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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 a method for quantitative analysis of bacterial endotoxin in hepatocyte growth-promoting hormone (HGF) for injection. Methods: The turbidimetric method was used to investigate the interference effect of HGF on the injection of HGF and the comparative analysis with pyrogen test. Results: The result of dynamic turbidity interference test showed that HGF solution for injection (1mg · ml-1) did not interfere with the stilbene reagent. Conclusion: The bacterial endotoxin in HGF for injection can be controlled by dynamic turbidity method.