口服非那甾胺片和非那甾胺胶囊的人体生物等效性研究  

Bioequivalance of single oral administration of finasteride tablet and capsule in healthy volunteers

作　　者：赵亚男[1] 裘福荣[1] 王伟佳[1] 孙华[1] 戴敏[1] 杨青青[1] 冒国光[1] 

机构地区：[1]皖南医学院弋矶山医院国家药品临床研究基地

出　　处：《中国临床药理学与治疗学》2004年第12期1411-1414,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的 :研究非那甾胺片剂和胶囊在健康志愿者体内的生物等效性。方法 :2 4名健康男性志愿者随机三交叉给药 ,分别单剂量口服 15mg试验药非那甾胺片剂、胶囊及非那甾胺片剂对照药 ,采用Wa tersOasis HLB固相萃取小柱提取 ,反相高效液相色谱法测定血药浓度 ,计算药代动力学参数及相对生物利用度。结果 :口服 15mg试验药非那甾胺片剂和胶囊及片剂对照药的主要药代动力学参数T1 2ke分别为 4 .38± 0 .90、4 .2 9± 0 .78和 4 .32± 0 .86h ;Tmax 分别为 3.0 4± 0 .88、2 .98± 0 .89和 2 .5 9±0 .86h ,Cmax 分别为 117.5 7± 19.15、118.5 9± 2 0 .2 3和 12 4 .5 3± 19.77μg·L-1;AUC0 -18分别为 897.5 7±185 .0 3、 871.5 7± 139.2 5和 837.5 9±14 9.0 5 μg·h·L-1;AUC0 -∞ 分别为 970 .0 4± 2 11.83、931.5 1+ 15 1.0 7和 896 .4 1± 16 4.92 μg·h·L-1。结论 :试验药非那甾胺片和胶囊与对照药非那甾胺片剂具有生物等效性 ,相对生物利用度分别为 (10 7.2 7± 9.86 ) %和 (10 5 .0 6± 12 .10 ) %。AIM: To study the bioequivalance of finasteride tablet and c ap sule in 24 healthy volunteers. METHODS: A reversed-phase high performance liquid chromatography (RP-HPLC) method was established for the dete rmination of the finasteride concentrations in human plasma after a single oral dose administration of 15 mg finasteride tablet and capsule and control finaster ide tablet (control group) to 24 healthy volunteers in an open randomized crosso ver design. RESULTS: The main pharmacokinetic parameters of fina steride tablet group, capsule group and finasteride tablet group were as follows : T 1/2 ke were 4.38± 0.90, 4.29± 0.78 and 4.32± 0.86 h; T max were 3.04± 0.88, 2.98± 0.89 and 2.59± 0.8 6 h; C max were 117.57± 19.15, 118.59± 20.23 and 124.5 3± 19.77 μg·L -1; AUC 0-18 were 897.57± 185.03, 871.57± 139.25 and 837.59± 149.05 μg·h·L -1; AUC 0- ∞ were 970.04± 211.83, 931.51± 151.07 and 896.41± 164.9 2 μg·h·L -1, respectively. CONCLUSION: The finaste ride tablet and capsule and the control finasteride tablet are bioequivalent.

关 键 词：非那甾胺 生物利用度 生物等效性 高效 液相色谱法 

分 类 号：R969.4[医药卫生—药理学]