气质联用法分析卤化丁基胶塞中的挥发性成分  

Analysis of composition of volatile substances in halogenated butyl rubber stoppers by GC-MS

作　　者：付蒙 袁怡 夏汉桥 胡敏 FU Meng;YUAN Yi;XIA Han-qiao;HU Min(Hubei Institute for Drug Control, Wuhau 430075, China;Yingcheng Hengtian Pharmaceutical Packaging Co. , Ltd. , Yingcheng 432400, China)

机构地区：[1]湖北省药品监督检验研究院,武汉430075 [2]应城市恒天药业包装有限公司,应城432400

出　　处：《药物分析杂志》2018年第5期818-826,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：湖北省食品药品监督管理局2016-2017年度科研项目(2016020+08)

摘　　要：目的:分析药品包装材料卤化丁基胶塞中的挥发性成分。方法:采用气质联用技术,并利用Xcalibur工作站中的NIST质谱库检索,结合有关文献人工图谱解析鉴定,分析卤化丁基胶塞中的挥发性成分和可提取物信息。结果:挥发性成分中的寡聚物和抗氧剂可以反映生胶的种类与来源,环硅氧烷类化合物可以体现不同胶塞的硅化工艺差异,其他挥发性成分如饱和烷烃类与胶塞具体配方有关,可提取物成分中的S_8,可用于部分硫化体系的识别。结论:卤化丁基胶塞中挥发性成分的分析,为胶塞配方一致性评价以及胶塞与药物之间的相容性考察奠定了基础。Objective：To analyze volatile substances in halogenated butyl rubber stoppers.Method：The volatile substances and extractables in the halogenated butyl rubber stoppers were analyzed by GC-MS,and were identified with NIST chromatography library in the Xcalibur workstation,combined with the artificial map of the relevant literature.Results：The oligomers and antioxidants in volatile substances could reflect the types and sources of raw rubber.The siloxane compounds in volatile substances could reflect differences in the silicidation process of rubber stoppers.Other volatile substance such as alkanes was associated with the specific formulation of the rubber stopper.S8 in extractables could be used to identify the part of vulcanization system.Conclusion：The results of the experiment to analyze the volatile substances in halogenated butyl rubber stoppers were the basis to study the consistency evaluation of formulation and the compatibility between rubber stoppers and drugs.

关 键 词：药品包装材料 气质联用法 卤化丁基胶塞 挥发性成分 可提取物 寡聚物 抗氧剂 

分 类 号：R917[医药卫生—药物分析学]