头孢泊肟酯片微生物限度检查方法的建立

Establishment of Method for Microbial Limit Test of Cefpodoxime Proxetil Tablets

目的:建立头孢泊肟酯片微生物限度检查方法。方法:采用薄膜过滤并在培养基中加入中和剂的方法,去除头孢泊肟酯片的抗菌活性。结果:本方法满足中国药典2010版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对头孢泊肟酯片最敏感,可作为头孢泊肟酯片微生物限度检查方法的质控菌株。结论:该方法可作为头孢泊肟酯片的常规微生物限度检查方法。

Objective： To establish a method for microbial limit test of cefpodoxime proxetil tablets. Methods： The membrane filtration method was used and neutralizer was added into the culture media to inhibit the residual antimicrobial activity of cefpodoxime proxetil. Results： The method can pass the validation test of Chinese pharmacopoeia （2010 version）. The bacillus subtilis is the most sensitive strain among the five validation strains, which is recommended as positive control for microbial limit test of cefpodoxime proxetil tablets. Conclusion： The method can be used as routine microbial limit test for cefpodoxime proxetil tablets.