克拉霉素片微生物限度检查方法学验证研究

Validation of microbial limit test of Clarithromycin Tablets

目的确定克拉霉素片微生物检查方法。方法采用离心与薄膜过滤联合法对克拉霉素片试验菌回收率的有效性进行评价。结果离心与薄膜过滤联合法的细菌、真菌回收率均高于70%。结论采用离心与薄膜滤过联合法测定细菌、真菌数,可有效除去克拉霉素片中的抑菌成分,使检验结果更准确、可靠。

Objective To establish a method for the microbial limit test of Clarithromycin Tablets. Methods The methods of centrifugation and membrane filtration were combined to evaluate the recovery rate of test bacteria in Clarithromycin Tablets. The antimicrobial effect of Clarithromycin Tablets was determined by recovery rate of the test bacteria. Results The recovery rates of bacteria and fungi in Cla- rithromycin Tablets were both over 70%. Conclusion The combination of centrifugation and membrane filtration can be used effectively in the microbial limit test of Clarithromycin Tablets. It is accurate and reliable.