中国临床药理学杂志2012，Vol.28Issue(1)：33-36,4.
国产与进口尼麦角林片在健康人体的生物等效性
Bioequivalence of domestic and imported nicergoline tablets in healthy volunteers
张冬慧 1徐培涵 2张俊东 1李琳 3巩慧敏 4冯泽岸 1王婷 2梁莉 1乔华 2常威 1李丹1
作者信息
- 1. 兰州大学第一医院,临床试验机构,兰州730000
- 2. 兰州大学药学院,兰州730000
- 3. 合肥合源医药科技股份有限公司,合肥230088
- 4. 兰州大学第一医院,检验科,兰州730000
- 折叠
摘要
Abstract
Objective To study the bioequivalence of domestic and imported nicergoline tablets in healthy volunteers. Methods An open randomized, two period crossover study on 18 healthy male volunteers was carried out with orally test drug ( domestic) and reference drug (imported) nicergoline tablets. The concentrations of nicergoline primary metabolites 6 - dimethyl - 8β - hydroxymethyl - 10α - methoxy - nicergoline ( MDL) in plasma were determined by LC - MS. The pharmacokinet-ic parameters and relative bioavalibility were calculated to evaluate the bioequivalence between the two kinds tablets by DAS 2. 1 software. Results The main pharmacokinetic parameters of test and reference drugs were as follows: Caxmwere(21. 94 ± 10. 10) and (23.48 ± 11. 10) ng ? mL-1; Tmax were (2.78 ±0.73) and (3.00 ±0.84) h; AUC0-60 were (264.47 ±134. 26) and (272. 77 ± 134. 35) ng · h · mL-1; AUC0-∞ were (286. 14 ± 140. 34) and (293. 38 ± 138. 86) ng · h · mL-1 ;t1/2 were (12. 13 ±4. 26) and (12. 07 ± 4. 29) h, respectively. The relative bioavailability of nicergoline was (98.6 ± 23. 5) % . Conclusion The results of statistical analysis shown that the two drugs were bioequivalent.关键词
尼麦角林/药代动力学/生物等效性/液相色谱-串联质谱法Key words
nicergoline/ pharmacokinetics/ bioequivalence/ LC - MS分类
医药卫生引用本文复制引用
张冬慧,徐培涵,张俊东,李琳,巩慧敏,冯泽岸,王婷,梁莉,乔华,常威,李丹..国产与进口尼麦角林片在健康人体的生物等效性[J].中国临床药理学杂志,2012,28(1):33-36,4.
