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目的:建立注射用红花黄色素的细菌内毒素检查方法,以控制药物质量,减少临床热原反应的发生.方法:按中国药典2015年版四部收载的细菌内毒素检测及指导原则进行操作,系统观察注射用红花黄色素对鲎试剂与细菌内毒素凝聚反应的干扰.确定凝胶法检测细菌内毒素的不干扰浓度.结果:注射用红花黄色素在稀释到0.4 mg·ml-1及以下浓度对鲎试剂干扰试验无干扰作用.结论:注射用红花黄色素可采用细菌内毒素检查法(凝胶法)进行细菌内毒素的限量检查,结果准确,重复性好.“,”Objective:To establish a bacterial endotoxin test for safflower yellow for injection to control the drug quality and reduce the incidence of clinical pyrogenic reaction. Methods:The bacterial endotoxin test was carried out according to the methods and guid-ing principles in Chinese Pharmacopoeia ( 2015 edition, volumeⅣ) . A systematic study was carried out to investigate the interference of safflower yellow for injection with limulus reagent and agglutination reaction to bacterial endotoxin in order to detect the non-interfer-ence concentration of bacterial endotoxin. Results: Safflower yellow for injection with the concentration below or equal to 0. 4 mg· ml-1 had no interference with tachypiens amebocyte lysate. Conclusion: Bacterial endotoxin test ( gel method) can be used for the limit test of bacterial endotoxin of safflower yellow for injection, and the results are accurate and reproducible.