动态浊度法检测水蛭注射液中细菌内毒素  

Quantitative method for the Measurement of bacterial endotoxin in Hirudo injection

作　　者：肖伟 

机构地区：[1]黑龙江惠美佳制药有限公司,黑龙江牡丹江157100

出　　处：《世界最新医学信息文摘》2012年第8期9-10,共2页World Latest Medicine Information Electronic Version

摘　　要：目的建立动态浊度法定量检测水蛭注射液中的细菌内毒素。方法按中国药典2010版二部收栽的细菌内毒素检查方法及其指导原则进行干扰试验，并与热源检查法比较。结果当样品作200倍稀释时用动态浊度法进行测试未见干扰作用，与热源法测试结果一致，均符合规定。结论该样品可以用动态浊度法进行定量检测水蛭注射液中的内毒素。Objective To develop an assay for determination of bacterial endotoxin in Hirudo injection and compare it with pyrogens test. Methods Detection was carried out according to the bacterial endotoxin test procedure and guiding principle for interfere factors test in Chinese Pharmacopeia, 2005 edition. Rsuits Hirudo injection did not interfere with limulus agent in 200 diluted concentration, It can get the same result which meets Pharmacopeia, 2005 edition using the two methods. Conclusion Turbidimetric-Kinetic method for the Measurement of bacterial endotoxin could be used in in Hirudo injection.

关 键 词：水蛭注射液 细菌内毒素 动态浊度法 

分 类 号：R927.1[医药卫生—药学]