动态浊度法检测注射用促肝细胞生长素中的细菌内毒素

To monitoring of bactrial endotoxins in the injection of hepatocxte growth factor(HGF) by turbidimetric technique

目的 :建立注射用促肝细胞生长素 (HGF)中细菌内毒素定量分析的方法。方法 :采用动态比浊定量法考察注射用HGF对鲎试剂的干扰作用并与热原检查法进行对比试验分析。结果 :动态浊度法干扰试验结果表明 ,注射用HGF溶解液 (1mg·ml-1)对鲎试剂无干扰作用。结论 :可用动态浊度法对注射用HGF中的细菌内毒素进行质量控制。

OBJECTIVE To establish method for monitoring bactrial endotoxins of injection of hepatocxte growth factor(HGF).METHODS The interference function of HGF to TAL was investigated precisely by turbidimetric technique, and the results were compared with pyrogen method.RESULTS The test showed that the reaction with tachyplens amebocyte lysate was not disturbed by injection of HGF(1 mg·ml -1 ). CONCLUSIONS The level of endotoxin, of injection HGF, can be detected by turbidimetric technique.