摘要
本实验建立了奥美拉唑在人体内血药浓度的HPLC测定方法,并对奥美拉唑片(供试品)及胶囊剂(对照品)在健康人体内的药物动力学进行了研究。结果表明,奥美拉唑片与胶囊剂的达峰时间(Tm)分别为3.3h和3.5h(P>0.05);Cm分别为774.5ng/ml和616.5ng/ml(P<0.05);AUC分别为3274.9(ng·h)/ml和2968.1(ng·h)/ml(P<0.05)。供试品的相对生物利用度为107.0±0.09%,显示奥美拉唑片生物利用度优于对照品。但以20%作为等效性判断检验标准,两者显示生物等效。
After oral administration of omeprazole tablets and capsules in 8 healthy volunteers,the plasma concentration of omeprezole was determined by HPLC.The concentration time profiles fitted to one compartment model.The pharmacokinetic parameters for tablets were T m= 3.3 h; C m= 774.5 ng/ml; AUC = 3274.9 (ng·h)/ml; T 1/2 = 1.4 h; K e= 0.57 h,for capsules were T m= 3.5 h; C m= 616.5 ng/ml; AUC = 2968.1 (ng·h)/ml; T 1/2 = 1.6 h; K e= 0.58 h.Relative bioavailability of tablets was 107.0% compared with capsules.It suggested that the tablets be the same as capsules in bioavailability.The two preparations were similar in bioequivalence.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1997年第3期99-101,共3页
Chinese Journal of Hospital Pharmacy