气质联用法测定膜式氧合器中偏苯三酸三辛酯的溶出量  

Determination of Tri-Octyltri-Meta-Benzoate(TOTM) Released from Membrane Oxyenator Oxyenator Using Gas Chromatography-Mass Spectrometry

作　　者：柯永乐 徐苏华[1] 潘晓芳[1] 谢新艺[1] 

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510006

出　　处：《医疗装备》2017年第19期68-70,共3页Medical Equipment

摘　　要：建立一种气相色谱-质谱联用仪测定膜式氧合器中偏苯三酸三辛酯(TOTM)的溶出量方法,采用70%乙醇水混合液作为浸提介质,模拟临床使用。研究结果表明,该方法在0.125~20μg/ml范围内线性关系良好,线性关系为r=0.9963,TOTM的回收率为80.89%~104.81%,RSD小于5.00%(n=3),说明该方法准确度高,重复性好。本研究还通过使用10%脂肪乳作为浸提介质,对比集成式膜式氧合器在两种浸提介质中TOTM溶出量随时间的变化情况,结果表明10%脂肪乳浸提液中TOTM溶出量几乎不随时间变化,且在允许限量范围内。Gas chromatography-mass spectrometry（GC-MS）was established to determinate tri-octyltri-meta-benzoate（TOTM）released from membrane oxyenator.Aqueous ethanol solution was the extraction medium in simulated clinical use.The experimental results showed good linearity in the range of 0.125~20μg/ml and the correlation coefficient was 0.9963.The spiked recoveries of TOTM ranged from 80.89%-104.81%,and the relatives standard deviations were less than 5.00%（n=3）.The results showed that method was accurate and reproducible.The 10%fat emulsion also was used as extraction medium in this paper,and the TOTM dissolution changes with time were compared between the two extraction mediums.Finally found that dissolving-out amount of TOTM almost had no change with time in 10%fat emulsion,and was in the allowable limit range.

关 键 词：气相色谱-质谱联用仪 氧合器 TOTM 溶出量 

分 类 号：R318.6[医药卫生—生物医学工程]