茴拉西坦血药浓度测定及药代动力学研究

 目的 研究茴拉西坦片的血药浓度测定及在健康人群中的药代动力学。方法 8名健康志愿者单剂量 po 茴拉西坦分散片，以反相高效液相色谱法测定人血浆中茴拉西坦浓度。结果 在0～100.0 mg·ml〈sup〉-1〈/sup〉范围内线性关系良好，最低检测浓度为2.0 ng·ml〈sup〉-1〈/sup〉。日内、日间误差小于4.47%和5.26%(n=5)，平均回收率为(90.19±0.69)%(n=5)。血药浓度-时间数据用3P87程序拟合，药-时曲线符合开放一室模型，其主要药代动力学参数为：达峰时间 t〈sub〉max〈/sub〉为(22.94±1.66) min；峰浓度 c〈sub〉max〈/sub〉为(61.24±4.15) ng·ml〈sup〉-1〈/sup〉；消除半衰期 t〈sub〉1/2ke〈/sub〉=(22.69±2.45) min；t〈sub〉1/2ke〈/sub〉=(9.54±2.01) min;药-时曲线下面积 AUC 为(3735.78±192.33) ng·min·ml〈sup〉-1〈/sup〉。结论 本方法简单准确，结果满意。

Studies on the assay of aniracetam in plasma and its pharmacokinetics

OBJECTIVE To study the assay drug concentration of aniracetam in plasma and its pharmacokinetics. METHODS Th plasma aniracetam concentrations of 8 male healthy volunteers after single oral dose of aniracetam dispersing tablet was detected by high pressure liquid chromatographic(HPLC) methods. RESULTS The linearity was obtained over the range of 0～100 ng·ml^-1and the lowest limit of dectection was 2.0 ng·ml^-1.The within-day precision and day-to-day precision was respectively 4.47% and 5.26%(n=5).The data of plasma concentrations was calculated with 3P87 program and fitted to an one-compartment open model with a first order absorption.The main pharmacokinetic parameters were t_max=(22.94±1.66) min,c_max=(61.24±4.15) ng·ml^-1,t_1/2ke=(22.69±2.45) min,t_1/2ke=(9.54±2.01) min,AUC=(3735.78±192.33) ng·min·ml^-1. CONCLUSION The assay method was simple and accurate.