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目的建立诺氟沙星胶囊的微生物限度检查方法。方法按照《中国药典》2015年版规定方法,需氧菌总数检查采用薄膜过滤法,霉菌和酵母菌总数检查采用平皿法,大肠埃希菌检查采用薄膜过滤法。结果各试验菌的回收比值均符合药典规定,控制菌检查中阳性对照试验检出大肠埃希菌。中和剂硫酸镁能有效去除诺氟沙星胶囊的抗菌活性。结论该法可用于诺氟沙星胶囊的微生物限度检查。
Objective To establish a microbiological limit test for norfloxacin capsules. Methods According to “Chinese Pharmacopoeia” 2015 version of the provisions of the method, the total number of aerobic bacteria using membrane filtration method, the total number of molds and yeasts using plate method, screening of Escherichia coli using membrane filtration method. Results The recovery ratio of each test bacteria were in line with the provisions of Pharmacopoeia, positive control test control bacteria were detected in Escherichia coli. The neutralization agent magnesium sulfate can effectively remove norfloxacin capsules antibacterial activity. Conclusion This method can be used to check the limit of micro-organisms of norfloxacin capsules.