摘要
目的:建立注射用还原型谷胱甘肽细菌内毒素及异常毒性的检查方法。方法:按照中国药典2015年版四部附录方法及要求对注射用还原型谷胱甘肽细菌内毒素检查法和异常毒性检查法进行研究。结果:注射用还原型谷胱甘肽细菌内毒素检查限值可定为0.125 EU·mg^(-1),异常毒性检查限值可定为1.0 g·kg^(-1)。结论:本文采用的注射用还原型谷胱甘肽的细菌内毒素及异常毒性检查方法均可行。为保证用药安全,有必要在其原质量标准的基础上增加异常毒性检查项,且细菌内毒素检查项可替代热原检查法。
Objective： To establish the bacterial endotoxin test method and the abnormal toxicity test method for reduced glutathi- one for injection. Methods： According to the requirements and methods in Chinese Pharmacopoeia （2015 edition, part IV）, the bacte- rial endotoxin test and the abnormal toxicity test for reduced glutathione were studied. Results： The limit of bacterial endotoxin for re- duced glutathione was 0. 125 EU · mg-1 , and the limit of abnormal toxicity was 1.0 g · kg-1. Conclusion： The bacterial endotoxin test method and the abnormal toxicity test method are feasible. The abnormal toxicity should be supplemented in the quality standard for reduced glutathione, and the bacterial endotoxin test can replace the pyrogen test.
出处
《中国药师》
CAS
2016年第6期1208-1211,共4页
China Pharmacist
关键词
还原型谷胱甘肽
细菌内毒素
异常毒性
Reduced glutathione
Bacterial endotoxin
Abnormal toxicity
作者简介
通讯作者：祝清芬Tel：13969128018 E-mail：13969128018@163.com
