含10—20％甘油的磷酸缓冲液浸泡纺丝1-6小时，然后拉伸、风干。
5.用于医用支架的医用辅料的制造方法，其特征是该方法包括如下步骤：
将聚酯材料于双螺杆挤压机内挤压拉伸并剪切成粒料，于干燥箱中25-35℃干燥6-12小时，然后通过单螺杆将其拉伸成合适尺寸的线材，再于3D打印机上打印所需支架材料。
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