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目的 :研究国产盐酸西替利嗪片的人体药代动力学和相对生物利用度。 方法 :选择 8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 (10 mg)口服国产盐酸西替利嗪片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 ,国产片和进口片的 cmax分别为(316 .71± 39.6 6 )和 (314.80± 31.79) ng/ ml,tmax分别为 (0 .72± 0 .0 9)和 (0 .72± 0 .0 9) h,t1 /2β分别为 (10 .71± 3.0 6 )和(9.95± 2 .41) h,AU C0～∞ 分别为 (2 72 8.5 2± 35 6 .0 6 )和 (2 75 3.0 1± 36 0 .33) ng· h/ ml。结论 :国产盐酸西替利嗪片剂的相对生物利用度为 (99.5 0± 8.89) % ;选择 cmax和 AU C0～∞ 进行三因素方差分析与双单侧 t检验 ,结果表明国产片和进口片两种制剂具有生物等效性。
Objective: To study the pharmacokinetics and relative bioavailability of domestic cetirizine hydrochloride tablets. Methods: Eight healthy male 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 oral dose of cetirizine hydrochloride (10 mg) Cetirizine concentration in the human body. Results: Cetirizine hydrochloride showed a two-compartment open model with first-order absorption in vivo. The cmax values of domestic and imported tablets were (316.71 ± 39.66) and (314.80 ± 31.79) ng / ml, respectively (0.72 ± 0.09) and (0.72 ± 0.09) h, t1 / 2β were (10.71 ± 3.06) and (9.95 ± 2.41) h, respectively, and AU C0 ~ ∞ were (2 72 8.5 2 ± 35 6 .0 6) and (2 75 3.0 1 ± 36 0 .33) ng · h / ml, respectively. Conclusion: The relative bioavailability of domestic cetirizine tablets was (99.5 ± 8.89)%. Three-factor analysis of variance (ANOVA) and double unilateral t-test were used to choose cmax and AU C0 ~ ∞. The results showed that domestic and imported tablets Both formulations are bioequivalent.