Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers

LV Zong-jie; et al

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Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers

更新时间：2024-01-17

- Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers
- Journal of Chongqing Medical University Vol. 34, Issue 11, Pages: 1552-1555(2009)
- 作者机构：
  
  重庆医科大学附属第二医院药剂科
- 作者简介：
- 基金信息：
- DOI：
  CLC： R969.1
- Published：2009，
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[1]吕宗杰,郑永.盐酸氨溴索缓释片人体生物等效性研究[J].重庆医科大学学报,2009,34(11):1552-1555.

LV Zong-jie, et al. Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers. [J]. Journal of Chongqing Medical University 34(11):1552-1555(2009)
[1]吕宗杰,郑永.盐酸氨溴索缓释片人体生物等效性研究[J].重庆医科大学学报,2009,34(11):1552-1555. DOI：

LV Zong-jie, et al. Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers. [J]. Journal of Chongqing Medical University 34(11):1552-1555(2009) DOI：

摘要

目的:研究盐酸氨溴索缓释片与对照制剂的人体生物等效性。方法:20名健康受试者采用双周期2制剂自身交叉单剂量口服盐酸氨溴索缓释片和对照制剂;用高效液相色谱法测定血药浓度

3P97软件计算药动学参数和等效性分析。结果:盐酸氨溴索缓释片与对照制剂的Cmax分别为78.19±11.60和77.26±18.50 ng/ml

Tmax分别为5.00±1.16和5.00±1.16 h

AUC（0～36h）分别为1234.70±58.50和1150.10±265.48（ng/ml）.h

AUC（0-inf）分别为1505.74±208.10和1381.25±364.37（ng/ml）.h。Cmax

AUC（0～36h）

AUC（0-in）f的90%可信区间分别为76.8%～125.6%

87.5%～109.1%

101.4%～120.3%。结论:试验制剂与对照制剂的人体相对生物利用度为（113.4±35.3）%

试验制剂与对照制剂具有生物等效性。

Abstract

Objective:To study the bioequivalence of ambroxol hydrochloride sustained-release tablets to the reference.Methods:A single oral dose(75 mg tested and reference formulation)was given to 20 healthy volunteers in a randomised crossover study.The concentrations of ambroxol hydrochloride sustained-release tablets in plasma were determined by HPLC.Results:After a single dose

the pharmaco kinetic parameters for ambroxol hydrochloride sustained-release tablets as compared with those of the reference were as follows:Cmax:(78.19±11.60)and(77.26±18.50)ng/ml;Tmax:(5.00±1.16)and(5.00±1.16)h;AUC(0~36h):(1234.70±58.50)and(1150.10±265.48)(ng/ml).h

AUC(0-in)f:(1505.74±208.10)and(1381.25±364.37)(ng/ml).h.The 90% confidential intervals of Cmax

AUC(0~36h)and AUC(0-in)fof tested formulation were 76.8%~125.6%

87.5%~109.1%

101.4%~120.3%

respectively.Conclusion:The relative bioavailability is(113.4±35.3)%.The results of the statistic analysis show that the two formulations are bioequivalent.

关键词

盐酸氨溴索生物等效性血药浓度

Keywords

ambroxol hydrochloridebioequivalencePlasma concentration

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