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中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (5): 545-549.

• 临床药理学 • 上一篇    下一篇

布洛芬缓释胶囊在健康人体的相对生物利用度研究

田炜超1, 杨瑞1, 沈杰2, 谢海棠2, 王方杰1, 肖坚1   

  1. 1中南大学湘雅医院药剂科,长沙 410078,湖南;
    2皖南医学院弋矶山医院临床药学部,芜湖 241001,安徽
  • 收稿日期:2012-08-14 修回日期:2013-04-11 出版日期:2013-05-26 发布日期:2013-05-22
  • 通讯作者: 肖坚,男,主管药师,主要从事临床药理和心血管药理学研究。Tel: 0731-84327460 E-mail: admanoas@163.com
  • 作者简介:田炜超,女,药师,主要从事药学研究。Tel: 0731-84327460 E-mail: 13875976713zeng@sina.com
  • 基金资助:
    湖南省自然科学重点项目(10JJ2008);863计划项目(2012AA02A518)

Study of the relative bioequivalence of sustained release capsules of Ibuprofen in healthy volunteers

TIAN Wei-chao1, YANG Rui1, SHEN Jie2, XIE Hai-tang2, WANG Fang-jie1, XIAO Jian1   

  1. 1Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410078,Hunan,China;
    2Institute of Clinical Pharmacology ,Yijishan Hospital,Wannan Medical College,Wuhu 241001,Anhui,China
  • Received:2012-08-14 Revised:2013-04-11 Online:2013-05-26 Published:2013-05-22

摘要: 目的: 研究两种国产布洛芬的相对生物利用度。方法: 采用双周期随机交叉试验设计。分别给予24名男性健康受试者试验制剂或参比制剂布洛芬 300 mg,采用HPLC法测定给药后不同时间的血药浓度。结果: 参比制剂与试验制剂单剂量给药主要药代动力学参数Cmax、tmax、AUC0-24和AUC0-∞分别为:(13.5±5.9)和(12.7±5.4) μg/mL;(5.1±1.0)和(5.5±1.5) h;(100.2±45.4)和(98.5±44.8) μg·h·mL-1;(105.7±47.3)和(103.8±47.0) μg·h·mL-1。参比制剂与试验制剂多剂量给药主要药代动力学参数Cmax、Cav、tmax、AUCss分别为:(14.1±5.3)和(14.9±6.4) μg/mL;(8.2±3.4)和(8.6±4.3) μg/mL;(4.8±1.0)和(4.6±0.9) h;(99.0±40.4)和(103.3±51.3) μg·h·mL-1结论: 经统计学分析,布洛芬参比制剂与试验制剂具有生物等效性。

关键词: 布洛芬, 相对生物利用度, 药代动力学

Abstract: AIM: To study the relative bioequivalence of sustained release capsules of Ibuprofen made by Jiangxi Pharmaceutical Co., Ltd.METHODS: A single dose of 300 mg domestic Ibuprofen, and its reference preparation made by Zhengzhou Fusheng Pharmaceuticals Co.,Ltd. were given to 24 healthy volunteers by oral in an open randomized two way crossover experiment.The plasma concentrations were determined by HPLC method.RESULTS: The main pharmacokinetic parameters of a single dose of Ibuprofen were as follows : Cmax were (13.5±5.9) and (12.7±5.4) μg/mL; tmax were (5.1±1.0), (5.5±1.5) h; AUC0-24 were (100.2±45.4) and (98.5±44.8) μg·h·mL-1;AUC0→∞ were (105.7±47.3) and (103.8±47.0) μg·h·mL-1 for the reference drug and the test drug, respectively.The main pharmacokinetic parameters of muti-dose of Ibuprofen were as follows: Cmax were (14.1±5.3) and (14.9±6.4) μg/mL;Cav were(8.2±3.4 )and (8.6±4.3) μg/mL; tmax were (4.8±1.0) and (4.6±0.9) h; AUCss were (99.0±40.4) and (103.3±51.3) μg·h·mL-1 for the reference drug and the test drug, respectively.CONCLUSION: Statistic analysis shows that the reference preparation and the test preparation are bioequivalent.

Key words: Ibuprofen, Relative bioavailability, Pharmacokinetics

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