摘要
目的:对奥美拉唑肠溶胶囊的"耐酸力"检查项进行评价。方法:采用2015年版《中国药典》方法,色谱柱为Agilent C8(4.6 mm×150 mm,5μm),以0.01 mol·L^(-1)磷酸氢二钠溶液(用磷酸调p H至7.6)-乙腈(75∶25)为流动相,检测波长302nm。结果:16个厂家的51批次奥美拉唑肠溶胶囊样品的"溶出度"与"耐酸力"检查结果相差较大。结论:2015年版《中国药典》奥美拉唑肠溶胶囊标准"耐酸力"检查项增加"如平均溶出量不小于标示量的90%,则不再进行测定。"值得商讨。
Objective：To evaluate the ＂acid resistance＂ of Omeprazole Enteric-coated Capsules. Methods： The method of ChP 2015 was adopted, the determination was performed on an Agilent Cscolumn （4. 6 mm × 150 mm, 5 μm） with the mobile phase of 0. 01 mol . L - 1 disodium hydrogen phosphate solution （ adjusted pH to 7.6 with phosphoric acid ） -acetonitrile （ 75 ： 25 ） , the detection wavelength was set at 302 nm. Results：The results of ＂dissolution＂ and＂ acid resistance＂ were quite difference for 51 batches of Omeprazole Enteric-coated Capsules from 16 manufacturers. Conclusion： It is worth discussing that the standard of Omeprazole Entericcoated Capsules in ChP 2015 added ＂acid resistance determination will not be performed if average dissolution is not less than 90% of labeled amount＂.
出处
《中国药品标准》
CAS
2016年第5期357-360,共4页
Drug Standards of China
