2种奥美拉唑胶囊的人体药动学参数比较

目的 :比较 2种奥美拉唑胶囊在健康志愿者体内的药动学参数。方法 :10对 (2 0名 )健康志愿者随机口服 2种奥美拉唑胶囊各 2粒 (每粒 2 0mg) ,1wk后再交叉服药。用RP HPLC法测定奥美拉唑在体内的血药浓度。用 3P97软件处理 2种胶囊制剂的药动学参数。结果 :奥美拉唑的药 时曲线符合单室模型。奥美拉唑胶囊口服给药 4 0mg后 ,经方差分析显示 2种胶囊的主要药动学参数差异无显著意义 (P >0 .0 5 )。 2种胶囊的相对生物利用度为 (95 .5～ 110 .7) %。结论 :2种奥美拉唑胶囊制剂具有生物等效性

Pharmacokinetic parameters comparison of two kinds of omeprazole capsules

AIM: To compare the pharmacokinetic parameters of the two kinds of omeprazole capsules, following per oral administration. METHODS: Twenty healthy volunteers were per orally cross-administrated two kinds of omeprazole two capsules (20 mg omeprazole per capsule). The plasma concentrations of omeprazole were determined by the reverse phase high performance liquid chromatography (RP-HPLC) method. The pharmacokinetic parameters of two capsules preparations were calculated and compared by 3P97 Software. RESULTS: The concentration-time curve of omeprazole complied with the single compartment model. Following per oral administration of omeprazole 40 mg, there were no statistical significant differences of the main pharmacokinetic parameters between the two capsules preparations by the analysis of variance (P>0.05). The relative biological availabilities of the two capsules preparations were (95.5-110.7) %. CONCLUSION: The results demonstrate that the two kinds of omeprazole capsules are bioequivalent.