雷帕霉素药物支架稳定性试验研究

Experimental study on the stability of rapamycin drug- eluting stent

目的对雷帕霉素涂层支架在室温下的贮存稳定性进行研究,以确定其有效期。方法将3个批号的产品放置于恒温培养箱内,设定不同温度,测定不同时间的药物含量、药物纯度、聚合物分子量、体外释放、无菌、球囊性能等。结果在稳定性研究的15个月时间内,各项检测指标符合标准。结论本文进行的产品稳定性研究数据可以作为本品的有效期及贮存方法的确立依据。

Objective To research the stability of rapamycin coated stents in room temperature in order to determine its validity period. Methods Three batches of the product were placed in the constant temperature incubator and set different temperature. To detected drug content,purity,molecular weight of polymer,in vitro release,sterile and balloon performance of the products at different time. Results In the study of the stability of 15 months, all the indices met the standard. Conclusion Stability data of the products could be established as the effective period of this products and storage methods.