顶空-气相色谱-三重四极杆质谱法同时测定一次性输液器中14种溶剂的迁移量  

Simultaneous Determination of Migration of 14 Solvents in Disposable Infusion Sets by Headspace-Gas Chromatography-Triple Quadrupole Mass Spectrometry

作　　者：秦瑶 余秋玲 张云冉 张永梅 龙梅 李根容 QIN Yao;YU Qiuling;ZHANG Yunran;ZHANG Yongmei;LONG Mei;LI Genrong(Chongqing Academy of Metrology and Quality Inspection,Chongqing 401123,China)

机构地区：[1]重庆市计量质量检测研究院,重庆401123

出　　处：《理化检验(化学分册)》2025年第2期202-207,共6页Physical Testing and Chemical Analysis(Part B:Chemical Analysis)

基　　金：重庆市市场监督管理局科研计划项目(CQSJKJ2021041)。

摘　　要：选取0.9%(质量分数,下同)氯化钠溶液作为输注药物,模拟静脉滴注方式,使0.9%氯化钠溶液以40~60滴·min^(-1)速率流经一次性输液器管路。分取5.0 mL流出液(迁移液)置于顶空瓶中,于80℃平衡30 min,所得气体流入气相色谱-三重四极杆质谱仪,其中的14种溶剂在TG-624Sil MS色谱柱上以升温程序分离,电子轰击(EI)离子源电离,选择反应监测(SRM)模式检测,外标法定量。结果显示,14种溶剂的质量浓度均在一定范围内和对应的峰面积呈线性关系,检出限(3S/N)为0.1~0.2μg·L^(-1);以0.9%氯化钠溶液为迁移基质进行3个浓度水平的加标回收试验,回收率为80.0%~122%,测定值的相对标准偏差(n=6)为0.42%~9.7%。方法用于不同厂家样品的分析,有7种溶剂迁移到了0.9%氯化钠溶液中,不同厂家样品的迁移量各不相同;聚氯乙烯(PVC)材质样品中环己酮和2-乙基己醇的迁移量明显较热塑性弹性体(TPE)材质样品的多,且相同厂家旧批次样品中的迁移量较新批次样品的多。Using 0.9%(mass fraction,the same below)sodium chloride solution as the infusion drug,simulating the intravenous drip method,0.9%sodium chloride solution flowed through the tube of disposable infusion set at a rate of 40-60 drops·min^(-1).An aliquot(5.0 mL)of the effluent(migration solution)was taken,placed into a headspace vial,and equilibrated at 80℃for 30 min.The resulting gas flowed into the gas chromatograph-triple quadrupole mass spectrometer.The 14 solvents were separated using the heating program on the TG-624Sil MS chromatographic column,ionized by EI ion source,detected by SRM mode,and quantified by external standard method.It was shown that linear relationships between values of the mass concentrations and corresponding peak areas of 14 solvents were kept in definite ranges,with detection limits(3S/N)in the range of 0.1-0.2μg·L^(-1).The spiked recovery test was made at 3 concentration levels using 0.9%sodium chloride solution as the migration matrix,giving recoveries in the range of 80.0%-122%,and RSDs(n=6)of the determined values ranged from 0.42%to 9.7%.The proposed method was used for the analysis of samples from different manufacturers.Seven solvents migrated to 0.9%sodium chloride solution,and the migration from samples of different manufacturers varied.The migration of cyclohexanone and 2-ethylhexanol from samples made of PVC was significantly higher than that from samples made of TPE,and the migration in old batches of samples from the same manufacturer was higher than that in new batches.

关 键 词：溶剂 迁移量 顶空-气相色谱-三重四极杆质谱法 一次性输液器 

分 类 号：O657.63[理学—分析化学]