流通池法测试雷帕霉素支架涂药工艺稳定性初探
Primary discuss on flow-cell elution release test method at stability of rapamycin on drug-eluting stents
分类号：
出版年·卷·期（页码）：2012,32 (4):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 用美国药典流通池方法测试雷帕霉素药物洗脱冠脉支架体外释放度,作为企业出厂检验方法,以评价其工艺稳定性。 方法: 用美国药典释放度测定第4法规定的溶出装置联机紫外分光光度计。释放介质为2%十二烷基硫酸钠溶解在10%乙腈-PBS(pH=5.0)的缓冲液;检测波长为280 nm。 结果: 相同批号(n=6)和不同批号(n=3)的药物支架的雷帕霉素在24 h的释放曲线一致。 结论: 本法适合评价冠脉支架涂药的工艺稳定性,快速简便,符合美国药典流通池法的要求,检测结果较为满意。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish a method for the analysis of release of rapamycin in drug eluting stents (DES) with flow-cell elution system . Method: Dissolution test method(modify USP 4) was adopted and used 50 mL the mixture of 2% SDS and 10% acetonitrile in PBS buffer(pH=5)as the release media.Keep the detective wavelength at 280 nm. Result: The release of rapamycin is identical to which between the same lots and different lots. Conclusion: The method is fast and convenient.
-----参考文献：---------------------------------------------------------------------------------------
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