Objective To establish a microbial limit test method for Roxithromycin Capsules based on the microbial suitability test.Methods According to the requirements of the biological examination method in the general rule 1100 of the Chinese Pharmacopoeia(2020 Edition Volume Ⅳ),the recovery test was carried out by the plate-count method,membrane filtration method,and dilution-neutralization method to study the microbial counting and control bacterial test methods.Results Dilution-neutralization method combined with the membrane filtration method with membrane filtration could effectively remove the antimicrobial activity of roxithromycin,and the recovery rate could meet the requirements.Conclusion The established test method can meet the requirements of the Chinese Pharmacopoeia,and can be used as the microbial limit test method for Roxithromycin Capsules.
关键词
罗红霉素胶囊/微生物方法验证/计数方法适用性试验/薄膜过滤法
Key words
Roxithromycin Capsules/microbial method validation/suitability test of counting method/membrane filtration method
维普
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