摘要
目的:建立注射用核糖核酸Ⅱ的细菌内毒素检查方法。方法:按《中国药典》2015年版四部通则进行实验和结果判断。结果:注射用核糖核酸Ⅱ稀释至1. 0mg·mL^(-1)时对细菌内毒素检查无干扰,细菌内毒素限值为0. 5 EU·mg^(-1)。对3批注射用核糖核酸Ⅱ进行常规检查,结果均符合规定。结论:所建立的细菌内毒素检查法可用于注射用核糖核酸Ⅱ的细菌内毒素检查。
Objective:To establish a bacterial endotoxin test method for Ribonucleic Acid for Injection Ⅱ. Method:The test was performed and the results were judged according to general notice of Chinese Pharmacopeia 2015 Vol Ⅳ.Results:There was no interference on bacterial endotoxin test when Ribonucleic Acid sodium was diluted to 1.0mg·mL^-1 solution.The limit value of bacterial endotoxin was 0.5EU·mg^-1 .The bacterial endotoxin test results of 3 batches of samples conformed to the requirements.Conclusion:The established bacterial endotoxin test method is applicable to bacterial endotoxin test of Ribonucleic Acid for Injection Ⅱ.
作者
唐先明
刘建辉
宋丽阳
王姝
TANG Xianming;LIU Jianhui;SONG Liyang;WANG Shu(Harbin Institute for Food and Drug Control,Harbin 150525,China)
出处
《中国药品标准》
CAS
2018年第6期469-472,共4页
Drug Standards of China
关键词
注射用核糖核酸Ⅱ
细菌内毒素
凝胶法
干扰实验
Ribonucleic Acid for Injection Ⅱ
bacterial endotoxin
gel method
interference test