CN114246992B - 一种缓释药物涂层的可降解血管支架及制备方法 - Google Patents
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Abstract
本发明提供了一种缓释药物涂层的可降解血管支架及制备方法,制备方法包括分别制备阴离子聚合物溶液和阳离子聚合物水溶液;将可降解金属支架置于富含DOPA的高分子蛋白溶液中浸泡晾干,再置于多巴胺溶液中反应,反应完用去离子水清洗,得到含有聚合多巴胺基团的蛋白修饰的可降解金属支架;将阴离子聚合物溶液和阳离子聚合物溶液进行混合,搅拌进行反应形成混合溶液,超声搅拌,得到载药凝胶;将载药凝胶加热为溶胶,再经超声均匀喷涂在含有聚合多巴胺基团的蛋白修饰的可降解金属支架表面,冷却,获得缓释药物涂层的可降解血管支架。本发明制备的缓释药物涂层的可降解血管支架的药物涂层结合力强,治疗药物和细胞因子分布均匀。
Description
技术领域
本发明涉及血管堵塞治疗医学领域,特别涉及一种缓释药物涂层的可降解血管支架及制备方法。
背景技术
心血管疾病作为全世界最为普遍患病人数最多的疾病,冠状动脉血管堵塞可以在短时间内导致患者死亡,血管支架仍然是紧急治疗血管堵塞的最有效的手段之一。传统的药物洗脱支架大部分采用钛合金、钴铬合金、316L不锈钢等材料制备,在体内不可降解,长期存在体内会有异物炎症反应及再植入占位问题,可降解血管支架解决了这一问题。
锌和镁是人体必需的微量元素,目前已经研制出可降解锌合金及镁合金的骨科植入物或血管植入物,锌合金及镁合金植入物具有一定的生物相容性,相比聚乳酸、钛合金、钽金属等植入物在临床应用方面的效果还有待研究,尤其是锌合金及镁合金生物降解后会析出金属离子,离子浓度对于机体的影响尚没有明确结论。
现有技术可以通过材料的配比及加工工艺优化实现对锌合金及镁合金可降解血管支架的降解速率进行控制,前期植入阶段需要提高锌合金血管支架的内皮化性能、抗凝血性能、抗增生性能,均可以通过载药实现,同时要满足药物缓释功能,并实现支架前期降解慢,后期加快降解。由于锌属于两性金属,可溶于酸碱,性质活泼,熔点较低,酸碱处理、等离子喷涂等相关工艺均不适用,目前在医用锌合金支架的表面改性和涂层制备方面还没有较好的解决方案。
因此,有必要提供一种既满足药物缓释功能又具备良好降解速率的可降解血管支架及制备方法。
发明内容
本发明提供了一种缓释药物涂层的可降解血管支架及制备方法,其目的是为了现有医用锌合金支架的表面改性和涂层制备方面应用受到限制的问题。
为了达到上述目的,本发明提供了一种缓释药物涂层的可降解血管支架的制备方法,所述制备方法包括如下步骤:
取阴离子聚合物溶于水,再加入细胞因子和治疗药物分散均匀,获得阴离子聚合物溶液;
取阳离子聚合物溶于水中,获得阳离子聚合物水溶液;
将可降解金属支架置于富含DOPA的高分子蛋白溶液中浸泡晾干,再置于多巴胺溶液中进行自聚成膜反应,反应完用去离子水清洗,得到含有聚合多巴胺基团的蛋白修饰的可降解金属支架;
将阴离子聚合物溶液和阳离子聚合物溶液进行混合,搅拌进行离子交联反应,形成含有阴阳离子聚合物、治疗药物和细胞因子的混合溶液,超声搅拌,得到载药凝胶;
将所述载药凝胶加热为溶胶,再经超声喷涂、旋涂或浸涂的方式均匀涂布在所述含有聚合多巴胺基团的蛋白修饰的可降解金属支架表面,冷却,获得缓释药物涂层的可降解血管支架。
进一步的,所述富含DOPA的高分子蛋白溶液包括贻贝足丝蛋白Mefp-5、DOPA修饰改性的聚氨酯、聚丙烯酸酯或四臂聚乙二醇溶液中的一种或多种。
进一步的,所述阴离子聚合物为海藻酸钠、透明质酸、阴离子聚乙烯醇、肝素溶液、小分子蛋白、特异性多肽链中的一种或多种,所述阳离子聚合物为壳聚糖、氢氧化铁、聚乙烯亚胺、聚多巴胺、聚赖氨酸、聚丙烯酰中的一种或多种。
进一步的,所述治疗药物包括聚阴离子治疗药物和非离子型治疗药物,所述聚阴离子治疗药物为肝素、阿司匹林中的一种或两种,所述非离子型药物包括紫杉醇、地塞米松、雷帕霉素、依维莫司、比伐卢定(BVLD)等及其衍生物中的一种或多种。
进一步的,所述细胞因子为促内皮化因子和CD34抗体、CD133抗体可特异性结合内皮细胞和内皮组细胞的分子中的一种或两种,所述促内皮化因子为REDV多肽、VEGF多肽及其变种多肽中的一种或多种。
