摘要
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
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.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2002年第6期332-335,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
奥美拉唑
胶囊
药动学参数
抗溃疡药
生物利用度
omeprazole
capsules
chromatography, high pressure liquid
pharmacokinetics
biological availability
