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本文在国内首次报道了用反相高效液相色谱法测定酮康唑血浆浓度的方法及名正常人口服400 mg酮康唑的药代动力学研究。固定和为HITACHI GEL 3056(ODS),流动相为甲醇:pH 7.61的0.02 mol/L磷酸盐缓冲液(72:28;流速0.7ml/min,紫外检测波长247nm;最低检测限10ng;平均回收率92％以上;不同浓度水平测定结果的日内和日间变异系数均小于5％。体内动力学过程符合丌放性二室模型。其消除半衰期(T1/2β)为6.21±0.78h;表现分布容积(Vd)为0.84±0.48L/kg;血浆清除率(CL)为0.09±0.05L/(kg·h);峰浓度(Cm)为7.66±4.05μg/ml;达峰时间(Tm)为4.35±1.76h。
This is the first report of a method for the determination of plasma concentration of ketoconazole by RP-HPLC and the pharmacokinetic study of a normal human oral ketoconazole 400 mg. Fixed and HITACHI GEL 3056 (ODS) with a mobile phase of methanol: 0.02 mol / L phosphate buffer at pH 7.61 (72:28; flow rate 0.7 ml / min, UV detection at 247 nm; 92%. The intra-and inter-day CVs of different concentration levels were all less than 5% .The kinetics of in vivo kinetics were in good agreement with the two-compartment models with an elimination half-life (T1 / 2β) of 6.21 ± 0.78 h, (Vd) was 0.84 ± 0.48L / kg; the plasma clearance (CL) was 0.09 ± 0.05L / (kg · h); the peak concentration (Cm) was 7.66 ± 4.05μg / ml; the peak time (Tm) ± 1.76h.