国产氨茶碱缓释片的人体药代动力学

PHARMACOKINETICS OF SUSTAINED—RELEASE AMINOPHYLLINE TABLET IN HUMAN

本文采用荧光偏振免疫分析法测定了6例健康受试者口服单剂量国产氨茶减缓释片的血药浓度,并计算其药代动力学参数,结果表明:茶碱缓释片代谢为一室开放模型,其药动力学参数Tlag为0.53±0.29h,Ka为0.99±0.26h^(-1),Ke为0.0629±0.012h^(-1),Tmax为3.53±0.44h,t1/2为11.02±0.29h,Cmax为6.47±2.12μg/ml,AUC为122.6±38.1μg/ml.h,CL为1.03±0.22ml/min.kg。茶碱缓释片与普通氨茶碱片相比较,具有血药浓度下降缓慢,波动较小等特点,是一个较好茶碱剂型。

Serum theophylline levels are measured by Fluorescence Polarization Immunoassay. The pharmacokinetics of theophylline from sustained -release aminophylline tablets have been observed in 6 healthy subjects a single oraldose (400 mg). The results suggest thatthe pharmacokinetics of theophyllinefrom sustained-release aminophylline isthe one compartment open model withfirst order absorption and lag time. Thepharmacokinetic parameters are Tlag0.53±0.29h, Ka 0.99±0.26h^(-1), Ke 0.0629±0.012h^(-1), Tmax 3.53±0.44h, T1/211.2±0.29h, Cmax 6.47±2.12μg/ml,AUC 122.6±38.1μg/ml.h, CL 1.03±0.22 ml/min.kg.The serum concentrations of sustained-release amino-phylline are decreasedslowly, it is a good proparation of thoep-hylline.