中国临床药理学杂志2011，Vol.27Issue(2)：118-120,3.
烟酸缓释片在健康人体的生物等效性
Bioequivalence of nicotinic acid sustained-release tablets in healthy volunteers
葛苗苗 1卫乐乐 1方凯 1黄露 1黎维勇1
作者信息
- 1. 华中科技大学附属协和医院临床药学研究室,武汉,430022
- 折叠
摘要
Abstract
Objective To study the pharmacokinetics of nicotinic acid sustained-release tablets in healthy volunteers and evaluate the bioequivalence. Methods Single oral dose ( 1.5 g of test and reference formulations) were given to 30 volunteers in an open randomized crossover way.The concentrations of nicotinic acid in plasma were determined by HPLC- MS/MS. The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program.Results The main pharmacokinetic parameters of test and reference preparations obtained from single oral dose were as follows: AUC0-t were (20. 05±16.29),(21.61 ± 18.06) μg · h · mL-1;AUC0-∞ were (20. 81 ± 16. 30 ), ( 22. 81 ± 18.47 ) μg · h · mL - 1; Cmax were ( 8. 72 ±6.81),(9.57 ±8.22) μg · mL-1;tmax were(4.41 ± 1.34), (4.31 ±1.29)h; t1/2 were ( 4. 00 ±4.90),(2.91 ±3.39)h. Conclusion The two preparations were bioequivalent.关键词
烟酸缓释片/生物利用度/生物等效性/高效液相色谱-串联质谱分类
医药卫生引用本文复制引用
葛苗苗,卫乐乐,方凯,黄露,黎维勇..烟酸缓释片在健康人体的生物等效性[J].中国临床药理学杂志,2011,27(2):118-120,3.
