文章摘要
许泽君,孙芳,景霞.高效液相色谱测定儿童体内霉酚酸血药浓度[J].安徽医药,2020,24(3):610-613.
高效液相色谱测定儿童体内霉酚酸血药浓度
Determination of mycophenolic acid in children’s plasma by high performance liquid chromatography
  
DOI:10.3969/j.issn.1009?6469.2020.03.048
中文关键词: 色谱法,高压液相  霉酚酸  内标法  血药浓度  儿童
英文关键词: Chromatography,high pressure liquid  Mycophenolic acid  Internal standard  Plasma concentration  Child
基金项目:
作者单位E-mail
许泽君 南京医科大学附属儿童医院药学部江苏南京 210008  
孙芳 南京医科大学附属儿童医院药学部江苏南京 210008  
景霞 南京医科大学附属儿童医院药学部江苏南京 210008 jing_xiaxia@163.com 
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中文摘要:
      目的建立儿童体内霉酚酸血药浓度高效液相色谱测定方法,为临床调整用药提供参考。方法内标(萘啶酸)法,血样先经甲醇沉淀,后经磷酸酸化,进样。色谱柱为 Agilent Eclipse Plus–C18(4.6 mm×50 mm,5 μm)色谱柱;流动相为 0.1%三乙胺溶液(磷酸调节 PH为 3.5±0.1)?乙腈= 60∶40;流速为 1.0 mL/min;柱温 25 oC;进样体积为 40 μL。按有限采样法模型,取南京医科大学附属儿童医院病儿清晨服药前( 0h),服药后 0.5 h和 2h3个时间点血样,从 2017年 11月至 2018年 4月 6个月内共检测 177例。结果霉酚酸在 0.20~50.00 μg/mL浓度范围内色谱峰面积与其相应的内标的峰面积比值呈良好线性关系(r=0.999 6);低中高三种浓度( 0.39,25.00,50.00 μg/mL)日内相对标准偏差( RSD)(n=5)为 2.00%~3.41%,日间 RSD(n=3)为 3.40% ~
英文摘要:
      Objective To establish a HPLC method for the determination of mycophenolic acid in plasma for children and providea reference for clinical adjustment of medication.Methods With internal standard(nalidixic acid)method,the plasma was pre? cipitated by methanol,then acidified by phosphoric acid and injected.The chromatographic column was Agilent Eclipse Plus–C18(4.6 mm×50 mm,5 μm).The mobile phase consisted of acetonitrile?water(contain 0.1% triethylamine pH=3.5±0.1)=40∶60,with a flow rate of 1.0 mL/min.Column temperature was 25 ℃;The volume of injection was 40 μL.With the limited sampling strategy, the blood samples were collected immediately before and 0.5,2h after the morning dose of mycophenolate mofetil in Children’s Hospital of Nanjing Medical University,and a total of 177 samples were detected in the six months from November 2017 to April 2018.Results The peak area of mycophenolic acid showed a good linear relationship with the corresponding peak area ratio of in?ternal markers in the range of 0.20~50.00 g/mL(r=0.999 6).The inter?run RSDs for the low,middle and high concentrations(0.39,25.00,50.00 μg/mL)were 2.00% to 3.41%(n=5)and intra?run RSDs were 3.40% to 4.38%(n=3)method recoveries were 97.44% to 104.80%.As calculated by the regression equation(AUC0?12 h=7.75+6.49×C0+0.76×C0.5+2.43×C2),,AUC of 63 cases was under 30 mg·L-1·h-1,accounting for 35.6%;AUC of 102 cases was between 30 and 60 mg·L-1·h-1,accounting for 57.6%;AUC of 12 cases was over 60 mg·L-1·h-1,accounting for 6.8%.Conclusion The method is specific,repeatable and accurate,and can be used for determination of mycophenolic acid in children’s plasma.
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