五种不同介质中瑞格列奈片溶出度对比研究

Dissolution Contrast of Repaglinide Tablets in Five Media

目的:比较国产与进口瑞格列奈片在不同介质中的溶出行为。方法:采用桨法,转速为50r/min,(37±0.5)℃,测定国产和进口瑞格列奈片在5种不同介质(0.1mol/L盐酸溶液、pH4.0、pH5.0、pH6.8缓冲液、水)、不同时间点的累积溶出度,高效液相色谱法进行含量测定。结果:在pH4.0缓冲液介质中,进口片剂在不同时间点的累积溶出度均高于国产片剂;在0.1mol/L盐酸溶液、pH5.0和pH6.8缓冲溶液及水介质中,两者溶出行为基本一致。结论:国产与进口片剂在pH4.0缓冲液介质中溶出度存在差异,在其他介质中溶出行为一致。

Objective：To compare the dissolution of domestic and imported repaglinide tablets in different media.Methods：Cumulative dissolution of domestic and imported repaglinide tablets in five different menstruum（0.1 mol/L HCl,pH4.0,pH5.0,pH6.8buffer,water）were measured by paddle method,50r/min,（37±0.5）℃and then assayed by HPLC.Results：Cumulative dissolution of imported repaglinide tablets was higher than that of the domestic in pH4.0buffer at different point in time.Cumulative dissolution of imported and domestic repaglinide tablets were the same in 0.1mol/L HCl,pH5.0,pH6.8buffer and water.Conclusion：Cumulative dissolutions of both imported and domestic repaglinide tablets have difference in pH4.0buffer and are the same in the other four media.