HPLC法测定肾脏移植患者血浆中霉酚酸浓度及其药代动力学  

Determination of mycophenolic acid in plasma of kidney transplantation patients by HPLC and its pharmacokinetic

作　　者：石茹[1] 文爱东[1] 赵磊[1] 林琳[1] 王萌[1] 吴寅[1] 

机构地区：[1]第四军医大学西京医院药剂科,陕西西安710033

出　　处：《第四军医大学学报》2004年第15期1416-1418,共3页Journal of the Fourth Military Medical University

摘　　要：目的 :HPLC法测定肾脏移植患者血浆霉酚酸(MPA)浓度 ,研究其在体内的药代动力学特征 .方法 :Discov erC1 8(2 5 0 .0mm× 4 .6mm ,5 μm)为分析柱 ,磷酸盐缓冲 液∶乙腈 (4 5∶5 5 )为流动相 ,流速 0 .8mL/min ,检测波长 2 5 0nm ,柱温 30℃ ,进样量 1 0 0 μL .根据 9例肾脏移植患者口服骁悉 (又霉酚酸酯 ,MMF) ,由标准曲线方程计算血浆中MPA的浓度和药代动力学参数 .结果 :当测定方法线性范围为 0 .0 995～2 7.85 1 6mg/L时 ,峰面积与浓度呈良好的线性关系 (r =0 .9997) ,最低检出浓度为 5 μg/L ,方法学平均回收率分别为96 .30 % ,97.82 %和 98.6 2 % ,日内精密度和日间精密度分别为 3.6 % ,1 .8% ,0 .5 %和 5 .6 % ,3.2 % ,1 .3% .药动学参数表明MPA人体过程符合单室开放模型 ,Tmax ,Cmax和AUC(0 -1 2h) 分别为 0 .93h ,1 0 .2 4mg/L和 31 .2 3mg/ (h·L) .结论 :该方法简单、快速、准确 。AIM: To determine mycophenolic acid (MPA) in plasma of kidney transplantation patients by HPLC and its pharmacokinetics. METHODS: Discover C18(250.0 mm× 4.6 mm, 5 μm)spectrum analytical column was used and phosphate buffer acetonitrile(45∶55) was adopted as the mobile phase. Flow rate was 0.8 mL/min, detection wavelength was 250 nm, column temperature was 30℃ and the dosage of MPA was 100 μL. The pharmacokinetic parameters of MPA taken by 9 kidney transplantation patients were standard curve calculated in plasma. RESULTS: The standard curve was linear ( r =0.9997) with the range of 0.0995- 27.8516 mg/L for MPA. The limit of detection in plasma was 5 μg/L. The average recovery were 96.30%, 97.82% and 98.62%, respectively. The inter day precision and intra day precision were 3.6%,1.8%, 0.5% and 5.6% , 3.2%, 1.3%, respectively. The results showed that the pharmacokinetic of MPA was in accordance with the one compartment open model. Tmax, Cmax and AUC (0-12 h) was 0.93 h,10.24 mg/L and 31.23 mg/(h· L), respectively. CONCLUSION: The method is simple, quick and precise, and can be used clinically in mentoring the plasma MPA in organ transplantation patients.

关 键 词：霉酚酸 肾移植 药代动力学 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]