中国药房2012，Vol.23Issue(22)：2047-2050,4.DOI:10.6039/j.issn.1001-0408.2012.22.10
2种盐酸美金刚片的人体生物等效性研究
Study on Bioequivalence of 2 Kinds of Memantine Tablets in Healthy Volunteers
李雪晴 1宋颖 1文爱东 1刘文星 1贾艳艳 1杨林 1冯智军 1宋薇 1周伦 1王茂湖 1鹿成韬1
作者信息
- 1. 第四军医大学第一附属医院药剂科,西安710032
- 折叠
摘要
Abstract
OBJECTIVE: To evaluate the relative bioavailability and bioequivalence of 2 kinds of Memantine tablets from different manufacturers. METHODS: In standard two step cross-design self-controlled trials, 20 healthy male volunteers were randomly divided into 2 groups. 2 groups orally took a single dose of 10 mg tablets of the test preparation (domestic tablet) and reference preparation (imported tablet). The plasma concentration of memantine was determined by LC-MS, and pharmacokinetic parameters were calculated by using DAS 2.0 software. RESULTS: The pharmacokinetic parameters of reference and test preparations were as follows:t1/2, were (69.77 ± 14.61 )h vs. (76.06 ± 17.92) h; tmax(5.15 ± 1.18)h vs. (5.05 ± 1.36)h; cmax( 13.64 ± 3.28)μg·mL‐1 vs. (13.34±4.18)μg·mL‐1;AUC0~240 h(857.73±164.45)μg·h·mL‐1 vs. (888.16±316) μg·h·mL‐1; AUC0~00(940.00 ± 180.70)μg·h· mL‐1vs.(999.00±346.40)μg·h·mL‐1, respectively. The relative bioavailability of test preparation was 104.2%, compared with reference preparation. CONCLUSION: 2 kinds of Memantine tablets are bioequivalent.关键词
盐酸美金刚/生物利用度/生物等效性/药动学Key words
Memantine/ Bioavailability/ Bioequivalence/ Pharmacokinetics
分类
医药卫生引用本文复制引用
李雪晴,宋颖,文爱东,刘文星,贾艳艳,杨林,冯智军,宋薇,周伦,王茂湖,鹿成韬..2种盐酸美金刚片的人体生物等效性研究[J].中国药房,2012,23(22):2047-2050,4.
