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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (4): 451-454.

• 研究原著 • 上一篇    下一篇

国产双氯芬酸钠缓释栓的人体药代动力学研究

胡爱萍, 胡国新, 邱相君, 代宗顺1   

  1. 温州医学院药理学教研室, 温州325027, 浙江;
    1华中科技大学同济医学院临床药理学教研室, 武汉430030, 湖北
  • 收稿日期:2003-10-22 修回日期:2004-01-09 出版日期:2004-04-26 发布日期:2020-11-20
  • 通讯作者: 胡爱萍, 女, 讲师, 研究方向:临床药理学。Tel:13968937060 E-mail:hap7102@yahoo.com.cn

Study of pharmacokinetics of diclofenac sodium sustained-released suppository in Chinese healthy volunteers

HU Ai-Ping, HU Guo-Xin, QIU Xiang-Jun, DAI Zong-Shun1   

  1. Department of Pharmacology, Wenzhou Medical College, Wenzhou 325027, Zhejiang, China;
    1Department of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China
  • Received:2003-10-22 Revised:2004-01-09 Online:2004-04-26 Published:2020-11-20

摘要: 目的:研究国产双氯芬酸钠缓释栓人体内的药代动力学特征。方法:20 名健康志愿者单剂量给予100 mg 双氯芬酸钠缓释栓, 采用反相高效液相色谱法测定血浆中双氯芬酸钠的浓度。用3p87 程序计算其药代动力学参数。结果:主要药代动力学参数Cmax 为1.1 ±0.3 mg·L-1;Tmax 为1.7 ±0.7 h;T1/2(ke) 为2.4 ±0.6 h;CL 为27 ±6 L·h-1;Vd 为74 ±25 L;AUC0-∞为4.0 ±1.2 mg·h-1·L-1结论:双氯芬酸钠缓释栓在健康人体内的药代动力学符合单室模型特征。

关键词: 双氯芬酸钠, 缓释栓, 药代动力学, 高效液相色谱法, 血浆

Abstract: AIM: To study the pharmacokinetics of diclofenac sodium sustained-released suppository in healthy volunteers.METHODS: A single dose of 100 mg diclofenac sodium sustained-released suppository was given to 20 healthy volunteers.The concentrations of diclofenac sodium sustained-released suppository in plasma were determined by HPLC method.The parameters of pharmacokinetics were calculated by 3p87 program.RESULTS: The Cmax of the drug was 1.1 ±0.310 mg·L -1; Tmax was 1.7 ±0.167 h;T1/2(ke) was 2.3 ±0.6 h;CL was 27 ±6 L·h -1;Vd was 74 ±25 L;AUC0-∞ was 4.0 ±1.2 mg·h -1·L -1.CONCLUSION: The pharmacokinetics of this drug in healthy volunteers can be fitted into one compartment model with 1st order absorption.

Key words: diclofenac sodium, sustained-released sppository, pharmacokinetics, HPLC, plasma

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