中药与临床2025，Vol.16Issue(6)：24-27,4.
丹参注射液细菌内毒素检查方法的研究
Study on the method of bacterial endotoxin test for Danshen injection
程亮 1唐芳 1杨强 1陈新迪 1熊晓明 1唐茜1
作者信息
- 1. 四川升和药业股份有限公司,四川 成都 611530
- 折叠
摘要
Abstract
Objective:To establish a bacterial endotoxin test method for Danshen injection.Methods:The bacterial endotox-in test method of Danshen injection was studied by gel method according to the general rules of the Chinese Pharmacopoeia(2020).Results:After diluting Danshen injection to 80 times,there was no interference effect,and the limit value of bacterial endotoxin was determined to be 5.0 EU·mL-1.Conclusion:The use of bacterial endotoxin test to evaluate the safety indicators of Danshen injection is feasible.This study provides a new method for evaluating the safety of Danshen injection and provides a basis for improving the quality standards.关键词
丹参注射液/细菌内毒素/凝胶法/鲎试剂/干扰实验Key words
Danshen injection/bacterial endotoxin/gel method/horseshoe crab reagent/interference experiment分类
医药卫生引用本文复制引用
程亮,唐芳,杨强,陈新迪,熊晓明,唐茜..丹参注射液细菌内毒素检查方法的研究[J].中药与临床,2025,16(6):24-27,4.
