中国药房2011，Vol.22Issue(46)：4358-4361,4.
2种恩替卡韦制剂的人体生物等效性研究
Bioequivalence of 2 Kinds of Entecavir Preparations in Healthy Volunteers
林琳 1马忠英 2乔逸 2杨林 2杭太俊 3文爱东2
作者信息
- 1. 解放军第522医院药剂科,洛阳市471003
- 2. 第四军医大学西京医院药剂科,西安市710032
- 3. 中国药科大学分析化学教研究室,南京市210009
- 折叠
摘要
Abstract
OBJECTIVE: To study the bioequivalence of 2 kinds of entecavir preparations in human bodies. METHODS: A total of 20 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single dose of 0.5 mg Entecavir capsule (test preparation) or Entecavir tablet (reference preparation). The plasma concentrations of entecavir were determined by LC-MS, and the pharmacokinetic parameters and bioavailability were calculated with DAS 2.1.1 program. RESULTS: Main pharmacokinetic parameters of test preparation and reference preparation were as follows: cmax (4.21 ± 1.26) ng·mL-1 vs.(4.06 ± 0.80)ng·m L-1,tmax(0.6 ± 0.4)h vs.(0.6 ± 0.2)h,t1/2β(29.97 ± 4.24)h vs.(36.36 ± 9.14)h, AUC0~96h (10.84 ±1.80) ng·h·mL-1 vs.(10.50 ± 1.25)ng·h·mL-1,AUC0~∞(11.69 ± 1.88)ng·h·mL-1 vs. (11.82 ± 1.54)ng·h·mL-1. The relative bioavailability of test preparation was (103.7 ± 16.6)% , compared with reference preparation. The 90% confidential intervals (CI) of test preparation in AUC0~96h were among the bioequivalent range as compared with reference preparation. CONCLUSION: 2 kinds of Entecavir preparations are bioequivalent.关键词
恩替卡韦/液-质联用法/药动学/生物等效性Key words
Entecavir/ LC-MS/ Pharmacokinetics/ Bioequivalence分类
医药卫生引用本文复制引用
林琳,马忠英,乔逸,杨林,杭太俊,文爱东..2种恩替卡韦制剂的人体生物等效性研究[J].中国药房,2011,22(46):4358-4361,4.
