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健康志愿者8人,随机,交叉,单剂量口服阿司匹林锌胶囊及等剂量的标准参比制剂阿司匹林胶囊900mg,不同时间测得的血药浓度数据在COPAMPC386S×B/16型计算机上用MCPKP软件进行拟合处理,符合开放单室模型。阿司匹林锌胶囊和阿司匹林胶囊的C_(max)T_(max),T_(1/2Ka),T_(1/2K)和AUC分别为65.45和66.11μg·ml ̄(-1),2.10和3.46h,0.64和1.76h,4.68和3.76h,609.03和679.79μg·h,ml ̄(-1)。阿司匹林锌胶囊的相对生物利用度为阿司匹林胶囊的91.58%±14.24%。药动学参数经统计学分析表明,两者的T_(1/2Ka),T_(max).有显著性差异(p<0.05),而T_(1/2K),C_(max)和AUC均无显著性差异(P>0.05),提示两种药具有生物等效性,但阿司匹林锌吸收更快,更易达到峰值血药浓度。
8 healthy volunteers, randomized, crossover, single-dose oral aspirin zinc capsules and an equal dose of standard reference preparation aspirin capsules 900mg, plasma concentration measured at different times data on the COPAMPC386S × B / 16 computer using MCPKP software Fitting treatment, in line with the open single-chamber model. The C max, T 1/2, T 1/2 and AUC of aspirin capsules and aspirin capsules were 65.45 and 66.11 μg · ml -1, respectively. 10 and 3.46 h, 0.64 and 1.76 h, 4.68 and 3.76 h, 609.03 and 679.79 μg · h, ml ~ (-1), respectively. The relative bioavailability of aspirin zinc capsules was 91.58% ± 14.24% of aspirin capsules. Pharmacokinetic parameters of the statistical analysis showed that the two T_ (1 / 2Ka), T_ (max). (P <0.05), but there was no significant difference between T 1K, C max and AUC (P> 0.05), which suggested that the two drugs were bioequivalent Aspirin zinc absorption faster, more easily reached the peak plasma concentration.