依达拉奉注射液细菌内毒素检查的质量标准研究

目的统一依达拉奉注射液细菌内毒素检查限值，为依达拉奉注射液标准的提高提供参考。方法按《中国药典））2010年版二部附录细菌内毒素检查法，采用2个不同厂家的鲎试剂对5个不同厂家的依达拉奉注射液样品进行研究。结果依达拉奉注射液最大不干扰浓度为0．1875mg／mL，可将细菌内毒素检查限值在现行国家标准基础上统一提高至“每毫克小于0．33EU”。结论统一后的限值可行，可更严格控制产品中的内毒素。

Study on the quality standard of bacterial endotoxin test for Edaravone Injection

Objective To unify the limit value for bacterial endotoxin test of Edaravone Injection and provide reference for improved standard of Edaravone Injection. Methods The experiment was carried out according to the bacterial en- dotoxin test method indexed in the appendix of Appendix of Chinese Pharmacopeia （2010 edition, 2 volume）. Tachy- pleus amabocyte lysate from two manufacturers were used to test bacterial endotoxin of Edaravone Injection from five manufacturers. Results The maximum noninterference concentration for Edaravone Injection was 0.187 5 mg/mL. The bacterial endotoxin test could be improved to ＂it contains less than 0.33 EU per mg＂ on the basis of present national standards. Conclusion The limit value unified is feasible, which can be used to more strictly control endotoxin in the products.