GC-MS法测定医用疫苗中抗氧化剂BHT的含量  

Determination of the Content of Antioxidant BHT in Medical Vaccine by GC-MS

作　　者：刘蔓[1] 方科益[2] 韩莹莹 盛华峰 

机构地区：[1]中国科学院宁波材料技术与工程研究所,宁波315201 [2]宁波出入境检验检疫局,宁波315000

出　　处：《中国药事》2017年第11期1331-1335,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:测定抗氧化剂2,6-叔丁基-4-甲基-苯酚(BHT)从样品瓶胶塞迁移至医用疫苗中的含量。方法:采用GC-MS法进行测试,利用NIST谱库,对BHT进行定性确认,利用SIM模式进行定量。结果:本文建立的检测方法对于每瓶疫苗中的迁移量检出限(3S/N)为0.005μg,定量限(10S/N)为0.01μg。低、中、高3个添加浓度水平的回收率在85%~120%,相对标准偏差小于10%。结论:该方法简单易行、精密度较高,方法重现性良好,定量分析结果准确性好,该方法为评价药品包装材料与药物之间的相容性提供了技术支持。To determine the content of 2,6-di-tert-butyl-4-methylphenol（BHT） in medical vaccine transferred from the rubber stopper. Methods： GC-MS method was used to do the test; NHT library was used to qualitatively confirm the BHT and SIM mode was used to carry out the quantitative analysis. Results： Transfer detection limit（3 S/N） of the established method was 0.005 μg per bottle and quantitative limit（10 S/N） was 0.01μg. Recovery rates of the three additive concentrations were in the range of 85%-120% with RSD less than 10%. Conclusion： The method was simple and practicable with high precision and good reproducibility. The quantitative analysis result was accurate. The method provides technical support for evaluating the compatibility between drug packaging materials and drugs.

关 键 词：GC-MS 医用疫苗 2 6-叔丁基-4-甲基-苯酚 

分 类 号：R927.2[医药卫生—药学]