进一步的,所述阴离子聚合物溶液浓度为wt1%-3%,所述阳离子聚合物溶液浓度为wt1%-3%,所述治疗药物为0.2-1g/mL,所述细胞因子0.2-1.5g/mL,DOPA的高分子蛋白溶液浓度0.5-5mg/mL,多巴胺水溶液浓度为1-5mg/mL。
进一步的,所述可降解金属支架采用合金熔炼、均匀化热处理、预热挤压、校直抛光、钻孔、拉拔、雕刻和抛光清洗制成。
进一步的,所述浸泡时间为1-10min,自聚成膜反应时间为10-30min,自聚成膜反应温度为30-40℃;所述超声搅拌时间为10-20min;所述加热是在30-40℃的恒温水浴中。
作为一个发明总的构思,本发明还提供一种缓释药物涂层的可降解血管支架,所述可降解血管支架包括可降解金属支架主体和载药缓释涂层,所述载药缓释涂层包含细胞因子和治疗药物。
进一步的,所述可降解金属支架为锌合金或镁合金,配比为Zn-(0%~1%)Li-(0.01%~0.1%)Mg。
本发明的载药凝胶形成顺序:阴离子和阴离子及非离子化合物先一起混合,所述混合物再和阳离子混合形成凝胶,能避免阴离子药物、阴离子多肽和部分阳离子先混合导致药物分布不均匀影响后续阳离子和阴离子凝胶组分的混合效果。
本发明的上述方案有如下的有益效果:
1、本发明可降解金属支架经过化学抛光后,采用富含DOPA的高分子蛋白进行处理,当接触到金属支架基质表面时,DOPA的羟基与金属表面形成的氢键远远超过水分子与金属表面的氢键,DOPA与表面发生有机金属络合反应,形成稳定的金属络合物,进而牢固地附着在物体表面,能够与任何界面强力粘覆,再多巴胺分子和富含DOPA基团的蛋白聚合为蛋白薄膜,与外层的凝胶紧密结合,对凝胶中的阴离子强力吸附,因此富含DOPA的蛋白可紧密粘覆于支架表面提高支架与载药凝胶涂层的结合力。
2、本发明载药涂层采用阴阳离子交联组装成的凝胶,结合力强,可以将抗增生、抗凝血、促内皮化的药物紧密包裹在凝胶内,且分布均匀,其中带有电荷的药物和细胞因子可与聚阳离子结合,具有载药凝胶的冠脉支架可以实现抗凝血、抗增生、促进血管内皮化,药物可以缓慢释放,最终支架和涂层均可以完全降解。
3、本发明的缓释药物涂层的可降解血管支架的制备方法简单高效,药物和细胞因子分布均匀,涂层可以一次性制备,也可以按需制备,经济环保。
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚,下面将结合具体实施方式进行详细描述。
本发明实施例中,所采用的可降解金属支架为湖南华耀百奥医疗科技有限公司特制的可降解锌合金支架,经合金熔炼、均匀化热处理、预热挤压、校直抛光、钻孔、拉拔、雕刻和抛光清洗工序制成。
实施例1
一种缓释药物涂层的可降解血管支架的制备方法,所述制备方法包括如下步骤:
取wt1%的海藻酸钠水溶液,再加入1.5g/mL的促内皮生长因子水溶液和0.6g/mL肝素水溶液分散均匀,获得海藻酸钠聚合物溶液、促内皮生长因子水溶液和肝素水溶液的混合溶液;
取壳聚糖溶于水中,配置浓度为wt2%的壳聚糖水溶液;
将可降解金属支架置于1mg/mL Mefp-5溶液中浸泡3min晾干,再置于3mg/mL多巴胺溶液35℃下反应20min,反应完用去离子水清洗,得到含有聚合多巴胺基团的蛋白修饰的可降解金属支架;
将海藻酸钠聚合物溶液、促内皮生长因子水溶液和肝素水溶液的混合溶液和乙酰度为70-85%的壳聚糖水溶液进行混合,搅拌进行离子交联反应,形成含有壳聚糖、海藻酸钠、促内皮生长因子和肝素的混合溶液,超声搅拌,得到载药凝胶;
将所述载药凝胶在30℃的恒温水浴中加热为溶胶,再经超声喷涂、旋涂或浸涂的方式均匀涂布在所述含有聚合多巴胺基团的蛋白修饰的可降解金属支架表面,冷却,获得缓释药物涂层的可降解血管支架。
其中可降解金属支架为可降解锌合金,配比为Zn-(0.1%~1%)Cu-(0.05%~0.1%)Mg。
实施例2
一种缓释药物涂层的可降解血管支架的制备方法,所述制备方法包括如下步骤:
取wt1%的透明质酸水溶液,再加入1.0g/mL的REDV多肽水溶液和1g/mL的雷帕霉素水溶液分散均匀,获得透明质酸水溶液、REDV多肽水溶液和雷帕霉素水溶液的混合溶液;
