人工乳房硅凝胶填充物中小分子物质的检测  

Determination of small molecular substances in artificial breast silicone gel filler

作　　者：付步芳[1] 冯晓明[1] 奚廷斐[1] 

机构地区：[1]中国药品生物制品检定所医疗器械检验中心,北京100050

出　　处：《生物医学工程与临床》2010年第5期387-389,共3页Biomedical Engineering and Clinical Medicine

基　　金：中国药品生物制品检定所中青年发展基金(2010C6)

摘　　要：目的初步建立了检测人工乳房硅凝胶填充物中小分子物质的方法,并对市场上的人工乳房产品进行检测。方法采用气相色谱-质谱联用仪对人工乳房硅凝胶填充物中小分子物质进行了分析,优化了溶剂切除时间、质荷比、扫描范围等实验条件。结果用该法测定出了人工乳房硅凝胶填充物中的数种小分子物质,包括烷烃类和硅氧烷类。结论国内产品与国外产品的差距通过改进生产工艺和控制工艺过程,是可以逐渐缩小的。人工乳房硅凝胶填充物中小分子物质气相色谱-质谱联用检测方法,灵敏度高,重复性好,简便可行,可用于人工乳房产品的质量控制,为国家对此类产品的监管提供了技术支撑。Objective To establish an initially determination method of small molecular substances in artificial breast silicone gel filler.Methods The gas chromatography-mass spectrometry（GC/MS） was used to detect small molecular substances in artificial breast silicone gel filler.Test conditions,such as solvent removal time,m/z,and scaning range were optimized.Results Several small molecular substances in artificial breast silicone gel filler were determined,included alkanes and siloxanes.Conclusion The GC/MS method is sensitive,simple and having good stability,which can be used for the quality control of artificial breast products,and also provides technical support for national regulation.

关 键 词：人工乳房 硅凝胶 小分子物质 气相色谱-质谱联用 

分 类 号：R318.08[医药卫生—生物医学工程]