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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(250mm×4.6 mm,5μm),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20μL。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21.6~2 160.0μg/L(r=0.999 2)线性关系良好,最低定量限21.6μg/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 a method for the determination of oxcarbazepine in human plasma by RP-HPLC and study its pharmacokinetics in human. Methods The liquid-liquid extraction method was used to extract oxcarbazepine in the plasma of patients with epilepsy with methyl tert-butyl ether as the extraction solvent. Alprazolam was used as an internal standard. The column was Kromasil 100A C18 (250 mm × 4.6 mm, 5 μm). The column temperature was 40 ℃. The mobile phase was methanol-acetonitrile-water-phosphoric acid (30:30:40:0.04) 243 nm, fixed injection volume 20μL. The mean pharmacokinetic parameters of 10 fasting single oral oxcarbazepine tablets 600 mg were calculated by 3p97 software in 10 subjects. Results The endogenous impurities in plasma did not interfere with the determination of the samples. The linearity of oxcarbazepine was 21.6 ~ 2 160.0 μg / L (r = 0.999 2), with the lowest limit of quantitation of 21.6 μg / L. The recovery was 95.45% -107.69 %. The daily RSD values ranged from 4.97% to 7.35% and the daytime RSD values ranged from 4.81% to 11.27%. Drug-containing plasma stability after 3 freeze-thaw stability. Conclusion The method is rapid, simple, sensitive and accurate. It can be used in the real-time assay and clinical pharmacokinetics of oxcarbazepine-containing blood samples.