盐酸环丙沙星的微生物限度检查方法学验证
Methodology Validation of Microbial Limit Test for Ciprofloxacin Hydrochloride
周东方 1朱菊红 1董秀玉 2朱飞松3
作者信息
- 1. 浙江华润三九众益制药有限公司,浙江 丽水 323000
- 2. 东阳市医疗保障中心,浙江 东阳 322100
- 3. 浙江孚诺医药股份有限公司,浙江 东阳 322100
- 折叠
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.
Abstract
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 filtration method,and rinse and filter 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.
关键词
微生物限度/盐酸环丙沙星/适用性试验/薄膜过滤法Key words
microbial limit/ciprofloxacin hydrochloride/suitability test/membrane filtration引用本文复制引用
出版年
2024
NETL
NSTL
万方数据