四种介质中国产和进口阿托伐他汀钙片溶出度对比研究

目的:比较国产与进口阿托伐他汀钙片制剂在不同介质中的溶出行为。方法:测定进口和国产阿托伐他汀钙片在4种不同介质(水、pH 1.2、pH 4.0、pH 6.8缓冲液)中的累积溶出度。采用桨法(转速为50转/min)、紫外分光光度法测定(检测波长240 nm)。结果:在pH1.2介质中,进口片剂在不同时间点的累积溶出度高于国产片剂;在水、pH 4.0和pH 6.8介质中,国产片剂与进口片剂溶出行为和累积溶出度基本一致。结论:国产中与进口片剂在pH1.2介质中溶出度存在差异,在其他介质中溶出行为一致。

Dissolution Contrast between Domestic and Imported Atorvastatin Calcium in Four Media

Objective： To compare the dissolution of domestic and imported atorvastatin calcium praeparatum in different media. Method： Cumulative dissolution of domestic and imported atorvastatin calcium praeparatum in four dif- ferent menstruum （water, pH 1.2, pH 4.0 and pH 6.8 buffer） were measured by paddle method （speed 50 r/min） and then assayed by ultraviolet spectrophotometry at wave length of 240 nm. Results： Cumulative dissolution of imported atorvastatin calcium praeparatum was higher than that of the domestic in pH 1.2 buffer at different point in time ; Cumu- lative dissolution of imported and domestic atorvastatin calcium praeparatum were the same in pH 4.0 and pH 6.8 buffer and water. Conclusion： Cumulative dissolutions of both imported and domestic atorvastatin calcium praeparatum have difference in pHI. 2 buffer and are the same in the other three media pH4.0 and pH6.8 buffer and water.