注射用盐酸溴己新原料中细菌内毒素的检测  

Study on the bacterial endotoxin test in the raw material of bromhexine hydrochloride for injection

作　　者：林金海 陈晓佳 丁友玲 LIN Jinhai;CHEN Xiaojia;DING Youling(Fuzhou Xinbei Biochemical Industrial Co.,Ltd.,Fuzhou 350101,China)

机构地区：[1]福州新北生化工业有限公司,福州350101

出　　处：《上海医药》2020年第7期75-77,共3页Shanghai Medical & Pharmaceutical Journal

基　　金：国家“十三五”海洋经济创新发展示范项目(FZHJ10)。

摘　　要：目的:建立注射用盐酸溴己新原料中细菌内毒素的检测方法。方法:对盐酸溴己新原料预处理后再进行细菌内毒素检测,并依据《中华人民共和国药典》2015年版细菌内毒素检查法中的干扰实验对预处理方法进行验证。结果:预处理并稀释160倍后的盐酸溴己新原料对鲎试剂(λ=0.06 EU/ml)无干扰作用。结论:所建立的注射用盐酸溴己新原料中细菌内毒素检测方法是可行的。Objective:To establish a method for the bacterial endotoxin test in the raw material of bromhexine hydrochloride for injection.Methods:The raw material of bromhexine hydrochloride for injection was pretreated and then bacterial endotoxin test was performed.The method was veri fied based on the interference experiment in the bacterial endotoxin test section of Chinese Pharmacopoeia 2015 Edition.Results:There was no interference on tachypleus amebocyte lysate(λ=0.06 EU/ml)after it was pretreated and diluted by 160 times.Conclusion:The established method can be used for the bacterial endotoxin test in the raw material of bromhexine hydrochloride for injection.

关 键 词：细菌内毒素 盐酸溴己新 干扰实验 

分 类 号：R927.12[医药卫生—药学] R974.1