双氯灭痛在正常人体内的药物动力学研究

The pharmacokinetic study of diclofenac sodium in healthy volunteers

采用反相高效液相色谱法测定了１０例健康人单剂量口服７５ｍｇ双氯灭痛片剂后血浆药浓度，研究了该药物在中国人体内药物动力学。经用ＰＫＢＰ－Ｎ＿１程序包在计算机上拟合计算表明，双氯灭痛口服给药多数人表现为二房室模型。其主要药动学参数分别为：Ｔ＿（α１／２）＝０．４０±０．１１ｈ，Ｔ＿（β１／２）＝１．７７±０．５ｈ，Ｔ＿（ｍａｘ）＝１．７８±０．３２ｈ，Ｃ＿（ｍａｘ）＝１．８７±０．９μｇ／ｍｌ，ＡＵＣ＝３．８１±１．７μｇ／（ｍｌ·ｈ）。结果表明，中国人体内的药动学参数与所报道的外国人体内相似。

The concentration of diclofenac sodium in plasma was determined by reversed-phase liquid chromatography.The pharma- cokinetics of diclofenac sodium were studied in 10 healthy chinese volunteers.After oral administration of 75 mg ,the data ob- tained were fitted with PKBP-N_1 program on computer. The results showed that the dispostion of diclofenac sodium was con-formed to a two-compartment model with T_(α1/2)=0.40±0. 11h, T_(β1/2)=1.8±0.5h,C_max=1.9±0.9μg/ml,T_max=1.78±0.32h and AUC=3.8±1.7μ g/(ml·h),and was absorbed rapidly, distributed widely in the body and also eliminated at afairly rapid rate.