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目的:应用同体系模型动态比浊法定量检测刺五加注射液中的细菌内毒素。方法:用刺五加注射液代替细菌内毒素检查用水配制不同浓度的细菌内毒素标准液,进行标准曲线的可靠性试验;对不同浓度的刺五加注射液中定量添加内毒素标准液,分别计算回收率,从中筛选出适宜的稀释倍数;再对3批刺五加注射液进行干扰试验,检测细菌内毒素的含量。结果:3批刺五加注射液的回收率均在50%～200%之间,对鲎试剂无干扰,可检测细菌内毒素的含量。结论:同体系模型动态比浊法可用于检测中药注射剂的细菌内毒素。
OBJECTIVE: To determine the bacterial endotoxin in Acanthopanax senticosus injection by dynamic nephelometry with the same system model. Methods: The acanthopanax senticosus injection was used instead of the bacterial endotoxin test water to prepare different concentrations of bacterial endotoxin standard solution, and the reliability test of the standard curve was carried out. The endotoxin standard solution was quantitatively added to acanthopanax senticosus injection The recoveries were calculated and the appropriate dilutions were screened out. Three batches of Acanthopanax senticosus injection were tested for interference and the content of bacterial endotoxin was tested. Results: The recoveries of Acanthopanax senticosus injection were all between 50% and 200%, and no interference was observed with the test reagents. The content of bacterial endotoxin was detected. Conclusion: The same system model dynamic nephelometry can be used to detect bacterial endotoxin injection of traditional Chinese medicine.