摘要
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 analysis method of mycophenolic acid in human plasma and to establish the standard procedure of therapeutic drug monitoring （TDM）.METHODS The concentration of mycophenolic acid in the human plasma was determined by the high-performance liquid chromatography （HPLC）.The internal standardization with correction factor and the standard curve method were compared.The date of drug concentration in patients were analyzed and the distribution in patients of steady state was observed.RESULTS High-performance liquid chromatography analysis technique was accurate and reliable.The internal standardization with correction factor showed no difference from the standard curve method,the concentration of mycophenolic acid in human was influenced by the combination therapy and significant variability was obtained among patients.CONCLUSION This standard procedure includs the fast and accurate analysis method and quality control method.The effective concentration of therapeutic drug monitoring （TDM） is still discussed.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2010年第9期690-694,共5页
Chinese Pharmaceutical Journal
关键词
吗替麦考酚酸
治疗药物监测
质量控制
mycophenolic acid
therapeutic drug monitoring （TDM）
Quality control （QC）