取聚赖氨酸溶于水中,配置浓度为wt2%的聚赖氨酸水溶液;
将可降解金属支架置于1mg/mL Mefp-5溶液中浸泡7min晾干,再置于5mg/mL多巴胺溶液40℃下反应30min,反应完用去离子水清洗,得到含有聚合多巴胺基团的蛋白修饰的可降解金属支架;
将透明质酸水溶液、REDV多肽水溶液和雷帕霉素水溶液的混合溶液和聚赖氨酸水溶液进行混合,搅拌进行离子交联反应,形成含有聚赖氨酸、透明质酸、REDV多肽和雷帕霉素的混合溶液,超声搅拌,得到载药凝胶;
将所述载药凝胶在40℃的恒温水浴中加热为溶胶,再经超声喷涂、旋涂或浸涂的方式均匀涂布在所述含有聚合多巴胺基团的蛋白修饰的可降解金属支架表面,冷却,获得缓释药物涂层的可降解血管支架。
其中可降解金属支架为可降解锌合金,配比为Zn-(0%~0.5%)Li-(0.01%~0.05%)Mg。
以上所述是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明所述原理的前提下,还可以作出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种缓释药物涂层的可降解血管支架的制备方法,其特征在于,所述制备方法包括如下步骤:
取阴离子聚合物溶于水,再加入细胞因子和治疗药物分散均匀,获得阴离子聚合物溶液;
取阳离子聚合物溶于水中,获得阳离子聚合物水溶液;
将可降解金属支架置于富含DOPA的高分子蛋白溶液中浸泡晾干,再置于多巴胺溶液中进行自聚成膜反应,反应完用去离子水清洗,得到含有聚合多巴胺基团的蛋白修饰的可降解金属支架;
将所述阴离子聚合物溶液和阳离子聚合物水溶液进行混合,搅拌进行离子交联反应,形成含有阴阳离子聚合物、治疗药物和细胞因子的混合溶液,超声搅拌,得到载药凝胶;
将所述载药凝胶加热为溶胶,再经超声喷涂、旋涂或浸涂的方式均匀涂布在所述含有聚合多巴胺基团的蛋白修饰的可降解金属支架表面,冷却,获得缓释药物涂层的可降解血管支架;
所述细胞因子为促内皮化因子和CD34抗体可特异性结合内皮细胞和内皮祖细胞的分子,所述促内皮化因子为REDV多肽、VEGF多肽及其变种多肽中的一种或多种;
所述阴离子聚合物溶液浓度为wt1%-3%,所述阳离子聚合物水溶液浓度为wt1%-3%,所述治疗药物为0.2-1g/mL,所述细胞因子0.2-1.5g/mL,所述富含DOPA的高分子蛋白溶液浓度0.5-5mg/mL,所述多巴胺溶液浓度为1-5mg/mL;
所述可降解金属支架为锌合金或镁合金;
所述富含DOPA的高分子蛋白溶液为贻贝足丝蛋白Mefp-5溶液。
2.根据权利要求1所述的制备方法,其特征在于,所述阴离子聚合物为海藻酸钠、透明质酸、阴离子聚乙烯醇、肝素溶液、小分子蛋白、特异性多肽链中的一种或多种,所述阳离子聚合物为壳聚糖、氢氧化铁、聚乙烯亚胺、聚多巴胺、聚赖氨酸中的一种或多种。
3.根据权利要求1所述的制备方法,其特征在于,所述治疗药物包括聚阴离子治疗药物和非离子型治疗药物,所述聚阴离子治疗药物为肝素及肝素衍生物、阿司匹林及阿司匹林衍生物中的一种或两种,所述非离子型治疗药物包括紫杉醇及紫杉醇衍生物、地塞米松及地塞米松衍生物、雷帕霉素及雷帕霉素衍生物、依维莫司及依维莫司衍生物、比伐卢定及比伐卢定衍生物中的一种或多种。
4.根据权利要求1所述的制备方法,其特征在于,所述可降解金属支架采用合金熔炼、均匀化热处理、预热挤压、校直抛光、钻孔、拉拔、雕刻和抛光清洗制成。
5.根据权利要求1所述的制备方法,其特征在于,所述浸泡时间为1-10min,自聚成膜反应时间为10-30min,自聚成膜反应温度为30-40℃;所述超声搅拌时间为10-20min;所述加热是在30-40℃的恒温水浴中。
6.一种如权利要求1-5任意一项所述的制备方法获得的缓释药物涂层的可降解血管支架,其特征在于,所述可降解血管支架包括可降解金属支架主体和载药缓释涂层,所述载药缓释涂层包含细胞因子和治疗药物。
7.根据权利要求6所述的可降解血管支架,其特征在于,所述可降解金属支架为锌合金,配比为Zn-(0%~1%)Li-(0.01%~0.1%)Mg。
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