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奥拉西坦健康人体药代动力学研究

魏春敏*, 王本杰, 郭瑞臣**   

  1. 山东大学齐鲁医院临床药理研究所, 济南 250012
  • 收稿日期:2004-11-24 修回日期:2005-02-10 出版日期:2005-03-15 发布日期:2005-03-15
  • 通讯作者: 魏春敏*, 郭瑞臣**

Pharmacokinetics of Oxiracetam in Healthy Volunteers

WEI Chun-min*, WANG Ben-jie, GUO Rui-chen**   

  1. Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China
  • Received:2004-11-24 Revised:2005-02-10 Online:2005-03-15 Published:2005-03-15
  • Contact: WEI Chun-min*, GUO Rui-chen**

摘要: 目的 进行健康志愿者单次和多次静脉给药后奥拉西坦人体药代动力学研究。方法 10名健康志愿者单次静脉输注2 000 mg奥拉西坦和每次2 000 mg, 静脉输注7天后, HPLC法测得奥拉西坦血清浓度, DAS软件进行药代动力学参数计算。结果 单次给药, 奥拉西坦AUC0~12, AUC0~∞, Ke, t1/2, MRT分别为256.26±16.84 μg·mL-1·h-1, 276.74±18.11 μg·mL-1·h-1, 0.18±0.03 h-1, 3.84±0.64 h4.39±0.39 h; 多次给药后AUC0~12, AUC0~∞, Ke, t1/2, MRT分别为259.36±25.43 μg·mL-1·h-1, 285.59±27.38 μg·mL-1·h-1, 0.17±0.04 h-1, 4.14±0.82 h4.87±0.69 h结论 奥拉西坦单次和多次给药后药动学参数无明显差异, 奥拉西坦多次给药后无蓄积。

关键词: 奥拉西坦, 奥拉西坦, 奥拉西坦, 高效液相色谱法, 高效液相色谱法, 高效液相色谱法, 药代动力学, 药代动力学, 药代动力学

Abstract: Aim To study the pharmacokinetics of oxiracetam after single and multiple intravenous administrations in healthy volunteers. Method A HPLC method was used to determine the serum concentration of oxiracetam after intravenous single dose and daily dose of 2 000 mg for 7 d in ten Chinese healthy volunteers. Pharmacokinetic analysis was carried out using Drug And Statistic software. Results The AUC0~12, AUC0~∞, Ke, t1/2, MRT after a single dose of 2 000 mg oxiracetam were 256.26±16.84 μg·mL-1·h-1, 276.74±18.11 μg·mL-1·h-1, 0.18±0.03 h-1, 3.84±0.64 h, and 4.39±0.39 h, and after multiple doses of oxiracetam were 259.36±25.43 μg·mL-1·h-1, 285.59±27.38 μg·mL-1·h-1, 0.17±0.04 h-1, 4.14±0.82 h, and 4.87±0.69 h, respectively. Conclusion The pharmacokinetic parameters of oxiracetam do not differ remarkably after single and multiple intravenous administration and there is accumulation in serum after 2000 mg multiple intravenous administration once a day for 7 d.

Key words: oxiracetam, oxiracetam, high performance liquid chromatography, high performance liquid chromatography, pharmacokinetic, pharmacokinetic

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Supporting: **Corresponding author. Tel.: 86-531-2169636
*2003 graduate, M. D. Shandong University