文章摘要
唐先明,刘景波,宋丽阳,王姝.注射用盐酸艾司洛尔细菌内毒素检查法研究[J].中国药品标准,2019,(3):255-258
注射用盐酸艾司洛尔细菌内毒素检查法研究
Study on the bacterial endotoxins testing method for Esmolol Hydrochloride for Injection
投稿时间:2018-09-06  修订日期:2018-09-12
DOI:
中文关键词: 注射用盐酸艾司洛尔  细菌内毒素  凝胶法  干扰实验
英文关键词: Esmolol Hydrochloride for Injection  bacterial endotoxin  gel method  interference test
基金项目:
作者单位E-mail
唐先明 哈尔滨市食品药品检验检测中心 15945160973@163.com 
刘景波 哈尔滨市食品药品检验检测中心  
宋丽阳 哈尔滨市食品药品检验检测中心  
王姝 哈尔滨市食品药品检验检测中心  
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中文摘要:
      目的:建立注射用盐酸艾司洛尔的细菌内毒素检查方法。方法:按《中国药典》2015年版四部通则进行实验和结果判断。结果:将注射用盐酸艾司洛尔样品溶解液加适量稀释剂Ⅰ稀释,用BET水稀释至1.25mg.mL-1时对细菌内毒素检查无干扰,细菌内毒素限值为0.10EU.mg-1。对3批注射用盐酸艾司洛尔进行常规检查,结果均符合规定。结论:所建立的细菌内毒素检查法可用于注射用盐酸艾司洛尔的细菌内毒素检查。
英文摘要:
      Objective:To establish a bacterial endotoxins testing method for Esmolol Hydrochloride for Injection.Methods:The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition Vol Ⅳ. Results:There was no interference in the agglutination reaction between tachypleus amebocyte lysatein and endotoxin when 1.25 mg.mL-1 solution of Ribonucleic Acid sodium was utilized with BET and BufferⅠ.The limit value of the bacterial endotoxin was 0.10 EU.mg-1. According to the established standard, the results of bacterial endotoxin test in 3 batches of samples were conformed to the required stipulation.Conclusion:The established bacterial endotoxin test may be applicable for bacterial endotoxin test of Esmolol Hydrochloride for Injection.
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