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中国临床药理学与治疗学 ›› 2003, Vol. 8 ›› Issue (3): 329-332.

• 研究原著 • 上一篇    下一篇

醋氯芬酸肠溶片在健康男性志愿者体内的药代动力学及生物等效性研究

胡国新, 邱相君, 谢虹1, 代宗顺2, 王桂珍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环境卫生学教研室, 2临床药理学教研室, 武汉 430030, 湖北
  • 收稿日期:2002-12-12 修回日期:2003-01-18 出版日期:2003-06-26 发布日期:2020-11-25
  • 作者简介:胡国新, 男, 教授, 硕士生导师, 研究方向:临床药理学和治疗学。Tel:0577-88833462 E-mail:huguoxin@hotmail.com

Pharmacokinetics and bioequivalance of aceclofenac enter-coated tablets in healthy male volunteers

HU Guo-Xin, QIU Xiang-Jun, XIE Hong1, DAI Zong-Shun2, WANG Gui-Zhen2   

  1. Department of Pharmacology, Wenzhou Medical College, Wenzhou 325027, Zhejiang; 1Department of Environmental Hygienics, 2Department of Clinical Pharmacology, TongjiMedical College of Huazhong University of Science and Technology, Wuhan 430030, Hubei
  • Received:2002-12-12 Revised:2003-01-18 Online:2003-06-26 Published:2020-11-25

摘要: 目的: 研究国产醋氯芬酸肠溶片在健康志愿者体内的药代动力学参数和生物等效性。方法: 20名健康男性志愿者随机交叉口服国产醋氯芬酸肠溶片100 mg 和进口醋氯芬酸片100 mg, 采用HPLC 法测定给药后不同时间点的血浆醋氯芬酸浓度。用3p97 程序计算其药代动力学参数, 评价两种制剂的生物等效性和生物利用度。AUC0 -24 , AUC0 -inf 和Cmax经方差分析和双单侧t 检验。结果: 试验药和参比药的醋氯芬酸Cmax 分别为20±5 mg·L-1 和20±6 mg·L-1 ;Tmax 分别为2.7 ±0.5 h 和2.0 ±0.5 h;AUC0 -24分别为55 ±26 mg·h-1·L-1和52 ±21 mg·h-1 ·L-1 。试验药与参比药AUC0 -24 之比和Cmax 之比的90 %可信区间分别为92.2 %~120.7 %和91.8 %~118.9 %。试验药的人体相对生物利用度为112 %±42 %。结论: 两种制剂的主要药代动力学参数均无显著性差异, 具有生物等效性。试验药的生物利用度符合要求。

关键词: 药理学, 醋氯芬酸, 肠溶片, 药代动力学, 生物等效性

Abstract: AIM: To study the pharmacokinetics and bioequivalence of aceclofenac enter-coated tablets in healthy volunteers. METHODS: A single oral dose of 100 mg aceclofenac and the same dose of airtal were given to 20 healthy male volunteers.Aceclofenac concentrations in plasma were determined by HPLC method.The parameters of pharmacokinetics were calculated by 3p97 program. The bioequivalence and bioavailability of the two formulations were analysed. RESULTS: The Cmax of the test and reference drug were 20 ±5 and 20 ±6 mg·L -1, respectively;Tmax were 2.7 ±0.5 and 2.0 ±0.5 h, respectively;AUC0-24 were 55 ± 26 and 52 ± 21 mg·h -1·L -1.The 90 % confident interval for AUC0 -24- ratio and Cmax-ratio of the mean values of test to reference formulations were 92.2 % -120.7 % and 91.8 % - 118.9 %, respectively.The bioavailability of the tested drug was 112 %±42 %. CONCLUSIONs: There are no significant differences between the parameters of the two formulations, and the two formulations are bioequivalence.

Key words: pharmacology, aceclofenac, enter-coated tablet, pharmacokinetics, bioequivalence

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