HPLC法测定人血浆中培美曲塞二钠的浓度及其临床应用

发布时间：2018-12-12 04:44

【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#174;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,P0.05,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。
[Abstract]:Objective: to establish a method for the determination of pemetrexide disodium in human plasma. Methods: the plasma samples were precipitated by strong acid and the protein was determined by high performance liquid chromatography (HPLC). The chromatographic column was Xterra#174;. The mobile phase of RP18, was acetonitrile-50mmol/L sodium dihydrogen phosphate buffer (15:85), the flow rate was 1.2 ml / min, and the detection wavelength was 225 nm. Results: the plasma concentration of pemetrexide was linear in the range of 1.0~32.0mg/L (r = 0.999 9). The recovery rate was 86.35% and the RSD was less than 4.21% (n = 5) during the day. The lowest plasma mass concentration was 0.05 mg / L. Patients with higher blood drug concentration were prone to higher bone marrow suppression, and the blood drug concentration with adverse reaction was (18.56 卤4.50) mg/L, and (14.05 卤6.72) mg/L, without adverse drug reaction. The mean of the two samples was tested by t test and the difference was statistically significant (P 0.05). Conclusion: this method is simple, rapid, accurate and sensitive. It is suitable for monitoring the blood concentration of pemetrexide and pharmacokinetics.
【作者单位】：徐州医学院附属医院;
【基金】：徐州市社会发展科技基金(No.XZZDY1304)
【分类号】：R969.1;R96

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