红霉素软膏微生物限度试验方法的验证

Verification of microbial limit test method for erythromycin ointment

目的:建立红霉素软膏的微生物限度检查方法。方法:用3个批号的红霉素软膏进行微生物限度试验的验证,确定适合红霉素软膏的微生物限度检查方法。结果:所采用的方法能有效消除红霉素的抑菌成分,使实验结果能真实反映产品微生物污染的情况。结论:可采用薄膜过滤法对红霉素软膏进行微生物限度试验。

Objective:To establish a method for microbial limit test in erythromycin ointment.Methods:According to the microbial limit standard of the test product,the verification test was conducted with three batches of erythromycin ointment to investigate the test method for determining microbial limit of erythromycin ointment.Results:The method used could effectively remove the bacteriostatic components in erythromycin ointment,so that the experimental results could truly reflect the situation of contaminated bacteria.Conclusion:The microbial limit of erythromycin ointment can be examined by membrane filtration.