中国药房2011，Vol.22Issue(34)：3201-3203,3.
2种硫酸氢氯吡格雷片在健康人体内的药动学及生物等效性研究
Study on Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Healthy Volunteers
吴寅 1栗艳 1丁黎 2王婧雯 1贾艳艳 1刘渝 1杨林 1文爱东1
作者信息
- 1. 第四军医大学西京医院药剂科,西安市710032
- 2. 中国药科大学药物分析教研室,南京市210009
- 折叠
摘要
Abstract
OBJECTIVE: To study the pharmacokinetic characteristics and bioequivalence of domestic and imported Clopido-grel hydrogen sulfate tablets. METHODS: In randomized crossover designed self-controlled study, 20 healthy volunteers were given single oral dose of Clopidogrel hydrogen sulfate tablets of trial preparation 75 mg (domestic product) or reference preparation 75 mg (imported product). The plasma concentrations of clopidogrel were determined by LC-MS. The pharmacokinetic parameters wes calculated and bioequivalence was evaluated. RESULTS: Main pharmacokinetic parameters of trial preparation and reference preparation were as follows: tmax(0.64±0.21) h and (0.68±0.27)h; cmax(1.724± 1.38)ng·mL-1 and (1.752 ± 1.856)ng·mL-1; t1/2(6.6± 4.9)h and (6.3±7.0) h; AUC0~36h(1.996±1.223)ng·h·mL-1 and (2.112 ± 1.493)ng·h·mL-1; AUC0~∞ (2.114± 1.209)ng·h·mL-1 and (2.117 ± 1.500) ng·h·mL-1. The relative bioavailability of trial preparation was (108.9 ± 52.2)%. CONCLUSION: The two kinds of Clopidogrel formulations are bioequivalent.关键词
硫酸氢氯吡格雷片/液-质联用法/药动学/生物等效性Key words
Clopidogrel hydrogen sulfate tablets/LC-MS/Pharmacokinetics/Bioequivalence分类
医药卫生引用本文复制引用
吴寅,栗艳,丁黎,王婧雯,贾艳艳,刘渝,杨林,文爱东..2种硫酸氢氯吡格雷片在健康人体内的药动学及生物等效性研究[J].中国药房,2011,22(34):3201-3203,3.
