CN117138128A - 一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法 - Google Patents
一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法 Download PDFInfo
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Abstract
本发明公开了一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法;其操作步骤:将聚氨酯输尿管支架浸泡在溶液中超声波清洗、干燥;将聚左旋聚乳酸和环丙沙星溶于三氯甲烷中配制成混合抗菌溶液;将浸渍提拉机真空泵的腔体充满保护性气体;将聚氨酯输尿管支架在保护性气体的环境下浸入至混合抗菌溶液中,后提拉出来进行风干;将得到的聚氨酯输尿管支架灭菌,真空密封包装,得到抗菌、抗结壳输尿管支架。本发明具有优异的抗菌性能;此外,本发明中使用的可降解高分子聚合物涂层在降解过程中能够调节pH值,较大幅度提升Ca2+、Mg2+的溶解度,抑制尿垢形核、生长、结晶过程,从而减少结壳的发生。
Description
技术领域
本发明属于医用材料及医疗器械技术领域,尤其的,是涉及了一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法。
背景技术
输尿管支架作为泌尿系统疾病中最常用的手术治疗工具,主要用于预防和治疗各种原因引起的泌尿道梗阻,如尿石症、输尿管水肿、肿瘤压迫等并发症,以提供从肾脏到膀胱的尿液引流;然而,输尿管支架在泌尿系统中暴露一段时间后,其也带来了一些不可避免的并发症,如膀胱刺激症、泌尿道感染、结壳形成等,增加了病患的痛苦。输尿管支架结壳是较为常见的并发症,主要是由于微生物的黏附、生长、定植及生物膜的形成,生物膜为细菌提供了一个良好的繁殖环境,为结壳提供了一定的条件,同时,患者尿液高钙镁离子浓度加速了结壳的过程;输尿管支架结壳增加了病患的拔管难度,若结壳严重可导致肾功能损伤,甚至死亡,加重了医疗负担。因此,对输尿管支架进行表面抗菌、抗结壳改性以获得满足临床需求的输尿管支架,具有重要的临床意义。
目前市面上已有的抗菌输尿管支架大多使用金属离子(Ag+、Cu2+、Zn2+)作为抗菌剂,金属纳米离子能够与细菌蛋白质和酶的优先位点结合以及产生活性氧导致细胞损伤和死亡;虽使用金属离子作为抗菌剂越来越普遍,但其在动物体内的抗菌成功率有限,且其细胞毒性仍具争议,已有研究证明银纳米颗粒具有诱导胚胎细胞毒性的潜力;含有银离子的输尿管支架针对的菌种较为单一,不能有效满足实际中多种细菌环境的临床需求;此外,大多浸渍提拉法并非在封闭、保护性气氛下进行,在镀膜过程中,镀液中残余气体、空气中的杂质都会导致膜层的缺陷,另外,空气成分影响镀膜反应的发生,引入副反应,例如镁合金,在潮湿空气中镀膜,表面会快速反应形成以氢氧化镁为主的反应产物,该产物和水汽导致镀膜和基体的结合力下降,最终导致工件提前失效,甚至发生安全事故;由此可见,改进当前浸渍提拉工艺,构建同时具有优异抗菌性能、抗结壳性能、低细胞毒性、良好生物相容性、膜层缺陷少,且价格低廉的输尿管支架是目前亟待解决的问题。
发明内容
针对上述问题,本发明目的在于提供了一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,旨在解决当前浸渍提拉工艺缺陷,同时解决临床上聚合物输尿管支架抗菌性低、高结壳率的问题,从而延长支架的服役周期,最终减少病人的手术负担,提高病人生活质量。
本发明的技术方案是:本发明所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其操作步骤如下:
(1):将预备的聚氨酯输尿管支架浸泡在溶液中进行超声波清洗、干燥后,备用;
(2):将特定分子量的聚左旋聚乳酸和环丙沙星溶于三氯甲烷中,使用磁力搅拌器搅拌配制成混合抗菌溶液后,备用;
(3):打开浸渍提拉机真空泵,排除腔体内的空气;开启保护气体阀门,将腔体充满保护性气体;
(4):将步骤(1)中清洗干燥后的聚氨酯输尿管支架在步骤(3)的环境下浸入步骤(2)配制的抗菌溶液中,并以一定的速度提拉出抗菌溶液后自然风干;
(5):将步骤(4)中得到的聚氨酯输尿管支架灭菌,真空密封包装,最终得到抗菌、抗结壳输尿管支架。
进一步的,在步骤(1)中,所述溶液为无水乙醇;
所述进行超声波清洗的时长为20~30min,干燥的温度为60℃。
进一步的,在步骤(2)中,所述特定分子量的聚左旋聚乳酸的浓度为1~5wt%,所述环丙沙星的浓度为0.5~2.5wt%,
