Because of the complexity of nanomedicines, analysis of their morphology and size has attracted considerable attention both from researchers and regulatory agencies. The atomic force microscope (AFM) has emerged as a powerful tool because it can provide detailed morphological characteristics of nanoparticles both in the air and in aqueous medium. However, to our knowledge, AFM methods for nanomedicines have yet to be standardized or be listed in any pharmacopeias. To assess the applicability of standardization of AFM, in this study, we aimed to identify robust conditions for assessing the morphology and size of nanoparticles based on a polystyrene nanoparticle certified reference material standard. The spring constant of the cantilever did not affect the size of the nanoparticles but needed to be optimized depending on the measurement conditions. The size analysis method of the obtained images affected the results of the analyzed size values. The results analyzed by cross-sectional line profiling were independent of the measurement conditions and gave similar results to those from dynamic light scattering. It was indicated that approximately 100 particles are required for a representative measurement. Under the optimized conditions, there were no significant inter-instrument differences in the analyzed size values of polystyrene nanoparticles both in air and under aqueous conditions.

由于纳米药物的复杂性，对其形态和大小的分析引起了研究人员和监管机构的极大关注。原子力显微镜（AFM）已成为一种强大的工具，因为它可以提供空气和水性介质中纳米颗粒的详细形态特征。然而，据我们所知，用于纳米药物的AFM方法尚未标准化，也未在任何药典中列出。为了评估AFM标准化的适用性，在本研究中，我们旨在基于聚苯乙烯纳米粒子认证的参考材料标准，确定用于评估纳米粒子的形态和尺寸的可靠条件。悬臂的弹簧常数不影响纳米颗粒的尺寸，但是需要根据测量条件进行优化。所获得图像的尺寸分析方法影响了所分析尺寸值的结果。通过截面线轮廓分析的结果与测量条件无关，并且给出的结果与动态光散射的结果相似。结果表明，代表性测量需要大约100个颗粒。在优化的条件下，在空气中和在水性条件下，聚苯乙烯纳米颗粒的分析尺寸值之间均没有显着的仪器间差异。结果表明，代表性测量需要大约100个颗粒。在优化的条件下，在空气中和在水性条件下，聚苯乙烯纳米颗粒的分析尺寸值之间均没有显着的仪器间差异。结果表明，代表性测量需要大约100个颗粒。在优化的条件下，在空气中和在水性条件下，聚苯乙烯纳米颗粒的分析尺寸值之间均没有显着的仪器间差异。