中国药物评价Issue(5)：273-276,4.
动态显色法定量测定加替沙星原料药中细菌内毒素含量
Content Determination of Bacterial Endotoxin in Gatifloxacin by Kinetic Chromogenic Analysis
夏博 1郭锋1
作者信息
- 1. 扬子江药业集团有限公司，江苏泰州225321
- 折叠
摘要
Abstract
Objective:To establish a method for the detection of bacterial endotoxins in gatifloxacin.Methods:Kinetic Chromogenic analysis was adopted to generate the standard curve and dilution rate of test sample.Bacterial endotoxin was added into test sample for in-terference test, and bacterial endotoxins in samples were determined.Results:The endotoxin test wasn′t interfered at concentrations be-low 0.312 mg・mL-1 .The recovery rate of bacterial endotoxin was 50%~200%.The concentration of endotoxin in the 3 batches of sam-ples met the requirements for bacterial endotoxins.Conlusion:The kinetic chromogenic analysis is suitable for bacterial endotoxin test of iodixanol injection.关键词
加替沙星/动态显色法/细菌内毒素Key words
Gatifloxacin/Bacterial endotoxin/Kinetic chromogenic analysis分类
医药卫生引用本文复制引用
夏博,郭锋..动态显色法定量测定加替沙星原料药中细菌内毒素含量[J].中国药物评价,2015,(5):273-276,4.
