阿替洛尔片人体相对生物利用度与生物等效性评价  

Evaluation for bioavailability and bioequivalence of atenolol in human

作　　者：杨敏[1] 陈铁锋[1] 余细勇[1] 钱忆之[1] 江桂芬[1] 林曙光[1] 

机构地区：[1]广东省心血管病研究所临床药理室,广东广州510080

出　　处：《中国现代应用药学》2003年第4期283-286,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的　了解不同厂家生产的阿替洛尔片的药动学特性和相对生物利用度的差异。方法　用高效液相色谱法测定血中阿替洛尔浓度 ;2 0名健康志愿者采用自身对照、随机交叉方法 ,分别单次口服两个厂家的阿替洛尔片 5 0mg ,测定不同时间的血药浓度 ,用 3P97程序计算药动学参数 ,并对Cmax,Tmax和AUC0～T进行生物等效性分析。结果　两种制剂的阿替洛尔Tmax为 (2 .5± 0 .8)h (受试药 )和 (2 .8± 0 .9)h(对照药 )P >0 .0 5 ;Cmax为 (32 6 .1± 10 1.4 ) μg/L(受试药 )和 (30 1.1± 73.3) μg/L(对照药 ) ,(P >0 .0 5 ) ;AUC0～T为 (2 5 73.2± 737.6 ) μg·h/L(受试药 )和 (2 4 85 .4± 6 0 6 .9) μg·h/L(对照药 ) ,P >0 .0 5。受试药阿替洛尔片相对生物利用度为 (10 5 .5± 2 7.4 ) %。结论　两制剂的体内吸收、消除过程基本一致 ,经统计学分析 。OBJECTIVE To study the difference in pharmacokinetices and relative bioavailability of atenolol produced by different factories. METHOD A single oral dose of 50 mg atenolol tablet was given respectively to 20 healthy volunteers in an open randomized crossover test. Atenolol concentration was determined by HPLC. Pharmacokinetic parameters were calculated by 3P97 program. Bioequivalence analysis was done to C max , T max and AUC 0～T .RESULTS The main pharmacokinetics of the two products (test and reference) were as follow. T max were (2.5 ± 0.8)h and (2.8 ± 0.9)h, P >0.05; C max were (326.1± 101.4)μg/L and (301.1 ± 73.3)μg/L,( P > 0.05 ); AUC 0～T were (2 573.2 ± 737.6)μg·h/L and (2 485.4 ± 606.9)μg·h/L , P >0.05。 The relative bioavailability of tested tablets was (105.5 ± 27.4)%.CONCLUSION The absorption and elimination processes of two products in human body were similar and the two products were bioequivalent.

关 键 词：阿替洛尔 高效液相色谱法 相对生物利用度 生物等效性 

分 类 号：R972[医药卫生—药品] R945[医药卫生—药学]