摘要
目的:建立依达拉奉细菌内毒素检查方法,为依达拉奉及其注射液质量控制提供依据。方法:采用中和法及稀释法,按照《中国药典》2015年版四部通则1143细菌内毒素检查法进行试验。结果:依达拉奉在pH值调整为7.0时,对鲎试剂与内毒素反应最大不产生干扰作用的浓度为0.25mg·mL^-1。结论:依达拉奉的细菌内毒素限值可定为2.0EU·mg^-1,建立的细菌内毒素检查方法可行。
Objective:To establish a bacterial endotoxins test method for edaravone and provide the reference forquality control ofedaravone and edaravone injection. Methods:The test was performed with neutralization and dilution methods in accordance in the test for bacterial endotoxins in general notice1143, Chinese Pharmacopoeia 2015 Volume Ⅳ. Results:The maximum non-interference concentration of edaravone for TAL and endotoxins reaction was 0.25 mg·mL^-1 when pH was adjusted as 7.0. Conclusion:The bacterial endotoxins limit of edaravone is set as 2.0 EU·mg^-1,and the established method forbacterial endotoxins test of edaravone is feasible.
作者
贾首前
呼延婷婷
焦洁
王莉芳
冯润东
JIA Shouqian;HUYAN Tingting;JIAO Jie;WANG Lifang;FENG Rundong(Shaanxi Institute for Food and Drug Control, Xi′an 710065, China)
出处
《中国药品标准》
CAS
2019年第3期251-254,共4页
Drug Standards of China
关键词
依达拉奉
细菌内毒素
干扰试验
edaravone
bacterial endotoxins
interference test
