Center for Nanotechnology Innovation@NEST, Istituto Italiano di Tecnologia, Piazza San Silvestro 12, Pisa, Italy.
AsSIS, Associazione di Studi e Informazione sulla Salute, Via Firenze 8, Pisa, Italy.
J Pharm Sci. 2020 Jan;109(1):891-899. doi: 10.1016/j.xphs.2019.07.008. Epub 2019 Jul 23.
A new method for detecting and characterizing nanoparticles in an injectable pharmaceutical solution is presented. The method is based on the simultaneous use, on those nanoparticles that are crystalline, of three-dimensional electron diffraction tomography and energy dispersive X-ray spectrometry. With three-dimensional electron diffraction tomography, the unit cell and the crystal symmetry of the nanoparticles are determined, while with energy dispersive X-ray spectrometry, the chemical composition is derived. With these data, through an inspection of a crystallographic database, it is possible to determine the crystal phase of the nanoparticles. The knowledge of the crystal phase is a valuable element for understanding the provenance and the formation of the nanoparticles, helping the researcher in solving any quality control issue related to the presence of nanoparticles in an injectable solution.
介绍了一种用于检测和描述可注射药物溶液中纳米颗粒的新方法。该方法基于同时使用三维电子衍射断层扫描和能量色散 X 射线光谱对结晶纳米颗粒进行分析。三维电子衍射断层扫描可以确定纳米颗粒的晶胞和晶体对称性,而能量色散 X 射线光谱则可以得出纳米颗粒的化学成分。通过对晶体数据库的检查,利用这些数据可以确定纳米颗粒的晶体相。了解晶体相对于理解纳米颗粒的来源和形成非常有价值,有助于研究人员解决与可注射溶液中存在纳米颗粒有关的任何质量控制问题。