注射用核糖核酸Ⅱ细菌内毒素检查法研究  

Study on the bacterial endotoxin test for Ribonucleic Acid for Injection Ⅱ

作　　者：唐先明[1] 刘建辉[1] 宋丽阳[1] 王姝 TANG Xianming;LIU Jianhui;SONG Liyang;WANG Shu(Harbin Institute for Food and Drug Control,Harbin 150525,China)

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150525

出　　处：《中国药品标准》2018年第6期469-472,共4页Drug Standards of China

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.

关 键 词：注射用核糖核酸Ⅱ 细菌内毒素 凝胶法 干扰实验 

分 类 号：R921.2[医药卫生—药学]