所述使用磁力搅拌器搅拌的转速为1000rpm,搅拌时间为6~8h。
进一步的,在步骤(3)中,所述保护性气体为氮气或二氧化碳气体。
进一步的,在步骤(4)中,所述浸渍的温度为25℃,浸入的速度为60mm/s,浸渍的时间为20~30s,提拉的速度为4mm/s。
进一步的,在步骤(5)中,所述灭菌使用的溶液为环氧乙烷,其灭菌的时间为60min。
进一步的,所述制备的一种在保护气氛中制备抗菌、抗结壳输尿管支架的内部为输尿管支架本体,其表面为抗菌、抗结壳层,厚度约为20μm,表面呈凸包状结构;
其中,所述抗菌、抗结壳层为环丙沙星药物。
进一步的,所述输尿管支架在体外对于大肠杆菌的抗菌率达99%以上,对金黄色葡萄球菌的抗菌率为71.49%。
进一步的,所述输尿管支架在人工尿液中浸泡40天后,与其他输尿管支架一样,表面均形成了块状结壳物质,其结壳重量为0.00086g,抗结壳率达到73.62%,经XPS分析得知结壳成分主要为碳酸盐、磷酸盐、氯化盐及少量草酸盐。
本发明的有益效果是:1、本发明所制备的抗菌、抗结壳输尿管支架在保护性气氛中通过浸渍提拉的方法对输尿管支架进行表面覆膜处理,制备方法简单高效,保护性气氛解决了传统浸渍提拉工艺的缺陷:空气中杂质及镀液中残余气体对膜层完整性的破坏。本发明提高了膜层的完整性和稳定性,且操作过程采用全自动化,避免人工操作的误差;2、本发明所制备的抗菌、抗结壳输尿管支架使用环丙沙星药物作为抗菌剂,直接抑制细菌DNA的合成和复制,进而导致细菌死亡,相较于临床上使用的银离子抗菌剂具有优异的抗菌性能;3、本发明所制备的抗菌、抗结壳输尿管支架不易产生耐药性、细胞毒性低且与市面上已有的银离子抗菌输尿管支架相比具有较低的结壳率;4、本发明所制备的抗菌、抗结壳输尿管支架使用特定分子量的聚左旋聚乳酸作为药物载体,确保了输尿管支架具有优异的药物缓释功能以及良好的生物相容性;5、本发明所制备的抗菌、抗结壳输尿管支架工艺简洁、成本低,利于工业化生产,极大程度上减轻了病患的经济负担。
附图说明:
图1为本发明的制备流程图;
图2为本发明中抗菌、抗结壳输尿管支架的表面及截面形貌图;
图3为聚氨酯输尿管支架、银离子抗菌输尿管支架及本发明的输尿管支架的抗菌率折线图;
图4为本发明实施例中输尿管支架在人工尿液中浸泡40天后表面结壳微观形貌的示意图;
图5为本发明实施例中输尿管支架在人工尿液中浸泡40天后表面结壳XPS分析的示意图;其中,(a)-(d)分别为Ca、K、Na、Mg元素精细图谱;(e)为全谱图;
图6为本发明实施例中输尿管支架在人工尿液中浸泡40天后的抗结壳率结构图。
具体实施方式
为了更清楚地说明本发明的技术方案,下面结合附图对本发明的技术方案做进一步的详细说明:
实施例1
如图2所示,本实施例提供了一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其具体制备步骤如下:
第一步、将聚氨酯输尿管支架浸泡在无水乙醇中进行超声波清洗30min、在60℃干燥箱中干燥后备用;
第二步、将0.37g聚乳酸和0.111g环丙沙星溶于7.4g三氯甲烷中,使用磁力搅拌器搅拌8h,配制成溶液后备用;
第三步、打开浸渍提拉机真空泵,将腔体内空气排除,缓缓开启保护气体阀门,使腔体充满氮气或二氧化碳气体;
第四步、将第一步所得到的输尿管支架放入第二步所得的溶液中,在第三步的保护性气体中以60mm/s的速度浸入溶液中,浸渍30s后以4mm/s的速度提拉出溶液,自然风干;
第五步、将第四步所得的输尿管支架用环氧乙烷灭菌,灭菌时间为60min,灭菌后的输尿管支架真空密封包装,得到抗菌、抗结壳输尿管支架。
参照GB/T20944.1-2007纺织品抗菌性能评价第1部分琼脂平皿扩散法对制得的输尿管支架进行体外抗菌实验,对大肠杆菌的抗菌率为99.98%,对金黄色葡萄球菌的抗菌率为65.06%,在人工尿液中浸泡40天后,抗结壳率为42.33%。
实施例2
如图2所示,本实施例提供了一种在真空环境中制备抗菌、抗结壳输尿管支架的方法,其具体制备步骤如下:
第一步、将聚氨酯输尿管支架浸泡在无水乙醇中进行超声波清洗30min、在60℃干燥箱中干燥后备用;
第二步、将0.37g聚乳酸和0.185g环丙沙星溶于7.4g三氯甲烷中,使用磁力搅拌器搅拌8h,配制成溶液后备用;
第三步、打开浸渍提拉机真空泵,将腔体内空气排除,形成真空环境;
第四步、将第一步所得到的输尿管支架放入第二步所得的溶液中,在第三步的保护性气体中以60mm/s的速度浸入溶液中,浸渍30s后以4mm/s的速度提拉出溶液,在特定温度和湿度下风干;
