摘要
为探索痰热清注射液细菌内毒素检查方法,依据《中华人民共和国药典:四部》(2015年版),确定痰热清注射液中细菌内毒素限值,同时运用凝胶法和动态浊度法测定其内毒素的含量.结果表明,采用凝胶法需要将其稀释至48倍及以上才能消除对鲎试剂的干扰作用,而动态浊度法则需稀释至240倍及以上,此时后者外加细菌内毒素的回收率在合理范围内,为50%～200%.因此,两种方法均可用于其内毒素含量的测定.
To explore the method for the determination of bacterial endotoxin in tanreqing injection,according to Pharmacopeia of PRC:Volume IV(2015edition),the limit for bacterial endotoxin was determined and at the same time,Adopt gel-clot and kinetic turbidity method for the determination of the bacterial endotoxin in the tanreqing injection were applied.The result showed that the interference effect to the limulus amoebocyte lysate test was excluded in the gel-clot method,when the samples were diluted to48times or more,but in the kinetic turbidity method,the samples should be diluted240times or more,and the recovery of the added endotoxin in the samples was within the reasonable range(50%-200%).Both methods are suitable for bacterial endotoxin test of tanreqing injection.
作者
牛杰振
何漫漫
刘丽霞
马跃新
李应才
刘黔
NIU Jiezhen;HE Manman;LIU Lixia;MA Yuexin;LI Yingcai;LIU Qian(Institute for Drug Control,Kunming Institute for Food and Drug Control,Kunming,Yunnan,China 650032;College of Life Science and Technology,Kunming University of Science and Technology,Kunming,Yunnan,China 650500;Institute for Food Control,Kunming Institute for Food and Drug Control,Kunming,Yunnan,China 650032)
出处
《昆明学院学报》
2018年第6期100-104,共5页
Journal of Kunming University
关键词
痰热清注射液
细菌内毒素
凝胶法
动态浊度法
干扰作用
tanreqing injection
bacterial endotoxin
gel-clot method
kinetic turbidity method
interference effect
