元胡止痛片中延胡索乙素血药浓度的UPLC-MS/MS测定及药动学研究

摘要

目的 建立大鼠血浆中延胡索乙素的UPLC-MS/MS测定方法,并探讨大鼠灌胃元胡止痛片后其在大鼠体内的药动学过程.方法 以流动相乙腈-0.1％甲酸水溶液,梯度洗脱,流速0.35 mL/min;采用电喷雾离子源,正离子检测模式扫描,多反应监测模式检测延胡索乙素血药浓度,并用DAS 3.0软件计算药动学参数.结果 延胡索乙素在2.93～711 ng/mL线性关系良好,平均回收率均＞87.6％,日内、日间RSD均＜15％.大鼠灌胃元胡止痛片后,延胡索乙素AUC0-1为(11 359±3026)ng·min/mL;t1/2为(342±36)min.结论 UPLC-MS/MS能够快速、灵敏、专属地分析大鼠血浆中延胡索乙素的血药浓度,该方法适用于元胡止痛片在大鼠体内的药代动力学分析.%Objective To establish an UPLC-MS/MS determination method of Tetrahydropalmatine in rat plasma,explore pharmacokinetic process in rat after intragastric administration of Yuanhuzhitong Tablets.Methods The chromatography was eluted with mobile phase consisted of acetonitrile and 0.1％ formic acid solution at the flow rate of 0.35 mL/min by gradient elution.Multiple-reaction monitoring scanning mode was employed for quantification with switching electrospray ion source polarity in positive mode.The pharmacokinetic parameters were calculated by using DAS 3.0 software.Results The linear ranges of Tetrahydropalmatine was 2.93-711 ng/mL.RSDs of inta-day and interday were all lower than 15％,and the average recovery was more than 87.6％.After intragastric administration of Yuanhuzhitong Tablets,AUC0-1 of Tetrahydropalmatine was (11 359±3026) ng·min/mL,t1/2 was (342±36)min.Conclusion UPLC-MS/MS is a rapid,sensitive and specific method for the determination of Tetrahydropalmatine in rat plasma.This method is suitable for pharmacokinetic analysis of Yuanhuzhitong Tablets in rats.