【摘要】 目的对6厂家小剂量阿司匹林肠溶制剂溶出度进行考察,为临床用药选择提供参考。方法采用2005年版《中国药典》溶出度测定的转篮法进行体外溶出度实验,对溶出数据进行威布尔方程拟合并获取释放参数(T50,Td,m);以相似因子f2为指标,比较各制剂溶出曲线的相似性。结果产家D、E和F的T50和Td较短,与厂家A(德国拜耳)生产的肠溶阿司匹林(即拜阿司匹灵)产品有统计学差异(P<0.05);以A为参比,B、C、D、E和F药厂产品的溶出度曲线的相似因子分别为42、52、28、29和31。结论各厂产品体外溶出均符合药典规定,厂家C与厂家A的溶出曲线具有相似性。更多还原

【Abstract】 OBJECTIVE To investigate of the dissolution results in virtro of low-dose aspirin enteric-coated drugs from six manufactures and provide suggestions for clinical use.METHODS The dissolution tests were carried out in dissolution test system with the rotating basket of Pharmacopoeia of People′s Republic of China.The T50,Td and m value were figured out by the Weibull′s equation,and similarity for dissolution profiles were evaluated by f2 factor.RESULTS T50 and Td of drugs from manufacturers D、E and F was smaller,and there were significant differences in between drugs from manufacturer A(made by Bayer Schering Pharma Ltd.);Compared with the A,the similarity factors of the drugs from manufacturers B、C、D、Eand F were 42,52,28,29 and 31,respectively.CONCLUSION The dissolution results of six kinds of aspirin drugs all met with the requirements of the Pharmacopoeia.The dissolution characteristics for product from manufacturer C was similar to Bayer Schering Pharma Ltd.更多还原