盐酸曲马多缓释片的相对生物利用度研究

Relative Bioavailability of Sustained Release Tablets of Tramadol Hydrochloride

:18名男性健康受试者 ,随机交叉口服两种盐酸曲马多缓释片 ,采用反相高效液相色谱 -荧光检测法测定血浆药物浓度。单剂量口服 10 0 mg两种缓释片的 Cmax为 2 0 5 .0± 5 1.3和 193.5± 44 .0 ng/ ml;Tmax为 5 .6± 2 .1和 5 .8±2 .6 h;t1 /2 为 7.3± 2 .6和 7.3± 2 .8h。供试制剂的相对生物利用度为 97.36± 10 .0 1%。多剂量口服两种缓释片达稳态后的峰谷比为 1.42± 0 .17和 1.44± 0 .2 2 ;波动度为 36 .0 9± 12 .78和 34.37± 14.2 2 %。经统计处理均无显著性差异 (P>0 .0 5 )。经双单侧 t检验 ,两种缓释片具有生物等效性。

The pharmacokinetics and relative bioavailability of two brands of sustained release tramadol hydrochloride tablets administrated orally by 18 healthy male volunteers were investigated, according to a randomized crossover design. The plasma concentration of tramadol hydrochloride was determined by RP HPLC method with fluorescence detection. The pharmacokinetic parameters for the single oral dose of 100 mg sustained release tramadol hydrochloride tablets were C max 205.0±51.3 and 193.5±44.0 ng/ml; T max 5.6±2.1 and 5.8±2.6 h; t 1/2 7.3±2.6 and 7.3±2.8 h, for tested and reference tablets, respectively. The relative bioavailability for the tested tablets was 97.36±10.01%. For the multiple dosing, the concentration peak trough ratio (PTR) were 1.42±0.17 and 1.44±0.22, the degree of fluctuation (DF) were 36.09±12.78 and 34.37±14.22%, respectively. The results of two one sided t test showed that the tablets of two brands were bioequivalent.