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

发布时间：2018-09-02 06:38

【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RSD5%,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。
[Abstract]:Objective: to establish a method for the determination of (DINCH) in plasticizer cyclohexane-1 and diisononyl dicarboxylate, and to determine the dissolution of DINCH in blood in a single use of cardiopulmonary bypass (CPB) in order to provide the basis for the safety evaluation of the product. Methods: extraction of DINCH, from blood samples by ethyl acetate and determination of DINCH dissolution in single-time extracorporeal circulation conduit by liquid-mass spectrometry (LCMS/MS). Results the linear range of mass concentration of DINC was 1.34 ~ 53.40 渭 g / mL ~ (-1) for DINC determined by 1: LC-MS / MS / MS method (r _ (0.999 ~ 5). The recovery rate of 0.134 ng, instrument was 82.11% for precise RSD5%, extraction. This method was used to determine one-off extracorporeal circulation conduit in simulated clinical use. The dissolution of DINCH in blood under the limit condition was 2.89 mg set -1. Conclusion: this method can be used to determine the dissolution of DINCH in blood.
【作者单位】：中国医学科学院输血研究所;山东威高新生医疗器械有限公司;
【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)
【分类号】：R96;O657.63

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