目的 建立人血浆中奥卡西平药物浓度的RP-HPLC检测方法，并研究其在人体内的药动学。方法 采用液–液萃取法，用萃取液甲基叔丁基醚萃取癫痫患者血浆中的奥卡西平后，以阿普唑仑为内标。色谱柱为Kromasil 100A C18（250 mm×4.6 mm，5 μm），柱温40 ℃，流动相为甲醇–乙腈–水–磷酸（30∶30∶40∶0.04），体积流量1.0 mL/min，紫外检测波长243 nm，固定进样量20 μL。以3p97软件计算10名受试者清晨空腹单剂量口服奥卡西平片600 mg后的平均药动学参数。结果 血浆中内源性杂质对样品测定无干扰，奥卡西平在21.6～2 160.0 μg/L（r=0.999 2）线性关系良好，最低定量限21.6 μg/L；方法回收率为95.45%～107.69%；日内RSD值为4.97%～7.35%，日间RSD值为4.81%～11.27%。含药血浆经3次冻融后稳定性良好。结论 本方法操作快速、简便、灵敏度高、准确度好，可用于含奥卡西平血样的即时检测分析和临床药动学研究。

Objective To establish an RP-HPLC method for the determination of oxcarbazepine in plasma of epileptic patient and to study its pharmacokinetics. Methods Acidified plasma samples were processed by a simple liquid-liquid extraction. Alprazolam was used as internal standard. The HPLC analytical column was Kromasil 100A C18 (250 mm × 4.6 mm, 5 μm) at 40 ℃, the mobile phase consisted of a mixture of CH3OH-CH3CN-H2O-H3PO4 (30∶30∶40∶0.04), and delivered at a flow of 1.0 mL/min. The UV detection wavelength was set at 243 nm, and the injection volume was 20 μL. The pharmacokinetic parameters of oxcarbazepine in 10 volunteer after a single oral dose of Oxcarbazepine Tablets (600 mg) were calculated using 3p97 Software. Results The drug from plasma did not interfere with the determination of oxcarbazepine and alprazolam. The concentration of oxcarbazepine in plasma had good linearity relationship (r = 0.999 2) in the range of 21.6 —2 160.0 μg/L. The lowest detection limit was 21.6 μg/L. The recovery ranges were 95.45% — 107.69%. The RSD values of intra- and inter-day were 4.97% — 7.35% and 4.81% — 11.27%, respectively. The sample stability was good after freeze thaw for three times. Conclusion The method is simple, sensitive, and accurate. This could be used for the immediate analysis of the concentration of oxcarbazepine in plasma and pharmacokinetics study.