红霉素片微生物限度检查方法的建立

目的建立红霉素片微生物限度检查方法。方法采用薄膜过滤并在冲洗液中加入增溶剂的方法，去除红霉素片的抗菌活性。结果本方法满足《中国药典》2005年版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对红霉素片最敏感，可作为红霉素片微生物限度检查方法的质控菌株。结论该方法可作为红霉素片的常规微生物限度检查方法。

Establishment of A Method for Microbial Limit Test of Erythromycin Tablets

Aim To establish a method for microbial limit test of erythromycin tablets.Methods The filtration method was used to inhibit the residual antimicrobial activity when the solubilizer was added into the solution.Results The method could pass the validation test of Chinese Pharmacopoeia 2005.The Bacillus subtilis was the most sensitive of the five validation strains,which is recommended as positive control in experiments.Conclusion The method can be used in microbial limit test for erythromycin tablets prepara...