两种奥拉西坦胶囊的人体生物等效性研究

Investigation of the bioequivalence of the two kinds of oxiracetam capsules

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。

BJECTIVE: To study the pharmacokinetics and bioequivalence of the two kinds of oxiracetam capsules in healthy volunteers.METHODS: A HPLC method was used to determine the serum oxiracetam concentrations following a single oral dose of 2g oxiracetam capsules administered to 8 adult male volunteers in an open randomized crossover design.Pharmaco kinetic analysis was carried out by using the 3P87 (Practical Pharmacokinetic ProgramVersion 87) software. RESULTS: The tmax,cmax,AUC,t1/2,Vd,Cl of the two kinds of oxiracetam capsules (Tianjins capsule and Shijiazhuangs capsule) were (1.10.3)h and (1.30.4)h,(5510) and (566)gml-1,(31036)ghml-1 and (30137)ghml-1,(5.42.6)h and (7.73.6)h,(5.65.7)L and (9.110.0)L,(6.50.8)Lh-1 and (6.80.9)Lh-1,respectively.The relative bioavailability of the Tianjins capsule was 104%. CONCLUSION: Statistical analysis showed that the relative pharmacokinetic parameters of the two formulations havent significant difference.The bioavailability of the two kinds of oxiracetam capsules w