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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 establish a method for the determination of DINCH, a plasticizer cyclohexane-1, 2-dicarboxylate and to determine the amount of DINCH released from the blood in a one-time use of extracorporeal circulation catheters for the safety of this product Provide the basis for sexual evaluation. METHODS: DINCH in blood samples was extracted with ethyl acetate and the DINCH dissolution in disposable extracorporeal tubes was determined by LC-MS / MS. Results: The linearity was good (r = 0.999 5), the sensitivity was 0.134 ng, the precision of instrument RSD was less than 5% when the concentration of DINC was determined by LC-MS / MS in the range of 1.34-53.40 μg · m L-1. The recovery rate of DINCH in the blood was estimated to be 2.89 mg · mL -1 with this method for determination of one-off extracorporeal circulation pipelines under simulated clinical use limits. Conclusion: This method is validated by methodology and can be used to determine DINCH in blood.