动态浊度法对血塞通注射液细菌内毒素的定量分析

Quantitative Determination of Bacterial Endotoxin in Xuesaitong Injection by Kinetic Turbidimetric Assay

目的建立血塞通注射液中内毒素的定量分析方法。方法采用2005年版《中国药典》细菌内毒素的动态浊度法测定血塞通注射液内毒素。结果血塞通注射液的16倍及以上稀释液对鲎试剂(TAL)反应无干扰作用,细菌内毒素的含量测定结果与热原检查结果一致。结论用动态浊度法定量测定血塞通注射液中的内毒素含量是可行的。

OBJECTIVE： To establish a method for quantitative analysis of bacterial endotoxin in Xuesaitong injection METHODS： The kinetic turbidimetry assay, stipulated in China Pharmacopeia （2005 Edition）, was adopted for determination of bacterial endotoxin in Xuesaitong injection. RESULTS： No interference in the response to TAL reagents was seen in the test conducted with Xuesaitong Injection diluted in 1 ： 16 or more, and the result obtained by kinetic turbidimetry was consistent with that by pyrogen test. CONCLUSIONS： It is feasible to use kinetic turbidimetry assay for the determination of bacterial endotoxin in Xuesaitong injection.