中国药房2011，Vol.22Issue(38)：3585-3588,4.
阿折地平片在中国健康人体内的药动学研究
Study on Pharmacokinetics of Azelnidipine Tablets in Chinese Healthy Volunteers
陈燕 1林阳 1韩敏 1李静 1聂晓敏 1段鹏 1周子杰 1汪柯1
作者信息
- 1. 首都医科大学附属北京安贞医院,北京市100029
- 折叠
摘要
Abstract
OBJECTIVE: To investigate the pharmacokinetic characteristics of Azelnidipine tablets in Chinese healthy volunteers. METHODS: 20 healthy volunteers(10 for male, 10 for female) were randomly divided into two dosage groups and received oral dose of Azelnidipine tablets 8 or 16 mg, respectively. The blood concentration of azelnidipine was determined by LC-MS and the pharmacokinetic parameters were calculated using DAS2.1.1 software. RESULTS: Main pharmacokinetic parameters of azelnidipine in health volunteers after the single and multiple oral dose of 8 mg were as follows: f_(2.6 ± 0.6)h and(2.8 ± 0.9)h;c?(4.16 ± 1.86) ug-L~' and (6.62±2.23)ug·L-１;t1/2β(23.0±6.8)h and (25.5±9.5)h;AUCo~96 h(44.1 ± 19.6)ug·h-L-1 and (113±67.0)ug·h·L-1; accumulative ratio: 1.90 ± 1.20; range of motion: 1.85 ±0.49. No significant differences existed in 4 trough concentrations of multiple doses administration (P=0.058). The pharmacokinetic parameters of azelnidipine in health volunteers after the single oral dose of 16 mg were asfollows:fmax(2.7±0.6)h,cmax(10.6±5.4)ug·L-1, tl/2β(25.2± 13.8)h, CL/F(80.5±50.4)L·h-1, V,/F(706±511)L, AUG0-96h(132± 76)ug-h-L"'. Pharmacokinetic parameters of single dose were consistent with those of multiple dose, no gender difference was found. The dosage of the trial was safe and no severe ADR of azelnidipine occurred. CONCLUSION: The method is sensitive, accurate and simple, and it provides reference for clinical drug use.关键词
阿折地平/液-质联用法/药动学Key words
Azelnidipine/ LC-MS/ Pharmacokinetics分类
医药卫生引用本文复制引用
陈燕,林阳,韩敏,李静,聂晓敏,段鹏,周子杰,汪柯..阿折地平片在中国健康人体内的药动学研究[J].中国药房,2011,22(38):3585-3588,4.
