文章摘要
王璐,王玮,刘勤.诺氟沙星葡萄糖注射液细菌内毒素检查法研究[J].中国药品标准,2019,20(6):521-520
诺氟沙星葡萄糖注射液细菌内毒素检查法研究
Resarch on Bacterial Endotoxin Test of Norfloxacin and Glucose Injection
投稿时间:2019-03-12  修订日期:2019-11-21
DOI:
中文关键词: 诺氟沙星葡萄糖注射液  细菌内毒素  质量标准提高
英文关键词: Norfloxacin and Glucose Injection  bacterial endotoxins  standard improvement
基金项目:
作者单位E-mail
王璐 云南省食品药品监督检验研究院 2461076750@qq.com 
王玮 云南省食品药品监督检验研究院  
刘勤 云南省食品药品监督检验研究院  
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中文摘要:
      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1mg诺氟沙星中含内毒素的量应小于0.75EU,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。
英文摘要:
      Abstract Objective:Estabilsh bacterial edotoxin determination method for Norfloxacin and Glucose Injection.Methods:The test was performed as per CHP 2015.Vol Ⅳ:1143, the experiment was carried on and the result as judged by the gel clot method and kinetic turbidimetric method.Results:The limit was set as 1 mg Norfloxacin containing less than 0.75EU of endotoxin.There was no interference in the bacterial edotoxin test when Norfloxacin and Glucose Injection diluted 24 times.Maximum nondisturb concentration of Norfloxacin and Glucose Injection for bacterial endotoxins test was 0.08mg?mL-1.Concluions:It is feasible for bacterial endotoxin text instead of pyrogen test for quality control.
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