单剂量口服醋氯芬酸肠溶片的人体药代动力学研究

Study of the Pharmacokinetics of Domestic Aceclofenac Enter-coated Tablets with Single Dose in Male Healthy Volunteers

目的研究醋氯芬酸肠溶片的人体药代动力学。方法12名健康男性志愿者口服国产醋氯芬酸肠溶片100mg,采用HPLC法测定给药后不同时间点的血浆醋氯芬酸浓度。用DAS程序计算其药代动力学参数。结果健康志愿者单剂量口服醋氯芬酸肠溶片后,血浆的醋氯芬酸Cmax为(9.13±3.73)mg/L;Tmax为(2.27±0.88)h;t1/2(ke)为(2.54±1.35)h;CL为(1.96±0.79)L/h;Vd为(6.50±3.16)L;AUC为(54.40±20.22)mg·h/L。结论单剂量口服国产醋氯芬酸肠溶片,其人体药代动力学符合一级吸收的一室模型。

Objective To study the pharmacokinetics of Aceclofenac enter--coated tablets in healthy volunteers. Methods A single oral dose of 100rag Aceclofenac were given to 20 healthy volunteers. Aceclofenac concentrations in plasma were determined by HPLC method.The parameters of pharmacokinetics were calculated by DAS program.Results The Cmax of the drug was（9.13 ±3.73）mg/L; Tmax was（2.27 ± 0.88）h; t1/2（ke） was （2.54±1.35）h;CL was（1.96 ± 0.79）L/h; Vd was （6.50±3.16）L; AUC was（54.40± 20.22）mg.h/L. Conclusion The pharmacokinetic of this drug in healthy volunteers could be fitted into one compartment model with 1st order absorption.