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复方磷酸盐注射液细菌内毒素检查方法的研究
引用本文:王银娟,陆崟,岩林萍,王曙东. 复方磷酸盐注射液细菌内毒素检查方法的研究[J]. 中国医药导报, 2011, 8(32): 49-50
作者姓名:王银娟  陆崟  岩林萍  王曙东
作者单位:南京军区南京总医院制剂科,江苏南京,210002
摘    要:目的:建立复方磷酸盐注射液细菌内毒素检查方法。方法:采用《中国药典》2010年版二部细菌内毒素检查法进行干扰试验。结果:复方磷酸盐注射液原液对细菌内毒素的检测无干扰作用。结论:复方磷酸盐注射液的细菌内毒素限值确定为6EU/ml,所建方法可用于复方磷酸盐注射液的细菌内毒素检查。

关 键 词:复方磷酸盐注射液  细菌内毒素检查法  干扰试验

Study on the method of bacterial endotoxin test in Compound Phosphate Injection
WANG Yinjuan,LU Yin,YAN Linping,WANG Shudong. Study on the method of bacterial endotoxin test in Compound Phosphate Injection[J]. China Medical Herald, 2011, 8(32): 49-50
Authors:WANG Yinjuan  LU Yin  YAN Linping  WANG Shudong
Affiliation:WANG Yinjuan,LU Yin,YAN Linping,WANG Shudong Department of Preparations,Nanjing General Hospital of Nanjing Military Command,Jiangsu Province,Nanjing 210002,China
Abstract:Objective:To establish the method for determination of the bacterial endotoxin in Compound Phosphate Injection.Methods:The interference experiment was performed according to the bacterial endotoxin determination method in Chinese Pharmacopoeia 2010(section 2).Results:The Compound Phosphate Injection did not interfere in the result of the determination.Conclusion:The limit for bacterial endotoxin in Compound Phosphate Injection is 6 EU/ml.The method is suitable for the bacrerial endotoxins determination of t...
Keywords:Compound Phosphate Injection  Bacterial endotoxins test method  Interference experiment  
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