氨曲南及其注射剂无菌检查方法适用性试验  

Applicability of sterility test for aztreonam and its injection

作　　者：傅莉萍 王朝丽 李婷 张平 FU Liping;WANG Chaoli;LI Ting;ZHANG Ping(Department of Microbiological Laboratory,Shanghai Songjiang Institute for Food and Drug Control,Shanghai 201600,China;Haikou Pharmaceutical Factory Co.,Ltd.,Haikou 570311,China;Shanghai Medicilon Inc.,Shanghai 200120,China)

机构地区：[1]上海市松江食品药品检验所微生物检验室,上海201600 [2]海口市制药厂有限公司,海口570311 [3]上海美迪西生物医药有限公司,上海200120

出　　处：《药学服务与研究》2021年第6期419-423,共5页Pharmaceutical Care and Research

摘　　要：目的:研究并建立氨曲南及其注射剂的无菌检查方法。方法:采用薄膜过滤法,摸索消除氨曲南抑菌性的方法,接种6种阳性试验菌,对其生长情况进行对比分析。结果:采用薄膜过滤法,添加600万单位青霉素酶作为中和剂,用800 ml冲洗液进行冲洗,6种阳性试验菌生长良好。结论:青霉素酶作为氨曲南无菌检查方法的中和剂,能有效消除其抑菌性。该方法准确、高效,能有效控制氨曲南及其注射剂的质量。Objective:To research and establish an sterility test for aztreonam and its injection.Methods:The membrane filtration was used to explore a method for eliminating the antibacterial effect of aztreonam.6 positive test bacteria were inoculated and their growth was compared and analyzed.Results:With membrane filtration and addition of 6 million units of penicillinase as a neutralizing agent and 800 ml washing solution,6 positive test bacteria grew well.Conclusion:As a neutralizing agent for atreonam sterility test,penicillinase could effectively eliminate the antibacterial effect of aztreonam.This method is accurate and efficient,and could effectively assure the quality of aztreonam and its injections.

关 键 词：氨曲南 无菌检查 方法适用性试验 青霉素酶 

分 类 号：R927.1[医药卫生—药学] R978.11