摘要
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 e-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 e-caprolactam were corre- sponsive with the amounts added in compound Hongcao freeze-dried powder injection. In real detec- tion, caprolactam was not detected in three batches of compound Hongcao freeze-dried powder injection （detection limit： 2 p,g/g） Conclusions： This method is accurate, reproducible and easy for testing caprolactam residual volume in compound Hongcao freeze-dried powder injection.
出处
《贵阳医学院学报》
CAS
2011年第5期446-447,451,共3页
Journal of Guiyang Medical College
基金
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]
关键词
注射
粉剂
己内酰胺
色谱法
气相
compound Hongcao freeze-dried powder injection
caprolactam
chromatography, gas
