国产与进口奥美拉唑肠溶制剂的质量对比

Quality Comparison between Domestic and Imported Omeprazole Enteric-coated Preparations

目的:对国产与进口奥美拉唑肠溶制剂进行质量对比。方法:参照《中国药典》2005年版二部奥关拉唑的质量标准,对含量、缓冲液中释放度进行测定,并用威布尔(Weibull)分布模型拟合溶出曲线,并对缓冲液中释放参数m,T_(50),T_d等采用方差分析及t检验进行统计。同时增加耐酸力考察。结果:国产与进口奥美拉唑肠溶制剂含量、释放度均符合规定,无显著性差异(P>0.05),但耐酸力、缓冲液中释放度参数m,T_(50),T_d有显著差异(P<0.05或P<0.01)。结论:国产与进口奥美拉唑肠溶制剂质量不完全一致。

Objective： To compare the quality of domestic and imported omeprazole enteric-coated preparations.Method： The content and release rate were tested according to Chinese Pharmacopoeia 2005 Edition（Volume Ⅱ ）.The Weibull distribution model was adopted in dissolution curve.The parameters of m,T50,Td were statistically analyzed by analysis variance and t test.At the same time acid tolerance rate was tested. Result： The content and release rate showed no significant difference （P〉0.05）,while m,T50,Td and acid tolerance showed significant difference （P〈0.05 or P〈0.01） between domestic and imported omeprazole enteric-coated preparations. Conclusion：The quality of domestic and imported omeprazole enteric-coated preparations showed some difference.