不同厂家盐酸贝那普利片溶出度考察

Comparison of Dissolution of Benazepril Hydrochloride Tablets from Different Manufacturers

目的:考察国内不同药品生产企业盐酸贝那普利片的溶出度情况。方法:采用浆法,以水500 m L为溶出介质,转速50 r·min-1。用f2因子法,考察国内3家生产企业的盐酸贝那普利片与参比制剂的溶出度差异。结果与结论:3家企业的盐酸贝那普利片溶出曲线与参比制剂均不相似,2家企业样品的批间重复性良好,部分样品的批内均一性较差,1家企业样品的批内均一性和批间重复性均较差。

Objective： To compare the dissolution of benazepril hydrochloride tablets from different manufacturers. Methods： The dissolution tests were proceeded by using the paddle method at 50 r.min^-l, and 500 mL water was used as the medium. The difference in dissolution rate of the three domestic benazepril hydrochloride tablets and the reference preparation was evaluated by f2 factor method. Results and Conclusion： Solution curves of benazepril hydrochloride tablets from three manufacturers were not similar with those of the reference preparation. Samples from two manufacturers had good inter-batch reproducibility. Part of samples bad poor intra-batch homogeneity and samples from one manufacturer had both poor intra-batch homogeneity and Iooor inter-batch reoroducibilitv.