HPLC法测定人血浆中培美曲塞二钠的浓度及其临床应用  

Determination of Pemetrexed Disodium in Human Plasma by HPLC and Its Application

作　　者：刘磊[1] 王晖[1] 高静[1] 

机构地区：[1]徐州医学院附属医院,江苏徐州221006

出　　处：《中国药房》2015年第23期3210-3212,共3页China Pharmacy

基　　金：徐州市社会发展科技基金(No.XZZDY1304)

摘　　要：目的：建立测定人血浆中培美曲塞二钠浓度的方法。方法：血浆样品经强酸沉淀蛋白后采用高效液相色谱法进样测定,色谱柱为Xterra？RP18,流动相为乙腈-50mmol/L磷酸二氢钠缓冲液（15∶85）,流速为1.2ml/min,检测波长为225nm。结果：培美曲塞二钠血药浓度在1.0~32.0mg/L范围内线性关系良好（r=0.999 9,n=5）,提取回收率为86.35%~87.25%,日内、日间RSD均≤4.21%（n=5）。最低血浆检测质量浓度为0.05mg/L。血药浓度较高的患者在以后易出现较高的骨髓抑制,出现不良反应的血药浓度为（18.56±4.50）mg/L,无不良反应的血药浓度为（14.05±6.72）mg/L,两样本均数经t检验,P〈0.05,差异有统计学意义。结论：该方法简便、快速、准确、灵敏,适用于培美曲塞二钠血药浓度监测及人体药动学研究。OBJECTIVE：To establish the method for the determination of pemetrexed disodium in human plasma. METHODS：The plasma sample was determined by HPLC after protein were precipitated with strong acid. The determination was performed on Xterra#174; RP 18 column with mobile phase consisted of acetonitrile-50 mmol/L sodium dihydrogen phosphate buffer solution（15 ∶ 85）at the flow rate of 1.2 ml/min. The detection wavelength was set at 225 nm. RESULTS：The linear range of pemetrexed disodium were 1.0-32.0 mg/L（r=0.999 9,n=5） with recoveries of 86.35%-87.25%. RSDs of inter-day and intra-day were lower than4.21%（n=5）. Minimum detection concentration of plasma was 0.05 mg/L. The patients with high plasma concentration easily suffered from arrest of bone marrow. The plasma concentration was（18.56±4.50）mg/L,which could induce ADR;when the plasma concentration was（14.05 ± 6.72） mg/L,no ADR was found. There was statistical significance after t-test（P〈0.05）. CONCLUSIONS：The method is simple,quick,accurate,sensitive and suitable for the plasma concentration determination of pemetrexed disodium and human pharmacokinetics study.

关 键 词：高效液相色谱法 培美曲塞二钠 血药浓度 

分 类 号：R969.1[医药卫生—药理学] R979.1[医药卫生—药学]