建立乙烷硒啉在癌症患者血浆中的浓度测定方法及其药代动力学研究

Determination of ethaselen concentration in cancer patients plasma and study on its pharmacokinetics

目的建立湿法消解-电感耦合等离子体质谱法(ICP-MS)测定人血浆中乙烷硒啉的浓度,并将其用于乙烷硒啉分散片的人体药代动力学研究。方法血浆样品经硝酸消解后,用ICP-MS法测定给药后血浆中不同时间含硒药物总量,并用WinNonlin 5.2软件计算主要药代动力学参数。结果乙烷硒啉主要药代动力学参数如下:tmax为(9.20±0.98)h,Cmax为(597.58±221.73)ng·mL-1,AUC0-t为(2.57±0.92)μg·mL-1·h,平均滞留时间(MRT)为(24.60±0.63)h。结论建立的ICP-MS法简便、快速、灵敏,适用乙烷硒啉分散片临床监测。

Objective To establish inductively coupled plasma mass spectrometry （ICP -MS ） method for determining the concentration of ethaselen in human plasma , and to apply it to the pharmacokinetic study of ethaselen dispersible tablets. Methods Plasma samples were digested with nitric acid, then detected by ICP- MS method. The main pharmacokinetic parameters were calculated with non -compartmental analysis by WinNonlin 5. 2 software. Results The parameters pharmacokinetic results of ethaselen were as follows： tmax was （9.20 ±0.98） h, Cmax was （597. 58±221.73） ng . mL^-1, AUC0-t was （2. 57±0. 92） ng . h . mL^-1, the mean residence time （MRT） was （24. 60 ± 0. 63 ） h. Conclusion The ICP- MS method is simple, rapid and sensitive, which is suitable for clinical determination of the concentration of ethaselen dispersible tablets in hu- inan plasma.