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目的比较国产、进口阿斯咪唑混悬剂在健康中国人体的药代动力学。方法用放射免疫法测定血浆阿斯咪唑 +去甲阿斯咪唑含量 ,按交叉设计法对国产和进口阿斯咪唑混悬剂进行健康中国人体的药代动力学的比较,并求相对生物利用度。结果经3P87软件处理 ,阿斯咪唑的药代动力学呈二室模型。主要药代动力学参数 :国产剂 :Vd=6.88±1.36L;αT1/2=4.24±4.06h;βT1/2=170.31±73.80h;CL=0.067±0.023ng/ml;Tpeak=1.00±0.53h;Cmax=1.25±0.17ng/ml;AUC=162.97±48.57ng/ml·h-1。进口片 :Vd=6.40±3.07L;αT1/2=1.31±0.91h;βT1/2=156.02±120.74h;CL=0.079±0.045ng/ml;Tpeak=1.00±0.53h;Cmax=1.08±0.19ng/ml;AUC=173.46±114.66ng/ml·h-1。结论国产、进口阿斯咪唑混悬剂在中国人体的药代动力学参数均未发现明显差异。
Objective To compare the pharmacokinetics of domestic and imported Asmazole suspensions in healthy Chinese. Methods The content of plasma asimizole + noradimizole was determined by radioimmunoassay. The pharmacokinetics of Chinese and imported astemizole suspension were compared by cross design method and the relative bioavailability . Results 3P87 software processing, asimizazole pharmacokinetics showed a two-compartment model. Main Pharmacokinetic Parameters: Domestic Agent: Vd = 6.88 ± 1.36L; αT1 / 2 = 4.24 ± 4.06h; βT1 / 2 = 170.31 ± 73.80h; CL = 0.067 ± 0.023ng / ml; Tpeak = 1.00 ± 0.53h ; Cmax = 1.25 ± 0.17 ng / ml; AUC = 162.97 ± 48.57 ng / ml.h-1. Import tablets: Vd = 6.40 ± 3.07 L; αT1 / 2 = 1.31 ± 0.91 h; βT1 / 2 = 156.02 ± 120.74 h; CL = 0.079 ± 0.045 ng / ml; Tpeak = 1.00 ± 0.53 h; Cmax = 1.08 ± 0.19 ng / ml; AUC = 173.46 ± 114.66 ng / ml·h-1. Conclusion There are no significant differences in the pharmacokinetic parameters of domestic and imported astemizole suspensions in China.