不同厂家双嘧达莫片的溶出度比较

Comparison the dissolution of Dipyridamole tablets from different factories

目的 比较国产与国外双嘧达莫片的体外溶出度,以评价国产双嘧达莫片的质量。方法 采用USP 24版双嘧迭莫片溶出度项下有关规定测定其溶出度,利用Excel电子表格软件计算威布尔(Weibull)分布参数,并时溶出参数m、T50、Td等采用方差分析及t检验进行统计。结果 国产与国外双嘧达莫片在30 min的溶出量均超过标示量的70％。国产该药片基本达到要求,但两者溶出参数有显著性差异(P<0.05);不同厂家的国产片间也有显著性差异(P<0.05)。结论 试验中的山东和广东药片的溶出速率较快,而德国勃林格殷格翰大药厂药片较国产药片溶出更为迅速。

Objective To compare the vitro dissolution of Dipvridamole tablets from domestic pharmaceutical facories and one abroad pharmaceutical facory Mehtods The dissolutions of Dipyridamole tablets from different factories were checked according to the USP 24th edition. Data were analyzed by WeiBulls distribution and the variance of m ,T50 ,Td were analyzed by paire t lest . Results More than 70% of the labeled a mount of tablets from domestic pharmaceutical facories and abroad facory were dissolved in 30 minutes, but statistical analysis showed they were significant in T50 , Td (P<0.05) . Conclusions The vitro dissolution of Dipyridamole tablets from Shandong and Guangdong are more rapid than from the other domestic facories. The dissolution of Borehringer Ingelheims tablets is more rapid than the home-made ones.