高效液相色谱法测定血清碘海醇浓度方法的建立和应用  

Determination of iohexol concentration in serum and its clinical application by HPLC in children

作　　者：王宝宝[1] 武元[1] 付强[2] 弓孟春[1] 石希敏[3] 景红丽[3] 李方[3] 陈朝英[4] 宋红梅[5] 秦岩[1] 李雪梅[1] 

机构地区：[1]中国医学科学院北京协和医院肾内科,北京100730 [2]中国医学科学院北京协和医院药剂科,北京100730 [3]中国医学科学院北京协和医院核医学科,北京100730 [4]首都儿科研究所附属儿童医院肾内科,北京100020 [5]中国医学科学院北京协和医院儿科,北京100730

出　　处：《基础医学与临床》2015年第7期963-967,共5页Basic and Clinical Medicine

基　　金：国家自然科学基金(81100545);北京市科学技术委员会项目(D131100004713007;D09050704310901)

摘　　要：目的 建立利用高效液相色谱法（HPLC）测定血清碘海醇浓度的方法,为碘海醇血浆清除率临床应用及推广提供方法学支持.方法 设定色谱条件,对HPLC测定血清碘海醇浓度的方法进行方法学验证.对33例慢性肾脏病（CKD）儿童同时进行碘海醇清除率与99mTc-DTPA血浆清除率测定,并采用最新Schwartz公式估算肾小球滤过率（eGFR）.以99mTc-DTPA血浆清除率为参照,分析碘海醇清除率及eGFR与参照方法的相关性和一致性.结果 在设定HPLC色谱条件下,碘海醇浓度在10～1 000 mg/L范围内线性良好（R2 =0.9998）.批间测量和批内测量相对标准偏差（RSD％）＜5％,平均回收率（R％）＞96％.碘海醇血浆清除率、eGFR与99mTc-DTPA血浆清除率的相关系数（r）分别为0.95和0.63,偏差分别为（6.24±10.81）mL/（min·1.73 m2）和（12.11±22.96） mL/（min·1.73 m2）.结论 建立了测定血清碘海醇浓度的HPLC法;初步探索并验证了碘海醇血浆清除率评价儿童肾功能的准确、可行.Objective To establish a method for the quantification of iohexol in serum by high performance liquid chromatography （HPLC） and to evaluate its application for iohexol plasma clearance in children.Methods Set up the chromatographic conditions of HPLC and validate the linearity of standard curve,precision,trueness,stability of samples and drug interference.Thirty-three chronic kidney disease （CKD） children were included and examined by 99mTc-DTPA plasma clearance and iohexol plasma clearance and evaluated by the updated Schwartz formula （eGFR）.Using 99mTc-DTPA plasma clearance as reference,to compare the agreement and accuracy of the GFR-Iohexol or eGFR with GFR-99mTc-DTPA.Results The method for determination of the serum iohexol concentration was established by HPLC.The standard curve showed a good linearity （R2 =0.9998）.The relative standard deviation RSD％ of intra-assay and inter-assay were lower than 5％ and the recovery rate was more than 96％.Iohexol plasma clearance showed better agreement and accuracy with 99mTc-DTPA plasma clearance than eGFR.Conclusions A stable method for measurement of serum iohexol concentration by HPLC has been established.Iohexol plasma clearance in children for GFR determination is accurate and feasible.

关 键 词：高压液相色谱(HPLC) 碘海醇 含量测定 儿童 

分 类 号：R969[医药卫生—药理学]