Study on bioequivalence of allopurinol tablets

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Study on bioequivalence of allopurinol tablets

更新时间：2024-01-17

- Study on bioequivalence of allopurinol tablets
- Journal of Chongqing Medical University Issue 4, Pages: 410-412(2002)
- 作者机构：
  
  重庆医科大学临床学院国家临床药理基地
- 作者简介：
- 基金信息：
- DOI：
  CLC： R961
- Published：2002，
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[1]邱峰,何海霞,朱深银,周远大.别嘌醇片的生物等效性研究[J].重庆医科大学学报,2002(04):410-412.

Study on bioequivalence of allopurinol tablets. [J]. Journal of Chongqing Medical University (4):410-412(2002)
[1]邱峰,何海霞,朱深银,周远大.别嘌醇片的生物等效性研究[J].重庆医科大学学报,2002(04):410-412. DOI：

Study on bioequivalence of allopurinol tablets. [J]. Journal of Chongqing Medical University (4):410-412(2002) DOI：

摘要

目的：评价两种国产别嘌醇片的生物等效性。方法：采用双周期两制剂交叉试验设计法，通过20名健康男性自愿受试者分别单剂量口服300mg片剂A和片剂B，用RP-HPLC测定血清中别嘌醇浓度，计算并比较两药的药动学参数，判定两制剂是否生物等效。结果：测试药和对照药的AUC0～8分别为（8.02±2.08） g·h/ml 和（8.12±2.07）g·h/ml ，Cmax分别为（2.77±0.83） g/ml和（2.73±0.84） g/ml；Tmax 分别为（1.22±0.40）h和（1.27±0.33）h；t1/2分别为（1.79±0.77）h和（1.83±0.99）h相对生物利用度为 98.77%±13.09%。结论：两种别嘌醇片具有生物等效性。

Abstract

Objective: To evaluate the bioequivalence of two preparations of allopurinol tablets. Methods: Serum concentrations of allopurinol were measured by RP-HPLC. 300mg single oral allopurinol tablets were given to 20 healthy human subjects in an open randomized crossover way to study the pharmacokinetics and bioequivalence. Results: The AUC0～8

cmax

tmax and t1/2 of brands A and B were (8.02±2.08) g·h/ml and (8.12±2.07)g·h/ml

(2.77±0.83) g/ml and (2.73±0.84) g/ml

(1.22±0.40)h and (1.27±0.33)h

(1.79±0.77)h and (1.83±0.99)h

respectively. The mean relative bioavailability of brand A vs brand B was 98.77%±13.09%. Conclusion: The two formulations were bioequivalent.

关键词

别嘌醇生物等效性高效液相色谱法

Keywords

AllopurinolBioequivalentHPLC

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