论文部分内容阅读
采用改进的高效液相色谱法 ,以盐酸羟嗪为内标 ,测定了 12名健康男性受试者口服盐酸西替利嗪胶囊和盐酸西替利嗪片后不同时刻血浆中西替利嗪的浓度 ,绘制了血药浓度 时间曲线 ,并求出两种制剂的主要药物动力学参数 :Cmax分别为 (90 5 7± 185 9)和 (777 1± 10 5 8)ng/mL ,Tmax分别为 (0 79± 0 2 6 )和 (0 90± 0 45 )h ,t1/ 2 分别为 (7 5 9± 1 2 9)和 (7 73± 1 46 )h ,AUC0→∞ 分别为 (6774 8± 10 5 9 1)和 (6 6 0 3 2± 12 5 7 6 )ng·h/mL .以AUC0→∞ 计算相对生物利用度 ,盐酸西替利嗪胶囊的相对生物利用度平均为 (10 4 0± 14 4) % .采用方差分析和双单侧t检验法进行生物等效性判断 ,结果表明 ,两种制剂生物利用度无显著性差异 (P >0 0 5 ) ,可认为两者在人体内生物作用等效
Using improved HPLC and hydroxyzine hydrochloride as internal standard, the plasma concentrations of cetirizine at different time points in 12 healthy male subjects after oral administration of cetirizine hydrochloride capsules and cetirizine hydrochloride tablets were determined , The plasma concentration time curve was plotted, and the main pharmacokinetic parameters of the two formulations were calculated: Cmax were (905 7 ± 185 9) and (777 1 ± 10 58) ng / mL, respectively, Tmax was 0 79 ± 0 2 6 and 0 90 ± 0 45 h, t1 / 2 were (7 59 ± 1 2 9) and (7 73 ± 1 46) h, respectively. AUC0 → ∞ were (6774 8 ± 10 5 9 1) and (6 6 0 3 2 ± 125 7 6) ng · h / mL. The relative bioavailability of cetirizine hydrochloride capsules was calculated by AUC0 → ∞. The average relative bioavailability of cetirizine hydrochloride capsules was (10 4 0 ± 14 4)% .Analysis of bioequivalence (ANOVA) and two-sided one-tailed t-test showed that there was no significant difference in bioavailability between the two preparations (P> 0.05) The biological effect of human body equivalent