中国药业2011，Vol.20Issue(17)：14-16,3.
国产和进口盐酸氨溴索片的人体生物等效性研究
Study on Bioequivalence of Ambroxol Hydrochloride Tablets from Domestic and Import
王国才 1张丹 1杨漫 1韩静 1郑天雷 1王振龙 1王涛 1刘会臣1
作者信息
- 1. 航天中心医院临床药理室,北京,100049
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence(BE) of domestic and imported Ambroxol Hydrochloride Tablets. Methods Twenty healthy male volunteers were divided into two groups randomly and a single dosage of 30mg of testing or reference tablet to earh volunteer in the crossover way. Plasma concentratios of ambroxol were measured by LC - MS/MS. Results The pharmacokinetic of ambroxol in the testing and reference tablet were as follows: tmax were (1. 13 ±0. 48) h and (1. 25 ±0. 38) h; Camx were (61. 2 ± 17. 7) ng/mL and (60. 0 ± 18. 6) ng/mL; AUC0_t were (413. 3 ±114. 4) ng · h/mL and (420. 6 ± 109. 5) ng · h/mL; AUC0_∞ were (436. 8 ± 122. 8) ng · h/mL and (446. 4 ± 110. 8) ng · h/mL; t1/2 were( 7. 86 ± 1. 73 )h and( 8. 12 ± 1. 18 )h respectively. Conclusion Thie test and reference preparations are bioequivalent.关键词
氨溴索/液相色谱-串联质谱法/生物等效性Key words
ambroxol/ LC - MS/MS/ bioequivalence分类
医药卫生引用本文复制引用
王国才,张丹,杨漫,韩静,郑天雷,王振龙,王涛,刘会臣..国产和进口盐酸氨溴索片的人体生物等效性研究[J].中国药业,2011,20(17):14-16,3.
