不同厂家奥美拉唑肠溶胶囊的体外溶出度比较

Comparison of in Vitro Dissolution of Omeprazole Enteric-coated Capsules from Seven Different Pharmaceutical Factories

目的比较7个厂家奥美拉唑肠溶胶囊的体外溶出度,为临床用药提供参考。方法采用桨法进行体外溶出度实验,以高效液相色谱法进行含量测定,计算累积溶出百分率。以威布尔方程拟合溶出参数,并用方差分析对组间溶出参数进行统计学处理。结果7个奥美拉唑肠溶胶囊体外溶出度均符合《中国药典》(2005年版)的规定,但各厂家奥美拉唑肠溶胶囊的溶出参数m、t30、t50、td、t80间存在显著性差异(P<0.01)。结论不同厂家奥美拉唑肠溶胶囊的溶出参数存在差异,临床用药时应加以注意。

Aim To compare the in vitro dissolution of Omeprazole Enteric-coated capsules from seven different pharmaceutical factories and offer suggestions on clinical use.Methods Dissolution tests were carried out with a rotating paddle.High-performance liquid chromatography was used to determine the concentration of Omeprazole.The cumulative dissolution was calculated and the Weibull equation was used to fit the dissolution parameters.The difference between groups was statistically evaluated by variance analysis.Results The in vitro dissolution of these Omeprazole Enteric-coated capsules all fulfilled the requirements of Chinese Pharmacopoeia（2005 edition）.But significant difference of dissolution parameters m,td,t30,t50 and t80 was found（P〈0.01）between these Omeprazole Enteric-coated capsules.Conclusion There is significant difference in dissolution parameters of the Omeprazole Enteric-coated capsules from seven different pharmaceutical factories,indicating that attention should be paid to their difference in clinical use.