放射免疫法研究重组人集成干扰素α的猕猴药动学

 目的用放射免疫技术测定血药浓度的方法研究猕猴皮下注射重组人集成干扰素α注射液后的药动学。方法6只健康猕猴皮下注射10μg·kg^-1的重组人集成干扰素α注射液,用放射免疫法检测动物血清中的药物浓度,测定猕猴体内血药浓度并计算药动学参数。结果重组人集成干扰素α在猕猴体内代谢符合一室模型。其药动学参数是:t_1/2e(2.67±0.70)h;t_max(4.69±0.84)h,其中雌性猕猴的达峰时间明显比雄性动物短[雌性(3.99±0.23)h;雄性(5.38±0.49)h;P<0.01];ρ_max(3.07±1.77)g·L^-1;AUC_{0～21 h}(27.58±13.50)μg·h·L^-1。结论用放射免疫法测定猕猴皮下注射重组人集成干扰素α注射液血药浓度的方法稳定、灵敏度高、特异性强、准确性好,可用于动物和以后临床的药动学研究。

Pharmcokinetic Study of Recombinant Human Consensus Interferon-α in Rhesus Monkey by Means of Radioimmunoassay

OBJECTIVE To study pharmacokinetics of recombinant human consensus interferon-α in rhesus monkey by means of radioimmunoassay. METHODS The serum concentration and pharmacokinetic parameters of recombinant human consensus interferon-α in rhesus monkey were determined by radioimmunoassay.RESULTS The concentration-time profile of recombinant human consensus interferon-α after a single dose of 10 μg·kg^-1 in rhesus monkey was discribed by an one-compartment model.The pharmacokinetic parameters were as follows:t_1/2e(2.67±0.70)h,t_max(4.69±0.84)h[female: t_max(3.99±0.23)h;male: t_max(5.38±0.49)h;P<0.01)],ρ_max(3.07±1.77) μg·L^-1 and AUC_0～21h(27.58±13.50)μg·h·L^-1.CONCLUSION The method is sensitive,specific and accurate.It will be used for the clinical pharmacokinetic study of recombinant human consensus interferon-α.