中国药业2011,Vol.20Issue(5):31-32,2.
盐酸氨溴索注射液细菌内毒素检查法研究
Study on Bacterial Endotoxin Test of Ambroxol Hydrochloride Injection
王莉 1张红宇 1刘勤 1赵祎1
作者信息
- 1. 云南省食品药品检验所,云南,昆明,650011
- 折叠
摘要
Abstract
Objective To establish a method of the bacterial endotoxin test for Ambroxol Hydrochloride Injection. Methods The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the appendix Ⅺ of Chinese Pharmacopeia (Vol. Ⅱ, edition 2005).Results After five times and above dilution, the mass concentration of less than 1.5 g/L had no interference on tachypleus amebocyte lysate (TAL) and the reaction of endotoxin. Conclusion Bacterial endotoxin test (gel process) is applicable to the limit test of bacterial endotoxin for Ambroxol Hydrochloride Injection.关键词
盐酸氨溴索注射液/细菌内毒素检查/干扰试验分类
医药卫生引用本文复制引用
王莉,张红宇,刘勤,赵祎..盐酸氨溴索注射液细菌内毒素检查法研究[J].中国药业,2011,20(5):31-32,2.