茴拉西坦分散片在健康人体内的药动学研究

Pharmacokinetics Study of Aniracetam Dispersible Tablets in Healthy Volunteers

目的：建立测定人血浆中茴拉西坦浓度的方法。方法：采用高效液相色谱法测定人血浆中茴拉西坦的浓度，色谱柱为ODS C18（250mm×4．6mm，5μm），流动相为甲醇-水-冰乙酸（45：55：0．075），检测波长为250nm，内标为对羟基苯甲酸甲酯。结果：茴拉西坦血药浓度在0．40～12．0μg／ml范围内线性关系良好（r=0．9998）；回收率〉80％，日内和日间RSD均〈10％。结论：本方法简便、快速、准确，适用于茴拉西坦分散片药动学研究及血药浓度监测。

OBJECTIVE： To establish a method for the concentration determination of aniracetam in healthy volunteers. METHODS： HPLC method was adopted. The determination was performed on ODS C18（250 mm×.6 mm, 5μm） column with methanol-water-glacial acetic acid （45：55：0.075） as mobile phase. The detection wavelength was set at 250 nm, and methyl parahydroxybenzoate was taken as internal standard. RESULTS： The linear range of aniracetam were 0.40-12.0 μg/ml （r=0.999 8） with recovery above 80%. RSDs of intra-day and inter-day were below 10%. CONCLUSIONS： The method is convenient, rapid, accurate and suitable for the pharmacokinetic study and plasma concentration monitoring of Aniracetam dispersible tablets.