液质联用法测定体外循环管道中增塑剂DINCH在血液中的溶出量  

Determination of released DINCH in blood from disposable extracorporeal circulation tube by LC-MS/MS

作　　者：王红 韩玎玎 刘曦 吴瑕 吕汝举 刘承武 刘嘉馨 

机构地区：[1]中国医学科学院输血研究所,成都610052 [2]山东威高新生医疗器械有限公司,威海264209

出　　处：《药物分析杂志》2015年第12期2204-2208,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：国家科技支撑计划课题"新增塑剂的生物医用材料"(编号2012BAI22B07)

摘　　要：目的:建立测定增塑剂环己烷-1,2-二甲酸二异壬酯(DINCH)的测定方法,并测定一次性使用体外循环管道中DINCH在血液中的溶出量,为该产品的安全性评价提供依据。方法:采用乙酸乙酯萃取血液样品中的DINCH,并用液质联用方法(LCMS/MS)测定一次性体外循环管道中DINCH的溶出量。结果:LC-MS/MS方法测定DINC质量浓度在1.34~53.40μg·m L-1范围内线性关系良好(r=0.999 5),灵敏度为0.134 ng,仪器精密度RSD<5%,液相萃取的回收率为82.11%,用该方法测定一次性体外循环管道在模拟临床使用极限条件下DINCH在血液中的溶出量为2.89 mg·套-1。结论:本法经方法学验证,可以用于测定DINCH在血液中的溶出量。Objective： To develop a method for determination of released plasticizer di-isononyl-cyclohexane^（-1）,2-dicarboxylate（ DINCH） from disposable extracorporeal circulation tube in blood,so as to evaluate the safety of this product. Methods： Ethyl acetate was used to extract DINCH from blood,and the quantification was achieved by LCMS / MS. Results： The data on the methodology study of LC-MS / MS showed a good linear relationship of DINCH mass concentration which ranged in 1. 34-53. 40 μg·m L-1（ r =0. 999 5）. The method sensitivity was 0. 134 ng,with an instrumental precision RSD 5%,and the liquid-phase extraction recovery rate was 82. 1%. The amount of DINCH released into blood from this disposable extracorporeal circulation tube was 2. 89 mg per set under the maximum clinical conditions. Conclusion： The established method presented high accuracy,good reliability and stability for the determination of DINCH in blood.

关 键 词：环己烷-1 2-二甲酸二异壬酯(DINCH) 邻苯二甲酸二(2-乙基己)酯(DEHP) 溶出量 增塑剂 液质联用 全血样品 临床使用极限条件 

分 类 号：R917[医药卫生—药物分析学]