精氨酸布洛芬糖浆与布洛芬片剂人体药动学及生物等效性比较

Pharmacokinetics and bioequivalence of arginine ibuprofen syrup vs ibuprofen tablet in healthy volunteers

目的:比较精氨酸布洛芬糖浆与布洛芬片在健康人体中的药动学及生物等效性。方法:采用液相色谱法测定18位健康男性受试者交叉服用精氨酸布洛芬糖浆和布洛芬片后的血浆中布洛芬浓度。结果:糖浆剂的药动学参数为:AUC_(0-10)=(150±s 17)mg·h·L^(-1),C_(max)=(47±9)mg·L^(-1),t_(max)=(0．6±0．3)h;布洛芬片剂的药动学参数为:AUC_(0-10)=(136±13)mg·L^(-1),c_(max)=(28±4)mg·L^(-1),t_(max)=(2．7±1．0)h,相对生物利用度为 (98±7)％。结论:精氨酸布洛芬糖浆和布洛芬片生物等效。

AIM： To determine the pharmacokinetics and bioequivalence of arginine ibuprofen syrup vs ibuprofen tablet. METHODS： The pharmacokinetics and bioequivalence of arginine ibuprofen syrup were estimated in 18 healthy male volunteers by cross over method using ibuprofen tablet as control. The serum concentrations of ibuprofen was determined by HPLC method. RESULTS： The pharmacokinetic parameters of arginine ibuprofen syrup were AUC0-10=（150 ±s 17） mg·h·L^-1,Cmax =（47 ± 9） mg·L^-1,tmax =（0.6 ± 0.3） h vs those of ibuprofen tablets AUC0-10=（136± 13） mg·h·L^-1cmax =（28 ± 4） mg·L^-1,tmax =（2.7 ± 1.0） h. The relative bioavailability for arginine ibuprofen syrup was （98 ± 7）%. CONCLUSION： Arginine ibuprofen syrup were bioequivalent with ibuprofen tablets.