许慧,叶永彬,方旻,谢新艺
XU Hui,YE Yongbin,FANG Min,XIE Xinyi

• 1:广东省医疗器械质量监督检验所

摘要(Abstract)：

目的采用液液萃取法提取脂肪乳中的抗氧剂2,6-二叔丁基-4-甲基苯酚(BHT),在此基础上建立了高效液相色谱法检测脂肪乳注射液中抗氧剂BHT含量。方法色谱柱为Inertsil ODS-SP,柱温35℃,流动相为乙腈-水(4∶1),流速为1.5 m L/min,检测波长为280 nm。结果 BHT在2.07~259.00μg/m L范围内具有良好的线性关系。高中低三个浓度回收率为84.6%~89.8%,其RSD值小于2%。结论该方法快速准确,重复性好,能够满足脂肪乳注射液中抗氧剂BHT的测定。
OBJECTIVE To develop a method of quantitatively analyzing 2,6-Di-tert-butyl-4-methylphenol( BHT) in fat emulsion injection by HPLC based on liquid-liquid extraction. METHODS The Inertsil ODS-SP column was adopted with a mobile phase of acetonitrile-water( 4∶ 1),the flow rate was 1. 5 m L / min with the column temperature of 35 ℃. The detection wavelength was set at 280 nm. RESULTS It was linear in the concentration range of 2. 07- 259. 00 μg / m L,the average recoveries of high,middle,low concentration were in the range of 84. 6%- 89. 8%,the RSD values were all below 2%. CONCLUSION The established method is fast,accurate and reproducible,which can be used for the antioxidant BHT detection in fat emulsion injection.

关键词(KeyWords)： 脂肪乳注射液;BHT;高效液相色谱;迁移量
fat emulsion injection;BHT;HPLC;migration

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 许慧,叶永彬,方旻,谢新艺
XU Hui,YE Yongbin,FANG Min,XIE Xinyi

参考文献(References)：

• [1]严幼达,顾惠敏,侯惠民.胶塞对抗生素粉针剂质量的影响[J].中国医药工业杂志,2003,34(4):190-191.
• [2]Jaehnke RWO,Kreuter J,Ross G.Interaction of rubber closures with powders for parenteral administration[J].Journal of Parenteral Science and Technology,1990,44(5):282-288.
• [3]赵霞,胡昌勤,金少鸿.对考察药用丁基胶塞与药物相容性的思考与建议[J].中国药事,2007,21(10):810-812.
• [4]赵霞,胡昌勤,金少鸿.药用丁基胶塞中易挥发性成分的成分分析[J].药物分析杂志,2006,26(3):315-318.
• [5]Zhang F,Chang A,Karaisz K,et al.Structural identification of extractables from rubber cloures used for pre-filled semisolid applicator by chromatography,mass spectrometry and organic synthesis[J].Journal of Pharmaceutical and Biomedical Analysis,2004,34(5):841-849.
• [6]周劼,殷果,刘洪伟,等.药用丁基胶塞中BHT的GC-MS/MS法测定.中国医药工业杂志,2013,44(8):801-803.