沙丁胺醇口腔崩解片人体生物等效性研究

李祖惠; 周远大; 何海霞

doi:10.13406/j.cnki.cyxb.2005.02.036

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沙丁胺醇口腔崩解片人体生物等效性研究

更新时间：2024-01-17

- 沙丁胺醇口腔崩解片人体生物等效性研究
- Bioequivalence of salbutamol orally disintegrating tablet in healthy subjects
- 重庆医科大学学报 2005年第2期页码：289-291
- 作者机构：
  
  1. 重庆医科大学临床学院药剂科
  2. 重庆医科大学临床药理研究室,重庆,400016
- 作者简介：
- 基金信息：
- DOI：10.13406/j.cnki.cyxb.2005.02.036
  中图分类号： R96
- 纸质出版日期：2005，
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[1]李祖惠,周远大,何海霞.沙丁胺醇口腔崩解片人体生物等效性研究[J].重庆医科大学学报,2005(02):289-291.

LI Zuhui, et al. Bioequivalence of salbutamol orally disintegrating tablet in healthy subjects[J]. Journal of Chongqing Medical University, 2005,(2):289-291.
[1]李祖惠,周远大,何海霞.沙丁胺醇口腔崩解片人体生物等效性研究[J].重庆医科大学学报,2005(02):289-291. DOI： 10.13406/j.cnki.cyxb.2005.02.036.

LI Zuhui, et al. Bioequivalence of salbutamol orally disintegrating tablet in healthy subjects[J]. Journal of Chongqing Medical University, 2005,(2):289-291. DOI： 10.13406/j.cnki.cyxb.2005.02.036.

摘要

目的:比较沙丁胺醇口腔崩解片和普通片的人体生物利用度。方法:18名健康志愿受试者随机交叉单剂口服沙丁胺醇口腔崩解片和普通片

用高效液相色谱法测定血药浓度

3P97计算药动学参数和生物利用度。结果:口腔崩解片和普通片体内药时曲线符合二室模型

口腔崩解片和普通片Cmax分别为17.4 8±5 .5 2、16 .6 0±6 .2 1ng/ml

Tmax分别为2 .4 7±1.0 4和2 .0 3±1.17h

AUC（0 -2 4）分别为12 7.34±32 .6 6和131.4 2±37.73ng·h/ml

相对生物利用度为98.76 %±12 .92 %。结论:经方差分析和双单侧t检验

口腔崩解片和普通片具有生物等效性

Abstract

Objective:To study the relative bioavailability and pharmacokinetics of salbutamol orally disintegrating tablet in 18 healthy male volunteers.Methods:A single dose of 8 mg of salbutamol orally disintegrating tablet was administered in a randomized crossover way in 18 volunteers and the plasma concentrations of salbutamol were determined by HPLC.The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioavailability was evaluated.Results:The concentration-time curve of two preparations fitted two compartment model.The peak plasma levels(cmax) of salbutamol orally disintegrating tablet and market of salbutamol were 17.48±5.52 and 16.60±6.21 ng/ml

respectively.The peak time(Tmax) were 2.47±1.04 and 2.03±1.17h and AUC(0-24) were 127.34±32.66 and 131.42±37.73 ng·h/ml

respectively

The relative bioavailability of salbutamol orally disintegrating tablet was 98.76%±12.92%.Conclusion:The results of two one-side tests suggest that salbutamol orally disintegrating tablet is bioequivalent to the market tablet of salbutamol.

关键词

沙丁胺醇口腔崩解片药动学生物等效性

Keywords

Salbutamol orally disintegrating tabletpharmacokineticsbioequivalence

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