国产与进口西替利嗪片的人体相对生物利用度比较

目的 :比较西替利嗪 2种片剂在健康受试者体内的药物动力学和生物利用度。方法 :10例健康受试者随机交叉口服进口西替利嗪和国产西替利嗪各 2 0mg ,采用反相高效液相色谱法测定血浆中药物浓度。结果 :国产西替利嗪与进口西替利嗪的主要药物动力学参数如下 :Cmax 分别为 ( 0 .83±0 .19)mg·L- 1和 ( 0 .71± 0 .18)mg·L- 1,Tmax分别为( 0 .88± 0 .2 9)h和 ( 0 .80± 0 .32 )h ,MRT0 -T分别为( 9 .9± 1.4 )h和 ( 10 .2± 1.0 )h ,AUC0 -T分别为 ( 6.3± 1.1)mg·h·L- 1和 ( 6.6± 1.2 )mg·h·L- 1。 2种药品的上述药动学参数差异无显著意义 (P >0 .0 5)。国产西替利嗪相对生物利用度为 ( 95± 9) %。结论 :国产西替利嗪与进口西替利嗪在受试者体内的药物动力学参数相似 ,具有生物等效性

Domestic vs imported cetirizine tablets relative bioavailability in healthy volunteers

AIM: To compare the bioavailabilities and pharmacokinetics of two cetirizine tablets. METHODS: Ten healthy volunteers were given domestic cetirizine 20 mg and imported cetirizine 20 mg in a random crossover study. Plasma drug concentration was detected by reverse phase HPLC. RESULTS: The pharmacokinetic parameters of domestic cetirizine and imported cetirizine were C max :(0.83±0.19)mg·L -1 and ( 0.71 ± 0.18 )mg·L -1 , T max :( 0.88 ± 0.29 )h and ( 0.80 ± 0.32 )h, MRT 0-T :( 9.9 ±1.4)h and (10.2±1.0)h, AUC 0-T :(6.3± 1.1 )mg·h·L -1 and (6.6± 1.2 )mg·h·L -1 , respectively. The relative bioavailability of the domestic cetirizine was (95±9)%. CONCLUSION: There are no significant differences of the pharmacokinetic parameters between the two preparations. The domestic cetirizine is bioequivalent to the imported cetirizine.