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目的:建立以高效液相色谱法测定人血浆中霉酚酸浓度的方法,并对其在人体内的药动学参数进行研究。方法:霉酚酸血浆样品经甲醇沉淀后直接进样测定,其中色谱柱为Symmetry Shield C18,流动相为乙腈-水-三乙胺(40∶60∶0.3),流速为1.0mL·min-1,柱温为30℃,测定波长为218nm,进样量为20μL。结果:霉酚酸检测浓度在0.2~50mg·L-1范围内与峰面积积分值线性关系良好(r=0.9996),定量下限为0.2mg·L-1;平均方法回收率为101.94%,平均提取回收率为87.06%;日内、日间RSD均<6%。另,人体药动学研究表明,霉酚酸在体内存在肠肝循环导致双峰出现,人体过程符合单室开放模型。结论:本方法简便、灵敏、专一、准确、精密,可用于霉酚酸的药动学研究。
Objective: To establish a method for the determination of mycophenolic acid in human plasma by high performance liquid chromatography (HPLC) and to study its pharmacokinetic parameters in human. Methods: Mycophenolate mofetil plasma samples were directly injected into methanol solution. The chromatographic column was Symmetry Shield C18, the mobile phase was acetonitrile-water-triethylamine (40:60:0.3) and the flow rate was 1.0 mL · min -1 , The column temperature was 30 ℃, the determination wavelength was 218nm, the injection volume was 20μL. Results: The calibration curve of mycophenolic acid showed a good linearity (r = 0.9996) in the range of 0.2-50 mg · L-1 and the lower limit of quantification was 0.2 mg · L-1. The average recovery was 101.94% The extraction recovery rate was 87.06%. The daily RSD and intraday RSD were both <6%. In addition, human pharmacokinetic studies have shown that mycophenolic acid in the body there enterohepatic circulation leading to bimodal human body processes consistent with single-compartment open model. Conclusion: The method is simple, sensitive, specific, accurate and precise and can be applied to the pharmacokinetics of mycophenolic acid.