摘要
目的:建立注射用苯唑西林钠细菌内毒素动态浊度法检测方法。方法:按照《中华人民共和国药典》2015年版四部,采用动态浊度法进行干扰试验,发现注射用苯唑西林钠对细菌内毒素检查有抑制作用,实验中用辅剂稀释剂Ⅰ稀释供试品以加入适量镁离子的方式消除注射用苯唑西林钠对细菌内毒素检查的抑制作用,定量测定样品中细菌内毒素含量。结果:补充适量的金属镁离子可以有效地消除注射用苯唑西林钠对细菌内毒素的抑制,降低样品的稀释倍数,细菌内毒素回收率在50%～200%之间。结论:可建立动态浊度法进行注射用苯唑西林钠细菌内毒素定量检测,样品中细菌内毒素含量均远低于《中华人民共和国药典》规定的0. 10 EU·mg^(-1),建议提高现有标准。
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 Mg^2+to eliminate the inhibition to BET.Results:Supplementing the right amount of metal cations Mg^2+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.
作者
李慧
周雪艳
龚倩
刘音
LI Hui;ZHOU Xue-yan;GONG Qian;LIU Yin(Shijiazhuang Institute for Food and Drug Control,Hebei Shijiazhuang 050000,China)
出处
《中国药物评价》
2018年第6期414-417,共4页
Chinese Journal of Drug Evaluation
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
Oxacillin sodium for injection
Bacterial endotoxin
Dynamic turbidimetry
Mg^2+
Interference test
