中国药物评价2018，Vol.35Issue(6)：414-417,4.
动态浊度法检测注射用苯唑西林钠细菌内毒素的研究
Study on Dynamic Turbidimetry of Bacterial Endotoxin Test for Oxacillin Sodium for Injection
李慧 1周雪艳 1龚倩 1刘音1
作者信息
- 1. 石家庄市食品药品检验中心,河北 石家庄 050000
- 折叠
摘要
Abstract
Objective:To establish a method of dynamic turbidimetry of bacterial endotoxin test for Oxacillin sodium for injection.Methods:According to the Chinese Pharmacopoeia 2015 fourth section, dynamic turbidimetry was used for the interference test of Oxacillin sodium for injection.The auxiliary agent dilution solutionⅠwas used to dilute test samples in order to add the right amount of metal cations Mg2+to eliminate the inhibition to BET.Results:Supplementing the right amount of metal cations Mg2+could effectively eliminate inhibition to BET and reduce the dilution factor of the sample, the recovery rate of bacterial endotoxin was within 50％-200％.Conclusion:Dynamic turbidimetry can be used for bacterial endotoxin in test of Oxacillin sodium for injection, the content of endotoxinis far less than standard of Chinese Pharmacopoeia 0.10 EU·mg-1, which suggest that the current standard to be improved.关键词
注射用苯唑西林钠/细菌内毒素/动态浊度法/镁离子/干扰试验Key words
Oxacillin sodium for injection/Bacterial endotoxin/Dynamic turbidimetry/Mg2+/Interference test分类
医药卫生引用本文复制引用
李慧,周雪艳,龚倩,刘音..动态浊度法检测注射用苯唑西林钠细菌内毒素的研究[J].中国药物评价,2018,35(6):414-417,4.
