多肽纯度测量方法及国际比对的进展

    Progress in Peptide Purity Measurement Methods and International Comparisons

    • 摘要: 多肽是氨基酸缩合产物,被广泛用于疾病诊断、预防与治疗、营养、美容与个护等诸多领域。多肽相关产业的迅速发展,对关于多肽测量的活动提出了计量溯源性要求,而多肽纯度测量是多肽测量活动实现量值溯源的重要技术基础。多肽纯度测量方法主要包括质量平衡法、氨基酸分析法、定量核磁法、元素分析法等四种方法。为实现多肽纯度测量结果的准确性、一致性、等效性,国际计量委员会物质的量咨询委员会蛋白质分析工作组制定了多肽纯度测量的国际比对计划,目前国际计量局已联合中国计量科学研究院、新加坡卫生科学局等计量机构组织了人C肽、缩宫素、糖化六肽的国际计量比对,显著提升了参加国际比对的各国计量实验室的多肽纯度测量能力。拟对多肽纯度测量方法的原理、不确定度评估、优缺点等进行详细概述,并介绍多肽纯度测量方法的国际比对情况,展望多肽纯度测量的发展趋势,旨在推动我国多肽计量的科学与技术研究。

       

      Abstract: Peptides, amino acid condensation products, have been widely used in various fields such as disease diagnosis, prevention and treatment, nutrition, cosmetics, and personal care. The rapid development of peptide-associated industries has put forward metrological traceability requirements for peptide measurement activities. Peptide purity measurement is an important technical foundation for achieving SI traceability in peptide measurement activities. The primary methods for measuring peptide purity include mass balance, amino acid analysis, quantitative nuclear magnetic resonance (qNMR), and elemental analysis. To achieve accuracy, consistency, and equivalence in peptide purity measurement results, the Protein Analysis Working Group (PAWG) of the Consultative Committee for Amount of Substance (CCQM) has planned a series of international comparisons on purity assessment for peptides. Currently, the International Bureau of Weights and Measures (BIPM), in cooperation with the National Institute of Metrology, China, and the Health Sciences Authority, Singapore, has organized international metrological comparisons on human C-peptide, oxytocin, and glycated hexapeptide, significantly improving the capabilities of participating laboratories from various countries. This review provides detailed principles, uncertainty evaluations, advantages, and disadvantages of peptide purity measurement methods and carefully introduces the international comparisons on peptide purity measurement. The development trends of peptide purity measurement are discussed, aiming to promote scientific and technological research on peptide metrology.

       

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