注射用头孢呋辛钠无菌检查法的优化  

Optimization of the sterility test method of cefuroxime sodium for injection

作　　者：欧国栋 江艳芳 肖建光[1] 刘钰纯 赖珊[1] Ou Guodong;Jiang Yanfang;Xiao Jianguang;Liu Yuchun;Lai Shan(Guangdong Institute of Drug Control,Guangzhou 510663)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国抗生素杂志》2025年第3期357-362,共6页Chinese Journal of Antibiotics

基　　金：2024年国家药品抽检中央补助地方经费项目资助国药监药管(No.[2024]1号)。

摘　　要：目的对注射用头孢呋辛钠无菌检查法进行优化并建立符合新版《中国药典》要求的统一检测方法。方法依据《中国药典》2025年版四部通则1101无菌检查法公示稿(第二次),通过对供试液浓度、每膜过滤样品量、试验菌株和阳性对照菌、冲洗液和冲洗次数、中和剂及其使用方式、使用量等因素的考察,对注射用头孢呋辛钠无菌检查中的供试液浓度、冲洗液和冲洗次数、中和剂及其使用量等方面进行优化。结果采用与2020年版《中国药典》相同的菌株为试验菌,使用优化的无菌检查法对21个厂家的样品进行实验确认,结果均符合规定。结论该方法能有效去除注射用头孢呋辛钠的抑菌性,操作简单,高效可靠,可作为适合《中国药典》新变化的无菌检查方法应用。Objective To optimize the sterility test method of cefuroxime sodium for injection and establish a unified test method that met the new requirements for the Chinese Pharmacopoeia.Methods Based on the second draft of public notice for the sterility test method in general rule 1101 of Chinese Pharmacopoeia No.4(2025 Edition),the factors such as the concentration of test solution,the volume of samples filtered per membrane,the test strains and positive control strains,the rinse solution and rinsing times,the neutralizer and its usage,the usage amount,etc,were investigated to optimize the sterility test method of cefuroxime sodium for injection in the aspects of the concentration of test solution,the rinse solution and its rinsing times,the neutralizer and its usage amount,etc.Results The optimized sterility test method was used to experimentally confirm the samples from twenty.one manufacturers,using the same strain as the 2020 edition as test strains,and all the results met the requirements.Conclusion This method,effectively eliminating bacteriostasis and suitable for the new changes in the Chinese Pharmacopoeia,can be used as a sterility test method of cefuroxime sodium for injection,which is easy to operate,efficient and reliable.

关 键 词：注射用头孢呋辛钠 无菌检查法 头孢菌素酶 阳性对照 方法适用性试验 

分 类 号：R917[医药卫生—药物分析学]