人工乳房硅凝胶填充物中小分子物质的检测

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。

Determination of small molecular substances in artificial breast silicone gel filler

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.