卤化丁基胶塞中小分子的研究

Study on Small Molecules of Halogenated Butyl Rubber Plugs

目的:根据卤化丁基胶塞的工艺,采用气相色谱质谱联用,推断卤化丁基胶塞在生产可能产生的小分子,为药品生产企业选择合适的包材提供可靠的数据。方法:以气相色谱质谱联用法进行实验,根据数据进行分析、推测。结果:通过气相色谱质谱联用法可以发现,卤化丁基胶塞在受热及外界其他因素的影响,会产生一系列的小分子物质,这些小分子物质可能会进入到药品中,影响药品的质量。结论:在使用卤化丁基胶塞的时候一定要考察胶塞与药品相容性之间的关系,保证分解出的小分子物质,不会影响药品的质量。

Objective： According to the process of halogenated butyl rubber plugs,it is concluded that the halogenated butyl rubber plugs may produce the small molecules via using gas chromatography-mass spectrometry,and it can provide reliable data for selecting suitable packaging materials for pharmaceutical production. Methods： The experiment was carried out by the way of gas chromatography-mass spectrometry,and based on the data to do analysis speculation. Results： It can be found by gas chromatography mass spectrometry that Halogenated butyl rubber plugs produce a series of small molecules under the influence of heat and other external factors,these small molecules may enter the drug and affect the quality of the drug. Conclusion： Therefore,when using the halogenated butyl rubber plugs,it is necessary to investigate the compatibility between the rubber stopper and the drug,and to ensure that the decomposed small molecules do not affect the quality of the drug.