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8名健康受试者口服两种吉非罗齐胶囊剂后,血清样品经提取、甲酯化,以气相色谱法测定吉非罗齐的含量。其血药浓度-时间过程符合一房室模型。国产制剂的药代动力学参数分别为:k_a=2.97±2.84h~(-1),k=0.761±0.215h~(-1),t_(max)=1.42±0.83h,C_(max)=21.68±6.50mg/l,t_0=0.65±0.52h,V/F=0.122±0.040l,AUC=61.4±14.0mg·h/l。国外制剂的药代动力学参数分别为:k_a=3.26±2.94h~(-1),k=0.712±0.266h~(-1),t_(max)=1.26±0.54h,C_(max)=18.56±7.46mg/l,t_0=0.33±0.43h,V/F=0.153±0.045l,AUC=53.74±10.57mg·h/l。两者相对生物利用度F=1.14。4名受试者3次服药的峰浓度与谷浓度同单剂量给药的药代动力学参数结果的拟合值较为一致。
After oral administration of two kinds of gemfibrozil capsules to eight healthy volunteers, the serum samples were extracted and methyl esterified to determine the content of gemfibrozil by gas chromatography. The plasma concentration - time course consistent with a ventricular model. The pharmacokinetic parameters of domestic preparations were as follows: k_a = 2.97 ± 2.84 h -1, k = 0.761 ± 0.215 h -1, t max = 1.42 ± 0.83 h, C max = 21.68 ± 6.50 mg / l, t_0 = 0.65 ± 0.52 h, V / F = 0.122 ± 0.0401, AUC = 61.4 ± 14.0 mg · h / l. The pharmacokinetic parameters of foreign preparations were as follows: k_a = 3.26 ± 2.94 h -1, k = 0.712 ± 0.266 h -1, t max = 1.26 ± 0.54 h, C max = 18.56 ± 7.46 mg / l, t_0 = 0.33 ± 0.43 h, V / F = 0.153 ± 0.045 l, AUC = 53.74 ± 10.57 mg · h / l. The relative bioavailability between the two groups was F = 1.14. The fitting results of the peak concentration and the trough concentration of the three administrations of the four subjects with the pharmacokinetic parameters of the single dose administration were consistent.