NMR 光谱分析评估胰岛素的质量：浓度、变异性和赋形剂含量。
NMR Spectroscopic Analysis to Evaluate the Quality of Insulin: Concentration, Variability, and Excipient Content.
机构信息
Swedish NMR Centre at the University of Gothenburg.
Queen Silvia Children's Hospital, Sahlgrenska University Hospital and Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.
出版信息
J Diabetes Sci Technol. 2020 Jan;14(1):180-184. doi: 10.1177/1932296819831995. Epub 2019 Feb 19.
Abstract
Known and consistent bioactivity between samples of insulin is essential to correctly estimate the dose. Insulin concentration is not the same thing as bioactivity, however, and methods to correctly determine both are required. Here we show that one dimensional nuclear magnetic resonance (1D NMR), in contrast to, for example, reverse phase high pressure liquid chromatography, can be used to determine both insulin concentration as well as confirm the structural integrity required for activity. In response to the report by Carter and Heinemann, we decided to investigate insulin intended for public use. Insulin from several manufacturers was investigated. Correct insulin concentrations were found in all tested samples although the general sample variability, which possibly could influence the bioactivity, varied depending on insulin type and manufacturer.
摘要
胰岛素样品之间的已知且一致的生物活性对于正确估计剂量至关重要。然而，胰岛素浓度与生物活性并不相同，因此需要正确确定两者的方法。在这里，我们表明，与例如反相高压液相色谱法相反，一维核磁共振（1D NMR）可用于确定胰岛素浓度以及确认活性所需的结构完整性。针对 Carter 和 Heinemann 的报告，我们决定研究供公众使用的胰岛素。研究了来自几家制造商的胰岛素。尽管一般的样品可变性（可能会影响生物活性）因胰岛素类型和制造商而异，但在所有测试的样品中都发现了正确的胰岛素浓度。
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