头孢泊肟酯片溶出度方法研究

Studies On Dissolution Method Of Cefpodoxime Proxetil Tablets

目的:考察国内12个生产企业62批头孢泊肟酯片的溶出度情况,对其现行标准方法的合理性与有效性进行评价。方法:分别采用《中国药典》2010年版、《美国药典》35版与《日本药局方》16版所收载方法测定头孢泊肟酯片的累积溶出量。结果:采用《中国药典》的方法检查,国内12个生产企业的62批样品溶出度合格率为100%,而采用《美国药典》与《日本药局方》的方法测定,合格率仅分别为40.3%与30.7%;大部分生产企业的样品的3条累积溶出曲线与国外原研制剂相差较大。结论:头孢泊肟酯片现行标准中的溶出度检查方法不能很好的区分不同处方的产品质量,同时,根据头孢泊肟酯制剂需饭后服用的要求(餐后胃液pH值为3.5),该溶出介质也不能合理地反映产品在体内的真实溶出状况,建议对该检验方法进行修订。

Objective： To investigate the dissolutions of 62 Cefpodoxime Proxetil Tablets produced by 12 domestic enterprises, and to evaluate the rationality and efficacy of the present dissolution method. Methods： The cumulative dissolutions were determined by the methods recorded in ChP 2010, USP 35 and JP 16. Results： All the samples of Cefpodoxime Proxetil Tablets were qualified by the method in ChP 2010,but only 40. 3% and 30. 7% by the method in USP 35 and JP 16, respectively. Vast differences also existed in cumulative stripping curves between original products and domestic samples. Conclusion： The present dissolution method cannot distinguish the quality of different prescriptions, and the solution cannot reasonably reflect the real dissolution in body according to the requirements of taking Cefpodoxime Proxetil Tablets （after meal postprandial gastric pH is 3.5 ） . Amendments are recommended to revise the test method.