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目的:建立气相色谱-串联质谱(GC-MS/MS)测定一次性使用输液器产品中1,2,4-苯三甲酸三(2-乙基己基)(偏苯三酸三辛酯,TOTM)增塑剂溶出量的分析方法,分析不同浸提介质对1,2,4-苯三甲酸三(2-乙基己基)增塑剂溶出量的影响。方法:以氯仿、乙醇水、生理盐水和3种不同p H的缓冲盐溶液为提取介质,室温下利用蠕动泵对输液器中的TOTM进行提取,采用HP-5MS(30 m×250μm×0.25μm)色谱柱对提取液进行气相色谱-串联质谱分析。结果:该方法检出限低(定量下限0.03μg·m L~(-1)),氯仿作为浸提介质TOTM溶出量为10.62μg·m L~(-1);30%乙醇水为6.55μg·m L~(-1);氯化钾-盐酸缓冲液(0.2 mol·L~(-1),p H=2)为5.11μg·m L~(-1);0.9%生理盐水和另外2种缓冲盐溶液未检出。结论:本方法考察了浸提液的极性和酸碱度对1,2,4-苯三甲酸三(2-乙基己基)溶出的影响,间接分析了采用TOTM为增塑剂的PVC输液器临床使用安全性,为风险评估提供依据。
OBJECTIVE: To establish a gas chromatography-tandem mass spectrometry (GC-MS / MS) for the determination of tris (2-ethylhexyl) trimellitate ) Plasticizer dissolution analysis, analysis of different extraction medium on trimellitic acid tri (2-ethylhexyl) plasticizer dissolution rate. Methods: TOTM was extracted from the infusion set by using a peristaltic pump at room temperature using chloroform, ethanol, saline and three kinds of buffered saline solution with different p H as extraction media. HP-5MS (30 m × 250 μm × 0.25 μm ) Column extract gas chromatography - tandem mass spectrometry. Results: The detection limit of the method was lower (the lower limit of quantification was 0.03 μg · mL -1). The extraction rate of TOTM was 10.62 μg · m L -1 with chloroform as extraction medium and 6.55 μg · M L -1; potassium chloride-hydrochloric acid buffer (0.2 mol·L -1, p H = 2) was 5.11 μg · m L -1; 0.9% saline and other 2 buffer salt solution not detected. Conclusion: This method investigated the influence of the polarity and pH of the extract on the dissolution of tris (2-ethylhexyl) trimellitate, and indirectly analyzed the clinical application of PVC infusion with TOTM as plasticizer Use safety to provide a basis for risk assessment.