缬沙坦胶囊质量一致性研究

Research on Quality Consistency of Valsartan Capsules

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 evaluate the quality consistency of the original product （ DIOVAN ） and generic valsartan capsules （ VSC） . Methods：The dissolution of the two capsules in four media was monitored by the UV method described in Chinese Pharmacopoeia （ ChP 2010 edition） . The f2 similarity factor approach was used to evaluate the dissolution similarity between DIOVAN and VSC and the production quality of the enterprises. Meanwhile, the homogeneity in the same batch was studied by dissolution precision and the reproducibility in the different batches were also evaluated by a similar equivalent limit method to show the production quality of the manufacturers. Results：The dissolution of VSC and Diovan in pH 6. 8 phosphate buffer medium was both above 85% in 15 min. The f2 similarity factors in the other three media （ water, pH 4. 5 acetate buffer and 0. 1 mol·L-1 HCl） were all above 50. The relative standard deviation （ RSD） of precision in the same batch was less than 10%. Among the different batches, dissolution limit value （ Q） was within the range of the upper and lower limit value of probability levels （δ） . Conclusion：The f2 similarity factor results indicate the in vitro dissolution of the reference drug （ DIOVAN） and generic drug （ VSC） is consistent in the four media. The production quality of generic manufacturer is also good with promising homogeneity and reproducibility evaluation results.