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醒脑静注射液细菌内毒素检查法研究
引用本文:匡翠莲,王璐,张红宇. 醒脑静注射液细菌内毒素检查法研究[J]. 中医临床研究, 2012, 0(20): 114-115,117
作者姓名:匡翠莲  王璐  张红宇
作者单位:[1]云南省医疗器械检验所,云南昆明650034 [2]云南省食品药品检验所,云南昆明650034
摘    要:目的:建立醒脑静注射液细菌内毒素检查方法。方法:按中国药典2005年版二部附录ⅪE收载的细菌内毒素检查方法进行试验和结果判断,计算醒脑静注射液的细菌内毒素限值。结果:醒脑静注射液的细菌内毒素限值为2.5EUmg。结论:可建立醒脑静注射液的细菌内毒素检查方法。

关 键 词:醒脑静注射液  细菌内毒素  鲎试剂  干扰试验

The study for the bacterial endotoxins determination method of the Xingnaojing injection
Abstract:Objective:To set up the bacterial endotoxins determination method for the Xingnaojing injection.Methods:The experiment was carried on and the result was judged according to the appendix ⅪE of Chinese Pharmacopoeia 2005 Vol.Ⅱ.To calculate bacterial endotoxin limit of the Xingnaojing injection.Results:Bacterial endotoxins limit of XingNaojing injection was 2.5EU mg.Conclusions:The established method of endotoxins test was feasible for XingNaojing injection.
Keywords:XingNaojing injection  Bacterial endotoxins  Limulus reagent  Interfere test
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