【摘要】 目的　研究阿尼西坦胶囊的相对生物利用度。方法12名志愿受试者单剂量口服 4 0 0mg阿尼西坦胶囊供试品与标准参比制剂三乐喜后 ,采用反相高效液相色谱法 ,测定阿尼西坦主要活性代谢产物对甲氧基苯甲酰氨基丁酸 (ABA)的血药浓度经时变化情况 ,使用 3p87软件计算药代动力学参数 ,并进行统计学分析。结果　受试药 (T)与参比药 (R)的药 时曲线下面积 (AUC0～t)分别为 (781.0± 16 9.5 )和(792 .3± 15 6 .6 ) μg·min·ml- 1,实测达峰时间(tmax)分别为 (40 .9± 9.7)和 (37.3± 11.5 )min ,实测峰浓度 (cmax)分别为 (10 .4± 3.0 )和 (10 .5±3.0 ) μg·ml- 1。配对t检验结果表明 ,两制剂的AUC0～t、cmax及tmax均无显著性差异 (P >0 .0 5 ) ,生物等效性检验结果 ,两制剂的AUC0～t、cmax有显著性差异 (P <0 .0 5 )。阿尼西坦胶囊的相对生物利用度 (F)为 (99.4± 14 .4 ) %。结论　阿尼西坦胶囊和三乐喜为生物等效制剂更多还原

【Abstract】 Aim The relative bioavailabilities of aniracetam capsules were studied. Methods The blood concentrations of the main metabolite of aniracetam, N anisoyl GABA(ABA), were determined by RP HPLC after a single oral dose of 400 mg aniracetam of test(capsules) or reference(capsules) drugs was given separately to 12 volunteers in an open randomized cross over test. Statistical software’s 3p87 were used for the calculation of results. Results After taking a single oral dose of 400 mg aniracetam test capsules and reference capsules, thd AUC 0～t of aniracetam of the two formulations were ( 781.0 ± 169.5) μg ·min·ml -1 and ( 792.3 ± 156.6) μg ·min·ml -1 ; t max were ( 40.9 ± 9.7) min and ( 37.3 ± 11.5) min ; c max of ABA were ( 10.4 ± 3.0) μg ·ml -1 and ( 10.5 ± 3.0) μg ·ml -1 . The results of statistical analysis showed that there were no significant difference in the AUC 0～t ,t max and c max of ABA between the formulations ( P<0.05 ). The relative bioavailability of aniracetam capsule was ( 99.4 ± 14.4 )%. Conclusion The two aniracetam capsules were bioequivalent.更多还原