第五步、将第四步所得的输尿管支架用环氧乙烷灭菌,灭菌时间为60min,灭菌后的输尿管支架真空密封包装,得到抗菌、抗结壳输尿管支架。
参照GB/T20944.1-2007纺织品抗菌性能评价第1部分琼脂平皿扩散法对制得的输尿管支架进行体外抗菌实验,对大肠杆菌的抗菌率为99.99%,对金黄色葡萄球菌的抗菌率为71.49%,在人工尿液中浸泡一个月后,抗结壳率为73.62%。
对比例1
如图2所示,纯聚氨酯输尿管支架及其制备方法,其具体制备步骤如下:
第一步、将纯聚氨酯输尿管支架浸泡在无水乙醇中进行超声波清洗30min、在60℃干燥箱中干燥后备用;
第二步、将第一步所得的输尿管支架用环氧乙烷灭菌,灭菌时间为60min,灭菌后的输尿管支架真空密封包装。
参照GB/T20944.1-2007纺织品抗菌性能评价第1部分琼脂平皿扩散法对制得的输尿管支架进行体外抗菌实验,对大肠杆菌的抗菌率为9.35%,对金黄色葡萄球菌的抗菌率为45.78%,在人工尿液中浸泡一个月后,结壳重量约为0.00326g。
对比例2
如图2所示,含银离子的输尿管支架及其制备方法,其具体制备步骤如下:
第一步、将含银离子的输尿管支架浸泡在无水乙醇中进行超声波清洗30min、在60℃干燥箱中干燥后备用;
第二步、将第一步所得的输尿管支架用环氧乙烷灭菌,灭菌时间为60min,灭菌后的输尿管支架真空密封包装。
参照GB/T20944.1-2007纺织品抗菌性能评价第1部分琼脂平皿扩散法对制得的输尿管支架进行体外抗菌实验,对大肠杆菌的抗菌率为19.42%,对金黄色葡萄球菌的抗菌率为59.44%,在人工尿液中浸泡一个月后,抗结壳率为46.32%。
Claims (10)
1.一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:其操作步骤如下:
(1):将预备的聚氨酯输尿管支架浸泡在溶液中进行超声波清洗、干燥后,备用;
(2):将特定分子量的聚左旋聚乳酸和环丙沙星溶于三氯甲烷中,使用磁力搅拌器搅拌配制成混合抗菌溶液后,备用;
(3):打开浸渍提拉机真空泵,排除腔体内的空气;开启保护气体阀门,将腔体充满保护性气体;
(4):将步骤(1)中清洗干燥后的聚氨酯输尿管支架在步骤(3)中充满保护性气体的环境下浸入步骤(2)中配制的混合抗菌溶液中,并以一定的速度提拉出抗菌溶液后进行风干;
(5):将步骤(4)中得到的聚氨酯输尿管支架灭菌,真空密封包装,最终得到抗菌、抗结壳输尿管支架。
2.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(1)中,所述溶液为无水乙醇。
3.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(1)中,所述进行超声波清洗的时长为20~30min,干燥的温度为60℃。
4.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(2)中,所述特定分子量的聚左旋聚乳酸的浓度为1~5wt%,所述环丙沙星的浓度为0.5~2.5wt%。
5.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(2)中,所述使用磁力搅拌器搅拌的转速为1000rpm,搅拌时间为6~8h。
6.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(3)中,所述保护性气体为氮气或二氧化碳气体。
7.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(4)中,所述浸渍的温度为25℃,浸入的速度为60mm/s,浸渍的时间为20~30s,提拉的速度为4mm/s。
8.根据权利要求1所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架的方法,其特征在于:在步骤(5)中,所述灭菌使用的溶液为环氧乙烷,其灭菌的时间为60min。
9.如权利要求1-8任一项所述的制备方法制备的一种在保护气氛中制备抗菌、抗结壳输尿管支架,其特征在于,所述制得的抗菌、抗结壳输尿管支架的内部为输尿管支架本体,其表面为抗菌、抗结壳层;厚度为20μm,且表面呈凸包状结构;
其中,所述抗菌、抗结壳层为环丙沙星药物。
10.如权利要求9所述的一种在保护气氛中制备抗菌、抗结壳输尿管支架,其特征在于,所述输尿管支架在人工尿液中浸泡40天后,表面形成块状结壳物质;
其中,结壳重量为0.00086g,经XPS分析得到其结壳成分为碳酸盐、磷酸盐、氯化盐及草酸盐。
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