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目的 :研究国产盐酸西替利嗪片和胶囊的人体药动学和生物等效性。方法 :选择 2 1名男性健康志愿者 ,采用反相高效液相色谱法 ,以紫外 2 2 9nm为检测波长 ,测定了单剂量 (2 0mg)口服国产盐酸西替利嗪片、胶囊和进口盐酸西替利嗪片在人体内的西替利嗪浓度。结果 :盐酸西替利嗪的体内动态过程呈一级吸收的二房室开放模型 ,国产片、胶囊和进口片的Cmax分别为 (6 4 8.5± 117.6 ) ,(6 78.8± 10 4 .6 )和 (6 6 1.5± 12 0 .6 )ng·ml-1,Tmax分别为 (1.0± 0 .4 ) ,(1.2± 0 .5 )和 (1.1± 0 .4 )h ,t1/ 2 β分别为 (7.8± 2 .6 ) ,(7.6± 2 .7)和 (9.4± 5 .2 )h ,MRT分别为 (7.2± 0 .6 ) ,(7.3± 0 .6 )和 (7.4± 0 .4 )h ,AUC0→ 2 5分别为(45 0 3.3± 6 89.5 ) ,(46 0 1.2± 739.1)和 (484 0 .5± 937.1)ng·h-1·ml-1,AUC0→∞ 分别为 (5 0 34.4± 84 1.4 ) ,(5 12 9.6± 776 .2 )和(5 4 32 .8± 10 2 4 .0 )ng·h-1·ml-1。结论 :国产盐酸西替利嗪片和胶囊与进口片具有生物等效性
Objective: To study the pharmacokinetics and bioequivalence of domestic cetirizine hydrochloride tablets and capsules. Methods: Twenty-one male healthy volunteers were enrolled in this study. Reversed-phase high performance liquid chromatography (HPLC) was used with a UV detection wavelength of 22 9 nm. A single dose of 20 mg domestic cetirizine hydrochloride tablets and capsules Cetirizine tablets in the human body cetirizine concentration. Results: The two-compartment open model with first order absorption of cetirizine hydrochloride in vivo showed that the Cmax values of domestic tablets, capsules and imported tablets were (6 4 8.5 ± 117.6), (6 78.8 ± 104.6) and (6 ± 1.5 ± 12 0 .6) ng · ml-1 and Tmax were (1.0 ± 0.4), (1.2 ± 0.5 and 1.1 ± 0.4) h and t1 / 2β were (7.8 ± 2 .6), (7.6 ± 2 .7) and (9.4 ± 5.2) h respectively. The MRT were (7.2 ± 0.6, 7.3 ± 0.6 and 7.4 ± 0.4 ) h and AUC0 → 2 5 were (45 0 3.3 ± 6 89.5), (46 0 1.2 ± 739.1) and (484 0 5 ± 937.1) ng · h-1 · ml-1, respectively 5 0 34.4 ± 84 1.4), (5 12 9.6 ± 776 .2) and (5 4 32 .8 ± 10 2 4 .0) ng · h -1 · ml -1. CONCLUSION: Domestic cetirizine hydrochloride tablets and capsules have bioequivalence with imported tablets