摘要
探讨采用鲎试剂法代替家兔法进行复方泛影葡胺注射液热原物质检查的可行性.根据临床最大给药剂量计算细菌内毒素限值,按《中国药典》2015年版四部进行实验和结果判断.实验结果表明复方泛影葡胺注射液稀释20倍时对细菌内毒素检查无干扰,细菌内毒素限值为1. 25 EU·m L-1.对3批复方泛影葡胺注射液进行常规检查,结果均符合规定.本项研究建立的复方泛影葡胺注射液细菌内毒素检查法可以替代原有的家兔热原检查法.
To investigate the feasibility of replacing pyrogen test with tachypleus amebocyte lysate test for compound meglumine diatrizoate injection.According to the maximum dosage of the drug prescribed,the limiting value of bacterial endotoxin in the drug was set,and the experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition Vol Ⅳ.The experimental results showed that the interference on bacterial endotoxin test could be excluded when the sample was diluted 20 times.The limit value of the bacterial endotoxin was 1.25 EU·mL^-1 .According to the established standard,the results of bacterial endotoxin test in 3 batches of samples were conformed to the required stipulation.The established bacterial endotoxin test bacterial endotoxin test can be used for compound meglumine diatrizoate injection to replace pyrogen test.
作者
唐先明
刘建辉
宋丽阳
王姝
TANG Xian-ming;LIU Jian-hui;SONG Li-yang;WANG Shu(Harbin Food and Drug Inspection Center,Harbin 150525,China)
出处
《哈尔滨商业大学学报（自然科学版）》
CAS
2019年第2期134-137,共4页
Journal of Harbin University of Commerce：Natural Sciences Edition
关键词
复方泛影葡胺注射液
细菌内毒素
凝胶法
干扰实验
鲎试剂
可行性
compound meglumine diatrizoate injection
bacterial endotoxin
gel method
interference test
tachypleus amebocyte lysate
feasibility
