罗红霉素片的微生物限度研究  

Microbial Limit Suitability Test Method for Roxithromycin Tablets

作　　者：沈锐 周剑 严海元 沈伟 SHEN Rui;ZHOU Jian;YAN Hai-Yuan;SHEN Wei(Chongqing Yongchuan Institute for Food and Drug Control,Chongqing 402160,China;Chongqing Medical and Pharmaceutical College,Chongqing China,401121;Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control,Chongqing 401121,China)

机构地区：[1]重庆市永川食品药品检验所,重庆402160 [2]重庆市食品药品检验检测研究院,重庆401121 [3]重庆市药物过程与质量控制工程技术研究中心,重庆401121

出　　处：《海峡药学》2022年第1期81-84,共4页Strait Pharmaceutical Journal

摘　　要：目的建立罗红霉素片的微生物限度检查方法。方法按《中国药典》2015年版通则1105,1106,采用平皿稀释法、薄膜过滤法分别进行测试。结果采用增加稀释液-薄膜过滤法(1∶10供试液)对需氧菌总数进行计数,霉菌和酵母菌总数计数采用平皿法(1∶10供试液,m/V),大肠埃希氏采用培养基用量100 mL的薄膜过滤法进行检查。结论薄膜过滤法可有效去除罗红霉素片对需氧菌和控制菌的抑制作用,建立切实有效的微生物限度方法学。OBJECTIVE To establish a microbial limit test method for Roxithromycin Tablets.METHODS According to the requirements of microbiological count method and control bacteria test method for non-sterile products in volume IV of Chinese Pharma copoeia(2015 edition),plate method and membrane filtration methodwere adopted for the suitability test of counting method.RESULTS The membrane filtration method was used for the determination of the total number of aerobic bacteria(1∶10 of test solution,m/V),the plate method was used for the determination of the total number of mould and yeast(1∶10 of test solution,m/V),theplate method with the amount of culture medium of 100 mL was used for the control bacteria test,which met the require ments.CONCLUSION The microbial count method combined with the plate method and membrane filtration method can effectively remove the antibacterial effect of microorganisms in Roxithromycin Tablets,which is conducive to the detection of potentially contaminated microorganisms.

关 键 词：罗红霉素片 微生物限度 抑菌 计数方法 质量控制 

分 类 号：R927[医药卫生—药学]