Laboratory of Molecular Imaging, Department of Radiology, Howard University, Washington, DC 20060, USA.
Department of Radiation Oncology, Howard University, Washington, DC 20060, USA.
Biotechnol Adv. 2014 Jul-Aug;32(4):711-26. doi: 10.1016/j.biotechadv.2013.11.006. Epub 2013 Nov 16.
Advances in nanotechnology have opened up a new era of diagnosis, prevention and treatment of diseases and traumatic injuries. Nanomaterials, including those with potential for clinical applications, possess novel physicochemical properties that have an impact on their physiological interactions, from the molecular level to the systemic level. There is a lack of standardized methodologies or regulatory protocols for detection or characterization of nanomaterials. This review summarizes the techniques that are commonly used to study the size, shape, surface properties, composition, purity and stability of nanomaterials, along with their advantages and disadvantages. At present there are no FDA guidelines that have been developed specifically for nanomaterial based formulations for diagnostic or therapeutic use. There is an urgent need for standardized protocols and procedures for the characterization of nanoparticles, especially those that are intended for use as theranostics.
纳米技术的进步开创了疾病和创伤诊断、预防和治疗的新时代。纳米材料，包括具有临床应用潜力的那些，具有影响其生理相互作用的新颖物理化学性质，从分子水平到系统水平。目前缺乏用于检测或表征纳米材料的标准化方法或监管协议。本综述总结了常用的研究纳米材料的大小、形状、表面性质、组成、纯度和稳定性的技术，以及它们的优缺点。目前，FDA 尚未专门针对用于诊断或治疗用途的基于纳米材料的制剂制定指南。需要制定标准化的协议和程序来表征纳米颗粒，特别是那些用作治疗诊断的纳米颗粒。
