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目的：通过交叉试验比较２种奥拉西坦胶囊的人体药代动力学及生物等效性。方法：８名健康男性志愿者按随机交叉试验方案一次ｐｏ２ｇ奥拉西坦天津胶囊或石家庄胶囊，采用ＨＰＬＣ测定不同时间的血清药物浓度。用３Ｐ８７软件进行拟合处理。结果：天津胶囊与石家庄胶囊的ｔｍａｘ，ｃｍａｘ，ＡＵＣ，ｔ１／２β，Ｖｄ，Ｃｌ分别为（１．１±０．３）ｈ和（１．３±０．４）ｈ，（５５±１０）和（５６±６）μｇ·ｍｌ－１，（３１０±３６）μｇ·ｈ·ｍｌ－１和（３０１±３７）μｇ·ｈ·ｍｌ－１，（５．４±２．６）ｈ和（７．７±３．６）ｈ，（５．６±５．７）Ｌ和（９．１±１０．０）Ｌ，（６．５±０．８）Ｌ·ｈ－１和（６．８±０．９）Ｌ·ｈ－１。天津胶囊的相对生物利用度为１０４％，结论：经统计分析，两种制剂的药代动力学参数无显著差异。两制剂的生物利用度相当，具有生物等效性。
OBJECTIVE: To compare the pharmacokinetics and bioequivalence of two oxiracetam capsules by crossover test. Methods: Eight healthy male volunteers were randomized to a po2g oxiracetam Tianjin capsule or Shijiazhuang capsule randomized cross-test program, the determination of serum drug concentrations at different times by HPLC. Fitting with 3P87 software. Results: The tmax, cmax, AUC, t1 / 2β, Vd and Cl of Tianjin Capsule and Shijiazhuang Capsule were (1.1 ± 0.3) h and (1.3 ± 0.4) h and (55 ± 10) And (56 ± 6) μg · ml -1, (310 ± 36) μg · h · ml -1 and (301 ± 37) μg · h · ml -1, (5.4 ± 2.6) h and ( 7.7 ± 3.6 h, 5.6 ± 5.7 L and 9.1 ± 10.0 L, 6.5 ± 0.8 L · h-1, 8 ± 0.9) L · h-1. The relative bioavailability of Tianjin Capsules was 104%. Conclusion: There was no significant difference in the pharmacokinetic parameters of the two formulations after statistical analysis. The bioavailability of the two formulations is comparable and bioequivalent.