摘要
目的:建立凝胶法和光度法测定诺氟沙星葡萄糖注射液中细菌内毒素的方法。方法:按《中国药典》2015年版四部1143检查法,采用凝胶限量法和动态浊度法进行实验和结果判断。结果:拟定每1 mg诺氟沙星中含内毒素的量应小于0.75 EU,诺氟沙星葡萄糖注射液24倍稀释后对细菌内毒素检查法无干扰作用,即最大不干扰浓度为0.08 mg·mL^-1。结论:该品种采用细菌内毒素检查法代替热原检查法控制质量,方法可行。
Objective:To establishthe gel-clot method and photometric methodfor bacterial edotoxintest inNorfloxacin and Glucose Injection.Methods:As per ChP 2015.VolⅣ:1143,the test was carried on and the result as judged by the gel clot method and kinetic turbidimetric method.Results:The limit was set as 0.75 EU per 1 mg Norfloxacin.There was no interference in the bacterial edotoxin test when Norfloxacin and Glucose Injection was diluted 24 times.Maximum non-interferenceconcentration of Norfloxacin and Glucose Injection for bacterial endotoxins test was 0.08 mg·mL^-1.Concluions:It is feasible to substitutepyrogen test with bacterial endotoxin test for quality control of Norfloxacin and Glucose Injection.
作者
王璐
刘勤
王玮
WANG Lu;LIU Qin;WANG Wei(Yunnan Institute for Food and Drug Control,Kunming 650106,China)
出处
《中国药品标准》
CAS
2019年第6期521-525,共5页
Drug Standards of China
