【摘要】 目的 :对国产盐酸氟西汀 (Flu)胶囊进行相对生物利用度研究。方法 :10名健康志愿者随机分成 2组 ,单剂量交叉服用国产及进口盐酸 Flu胶囊 40 m g,分别于 0、1、2、4、6、8、12 h及 1、2、3、4、7、18、2 8、42、5 6 d抽取血样 ,用高效液相色谱法检测Flu血药浓度 ;用 3P97软件计算药物动力学参数。结果 :国产及进口 Flu的主要药物动力学参数分别为 T1 /2β(2 9.7± 14.5 ) h、(32 .3± 7.3) h;tmax(6 .4± 2 .4) h、(6 .8± 2 .5 ) h;cmax(99.2± 2 4.3) nm ol/ L、(10 2 .3± 16 .8) nmol/ L ;AU C (5 0 0 9± 2 6 85 )、(5 42 8± 16 5 2 ) nmol/ L· h;差异均无统计学意义 (P>0 .0 5 ) ;国产 Flu的相对生物利用度为 (97.5± 2 2 .5 ) %。结论 :国产与进口盐酸 Flu胶囊为生物等效更多还原

【Abstract】 AIM: To study the relative bioavailability of domestic fluoxetine hydrochloride (Flu) capsules. METHODS: Ten volunteers were randomly divided into 2 groups (tested and reference groups), 5 for each, with crossover design. Blood samples were collected at 0, 1, 2, 4, 6, 8, 12 h and 1, 2, 3, 4, 7, 18, 28, 42, 56 d after taking single dose of 40 mg of domestic Flu and imported Flu capsules, respectively. The drug concentration of Flu were determined by high performance liquid chromatography (HPLC). Pharmarcokinetic parameters were calculated by the software of 3P97. RESULTS: The pharmacokinetic parameters of 2 groups were as follows: the elimination half life ( T 1/2β ) were (29 7±14 5) and (32 3±7 3) h, the time to maximum concentration ( t max ) were (6 4±2 4) and (6 8±2 5) h, the maximum concentration ( c max ) were (99 2±24 3) and (102 3±16 8) nmol/L, the area under curve (AUC) were (5 009±2 685) and (5 428±1 652) noml/L·h, respectively. There were no statistical differences of T 1/2 , t max , c max and AUC between the 2 groups. There wre no significant difference between 2 formulations ( P >0 05). The relative bioavailabilities of Flu were (97 5±22 5)%. CONCLUSION: The domestic Flu capsules are bioequivalent to the imported capsules.更多还原