医药导报2012，Vol.31Issue(11)：1400-1403,4.DOI:10.3870/yydb.2012.11.003
佐匹克隆片人体相对生物利用度与生物等效性研究
Relative Bioavailability and Bioequivalence of Zopiclone Tablets in Healthy Volunteers
陈倩 1刘宇 1任秀华 1张冬林 1刘东1
作者信息
- 1. 华中科技大学同济医学院附属同济医院药学部,武汉430030
- 折叠
摘要
Abstract
Objective To investigate the pharmaeoknietics and bioequivalence of zopiclone test and control tablets in health volunteers. Methods A single oral dose of 15 mg zopiclone test or control tablets were given to 20 healthy male volunteers in a randomized, two-way crossway study. HPLC- fluorescence detector was used to determine the concentralion of zopiclone in plasma. By the DAS 2. 1 pharmacokinetic software, the pharmacokinetic parameters of the two preparations were calculated and the bioequivalence of two tablets was evaluated. Results The main pharmacokinetic parameters of test and control preparations were as follows: t1/2 were (4.93±2.45) and (5.46±2.51) h; Cmax were (101. 18+23.47) and (105.39± 35.21) ng ·mL-1 ;tmax were( 1.60+1.16) and ( 1.64± 1. 35) h; AUC0.24 were (612. 66+ 157. 35) and (617.27 + 207. 11) ng · h · mL-1 ; AUC0-∞ was (664. 88+ 160. 27) and (679. 12+223. 75) ngoh o mL-1 ; The relative bioavailability of test preparations (Fo_1) was calculated to be (105. 1 ±28. 9)% according to AUC0.\. Conclusion The two kinds of domestic preparations are bioequivalent.关键词
佐匹克隆/生物等效性/生物利用度/高效液相色谱法Key words
Zopiclone/ Bioavailability/Bioequivalence/ HPLC分类
医药卫生引用本文复制引用
陈倩,刘宇,任秀华,张冬林,刘东..佐匹克隆片人体相对生物利用度与生物等效性研究[J].医药导报,2012,31(11):1400-1403,4.
