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中国临床药理学与治疗学 ›› 2001, Vol. 6 ›› Issue (2): 129-131.

• 基础研究 • 上一篇    下一篇

阿尼西坦胶囊的相对生物利用度研究

王川平, 任进民, 贾晓东1, 靳怡然, 赵树藩, 蒋俊康   

  1. 河北医科大学附属第二医院药品科, 石家庄 050000;
    1太阳石药业有限公司, 唐山 063000
  • 收稿日期:2000-07-27 修回日期:2001-02-01 出版日期:2001-04-26 发布日期:2020-11-25
  • 作者简介:王川平, 女, 34 岁, 硕士, 主管药师, 主要从事临床药理学工作。

Study on relative bioavailability of aniracetam capsules

WANG Chuan-Ping, REN Jin-Min, JIA Xiao-Dong1, JIN Yi-Ran, ZHAO Shu-Fan, JIANG Jun-Kang   

  1. The Second Hospital of Hebei Medical University, Shijiazhuang 050000;
    1TaiYangShi Pharmacy Limited Company, Tangshan 063000
  • Received:2000-07-27 Revised:2001-02-01 Online:2001-04-26 Published:2020-11-25

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400 mg 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 ±169.5) 和(792.3 ±156.6) 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 >0.05), 生物等效性检验结果, 两制剂的A UC0~t、cmax有显著性差异(P <0.05)。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。

关键词: 阿尼西坦, 对甲氧基苯甲酰氨基丁酸, 药代动力学, 相对生物利用度, 反相高效液相色谱法

Abstract: Aim The relative bioavailabilities of aniracetam capsules were studied. Methods The blood concentrations of the main metabolite of aniracetam, Nanisoyl- GABA (ABA), were determined by RPHPLC 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 w ere used for the calculation of results. Results After taking a single oral dose of 400 mg aniracetam test capsules and reference capsules, thd AUC0~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; tmax were (40.9 ±9.7) min and (37.3 ±11.5) min; cmax of ABA were (10.4 ±3.0) μg ·ml -1 and (10.5 ± 3.0) μg ·ml-1. The result s of statistical analysis showed that there were no significant difference in the AUC0~t, tmax and cmax 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.

Key words: aniracetam, N-anisoyl-GABA, pharmacokinetics, relative bioavaliability, HPLC

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