国产与进口盐酸西替利嗪片的溶出度比较  

Comparison the dissolution of domestic and imported Cetirizine hydrochloride tablets in vitro

作　　者：孙黎[1] 刘晓琰[1] 王平全[1] 

机构地区：[1]上海第二医科大学附属仁济医院临床药学药理研究室,上海200001

出　　处：《华西药学杂志》2003年第2期114-116,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的　比较国产与进口盐酸西替利嗪片的体外溶出度 ,以评价国产盐酸西替利嗪片的质量。方法　采用转篮法测定溶出度 ,用威布尔 (Weibull)分布模型拟合溶出曲线 ,并对溶出参数m、T50 、Td 等采用方差分析及t检验进行统计。结果　国产与进口盐酸西替利嗪片的溶出参数有显著性差异 (P <0 .0 5 ) ;部分批号的国产片间有显著性差异 (P <0 .0 5 ) ,进口片两批号间无显著性差异 (P >0 .0 5 )。结论　国产片及进口片制剂工艺均符合规定。进口片的体外溶出度较国产片为优 ,工艺较稳定 。OBJECTIVE To compare the dissolution of domestic and imported Cetirizine hydrochloride tablets in vitro . To assess the quality of domestic Cetirizine hydrochloride.METHODS The basket-stirring method was used to determine the dissolubility of Cetirizine hydrocloride tablets. The Weibull distribution model was adopted in dissolution curve. The parameters of m, T 50 ,T d were statistically analyzed by analysis variance and t test.RESULTS There were significant difference between the parameters of domestic and imported tablets(P< 0.05 ). There were significant difference among three batches of domestic tablets(P<0.05), no significant difference existed between two batches of imported tablets(P>0.05) CONCLUSION The technology of domestic and imported preparations manufacturing was qualitified. The dissolution of imported Cetirizine hydrochloride tablets in vitro was better than that of domestic.

关 键 词：盐酸西替利嗪片 体外溶出度 质量评价 转篮法 威布尔分布模型 溶出参数 

分 类 号：R971.1[医药卫生—药品] R927.11[医药卫生—药学]