一次性使用输液器产品中1,2,4-苯三甲酸三(2-乙基己基)酯溶出量测定研究  

Research on the determination for 1,2,4-benzenetricarboxylic acid tris(2-ethylhexyl) ester released from disposable infusion set

作　　者：张莉[1] 郑建[1] 徐萍华[1] 韩银[1] 王安燕[1] 王敏珠[1] 徐方明[1] 鲍娇慧 

机构地区：[1]国家食品药品监督管理局杭州医疗器械质量监督检验中心,杭州310009

出　　处：《药物分析杂志》2017年第11期2106-2111,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：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 an effective GC-MS/MS method for the determination of the residual plasticizer TOTM in disposable infusion set, and investigate the effect of different extraction media on the release of TOTM. Methods： Chloroform, ethanol water, physiological saline and three buffered salt solutions with various pH were used as extraction media, which were pumped with a peristaltic pump to extract TOTM from infusion sets at room temperature; then an HP-5MS column （ 30 m × 250 μm× 0.25 μm ） chromatographic column was used for analyzing the extracts by gas chromatography-mass spectrometry. Results： This method is quite convenient, fast, accurate and of low detection limit （ low limit of quantification ： 0.03 μg· mL-1 ）. When chloroform was used as extraction medium, the release of TOTM was determined to be 10.62 μg· mL-1; for 30 % ethanol water, the release of TOTM was determined to be 6.55 μg· mL-1; and the value was 5.11 μg· mL-1 for potassium chloride- hydrochloric acid buffer （ 0.2 mol· L-1, pH=2 ） ; TOTM was not detected when the extraction media were 0.9% physiological saline and the other two buffered salt solutions. Conclusion： The present research investigated the influence of polarity and pH of extraction media on the release of TOTM. Moreover, the clinical safety of PVC infusion sets adopting TOTM as plasticizer was also analyzed indirectly, which provided the basis for the risk assessment.

关 键 词：气相色谱-串联质谱 1 2 4-苯三甲酸三(2-乙基己基)酯 TOTM 增塑剂 溶出 一次性使用输液器 

分 类 号：R97[医药卫生—药品]