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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 omeprazole enteric-coated preparations made in China and imported. Methods: According to the quality standard of two Chinese omeprazole (EP) 2005 edition, the content and the release degree of buffer were determined. The dissolution curve was fitted by Weibull distribution model. The release parameters m, T_ (50), T_d and other analysis of variance and t test statistics. At the same time increase the acid resistance inspection. Results: The content and release of omeprazole enteric preparations both in China and in China were in line with the regulations, but there was no significant difference (P> 0.05), but the acid resistance and the release parameters m, T 50 and T d in the buffer were significant Difference (P <0.05 or P <0.01). Conclusion: The quality of enteric-coated preparations of domestic and imported omeprazole is not exactly the same.