两种奥拉西坦胶囊的人体生物等效性研究

 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po 2g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t_max,c_max,AUC,t_1/2β,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?

Investigation of the bioequivalence of the two kinds of oxiracetam capsules

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