国产卡托普利片溶出度对比分析

Comparative Analysis on Dissolution of Domestic Captopril Tablets

目的:比较国内6家卡托普利片与原研企业产品溶出曲线的相似性,以评价国内该产品的质量差异和现行溶出度测定方法的质量可控性。方法:按照《中国药典》2010年版标准,测定溶出度并绘制溶出曲线并计算各时间点溶出量的RSD,考察片间重复性;以原研企业产品作为参比制剂,采用差异因子(f_1)和相似因子(f_2)比较溶出曲线的相似性。结果:选取的生产企业产品片间重复性较好;当采用2010年版药典方法单点评价,产品溶出度均高于原研企业;采用f_1和f2评价,有1家生产企业产品与原研企业产品溶出曲线相似。结论:采用f1和f_2比较溶出曲线的相似性能更好地反应产品的内在质量差异。

Objective： To compare the similarity of captopril tablets from the original drug enterprise and the other 6 enterprises to assess their quality difference and the quality controllability of current dissolution determination method. Method： The dissolution was determined on the basis of CP 2010 Edition. The RSD of each point in the dissolution curves was calculated in order to study the re- peatability of each tablet. The similarity was compared by the calculation of fl and f2 factors using the product from the original enter- prise as the reference preparation. Result： The good repeatability of each tablet could be found. Single-point dissolution of the tablets from the 6 enterprises was all better than that from the original drug enterprise. The dissolution curve of the product from one enterprise was similar to that from the original drug enterprise evaluated by the method of f1 arid f2 factors. Conclusion： It is promising to assess product intrinsic quality by f1 and f2 factors.