动态浊度法测定血栓通注射液细菌内毒素含量

Determination of Bacterial Endotoxin in Xueshuantong Injecta by Kinetic Nephelometry

目的:建立血栓通注射液中细菌内毒素定量分析方法.方法:参照《中国药典》2010年版二部细菌内毒素检查法进行试验,将样品进行25～200倍稀释可以有效地消除其对鲎试验的干扰.结果与结论:用动态浊度法定量测定血栓通注射液中的细菌内毒素是可行的.

Objective：To establish a kinetic nephelimetry method for the determination of bacterial endotoxin in Xueshuantong Injecta. Methods：In accordance with the Bacterial Endotoxin test in China Pharmacopoeia （2010,Volume Ⅱ ）the samples were diluted respectively from 25 to 200 folds.And then the interference for Limulus test was eliminated effectively. Results and Conclusion：The kinetic nephelometric assay can be used for quantitative determination of bacterial endotoxin in Xueshantong Injecta.