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本文首次报道了测定苯丙哌林血浆浓度的高效液相色谱法及该药在人体内的药代动力学行为。绘制了10名健康男性受试者服用磷酸苯丙哌两种制剂60mg(以苯丙哌林计)后的血浆浓度-时间曲线,用TopFit2.0软件进行房室模型拟合,结果表明苯丙哌林体内药代动力学过程符合二室模型。磷酸苯丙哌林分散片和胶囊的Tmax分别为1.76±0.29h和1.80±0.41h,Cmax分别为479.4±171.5和456.4±173.9μg·L-1;AUC0-t;为4309.4±1549.9和4119.5±2018.8μg·L-1·h。统计检验表明,10名受试者服用两种制剂后的药代动力学参数无显著性差异,具有生物等效性。
This is the first report of a HPLC method for the determination of benproperine in plasma and its pharmacokinetics in humans. The plasma concentration-time curves of 60 healthy male subjects after taking 60 mg of benproperine diphosphate (benproperine) were plotted, and fitted with a TopFit 2.0 software for fitting atrioventricular model. The results showed that phenylpropanoid The pharmacokinetics of pirinidazole in vivo is in accordance with the two-compartment model. Tmax for benproperine phosphate dispersible tablets and capsules were 1.76 ± 0.29 h and 1.80 ± 0.41 h, respectively, and Cmax were 479.4 ± 171.5 and 456.4 ± 173.9 μg · L-1, respectively; AUC0-t was 4309.4 ± 1549.9 and 4119.5 ± 2018.8 μg · L-1 · h. Statistical tests showed that 10 subjects had no significant difference in pharmacokinetic parameters after taking the two formulations, and was bioequivalent.