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中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (9): 1043-1047.

• 研究原著 • 上一篇    下一篇

酒石酸美托洛尔片人体生物利用度和生物等效性研究

王静, 付良青, 关勇彪1, 方翼2, 刘泽源   

  1. 中国人民解放军军事医学科学院附属医院国家药物临床试验机构, 北京 100071;
    1中国人民解放军军事医学科学院毒物药物研究所, 北京 100850;
    2中国人民解放军总医院临床药理研究室, 北京 100853
  • 收稿日期:2006-05-25 修回日期:2006-06-30 出版日期:2006-09-26 发布日期:2020-11-05
  • 通讯作者: 付良青, 博士, 研究方向:主要从事I 期临床实验研究。Tel:010-66947186
  • 作者简介:王静, 硕士研究生, 研究方向:主要从事药代动力学研究。Tel:13810496856 E-mail:xiujidezhengzi@eyou.com

Bioequivalence of Metoprolol Tartrate Tablets in healthy volunteers

WANG Jing, FU Liang-qing, GUAN Yong-biao1, FANG Yi2, LIU Ze-yuan   

  1. Department of Clinical Pharmacology , Affiliated Hospital , Academy of Military Medical Sciences , Beijing 100071 , China;
    1Institute of Pharmacology Toxicology , Academy of Military Medical Sciences , Beijing 100850 , China;
    2Department of Clinical Pharmacology , Chinese PLA General Hospital , Beijing 100853 , China
  • Received:2006-05-25 Revised:2006-06-30 Online:2006-09-26 Published:2020-11-05

摘要: 目的 对比研究国产与进口酒石酸美托洛尔片的人体药代动力学, 评价两者的生物等效性。方法 按照国家食品药品监督管理局颁布条例, 选择18 ~ 40 岁健康成年男性20 名, 采用随机交叉实验设计, 应用高效液相-荧光检测方法测定健康志愿者分别应用国产与进口酒石酸美托洛尔片口服给药0.1 g 后各时血药浓度, 应用DAS 软件计算药代动力学参数。结果 采用高效液相-荧光检测方法测定血药浓度对酒石酸美托洛尔进行临床药代动力学研究, 方法灵敏、可靠、准确、可行。国产酒石酸美托洛尔片与进口制剂的主要药代动力学参数:Tmax 为1.11 ±0.36 h 、1.39 ±0.65 h;Cmax为269 ±87 、262 ±76 μg·L-1;AUC0-12h为1088.91 ±510.52 、1098.29 ±555.14 μg·L-1·h 。国产酒石酸美托洛尔片相对参比制剂的人体相对生物利用度为100.09 %。结论 国产酒石酸美托洛尔片与进口制剂生物等效。

关键词: 酒石酸美托洛尔片, 高效液相-荧光检测, 生物等效性

Abstract: AIM: To study the bioequivalence of domestic and imported Metoprolol Tartrate Tablets in Chinese healthy volunteers.METHODS: According to the rule published by SFDA , the serum concentration of 20 selected volunteers among 18 to 40 years old was determined by HPLC-fluorescence detection after giving domestic and imported Metoprolol Tartrate Tablets 0.1g , and the pharmacokinetic parameters were calculated by DAS software.RESULTS: The method of HPLC-fluorescence detection to study the pharmakokinetics of Metoprolol Tartrate was sensitive , reliable , accurate and reasonable.The main pharmakokinetics parameters of domestic and imported Metoprolol Tartrate Tablets were Tmax:1.11 ±0.36 h and 1.39 ±0.65 h respectively;Cmax:269.20±87.15 μg·L-1 and 262.03 ±75.52 μg·L-1 respectively;AUC0 -12h:1088.91 ±510.52 μg·L-1·h and1098.29 ±5 55.14 μg·L-1·h respectively.The relative bioavailability of domestic Metoprolol Tartrate Tablets was 100.09 %.CONCLUSION: The domestic and imported Metoprolol Tartrate Tablets was bioequivalents.

Key words: Metoprolol Tartrate Tablets, HPLC-fluorescence detection, bioequivalence

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