中国药房2011，Vol.22Issue(18)：1672-1674,3.
阿折地平片在健康人体内的药动学研究
Pharmacokinetic Study of Azelnidipine Tablets in Healthy Volunteers
钟世敬 1施爱明 1华雯妍 1黄明 1张全英1
作者信息
- 1. 苏州大学附属第二医院药剂科,苏州市,215004
- 折叠
摘要
Abstract
OBJECTIVE: To establish a method for the content determination of Azelnidipine tablet in human plasma and study the pharmacokinetics of Azelnidipine tablet. METHODS: 20 healthy volunteers were randomly distributed into 2 groups and received a single-dose of Azeinidipine tablet 8 and 16 mg respectively. The group receiving Azelnidipine tablet 8mg participated in the multi-dose test at the same time. The concentration of azelnidipine in human plasma was determined by LC-MS and the phannacokinetie parameters were calculated after single-dose or multi-dose administration. RESULTS: The pharmacokinetie parameters of azelnidipine after single dose of Azelnidipine tablet 8 and 16 mg were as follows: Cmax( 1.66 ± 0.45)μg·L-1 and (4.25 ± 1.38)μg·L-1, tmax (3.50 ± 1.08)h and (4.00 ± 1.16)h, t1/2(21.3 ± 8.1)h and ( 19.5 ± 4.0)h, AUC0～72( 17.9 ± 6.0)μg·h·L-1 and (49.9 ± 17.5)μg·h·L-1,respectively. The pharmacokinetic parameters of azelnidipine after multi-dose of Azelnidipine tablet 8 mg were as follows: Cmax (2.63 ± 1.41 )μg· L-1,tmax(3.50 ± 1.08)h, t1/2(32.5 ± 9.2) h, AUC0～72(43.8 ± 26.4) μg·h· L-1, Csv( 1.19 ± 0.671 )μg·L-1, AUCss(28.4±16.1)μg·h·L-1, DF(1.78 ± 0.49), Rs(l.56 ± 0.95). CONCLUSION: The method is sensitive, accurate and simple. The values of Cmax and AUC0～72 of Azelnidipine tablet after single-dose administration increase along with the increasing of the dose. And the azeinidipine has accumulated after multi-dose of administration.关键词
阿折地平/液-质联用法/药动学分类
医药卫生引用本文复制引用
钟世敬,施爱明,华雯妍,黄明,张全英..阿折地平片在健康人体内的药动学研究[J].中国药房,2011,22(18):1672-1674,3.
