国产双氯芬酸钠缓释栓的人体药代动力学研究  

Study of pharmacokinetics of diclofenac sodium sustained-released suppository in Chinese healthy volunteers

作　　者：胡爱萍[1] 胡国新[1] 邱相君[1] 代宗顺[2] 

机构地区：[1]温州医学院药理学教研室 [2]华中科技大学同济医学院临床药理学教研室

出　　处：《中国临床药理学与治疗学》2004年第4期451-454,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的 :研究国产双氯芬酸钠缓释栓人体内的药代动力学特征。方法 :2 0名健康志愿者单剂量给予 10 0mg双氯芬酸钠缓释栓 ,采用反相高效液相色谱法测定血浆中双氯芬酸钠的浓度。用 3p87程序计算其药代动力学参数。结果 :主要药代动力学参数Cmax 为 1.1± 0 .3mg·L-1;Tmax 为 1.7± 0 .7h ;T1 2 (ke) 为 2 .4± 0 .6h ;CL为 2 7± 6L·h-1;Vd 为 74±2 5L ;AUC0 -∞ 为 4 .0± 1.2mg·h-1·L-1。结论 :双氯芬酸钠缓释栓在健康人体内的药代动力学符合单室模型特征。AIM : To study the pharmacokinetics of diclofenac sodium sustained-released suppository in healthy volunteers. METHODS : A single dose of 100 mg diclofenac sodium sustained-released suppository was given to 20 healthy volunteers. The concentrations of diclofenac sodium sustained-released suppository in plasma were determined by HPLC method. The parameters of pharmacokinetics were calculated by 3p87 program. RESULTS : The C max of the drug was 1.1± 0.310 mg·L -1; T max was 1.7± 0.167 h; T 1/2(ke) was 2.3± 0.6 h; CL was 27± 6 L·h -1; V d was 74± 25 L; AUC 0-∞ was 4.0± 1.2 mg·h -1·L -1. CONCLUSION : The pharmacokinetics of this drug in healthy volunteers can be fitted into one compartment model with 1st order absorption.

关 键 词：双氯芬酸钠 缓释栓 药代动力学 高效液相色谱法 血浆 

分 类 号：R969.1[医药卫生—药理学] R971.1[医药卫生—药学]