盐酸曲马多分散片人体药物动力学及相对生物利用度  

Pharmacokinetics and relative bioavailability of tramadol hydrochloride tabletin Chinese healthy volunteers

作　　者：陈波[1] 曾照宏[1] 冒国光[1] 马越鸣[1] 钟秋[1] 

机构地区：[1]皖南医学院弋矶山医院临床药理研究所,芜湖241001

出　　处：《中国临床药理学与治疗学》1999年第4期292-295,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的 研究国产盐酸曲马多分散片的人体药代动力学参数和生物等效性.方法 12名健康受试者交叉口服国产盐酸曲马多分散片100mg和进口盐酸曲马多胶囊100mg,用HPLC法测定血浆中药物浓度.结果 两种制剂的血药浓度曲线均符合二室模型,T_(1/2)分别为(7.69±3.74)h和(7.66±3.41)h,血药浓度曲线下面积分别为(3100±1165)μg·h·L^(-1)和(3212±1260)μg·h·L^(-1),两种制剂的药代动力学参数均无显著性差异(P>0.05).结论 两种制剂的口服生物利用度具有生物等效性.Aim To study the pharmacokinetics and relative bioavailability of tramadol hy-drochloride tablet. Methods Twelve male Chinese healthy volunteers received asingle oral dose of tramadol hydrochloride tablet(THT) 100mg and tramadol hy-drochloride capsule(THC) 100mg in a random crossover design. Drug concentrationsin plasma were determined by HPLC. Results The concentration time profile con-formed to an open two-compartment model. The T1/2 and AUC0~24 of two productswere (7. 69±3. 74) h and (7. 66±3. 41) h, (3100±1165)μg·h·L-1 and (3212±1260) μg·h·L-1, respectively. No significant difference was observed in pharma-cokinetic parameters between tested and reference preparations(P> 0. 05). Conclu-sion The THT and THC have bioequivalence.

关 键 词：盐酸曲马多分散片 药物动力学 相对生物利用度 生物等效性 

分 类 号：R971.1[医药卫生—药品] R969.1[医药卫生—药学]