盐酸莫西沙星片微生物限度方法适用性研究

Methodological Study on Microbial Limit Test of Moxifloxacin Hydrochloride Tablets

目的建立盐酸莫西沙星片微生物限度检查方法。方法按照《中国药典》2015年版四部通则进行盐酸莫西沙星片微生物限度检查方法适用性试验,对供试液稀释级、中和剂的种类、薄膜过滤冲洗液体积和初始浓度、菌液加入时间等进行考察,通过试验菌株的回收试验确立需氧菌总数、霉菌和酵母菌总数计数方法,并确立大肠埃希菌的检查方法。结果试验样品盐酸莫西沙星片的需氧菌总数检查需采用1:103稀释级供试液,联合使用薄膜过滤法和中和法去除其抑菌性。霉菌和酵母菌总数可增加稀释液体积,取1:50供试液,采用平皿倾注法进行检验。大肠埃希菌检查采用薄膜过滤结合中和剂硫酸镁的方法。结论建立的盐酸莫西沙星片微生物限度检查方法符合《中国药典》2015年版要求,可用于常规的药品质量控制检验工作。

Objective To establish methods of microbial limits for Moxifloxacin Hydrochloride Tablets. Methods Applicability tests were conducted according to the general principles of the 2015 edition Chinese pharmacopoeia. We had experiments on the following aspects： dilution level of the test liquid, varieties of neutralizing agent, volume of rinse solution, initial concentration of the filtrate and time of bacteria suspension＇s joining. The count methods were established by the recovery tests with tested strains. The method for the detection of Escherichia1 coli was also established. Results The antimicrobial activities on bacteria can be eliminated effectively through the membrane filtration method combined with the neutralization method, while level 1：103 diluted solution to be used in the test of the total number of aerobe. The total number of mold and yeast can be detected with 1：50 diluted solution, by agar pouring method. The membrane filtration method combined with the neutralizing agent, magnesium sulfate can be used in the examining of Escherichia coli.Conclusion The method met the requirements of the 2015 edition Chinese pharmacopoeia and can be used in conventional microbial limits test for Moxifloxacin Hydrochloride Tablets.