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以气相色谱法检测丁咯地尔血药浓度 ,比较了国产与进口盐酸丁咯地尔片在健康人体内的药代动力学过程 ,并进行了相对生物利用度与生物等效性评价。结果显示 ,国产和进口盐酸丁咯地尔片的体内药动学过程均符合无滞留时间的一级吸收、一级消除的一室模型 ,它们的吸收、分布和消除也基本相似 ,t1/ 2ka分别为 0 9± 0 4、0 .7± 0 .3h ,t1/ 2ka分别为 3 0± 0 .8、30± 0 .9h ,AUC0～ 2 4 分别为 17± 6、17± 7mg/L·h ,AUC0 -∞分别为 18± 6、18± 7mg/L·h ,Cmax分别为 2 .6± 0 .6、2 .7± 0 .7mg/L。国产盐酸丁咯地尔片的相对生物利用度为 97± 19% ,与进口片剂具有生物等效性
The plasma concentration of buflomedil was detected by gas chromatography. The pharmacokinetics of buflomedil hydrochloride in China and in China were compared and the relative bioavailability and bioequivalence were evaluated. The results showed that the in vivo pharmacokinetics of domestic and imported buflomedil hydrochloride tablets were in accordance with the first-order absorption without residence time and the first-order elimination one-compartment model. Their absorption, distribution and elimination were also similar. T1 / 2ka Respectively, 0 9 ± 0 4,0 .7 ± 0. 3h, t1 / 2ka respectively 30 ± 0. 8,30 ± 0 .9h, AUC0 ~ 2 4 were 17 ± 6,17 ± 7mg / L · h, AUC0-∞ were 18 ± 6,18 ± 7mg / L · h, respectively, Cmax were 2.6 ± 0. .6,2 .7 ± 0 .7mg / L. The relative bioavailability of domestic buflomedil tablets was 97 ± 19%, which was bioequivalent to imported tablets