阿奇霉素分散片微生物限度检查方法验证

Method Validation of Microbial Limit Test for Azithromycin Dispersible Tablets

目的建立阿奇霉素分散片的微生物限度检查方法。方法人工加入5种阳性对照菌,测定其回收率。结果根据回收率试验结果,判定阿奇霉素分散片对细菌的抑菌作用强。结论必须采用离心集菌薄膜法才能清除样品的抑菌作用,该法可用于阿奇霉素分散片的微生物限度检查。

Objective To establish the microbial limit test method for azithromycin dispersible tablets. Methods The antimicrobial effect of azithromycin dispersible tablets was determined by recovery rate with 5 control strains. Results According to the results of the recovery rate test, azithromycin dispersible tablets had higher antimicrobial effects. Conclusion The antimicrobial effect must be eliminated by centrifugation and membrane filtration. The method can be used to the microbial limit test for azithromycin dispersible tablets.