盐酸曲马多口腔崩解片的生物等效性

Bioequivalence of Tramadol hydrochloride orally disintegrating tablet in healthy volunteers

目的考察盐酸曲马多口腔崩解片(受试制剂)和盐酸曲马多片(参比制剂)在健康人体内的生物等效性。方法血清样品采用液-液萃取预处理,采用HPLC测定血药浓度。18名男性健康志愿者随机均分成两组,采用自身交叉法,每组分别单剂量口服受试制剂和参比制剂各100 mg。结果受试和参比制剂的主要药动学参数t1/2为7.6±2.2、7.3±1.8 h,Tmax为1.9±0.8、1.8±0.8 h,Cmax为282.2±58.6、285.0±55.7μg.L-1,AUC0-t为2.455±0.647、2.574±0.715 mg.h.L-1,AUC0-∞为2.756±0.723、2.851±0.737 mg.h.L-1。结论制剂具生物等效性。与参比制剂相比,受试制剂的生物利用度为96.3%±8.2%。

OBJECTIVE To evaluate the bioequivalence of Tramadol hydrochloride(TH) orally distintegrating tablets(test preparations) and TH tablets(reference preparations) in Chinese healthy volunteers.METHODSSerum samples were extracted by liquid-liquid extraction methods,and blood drug concentrations of TH were measured by HPLC.Eighteen healthy male volunteers were divided randomly into 2 groups.According to two-formulas double-period crossover protocol,volunteers in each group were administrated with an single oral ...