国产盐酸阿夫唑嗪片人体生物利用度

Bioavailability of domestic alfuzosin hydrochloride tablets in healthy volunteers

目的 :比较国产和进口阿夫唑嗪片的人体生物利用度。方法 :2 0名男性健康受试者自身交叉口服单剂量国产和进口盐酸阿夫唑嗪片 5 m g,用高效液相色谱法测定人血清中盐酸阿夫唑嗪的浓度 ,计算药物动力学参数 ,以方差分析与双向单侧 t检验进行统计学分析。结果 :国产和进口盐酸阿夫唑嗪片的 cmax分别为 (31.0 2± 10 .83)︼g/ L和 (32 .98± 10 .48)︼g/ L ;tmax分别为 (1.4± 0 .6 ) h和 (1.6± 1.0 ) h;AU C0 - t分别为 (2 0 5 .15± 6 5 .42 )︼g/ L· h和 (2 2 5 .2 0± 5 3.6 3)︼g/ L· h。两药各药物动力学参数间均无统计学差异。国产盐酸阿夫唑嗪片的相对生物利用度为 (90 .31± 12 .79) %。结论

AIM: To compare the relative bioavailability of alfuzosin between domestic and imported tablets in 20 male healthy volunteers. METHODS: A single dose of alfuzosin (5 mg) was given by oral route to the 20 volunteers. Alfuzosin concentration in serum was determined by reversed phase high performance liquid chromatography (RP HPLC) method. Pharmacokinetic parameters were calculated. The analysis of variance and double single side t test were used as statistical analysis. RESULTS: After oral administration, main pharmacokinetic parameters of domestic and imported tablets were c max (31 02±10 83) μg/L, (32 98±10 48) μg/L, t max (1 4±0 6) h, (1 6±1 0) h and AUC 0 t (205 15±65 42) μg/L·h, (225 20±53 63) μg/L·h, respectively. The pharmacokinetic parameters showed no significant difference between the 2 preparations ( P >0 05). The relative bioavailability of domestic tablet was (90 31±12 79)%. CONCLUSION: The 2 preparations are bioequivalent.