盐酸莫西沙星原料药微生物限度检测方法验证  

Methodological validation of microbial limit test for moxifloxacin hydrochloride

作　　者：孙蓉 潘玲利 张军东 SUN Rong;PAN Lingli;ZHANG Jundong(Shanghai Haohai Biotechnology Co., Ltd., Shanghai 201613, China;Shanghai Li Kang Rui Biological Engineering Co., Ltd., Shanghai 201707, China)

机构地区：[1]上海昊海生物科技股份有限公司,上海201613 [2]上海利康瑞生物工程有限公司,上海201707

出　　处：《上海医药》2019年第13期68-72,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立合适的盐酸莫西沙星原料的微生物限度检测方法,对该方法进行验证,确保适用。方法:根据中国药典2015版指导原则,采用薄膜过滤法,分别以聚山梨酯80和氯化镁作为中和剂,比较对盐酸莫西沙星的抑菌活性的影响。结果:加入氯化镁作为中和剂可以较好的消除盐酸莫西沙星的抑菌活性。结论:该方法准确,可靠,操作方便,适用于盐酸莫西沙星原料的微生物限度检测。Objective: To establish a suitable method for the detection of the microbiological limit in moxifloxacin raw material and to verify the method so as to ensure its application. Methods: The effects of polysorbitol 80 and magnesium chloride as neutralizers on the antibacterial activity of moxifloxacin itsself in microbiological limit test were compared by membrane filtration method based on the Guideline of Chinese Pharmacopoeia 2015 Edition. Results: The antibacterial activity of moxifloxacin itsself could be better eliminated when magnesium chloride was added. Conclusion: This method is accurate, reliable, and convenient to operate and is suitable for the detection of microbial limits in moxifloxacin hydrochloride raw materials.

关 键 词：盐酸莫西沙星 微生物限度 薄膜过滤法 

分 类 号：R927.11[医药卫生—药学]