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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (8): 897-900.

• 研究原著 • 上一篇    下一篇

反向高效液相色谱法测定盐酸伊托必利颗粒血药浓度及其人体药动学和生物等效性分析

李庆忠, 顾世芬, 吴际, 陈汇   

  1. 华中科技大学同济医学院临床药理研究所, 武汉430030, 湖北
  • 收稿日期:2004-04-27 修回日期:2004-07-02 出版日期:2004-08-26 发布日期:2020-11-20
  • 通讯作者: 陈汇,女,教授,硕士生导师,研究方向:临床药理学。Tel:027-83692628Fax:027-83622308 E-mail:chhuitj@sina.com.cn
  • 作者简介:李庆忠,男,在读硕士,助教,研究方向:临床药理学。Tel:027-62327332 E-mail:qingzhongli@sohu.com

RP-HPLC assay for plasma concentration of itopride hydrochloride granule and its pharmacokinetcs and bioequivalence in healthy volunteers

LI Qing-Zhong, GU Shi-Fen, WU Ji, CHEN Hui   

  1. Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China
  • Received:2004-04-27 Revised:2004-07-02 Online:2004-08-26 Published:2020-11-20

摘要: 目的: 测定人血浆中盐酸伊托必利颗粒的血药浓度并对其在健康人体内的药代动力学及生物等效性进行分析。方法: 采用反相高效液相色谱法(RP-HPLC)测定20 名男性健康志愿者单剂量口服100 mg 盐酸伊托必利颗粒剂(受试药)和盐酸伊托必利片(参比药)后,血浆中伊托必利浓度变化情况,用3P97 程序进行药代动力学分析。结果: 测得受试药和参比药Cmax 分别为594.8 ±152.3 和628.6 ±261.4 μg·L-1,Tmax 分别为0.766 ±0.213 和0.900 ±0.392 h,T12ke 分别为3.21 ±0.86 和3.49 ±0.77 h,AUC0-15 分别为2266.0 ± 1340.9 和2339.4 ±1831.7 μg·L-1·h-1,AUC0-∞分别为2472.1 ±1800.3和2496.9 ±1952.3 μg·L-1 ·h-1结论: 盐酸伊托必利颗粒的相对生物利用度为106.9 % ±27.3 %;选择Cmax 、AUC0-15 和AUC0-∞进行三因素方差分析与双单侧t 检验,结果表明受试药与参比药具有生物等效性。

关键词: 反相高效液相色谱, 盐酸伊托必利, 血药浓度, 药代动力学, 生物利用度, 生物等效性

Abstract: AIM: To determine the plasma concentration of itopride hydrochloride granule and study its pharmacokinetics and bioequivalence in healthy volunteers. METHODS: A reversed-phase high performance liquid chromatography (RP-HPLC)method was established for the determination of itopride hydrochloride in human plasma after a single oral dose administration of 100 mg itopride hydrochloride granule (test preparation) and itopride hydrochloride tablet (reference preparation) in a crossover design.RESULTS: The main pharmacokinetic parameters after a single oral dose administration of 100 mg itopride hydrochloride granule and tablet were as follows:Cmax 594.8 ±152.3 and 628.6 ±261.4 μg·L-1 ,Tmax 0.766 ±0.213 and 0.900 ±0.392 h, T12ke 3.21 ±0.86 and 3.49 ±0.77 h, AUC0-152266.0 ±1340.9 and 2339.4 ± 1831.7 μg·L-1 ·h-1, respectively.CONCLUSION: The relative bioavailability of itopride hydrochloride granule is 106.9 %±27.3 %.The results of statistical analysis for Cmax, AUC0-15 and AUC0-∞ show that itopride hydrochloride granule and itopride hydrochloride tablet are bioequivalent.

Key words: reversed-phase high performance liquid chromatography, itopride hydrochloride, plasma concentration, pharmacokinetics, bioavailability, bioequievence

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