高效液相质谱法测定肾功能不全病人那格列奈的血药浓度及药动学  

Assay plasma nateglinide by HPLC-MS:application for pharmacokinetic in renal dysfunction patient

作　　者：朱南平[1] 梁高林 李树华[3] 彭文兴[1] 

机构地区：[1]中南大学湘雅二医院临床药学研究室,湖南长沙410011 [2]广济医院,广西贺州542800 [3]湖南师范大学医学院,湖南长沙410006

出　　处：《中国新药与临床杂志》2006年第5期343-345,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的：建立测定血浆中那格列奈药物浓度的测定方法并应用于肾功能不全的药动学研究。方法：22例糖尿病病人,其中12例为肾功能正常者,其余为轻度肾功能不全病人,单次服用那格列奈120 mg后,以高效液相质谱法(HPLC-MS)测定其血药浓度,以成组t检验分析2组间药动学参数是否存在差异。结果：那格列奈的血药浓度范围在0.05～16.00 mg·L^(-1)内线性关系良好；定量下限为0.02 mg·L^(-1),日内、日间误差小于10%。22例受试者单次服用那格列奈120 mg后药动学参数相似,统计学检验无差异。结论：HPLC-MS法测定那格列奈血药浓度,方法简单、准确、快速。轻度肾功能不全对那格列奈的体内药动学无影响。AIM ：To develop a selective and sensitive high performance liquid chromatography-mass spectrometric （HPLC-MS） method for determining concentration of plasma nateglinide and apply to clinical pharmacokinetic study for diabetic patients with or without renal dysfunction. METHODS：An open, parallel-group study, 22 diabetic patients including 10 patients with mild renal dysfunction group and 12 with normal renal function group were taken a single dose of nateglinide tablets 120 mg. The pharmacokinetics and concentration of plasma nateglinide between the two groups were compared and analized using HPLC-MS. RESULTS： The method was good linear relationships of plasma nateglinide concentration of 0.05-16.00 mg·L^-1 with quantitative lower threshold as 0.02 mg·L^-1 and the relative standard deviation（RSD）of intra-day and inter-day was less than 10 %. There wasn＇t significant difference in nateglinde pharmacokinetic parameters between the two groups. CONCLUTION. HPLC-MS is a simple, accurate and quick method for determining plasma nateglinide concentration and furthermore there is no need to have dose adjustment due to no pharmacokinetics change in diabetic patients with mild renal dysfunction.

关 键 词：那格列奈 色谱法 高压液相 光谱法 质量 电喷雾电离 药动学 肾功能衰竭 糖尿病 

分 类 号：R977.15[医药卫生—药品] R969.1[医药卫生—药学]