药用复合硬片中氯乙烯和偏二氯乙烯单体残留量的测定  

Determination of Vinyl Chloride and Vinylidene Chloride Monomer Residues in Medicinal Composite Sheet

作　　者：饶艳春 左军凤 熊马剑 常亮 陈希 RAO Yan-chun;ZUO Jun-feng;XIONG Ma-jian;CHANG Liang;CHEN Xi(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院国家药品监督管理局中成药质量评价重点实验室、江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《塑料科技》2024年第6期122-125,共4页Plastics Science and Technology

基　　金：江西省药品监督管理局科研项目(2021KY01)。

摘　　要：文章建立了顶空-气相色谱法测定药用复合硬片中氯乙烯和偏二氯乙烯单体残留量的方法。采用HPINNOWAX毛细管柱(60 m×0.32 mm×0.5μm)分离,氢火焰离子化检测器检测,顶空平衡温度80℃,平衡时间30 min,柱温50℃,分流比10∶1,进样口温度200℃,检测器温度为220℃。结果表明:氯乙烯和偏二氯乙烯在0.05~5.0μg范围内线性关系良好(r>0.999),平均回收率分别为102.1%、101.3%,相对偏差(RSD)分别为1.7%、1.9%,氯乙烯的检出限为0.020μg/g,偏氯乙烯的检出限为0.025μg/g。此方法操作简便、结果准确、灵敏度高,可用于药用复合硬片中氯乙烯和偏二氯乙烯单体残留量的测定。The article establishes a headspace gas chromatography method for the determination of vinyl chloride and vinylidene chloride monomer residues in medicinal composite sheet.The separation was performed by HP-INNOWAX capillary column(60 m×0.32 mm×0.5μm),and hydrogen flame ionization detector was used for testing.Headspace equilibrium temperature was 80℃,equilibrium time was 30 min.The column temperature was 50℃.The split ratio was 10∶1.The inlet temperature was 200℃,and the FID detector temperature was 220℃.The results showed that the linear relationship between vinyl chloride and vinylidean chloride was good(r>0.999)in the range of 0.05~5.0μg.The average recoveries were 102.1%,101.3%,and the relative standard deviations(RSD)were 1.7%and 1.9%,respectively.The detection limit of vinyl chloride was 0.020μg/g,and the detection limit of vinylidene chloride was 0.025μg/g.This method is characterized by its simplicity in operation,accuracy of results,and high sensitivity,and is applicable for the determination of residual vinyl chloride and vinylidene chloride monomer in medicinal composite sheet.

关 键 词：顶空气相色谱法 药用复合硬片 氯乙烯 偏二氯乙烯 

分 类 号：O657.7[理学—分析化学] TQ460.69[理学—化学]