发展用于定量赋形剂疫苗制剂中磷酸铝的 Al 和 P NMR 光谱法。
Al and P NMR spectroscopy method development to quantify aluminum phosphate in adjuvanted vaccine formulations.
机构信息
Departments of Biology and Chemistry, York University, 4700 Keele Street, Toronto, Ontario, Canada.
York University, 4700 Keele Street, Toronto, Ontario, Canada.
出版信息
J Pharm Biomed Anal. 2018 Sep 10;159:166-172. doi: 10.1016/j.jpba.2018.06.025. Epub 2018 Jun 21.
A novel qNMR method is described for the quantitative determination of total aluminum and phosphate in aluminum phosphate (AlPO) adjuvanted vaccine samples using solution Al and P nuclear magnetic resonance (NMR) spectroscopy. External standard calibrations of AlPO solutions established excellent linearity in the range of 15-40 × 10 M and additional studies determined the level of detection for both nuclei. A commercialized combination vaccine product (Quadracel®), along with several individual adsorbed antigen components used in the vaccine were employed as model systems for method development. The developed method is also capable of quantitating the free phosphate (i.e. the fraction not bound to AlPO particles) in adjuvanted vaccines. This study is the first demonstration of a solution NMR method that is suitable for measuring total aluminum, and free and total phosphate concentrations in vaccine formulations consisting of antigen(s) adsorbed to aluminum adjuvant, in a single analytical workflow.
一种新型 qNMR 方法被描述用于定量测定含铝磷酸铝（AlPO）佐剂疫苗样品中的总铝和磷酸盐，该方法使用溶液 Al 和 P 核磁共振（NMR）光谱法。AlPO 溶液的外部标准校准在 15-40×10M 范围内建立了极好的线性关系，此外的研究还确定了两种核的检测水平。商品化的联合疫苗产品（Quadracel®）以及疫苗中使用的几种单独吸附的抗原成分被用作方法开发的模型系统。所开发的方法也能够定量测定佐剂疫苗中的游离磷酸盐（即未与 AlPO 颗粒结合的部分）。这项研究首次证明了一种溶液 NMR 方法，该方法适用于在单个分析工作流程中测量由吸附在铝佐剂上的抗原组成的疫苗制剂中的总铝以及游离和总磷酸盐浓度。
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