Analysis of Heparin Samples by Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy in the Solid State.
Analysis of Heparin Samples by Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy in the Solid State.
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固态下采用衰减全反射傅里叶变换红外光谱法对肝素样品的分析
DOI：
10.1021/acscentsci.2c01176
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发表时间：
2023-03-22
影响因子：
18.2
通讯作者：
Skidmore, Mark A.
中科院分区：
文献类型：
--
作者：
Devlin, Anthony J.;Mycroft-West, Courtney J.;Turnbull, Jeremy E.;de Lima, Marcelo Andrade;Guerrini, Marco;Yates, Edwin A.;Skidmore, Mark A.
肝素是糖胺聚糖（GAG）类的多分散性、异质性多糖，已发现其作为强效抗凝剂在临床上广泛使用，并被世界卫生组织归类为基本药物。2008年，当现有的监管程序未能确定药用肝素与过硫酸软骨素（OSCS）的危及生命的掺假时，强调了对药用肝素进行严格监测和质量控制的重要性。随后的污染危机导致了对替代方法的探索，其中多维核磁共振（NMR）光谱技术和多变量分析的使用成为黄金标准。然而，这一程序在技术上要求很高，需要使用昂贵的设备。另一种方法，利用衰减全反射傅里叶变换红外光谱（ATR-FTIR）结合多元分析，已被开发。所述方法能够区分不同的GAG样品，对不同种属来源的样品进行分类，并检测已确定的肝素污染物和外来多糖。该方法的灵敏度可与NMR相媲美，可用于快速、经济有效地监测和分析药用肝素。因此，它适用于整个供应链的未来部署。ATR-FTIR光谱结合多变量分析，使肝素的识别，物种来源的鉴定，并检测污染物多糖。
Heparin is a polydisperse, heterogeneous polysaccharide of the glycosaminoglycan (GAG) class that has found widespread clinical use as a potent anticoagulant and is classified as an essential medicine by the World Health Organization. The importance of rigorous monitoring and quality control of pharmaceutical heparin was highlighted in 2008, when the existing regulatory procedures failed to identify a life-threatening adulteration of pharmaceutical heparin with oversulfated chondroitin sulfate (OSCS). The subsequent contamination crisis resulted in the exploration of alternative approaches for which the use of multidimensional nuclear magnetic resonance (NMR) spectroscopy techniques and multivariate analysis emerged as the gold standard. This procedure is, however, technically demanding and requires access to expensive equipment. An alternative approach, utilizing attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR) combined with multivariate analysis, has been developed. The method described enables the differentiation of diverse GAG samples, the classification of samples of distinct species provenance, and the detection of both established heparin contaminants and alien polysaccharides. This methodology has sensitivity comparable to that of NMR and can facilitate the rapid, cost-effective monitoring and analysis of pharmaceutical heparin. It is therefore suitable for future deployment throughout the supply chain. ATR-FTIR spectroscopy combined with multivariate analysis enables the facile recognition of heparins, the identification of species provenance, and the detection of contaminant polysaccharides.
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影响因子：
46.9
作者：
Guerrini, Marco;Beccati, Daniela;Sasisekharan, Ram
通讯作者：
Sasisekharan, Ram
影响因子：
3.1
作者：
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影响因子：
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影响因子：
3.1
作者：
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通讯作者：
Yates, E. A.
影响因子：
2.9
作者：
KVAM, C;GRANESE, D;PAOLETTI, S
通讯作者：
PAOLETTI, S