国产非那雄胺片剂人体药动学及生物等效性研究  

Studies on the pharmacokinetics and bioquivalence of domestic finasteride tablet in healthy volunteers

作　　者：傅军[1] 李艳艳[1] 张会杰[1] 徐文炜[1] 熊玉卿[1] 

机构地区：[1]江西医学院临床药理研究所,江西南昌330006

出　　处：《中国药学杂志》2004年第7期533-535,共3页Chinese Pharmaceutical Journal

摘　　要：目的 评价非那雄胺国产片剂和进口片剂在人体内生物等效性。方法 采用高效液相色谱紫外检测法测定20名健康受试者单剂量po 10 mg非那雄胺国产或进口片剂后,血浆中非那雄胺的浓度。结果 非那雄胺国产片剂和进口片剂的AUC0-24均值分别为(840.63±140.84)和(847.51±166.96)ng·h·mL-1,实测cmax均值分别为(117.17±19.74)和(117.43±18.06)ng·mL-1,实测tmax分别为(1.88±0.48)和(1.95±0.43)h,国产非那雄胺片剂的相对生物利用度为(100.73±15.27)％。结论经统计学分析,供试制剂和参比制剂具有生物等效性。OBJECTIVE: To evaluate the bioequivalence of domestic finasteride tablet and imported tablet. METHODS: A single oral dose of 10 mg domestic tablet or imported tablet was given to 20 healthy volunteers in a randomized crossover study. The concentrations of finasteride were determined by HPLC method. RESULTS: The main pharmacokinetic parameters of the two products were as follows: AUC0-24 (840.63 ± 140.84) and (847.51 ± 166.96) ng &middot h &middot mL-1, cmax (117.17 ± 19.74) and (117.43 ± 18.06) ng &middot mL-1, tmax (1.88 ± 0.48) and (1.95 ± 0.43)h, respectively. The relative bioavailability of domestic tablet to imported tablet was (100.73 ± 15.27)%. There were no significant differences on the pharmacokinetic parameters between the two preparations (P > 0.05). CONCLUSION: The results demonstrated that the two preparations were bioequivalent.

关 键 词：非那雄胺 高效液相色谱法 药动学 生物等效性 

分 类 号：R961[医药卫生—药理学]