用于基因治疗的硅纳米颗粒的制备及生物安全性评价

Preparation and biological savety evaluation of silicon nanoparticles for gene therapy

采用化学合成法制备用于基因治疗的易修饰的氨基化硅纳米颗粒和荧光氨基化硅纳米颗粒。用透射电镜和Zeta电位仪对纳米颗粒进行分析,并参照ISO7406技术报告中的相关标准,对纳米颗粒的生物相容性进行一系列体内及体外实验,包括细胞毒性实验、动物急性毒性实验、动物生殖毒性实验。结果表明:新研制的氨基化硅纳米颗粒的粒径为40 nm左右;在中性条件下,氨基化硅纳米颗粒的表面净正电荷约为16 mV;纳米颗粒对细胞生长无明显影响,对实验动物无生长和生殖毒性,与对照组相比无显著性差异。

Silica nanoparticles and fluorescence silica nanoparticles with amino group modified on their surface were prepared as gene carrier. The size and Zeta potential of nanoparticles were tested by electron microscopy and Zeta potential measurement. According to the relate methods and regulations of medical devices prescribed by the International Organization for Standardization（ISO）, to evaluate their biological compatibility, their cytotoxicity, general acute toxicity and reproductive toxicity assessment were performed. The results show that the newly developed silica nanoparticles are 40 nm in size by electron microscopy, and Zeta potential of its surface is 16 mV on the condition of neuter ofpH value. Toxicity testing in vitro and in vivo reveals that it has no significant influence for silica nanoparticles when they are cultured with normal cells and are injected into mice by tail-vein intravenous administration to observe if they affect experimental animal reproductivity.