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目的研究吗替麦考酚酸血药浓度分析方法和肾移植患者药品暴露,初步形成其治疗药物监测的标准规程。方法采用高效液相色谱分析技术测定人血浆中吗替麦考酚酸浓度,比较内标法加校正因子与标准曲线法的差异,对临床患者血药浓度进行数据分析,参考医学检验正常参考值的制定方法,摸索临床稳定期患者血药浓度的分布规律。结果高效液相色谱分析技术准确可靠,内标法加校正因子计算监测浓度与传统标准曲线法计算没有差异,吗替麦考酚酸的血药浓度受合并用药影响,个体差异大。结论此标准规程包含快速准确的分析方法,相应的质量保证策略,血药浓度的有效浓度范围还需进一步的研究确定。
Objective To study the method of mycophenolate mofetil concentration analysis and drug exposure in renal transplant patients, and initially form the standard procedure for the monitoring of therapeutic drugs. Methods The plasma concentration of mycophenolate mofetil in human plasma was determined by high performance liquid chromatography (HPLC). The differences of the internal standard method with the calibration factor and the standard curve method were compared. The data of plasma concentrations in clinical patients were analyzed. The reference values The development of methods to explore the clinical stability of patients with plasma concentration distribution. Results HPLC was accurate and reliable. There was no difference between the standard concentration method and the internal standard method with the correction factor. The plasma concentration of mycophenolate mofetil was affected by the combination therapy, and the individual differences were large. Conclusion This standard procedure contains fast and accurate analysis methods. Corresponding quality assurance strategies and effective concentration range of plasma concentration need to be further studied and determined.