RP-HPLC法测定人血浆奥氮平浓度及其在健康志愿者的药代动力学研究  

Reversed phase high-performance liquid chromatography for determination of plasma olanzapine and pharmacokinetics of olanzapine in healthy Chinese volunteers

作　　者：朱军[1] 杨鸿[1] 刘伟忠[2] 

机构地区：[1]中山大学附属第二医院药学部,广东广州510120 [2]广州市精神病医院国家药品临床研究基地,广东广州510370

出　　处：《南方医科大学学报》2006年第9期1327-1329,共3页Journal of Southern Medical University

摘　　要：目的建立测定人血浆中奥氮平浓度的高效液相色谱法并进行药代动力学研究。方法10名男性健康志愿者单剂量口服奥氮平片20mg,血浆样品经液-液提取,用高效液相色谱法检测奥氮平的浓度,并用3P97程序进行数据处理。结果此方法适用于人血浆中奥氮平浓度的检测。单剂量口服奥氮平后,其血浆药-时曲线符合二室模型;主要药代动力学参数Cmax、Tmax、t1/2、AUC0-144、AUC0-inf分别为(113.7±33.1)μg·L-1、(5.07±0.65)h、(35.44±4.21)h、(2235±257)μg·h·L-1和(2516±301)μg·h·L-1。结论该方法灵敏、准确,能快速检测人血浆中奥氮平浓度。Objective To establish a reversed phase high-performance liquid chromatography （HPLC） system for determining plasma concentration of olanzapine and analyze the pharmacokinetics of olanzapine in healthy Chinese volunteers. Methods Ten healthy male subjects received a single oral dose of 20 mg olanzapine tablets. The plasma concentrations of olanzapine were determined by HPLC, and the data were analyzed using 3P97 program. Results The plasma concentration curve of olanzapine following a single oral dose conformed to the two compartment open model. The main pharmacokinetics parameters of olanzapine were as follow： Cmax, was 113.7±33.1μ/L, Tmax 5.07±0.65 h, t1/2 35.44＋4.21 h, AUC0-144 2 235±257μg ·h ·L^-1, and AUC0-inf 2 516±301μg ·h ·L^-1. Conclusion The system established in this study allows for highly sensitive, selective and accurate determination of plasma concentration ofolanzapine, and provides valuable information for clinical trials.

关 键 词：奥氮平 健康志愿者 药代动力学 高效液相色谱法 

分 类 号：R96[医药卫生—药理学]