丹红注射液凝胶法和动态浊度法细菌内毒素检查  

Detection of Bacterial Endotoxin in Danhong Injection by the Methods of Gel-clot Test and Kinetic Turbidimetric Limulus Test

作　　者：魏霞[1] 国明[1] 祝清芬[1] 李涛[1] 

机构地区：[1]山东省食品药品检验所,济南250101

出　　处：《中国药事》2012年第12期1357-1359,1376,共4页Chinese Pharmaceutical Affairs

基　　金：山东省中医药科学技术研究项目(编号2011-238)

摘　　要：目的应用凝胶法和动态浊度法检查丹红注射液中的细菌内毒素含量。方法按《中国药典》2010年版方法,确定丹红注射液细菌内毒素限值,分别进行凝胶法和动态浊度法细菌内毒素检查的干扰试验。结果凝胶法结果表明,本品稀释40倍后对试验无干扰作用;动态浊度法结果表明,本品在稀释40倍时外加内毒素回收率在50%～200%之间。结论凝胶法和动态浊度法可用于丹红注射液中的细菌内毒素检查。Objective To measure the endotoxin concentration in Danhong Injection by gel-clot test and kinetic turbidimetric test.Methods The limit for bacterial endotoxin in this product was designed according to CP2010.The interfering factor tests of the above-mentioned methods were carried out respectively.Results For the gel-clot method,there showed no interference effect when the sample was diluted to 40 times or more of its original volume.The kinetic turbidimetric test result showed that the recovery of the added endotoxin in the sample solution was within 50% to 200% when the sample was diluted to 40 times of its original volume.Conclusion Both the gel-clot test and the kinetic turbidimetric test are suitable for bacterial endotoxin test of Danhong Injection.

关 键 词：丹红注射液 细菌内毒素 干扰试验 凝胶法 动态浊度法 

分 类 号：R927.12[医药卫生—药学] R289-03