摘要
建立盐酸环丙沙星的微生物限度检测方法。按照《中国药典》2020版通则1105、1106,利用0.5 g/mL的硫酸镁溶液中的镁离子与盐酸环丙沙星结构中3、4位的羧基和酮羰基形成螯合物,中和其抑菌能力,采用薄膜过滤法,用pH值7.0氯化钠-蛋白胨缓冲液冲洗过滤。需氧菌总数、霉菌和酵母菌总数计数方法适用性试验回收率在50%~200%之间,大肠埃希菌(控制菌检查)适用性试验满足要求。可用于盐酸环丙沙星微生物限度计数和控制菌检测。
To establish a microbial limit test method for ciprofloxacin hydrochloride.According to General Principles 1105 and 1106 of Chinese Pharmacopoeia Edition 2020,magnesium ions in magnesium sulfate solution of 0.5 g/mL form chelate with carboxyl group and ketocarbonyl group at positions 3,4 in ciprofloxacin hydrochloride structure,neutralize its bacteriostasis ability,adopt membrane f iltration method,and rinse and f ilter with sodium chloride-peptone buffer solution of pH 7.0.The recoveries of aerobic bacteria,mould and yeast were between 50%-200%,and the suitability test of Escherichia coli(control bacteria test)met the requirements.The method can be used for microbial limit counting and control bacteria detection of ciprofloxacin hydrochloride.
作者
周东方
朱菊红
董秀玉
朱飞松
ZHOU Dongfang;ZHU Juhong;DONG Xiuyu;ZHU Feisong(Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co.,Ltd.,Lishui 323000,China;Dongyang Medical Security Center,Dongyang 322100,China;Zhejiang Funuo Medicine Co.,Ltd.,Dongyang 322100,China)
出处
《化工管理》
2024年第1期38-41,共4页
Chemical Engineering Management
关键词
微生物限度
盐酸环丙沙星
适用性试验
薄膜过滤法
microbial limit
ciprofloxacin hydrochloride
suitability test
membrane f iltration
