中国药业2017，Vol.26Issue(9)：26-28,3.DOI:10.3969/j.issn.1006-4931.2017.09.008
动态浊度法测定注射用阿莫西林钠克拉维酸钾细菌内毒素含量
Content Determination of Bacterial Endotoxin in Amoxicillin Sodium and Clavulanate Potassium for Injection by Kinetic Turbidimetric Method
李慧 1张彦丽 1崔晓燕 2刘琳 1刘云1
作者信息
- 1. 河北省石家庄市食品药品检验中心,河北石家庄 050031
- 2. 河北省药品检验研究院,河北石家庄 050011
- 折叠
摘要
Abstract
Objective To establish a method for determining the content of bacterial endotoxin in Amoxicillin Sodium and Clavulanate Potassium for Injection. Methods According to the Chinese Pharmacopoeia 2015 Edition fourth section. kinetic turbidimetric method was used for the interference test of Amoxicillin Sodium and Clavulanate Potassium for Injection and determining the content of bacterial endotoxin in samples. Results The interference was eliminated when the sample was diluted to 60 g/L. the recovery rate of bacterial endotoxin was within 50% -200%. Conclusion Dynamic turbidimetry can be used for bacterial endotoxin in test of Potassium Clavu-lanate and Amoxicillin for Injection. the content of bacterial endotoxin is less than the standard of Chinese Pharmacopoeia 0. 25 EU/mg. and the current standard can be further improved.关键词
注射用阿莫西林钠克拉维酸钾/细菌内毒素/动态浊度法Key words
Amoxicillin Sodium and Clavulanate Potassium for Injection/bacteria endotoxin/kinetic turbidimetric method分类
医药卫生引用本文复制引用
李慧,张彦丽,崔晓燕,刘琳,刘云..动态浊度法测定注射用阿莫西林钠克拉维酸钾细菌内毒素含量[J].中国药业,2017,26(9):26-28,3.
