中国临床药理学杂志2012，Vol.28Issue(1)：26-29,4.
石杉碱甲缓释片在健康人体的生物等效性
Bioequivalence of huperzine A sustain- release tablets in healthy volunteer
摘要
Abstract
Objective To study the bioavailability of the tested and reference huperzine A sustain - release tablets in healthy male volunteers. Methods According to the four - crossing design, each volunteer was o-rally given huperzine A sustain - release tablets or huperzine A . The plasma concentrations were determined by LC - MS/MS. Pharmacokinet-ic parameters were obtained using DAS 2. 0 program. Results The main pharmacokinetic parameters of huperzine A tablets test and reference were as follows; Cmaxwere(0. 75 ±0. 25), (1. 57 ±0.44)ng · mL-1,Tmax were (5. 77 ±3. 60),(1. 27 ±0. 98)h,AUC0-twere (14.4 ±5. 81), (15. 1 ± 5.66)ng-h · mL-1,AUC0-∞ were(17. 1 ±7. 29),( 16. 7 ±6. 77)ng ? H · mL-1 ,in 200 μg groups respectively. The relative bioavailability was (97. 2 ± 24. 4) %. The data of the reference and tested drugs were not different as shown by F test. Conclusion The result shows that the two huperzine A tablets made in two different preparations are bioequivalent. Huperzine A sustain - release tablets clearly have the characteristic of slow releasing properties.关键词
石杉碱甲/生物等效性/液相色谱/串联质谱Key words
huperzine A/ bioequivalence/ LC - MS/MS分类
医药卫生引用本文复制引用
魏振满,丁晋彪,胡琳,陈红鸽,吴荣荣,刘万卉,沙春洁..石杉碱甲缓释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):26-29,4.基金项目
国家科技部十一五重大新药创制课题基金资助项目(2008ZX09312-011) （2008ZX09312-011）
