双氯芬酸钠肠溶片的血药浓度测定及人体药代动力学研究

Determination Diclofenac Plasma Concentration by HPLC and Study on the Pharmacokinetcs Coated Tables in Healthy Volunteers

目的 :研究双氯芬酸在正常志愿者的血药浓度及体内的药代动力学 ,为临床用药提供依据。方法 :16名健康男性志愿者 ,单剂量口服双氯芬酸钠肠溶片 10 0 mg,在不同时间点取静脉血 ,血药浓度采用高效液相色谱法 (HPL C)测定。由血药浓度数据获得各自的主要药动力学参数。结果 :志愿者单次服用 10 0 mg双氯芬酸钠肠溶片后的药代动力学参数 AUC0→∞ 、AU C0→ 8、Cmax、Tmax分别为 (5 .98± 1.4 7) mg.h/ L、(6 .15± 1.5 2 ) mg.h/ L、(2 .96± 0 .84 ) m g.h/ L、(2 .2 5± 0 .32 ) h。结论 :双氯芬酸钠肠溶片在我国正常志愿者的药代动力学参数与国外的相似。

Objective A HPLC-UV method was developed and validated to determine diclofenac in human plasma and study the pharmacokinetics of enteric coated tablet in healthy volunteers.Methods Asingle oral dose of 100 mg enteric coated tablet was given to 16 heslthy male volunteers.The plasma concentrations of diclofenac were determined by HPLC method.Results The main pharmacokinectic parameters of enteric coated tablet were AUC 0～8( 5.98±1.47)mg.h/L,AUC 0→∞(6.15±1.52)mg.h/L,Cmax(2.96±0.84)mg.h/L,T max(2.25±0.32)h.Conclusion The pharmacokinetic parameters of diclofenac tablets in Chinese young volunteer is similar to that other report.