高效液相色谱法测定血清碘海醇浓度方法的建立和应用

基础医学与临床 ›› 2015, Vol. 35 ›› Issue (7): 963-967.

高效液相色谱法测定血清碘海醇浓度方法的建立和应用

王宝宝¹,武元¹,付强¹,弓孟春¹,石希敏¹,景红丽¹,李方²,陈朝英³,宋红梅⁴,秦岩⁵,李雪梅⁶

1. 北京协和医院
2. 中国医学科学院北京协和医院核医学科
3. 首都儿科研究所附属儿童医院
4. 中国医学科学院北京协和医学院北京协和医院
5. 中国医学科学院北京协和医学院北京协和医院
6. 中国医学科学院北京协和医学院北京协和医院肾内科

收稿日期:2014-12-29 修回日期:2015-03-23 出版日期:2015-07-05 发布日期:2015-06-23
通讯作者: 秦岩 E-mail:qinyan1974@126.com
基金资助:
CKD早期诊断路径与进展评估模型的建立与验证;优化、整合、推广适宜的CKD早期诊断方法;降低过度活跃的交感神经活性对慢性肾脏病的时间生物学作用

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

Received:2014-12-29 Revised:2015-03-23 Online:2015-07-05 Published:2015-06-23

摘要/Abstract

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10～1000mg/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?1.73m2) 和（12.11±22.96）ml/(min?1.73m2)。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。

关键词: 高压液相色谱（HPLC）, 碘海醇, 含量测定, 儿童

Abstract: 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, 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 with99mTc-DTPA plasma clearance than eGFR. Conclusion A stable method for the measurement of serum iohexol concentration by HPLC has been established. Iohexol plasma clearance in children for GFR determination was accurate and feasible.

Key words: High performance liquid chromatography (HPLC), Iohexol, Content determination, Children

中图分类号:

王宝宝武元付强弓孟春石希敏景红丽李方陈朝英宋红梅秦岩李雪梅. 高效液相色谱法测定血清碘海醇浓度方法的建立和应用[J]. 基础医学与临床, 2015, 35(7): 963-967.

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