4厂家吡格列酮片体外溶出度比较

目的:比较4厂家吡格列酮片的体外溶出度,为临床用药提供参考。方法:采用转篮法结合高效液相色谱法,分别测定4厂家吡格列酮片的累积溶出度,并以威布尔公式计算参数Td、T50、m值,再进行方差分析。结果:4厂家吡格列酮片溶出度均符合《中国药典》规定,除北京产品与江苏产品、杭州产品与天津产品的Td、T50比较无显著性差异外(P>0.05),其余两两之间Td、T50比较均存在显著性差异(P<0.05)。结论:同一品种不同来源的药品之间溶出度具有差异,临床用药时应考虑相关情况。

Comparison of Dissolution of Pioglitazone Hydrochloride Tablets from Four Manufacturers

OBJECTIVE:To compare the in vitro dissolution of Pioglitazone Hydrochloride Tablets from four manufacturers for references of clinical medication.METHODS:The cumulative dissolution of Pioglitazone Hydrochloride Tablets from 4 manufactures were determined by HPLC method together with basket-rotating method;the dissolution parameters of Td、 T50 were calculated by Weibull formula,then variance analysis was performed.RESULTS:The in vitro dissolutions of Pioglitazone Hydrochloride Tablets from four manufacturers were all in conformity with the standard stated in China Pharmacopoeia.There were no significant differences in Td and T50 of the Pioglitazone Hydrochloride Tablets among the four manufacturers(P<0.05),except those from Beijing manufacturer vs.those from Jiangsu manufacturer and those from Hangzhou manufacturer vs.those Tianjin manufacturer(P>0.05).CONCLUSION:There are significant differences in dissolution of Pioglitazone Hydrochloride Tablets from different producers,importance should be attached to which in clinical medication.