药物涂层球囊药物释放和微粒脱落的体外评估方法

摘要

Objective Development in vitro test methods for drug release and particle release from drug coated baloon to address the disadvantages and inadequacy of existing assessment methods. Methods In vitro drug transfer test were carried out using the isolated porcine vessel as target site in the self-designed iliofemoral artery model, drug loss experiment during dilatation and retraction were added in drug release test, the particle test channel was subdivided and the size and number of the large particles were measured by microscopy combined with Image-Pro Plus software.Results The result shows that the method is feasible and the discrimination is good. The material balance can be achieved. More detailed data can be obtained.Conclusion The developed in vitro evaluation method provides a reference for formulation screening, in vitro bench testing and in vivo pre-clinical animal testing.%目的 开发药物释放和微粒脱落的体外测试方法,解决现有评估方法的缺点与不足.方法 使用离体猪血管作为靶作用部位在自制的股髂动脉模型中进行体外转载实验,增加扩张过程和回撤过程的药物损失实验,细分微粒测试通道并使用显微法联合Image-Pro Plus软件测试大微粒的数量和具体尺寸.结果转载率测试方法分辨度较好,实现了物料平衡,可获得更详尽的数据.结论所开发的方法为企业配方筛选、台架实验和临床前动物试验提供了参考.