鄢艳,谭安菊,陈思颖,刘丽娜,王爱民
YAN Yan,TAN Anju,CHEN Siying,LIU Lina,WANG Aimin (School of Pharmacology

• 1:贵阳医学院药学院

摘要(Abstract)：

目的:建立复方荭草冻干粉针剂中己内酰胺残留量的检测方法。方法:采用气相色谱法,以聚酰胺聚合单体ε-己内酰胺为指标,对复方荭草冻干粉针剂中己内酰胺残留量进行检测。结果:三批复方荭草冻干粉针中均未检出己内酰胺(检出限为2μg/g),故在质量标准中规定复方荭草冻干粉针剂中不得检出己内酰胺。结论:该方法能准确检查复方荭草冻干粉针剂中己内酰胺残留量,重复性好,操作简便。
Objective: To establish a method for limit determination of caprolactam residual volume in compound Hongcao freeze-dried powder injection with gas chromatography.Methods: Polyamide polymerization monomer ε-caprolactam was used as indicater,and its residual volume in Hongcao freeze-dried powder injection was detected experimentally with gas chromatography.The results were analyzed.Results: The tested results of polyamide polymerization monomer ε-caprolactam were corresponsive with the amounts added in compound Hongcao freeze-dried powder injection.In real detection,caprolactam was not detected in three batches of compound Hongcao freeze-dried powder injection(detection limit: 2 μg/g) Conclusions: This method is accurate,reproducible and easy for testing caprolactam residual volume in compound Hongcao freeze-dried powder injection.

关键词(KeyWords)： 注射;粉剂;己内酰胺;色谱法,气相
compound Hongcao freeze-dried powder injection;caprolactam;chromatography,gas

Abstract:

Keywords:

基金项目(Foundation): 国家自然基金(30860366);; 贵州省科技厅科技计划项目[(2009)4001号]贵州省科技厅科技创新人才团队项目;; 贵州省重大科技项目[黔科合重大专项字(2007)6010号];; 贵州省科技攻关项目[黔科合SY字(2009)3092号];;

作者(Author): 鄢艳,谭安菊,陈思颖,刘丽娜,王爱民
YAN Yan,TAN Anju,CHEN Siying,LIU Lina,WANG Aimin (School of Pharmacology

DOI: 10.19367/j.cnki.1000-2707.2011.05.003

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