US FDA, Center for Drug Evaluation & Research, Office of Testing & Research, Division of Drug Safety Research, Building 64 Room 2086 HFD 910, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Nanomedicine (Lond). 2012 Feb;7(2):199-209. doi: 10.2217/nnm.11.125.
The ability of nanoparticles to form larger superstructures of aggregates and agglomerates has been extensively noted in the literature. The in vivo biological impact of these structures, however, has not been assessed. This knowledge gap is especially critical in the safety assessment of nanoparticles to be used for therapeutic purposes.
METHOD/RESULTS: Here we show that when administered intravenously into a mouse model, gold nanoparticle superstructures of reversible agglomerates and irreversible aggregates demonstrate significant differences in organ and cellular distribution compared with the primary particle building blocks. In addition, different structures produced different blood serum chemistry data.
These findings raise the possibility for different mechanisms of toxicity between the structures. Such a possibility necessitates complete characterization and stability assessment of nanomaterials prior to their in vivo administration.
文献中广泛指出，纳米颗粒能够形成更大的聚集物和聚集体的超结构。然而，这些结构的体内生物学影响尚未得到评估。在用于治疗目的的纳米颗粒的安全性评估中，这一知识空白尤为关键。
方法/结果：在这里，我们表明，当静脉内给药于小鼠模型时，金纳米颗粒超结构的可逆聚集体和不可逆聚集体与初级颗粒构建块相比，在器官和细胞分布上表现出显著差异。此外，不同的结构产生了不同的血清化学数据。
这些发现提示不同结构之间可能存在不同的毒性机制。这种可能性需要在纳米材料体内给药之前对其进行完全的特性描述和稳定性评估。
