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.
出处
《中国药事》
CAS
2017年第11期1331-1335,共5页
Chinese Pharmaceutical Affairs
作者简介
刘蔓，主要从事理化检测研究工作；E—mail：liuman@nimte．ac．cn
