Pharmacokinetics and bio-equivalence of evodiamine nanoemulsion oil-in-water in rats

Shi Mingxin; Hu Jiangbo; Zhang Xin; Wang Xue; Zhang Jingqing

doi:10.13406/j.cnki.cyxb.000924

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Pharmacokinetics and bio-equivalence of evodiamine nanoemulsion oil-in-water in rats

更新时间：2024-01-17

- Pharmacokinetics and bio-equivalence of evodiamine nanoemulsion oil-in-water in rats
- Journal of Chongqing Medical University Vol. 42, Issue 2, Pages: 196-199(2017)
- 作者机构：
  
  1. 重庆医科大学药学院重庆药物高校工程研究中心
  2. 重庆市南岸区妇幼保健计划生育服务中心药剂科
- 作者简介：
- 基金信息：
- DOI：10.13406/j.cnki.cyxb.000924
  CLC： R285.5
- Published：2017，
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Shi Mingxin, Hu Jiangbo, Zhang Xin, et al. Pharmacokinetics and bio-equivalence of evodiamine nanoemulsion oil-in-water in rats. [J]. Journal of Chongqing Medical University 42(2):196-199(2017)
DOI：

Shi Mingxin, Hu Jiangbo, Zhang Xin, et al. Pharmacokinetics and bio-equivalence of evodiamine nanoemulsion oil-in-water in rats. [J]. Journal of Chongqing Medical University 42(2):196-199(2017) DOI： 10.13406/j.cnki.cyxb.000924.

摘要

目的:研究吴茱萸碱的水包油型纳米乳（evodiamine nanoemulsion

EDN）在大鼠体内的药动学特征与生物等效性。方法:本试验将12只雄性大鼠随机分成2组

分别灌胃给予吴茱萸碱（evodiamine

ED）或EDN

并于给药后0、5、15、30、45 min、1、2、5、8、12、24、48、72 h时对大鼠眼底取血

用HPLC法测定ED的血药浓度

用DAS软件分析药动学参数

并经方差分析和双单侧检验进行生物等效性评价。结果:EDN的主要药动学参数:血药浓度-时间曲线下面积(area under concentration-time curve

AUC（0

2 h）)、药峰浓度（peak concentration

Cmax）和药峰时间（peak time

Tmax）分别为（3 636.79±1 642.94）μg/L*h、（192.49±37.68）μg/L和（4.94±1.67）h。EDN的大鼠口服生物利用度约为ED的4.66倍。AUC（0

2 h）的90%置信区间超出所规定的生物等效性标准区间。结论:EDN明显提高了ED的口服生物利用度。ED和EDN的生物不等效性。

Abstract

Objective:To study the pharmacokinetic characteristics and bio-equivalence of evodiamine nanoemulsion（EDN）prepared by the experiment in rats. Methods:Twelve male SD rats were randomly divided into 2 groups

and single dose of evodiamine（ED）or EDN was administrated respectively in the experiment. The blood was took from eye socket at 0

45 min and at 1

72 h after administration. The plasma concentration of ED was determined by HPLC;pharmacokinetic parameters was analyzed by DAS software;the bio-equivalence between ED and EDN was evaluated by analysis of variance and two one-sided test.Results:The main pharmacokinetic parameters of EDN:area under concentration-time curve（AUC（0

2 h））

peak concentration（Cmax）and peak time（Tmax）were（3 636.79±1 642.94）μg/L·h

（192.49±37.68）μg/L

（4.94±1.67）h

respectively. The oral bio-availability of EDN in rats was about 4.66 times higher than that of ED. The 90% confidence interval of AUC（0

2 h）exceeded the bio-equivalence criteria interval. Conclusion:EDN oil-in-water is successfully prepared. The bio-availability of ED in rats increases remarkably after oral administration of EDN.

关键词

吴茱萸碱纳米乳高效液相色谱法药动学生物等效性

Keywords

evodiaminenanoemulsionhigh pressure liquid chromatographypharmacokineticsbio-equivalence

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