气相色谱–质谱法测定血液净化装置的体外循环血路中DEHCH的溶出量

Determination of dissolution amount of DEHCH in extracorporeal circulation blood circuit of blood purification device by gas chromatography-mass spectrometry

建立了血液净化装置的体外循环血路在模拟临床试验的过程中环己烷–1,2–二甲酸二异辛酯(DEHCH)溶出的测试方法,选择密度为0.9376g/mL的乙醇/水混合液作为模拟的浸提溶液,采用气相色谱–质谱法检测DEHCH的溶出量。结果表明,DEHCH质量浓度在0.1~4.0mg/L时线性关系良好(R~2=0.99959),平均加标回收率在90.0%~110.0%,DEHCH的溶出量为0.148~0.173mg/L。该测定方法稳定性、精密度、准确度均较好,能够准确对DEHCH定性和定量,可用于血液净化装置的体外循环血路中DEHCH溶出量的日常监管检测。

A method was developed to test the dissolution of di(2-ethylhexyl)1,2-cyclohexane dicarboxylate(DEHCH)in the extracorporeal circulation blood circuit of a blood purification device during a simulated clinical trial.The ethanol/water mixture with density of 0.9376g/mL was selected as the simulated extraction solution,the dissolution amount of DEHCH was determined by gas chromatography-mass spectrometry.The results show that the linearity of DEHCH mass concentration is good at 0.1~4.0mg/L(R~2=0.99959),the average standard addition recovery rate is 90.0%~110.0%,the dissolution amount of DEHCH is 0.148~0.173mg/L.The method has good stability,precision and accuracy,and can accurately qualify and quantify DEHCH,which can be used for the daily supervision and determination of dissolution amount of DEHCH in the extracorporeal circulation blood circuit of the blood purification device.