盐酸缬更昔洛韦片万赛维的属性剖析

Analysis of properties of valganciclovir hydrochloride tablets

目的剖析盐酸缬更昔洛韦片万赛维的属性。方法采用观察及测试的方法考察三批盐酸缬更昔洛韦片万赛维的属性差异,对比分析三批盐酸缬更昔洛韦片万赛维在不同介质中的溶出曲线数据。结果三批盐酸缬更昔洛韦片万赛维的含量、有关物质及溶出度无明显差异,批间均一性较好。依照溶出曲线的测定方法,分别测定盐酸缬更昔洛韦片万赛维在4种不同溶出介质中的溶出曲线,其溶出曲线对比显示,三批盐酸缬更昔洛韦片万赛维在不同溶出介质中的溶出曲线数据无明显差异,批间均一性较好。结论盐酸缬更昔洛韦片万赛维不同批次之间重现性较好,批间差异在可接受范围内,各项指标无明显差异,是仿制药品优良的参比制剂,临床上也可以放心使用。

Objective To analyze the properties of valganciclovir hydrochloride tablets.Methods The differences in the properties of the three batches of valganciclovir hydrochloride tablets were investigated by observation and testing,and the dissolution curve data of the three batches of valganciclovir hydrochloride tablets in different media were compared and analyzed.Results There were no significant differences in the content,relevant substances and dissolution rate of the three batches of valganciclovir hydrochloride tablets,and the batch-to-batch uniformity was good.The dissolution curves of valganciclovir hydrochloride tablets in four different dissolution media were measured according to the method of dissolution curve,and the comparison of the dissolution curves showed that there was no significant difference among the three batches of valganciclovir hydrochloride tablets in different dissolution media,and the batch-to-batch uniformity was good.Conclusion Valganciclovir hydrochloride tablets have good reproducibility in different batches,the batch-to-batch variation is within an acceptable range,and there is no significant difference in various indicators.It is an excellent reference preparation for generic drugs and can be used with confidence in clinical practice.