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目的:考察仿制药缬沙坦胶囊(VSC)与原研药代文(DIOVAN)质量是否一致。方法:依据《中国药典》2010年版,采用UV法检测VSC与DIOVAN在4种介质中的溶出过程;以相似因子(f2)法对两者体外溶出曲线进行相似性评价,也对企业生产质量进行评价,利用同一批次产品的溶出度精密度数据进行均一性评估和利用相似等效限法对不同批次产品的溶出度进行重现性评估。结果:VSC与DIOVAN在pH6.8磷酸盐缓冲液中15 min时溶出度均大于85%,其余三种介质(水、pH 4.5醋酸盐缓冲液、0.1 mol·L-1HCl)f2因子均大于50;同一批内的溶出度数据精密度的相对误差RSD均小于10.0%,不同批次间的溶出限度值(Q),均位于概率水平(δ)上下限值之间。结论:对VSC与原研DIOVAN两者在四个介质中的体外溶出曲线进行f2评价,结果显示两者具有一致性。此外无论是均一性或重现性的评估均十分良好,这显示生产企业的缬沙坦胶囊生产质量十分良好稳定,与原研药质量具有一致性。
Objective: To investigate whether the quality of the generic drug Valsartan capsule (VSC) and the original research agent (DIOVAN) is the same. Methods: According to the 2010 edition of Chinese Pharmacopoeia, the dissolution of VSC and DIOVAN in four media was detected by UV method. Similarity factor (f2) method was used to evaluate the similarity of in vitro dissolution curve and the quality of enterprise production Evaluation, using the same batch of product dissolution precision data for homogeneity assessment and the use of similar equivalence limits for different batches of products dissolution reproducibility assessment. Results: The dissolution rates of VSC and DIOVAN in pH6.8 phosphate buffer were both higher than 85% at 15 min. The other three media (water, pH 4.5 acetate buffer, 0.1 mol·L-1HCl) f2 were greater than 50; the RSDs of the precision of the dissolution data within the same batch were less than 10.0%, and the dissolution limits (Q) among different batches were all located between the upper and lower limits of the probability level (δ). Conclusion: The in vitro dissolution curves of VSC and original DIOVAN in four media were evaluated by f2, and the results showed that they were consistent. In addition, the evaluation of homogeneity or reproducibility is very good, which shows that the manufacturing enterprises’ Valsartan capsule production quality is very good and stable, consistent with the quality of the original research drug.