非那雄胺片的人体生物等效性研究  

Study on Bioequivalence of Finasteride Tablets in Human Body

作　　者：高晨[1] 赵志刚[1] 余立[2] 庞青云[2] 王成刚[2] 李文东[2] 李冬梅[1] 朱立[1] 邵微[1] 王景田[1] 

机构地区：[1]北京天坛医院药剂科,北京市100050 [2]北京市药品检验所,北京市100035

出　　处：《中国药房》2005年第10期760-762,共3页China Pharmacy

摘　　要：目的:研究国产与进口非那雄胺片的人体生物等效性。方法:采用高效液相色谱法测定18名健康男性志愿者随机交叉单剂量口服非那雄胺片10mg后血清中的药物浓度,计算药动学参数和相对生物利用度,并进行生物等效性评价。结果:国产及进口非那雄胺片的AUC0～t 分别为(990 .80±302. 80)、(1007 .46±333. 65) (μg·h)/L ,Cmax 分别为(119. 22±18. 48)、(114. 08±22 .97) μg/L ,tmax 分别为(2. 89±1. 02)h、(2. 64±0. 54)h ,国产制剂相对于进口制剂的人体生物利用度为(103. 35±29 .75) %。结论:国产与进口非那雄胺片具有生物等效性。OBJECTIVE:To study the human body bioequivalence of finasteride tablets from both domestic and imˉport.METHODS:The serum concentration of18volunteers were determined by HPLC after a random cross single oral dose of10mg of finasteride tablets,the pharmacokinetic parameters and the relative bioavailability were calculated and the bioequivaˉlence was evaluated as well.RESULTS:For the domestic and the import finasteride tablets,the AUC (0～t) of which were(990.80±302.80)(μg·h)/L and(1007.46±333.65)(μg·h)/L respectively,the C max of which were(119.22±18.48)μg/L and(114.08±22.97)μg/L respectively,the t max of which were(2.89±1.02)h and(2.64±0.54)h respectively,the relative bioavailability of the domestic preparation was(103.35%±29.75)%of the imported one.CONCLUSION:The domestic and import finasteride tablets were of bioequivalence.

关 键 词：非那雄胺 高效液相色谱法 生物等效性 

分 类 号：R983[医药卫生—药品] R969.1[医药卫生—药学]