国产依普拉芬在健康人体中的生物利用度及药动力学研究  

Bioavailability and pharmacokinetics of ipriflavone

作　　者：曾珍[1] 王自正[1] 李宗桃 马晓红 邓思清[1] 刘天培[1] 

机构地区：[1]南京市第一医院中心实验室临床药理研究室,武汉滨湖制药厂药物研究所,南京医科大学临床药理研究所

出　　处：《中国骨质疏松杂志》1996年第4期30-32,27,共4页Chinese Journal of Osteoporosis

摘　　要：本文采用反相高效液相色谱法测定了血清中依普拉芬的浓度，该方法的最低检测限为３ｎｇ／ｍｌ，线性范围８～４００ｎｇ／ｍｌ，回收率为８４．７％。并对８名男性健康志愿者口服国产片与进口片的药物动力学与生物利用度进行了考察。结果表明，依普拉芬为口服吸收二室模型，国产片与进口片的各项药动学参数非常接近，经统计学分析，差异无显著性（Ｐ０．０５），国产依普拉芬相对于进口依普拉芬的生物利用度为１００．３％In this study the concentrations of unchanged ipriflavone in serum have been determined by using high performance liquid chromatography. The linear range of the assay was 8～400ng/mL, and the minimum quantifiable concentration was 3ng/mL for ipriflavone. The rate of recovery was 84. 7%. The pharmacokinetics and bioavailability were studied in 8 healthy male volunteers. The results suggest that ipriflavone conforms to a oral ad ministration two-compartment model. There is no statistically significant difference between China-made and imported ipriflavone in the pharmacokinetic parameters such as Cmax ,Tmax and AUC(P>0. 05). The comparative bioavailability of China-made to imported ipriflavone is 100. 3%.

关 键 词：生物利用度 药动力学 健康人体 口服 国产 二室模型 男性健康 统计学分析 药动学参数 反相高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学] R698[医药卫生—药学]