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.
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)
出处
《药学服务与研究》
CAS
2021年第6期419-423,共5页
Pharmaceutical Care and Research
