注射用红花黄色素细菌内毒素检查法可行性研究

Feasibility Study on Bacterial Endotoxin Test for Safflower Yellow for Injection

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, volume IV ）. 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.