UPLC测定人血白蛋白多聚体含量方法的实验室间比对与适用性论证

王敏力, 侯书婷, 宋兰坤, 何永兵, 马力, 付龙, 邵泓, 韩治国, 侯继锋

中国药学杂志 ›› 2019, Vol. 54 ›› Issue (20) : 1685-1691.

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中国药学杂志 ›› 2019, Vol. 54 ›› Issue (20) : 1685-1691. DOI: 10.11669/cpj.2019.20.010
论著

UPLC测定人血白蛋白多聚体含量方法的实验室间比对与适用性论证

  • 王敏力1, 侯书婷2, 宋兰坤3, 何永兵4, 马力5, 付龙6, 邵泓7, 韩治国3, 侯继锋1*
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Inter-laboratory Comparison of UPLC Determination of Polymers in Human Albumin and Evaluation of the Method Applicability

  • WANG Min-li1, HOU Shu-ting2, SONG Lan-kun3, HE Yong-bing4, MA Li5, FU Long6, SHAO Hong7, HAN Zhi-guo3, HOU Ji-feng1*
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摘要

目的 对UPLC测定人血白蛋白多聚体含量的方法进行实验室间比对和适用性论证。方法 向6家实验室发放来自国内外生产企业的人血白蛋白样品20份、人血白蛋白国家参考品合计21份样品,采用UPLC测定多聚体含量并用HPLC方法平行测定,开展实验室间比对和UPLC方法的适用性论证。结果 4家同时具备HPLC和UPLC条件的实验室平行比对显示,UPLC方法与现有药典HPLC方法实验室内结果比较无显著性差异(P>0.05)。6家实验室UPLC测定21份样品结果均值与4家实验室HPLC方法测定结果均值配对t检验(P>0.05),UPLC方法实验室间无显著性差异。6家协作实验室间UPLC法对21份样本平行测定结果标准差SD的均值仅为0.06,相对标准偏差RSD的均值仅为1.04%;而HPLC方法对21份样本平行测定标准差SD的均值为0.14,相对标准偏差RSD的均值为2.33%,提示UPLC方法测定结果的实验室间差异更小。结论 UPLC测定人血白蛋白多聚体与现有HPLC方法实验室间比对结果一致性高,但UPLC方法更为快速高效,测定结果的实验室间差异性更小,显著优于现有HPLC方法。

Abstract

OBJECTIVE To conduct an inter-laboratory comparison of UPLC method for polymer determination in human serum albumin and verify the method applicability. METHODS National reference of human serum albumin and 20 samples of human serum albumin from domestic and foreign manufactures were distributed to six laboratories in order to carry out inter-laboratory comparison and demonstration of applicability. UPLC was used to determine the content of polymer and HPLC method was used for parallel comparison. RESULTS There was no significant difference in the determination results between the UPLC method and current HPLC method in four laboratories (P>0.05) equipped with both HPLC and UPLC. The mean values of 21 samples measured with UPLC method by six laboratories were matched with those measured with HPLC method by four laboratories (t test P>0.05). The mean values of standard deviation (SD) and relative standard deviation (RSD) for 21 samples by UPLC method were only 0.06 and 1.02% respectively. The mean values of standard deviation (SD) and relative standard deviation (RSD) were 0.14 and 2.33% for parallel 21 samples determination by HPLC method, suggesting that the difference of UPLC test results between laboratories was smaller. CONCLUSION The results= of UPLC method are in good agreement with those of HPLC method. UPLC method is more effective and efficient, with smaller inter-laboratory difference, thus is significantly better than the HPLC method.

关键词

超高效液相色谱法 / 人血白蛋白 / 多聚体含量 / 分子排阻色谱 / 血液制品 / 实验室间比对

Key words

ultra performance liquid chromatography / human serum albumin / polymers / size-exclusion chromatography / blood products / laboratory comparison

引用本文

导出引用
王敏力, 侯书婷, 宋兰坤, 何永兵, 马力, 付龙, 邵泓, 韩治国, 侯继锋. UPLC测定人血白蛋白多聚体含量方法的实验室间比对与适用性论证[J]. 中国药学杂志, 2019, 54(20): 1685-1691 https://doi.org/10.11669/cpj.2019.20.010
WANG Min-li, HOU Shu-ting, SONG Lan-kun, HE Yong-bing, MA Li, FU Long, SHAO Hong, HAN Zhi-guo, HOU Ji-feng. Inter-laboratory Comparison of UPLC Determination of Polymers in Human Albumin and Evaluation of the Method Applicability[J]. Chinese Pharmaceutical Journal, 2019, 54(20): 1685-1691 https://doi.org/10.11669/cpj.2019.20.010
中图分类号: R917   

参考文献

[1] WANG M L, YANG P Y, XU M, et al. Establishment of a method for molecular-size distribution of human serum albumin by ultra performance liquid chromatography [J]. Chin Pharm J(中国药学杂志), 2018, 53(13):1110-1116.
[2] WANG M L, XIAO L, ZHOU Q, et al. Preparation of the first chinese national standard for human albumin [J]. Chin Pharm J(中国药学杂志), 2017, 52(6):480-487.
[3] Ch.P(2015) Vol Ⅲ(中国药典2015年版.三部)[S]. 2015: general rule 61.
[4] EP 9.0. Human albumin solution [S]. 2660-2662.
[5] USP 39. Albumin human [S]. 2352-2353.

基金

重大新药创制课题——创新生物技术药评价及标准化关键技术研究项目资助(2018ZX09101001);重组人血白蛋白生产工艺、质量控制和临床研究(重组人血白蛋白质量控制关键技术和标准研究)项目资助(2018ZX09301004)
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