气质联用法测定胶塞中环硅氧烷含量及提取研究  

Study on the Content of Cyclosiloxane Compound in Rubber Stoppers and Its Migration by Gas Chromatography-Mass Spectrometry

作　　者：方旻[1] 万易易 黄梓为 富强[1] 谢新艺[1] 邓颖敏 FANG Min;WAN Yi-yi;HUANG Zi-wei;FU Qiang;XIE Xin-yi;DENG Ying-min(Guangdong Medical Instruments Quality Surveillance and Inspection Institute,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《当代化工》2022年第9期2264-2268,共5页Contemporary Chemical Industry

基　　金：广东省药监局科技创新项目,药包材料与药品相容性研究重点实验室(项目编号:2018ZDZ05)。

摘　　要：建立了气相色谱-质谱法用于测定药用覆膜胶塞表面残留的环硅氧烷含量,并将该方法应用至疫苗模拟液分析。7种环硅氧烷物质线性关系良好,拟合系数(R^(2))大于0.999,检出限为0.001~0.005 mg·L^(-1),加标回收率为70%~120%,相对标准偏差(RSD)为0.39%~4.79%,方法快速高效,适用于胶塞及模拟液中7种环硅氧烷物质的检测。A gas chromatography-mass spectrometry method was established to determine the residual cyclosiloxane content on the surface of medicinal film-coated rubber stoppers,and the method was applied to the analysis of vaccine simulant.The method exhibited perfect linear relationship with correlation coefficient(R^(2))larger than 0.999.The limits of detection(LODs)for the seven substances were 0.001~0.005 mg·L^(-1),the recovery at three spiked levels ranged from 70%to 120%,with relative standard deviations(RSD)of 0.39%~4.79%.This method is efficient,and suitable for the detection of seven cyclosiloxane substances in film-coated rubber stoppers and vaccine simulation solution.

关 键 词：环硅氧烷 丁基胶塞 气质联用 提取 疫苗 

分 类 号：O657.63[理学—分析化学]