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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 similarities of the dissolution curves of six domestic captopril tablets with those of the original research enterprises in order to evaluate the quality differences of the products in China and the quality controllability of the current dissolution testing methods. Methods: According to the 2010 edition of Chinese Pharmacopoeia, the dissolution rate was determined and the dissolution curve was plotted and the RSD of dissolution at each time point was calculated. The repeatability between the two tablets was investigated. Using the original product as the reference preparation and the difference factor (f_1) and The similarity factor (f_2) compares the similarity of the dissolution curves. Results: The reproducibility of products in the selected manufacturing enterprises was better than that in the original research enterprises. When using the 2010 edition of the Pharmacopoeia method single point evaluation, the product dissolution rate was higher than that of the original research enterprises. Using f_1 and f2 evaluation, there were 1 product of the manufacturing enterprise and the original research enterprise The curves are similar. CONCLUSIONS: The similarities of f1 and f2 in comparing dissolution profiles better reflect the difference in intrinsic quality of the product.