(1. 中南大学 医用材料与器械研究中心，长沙 410013；2. 中南大学 湘雅三医院，长沙 410013；3. 中南大学 生物科学与技术学院，长沙 410013；4. 中南大学 粉末冶金国家重点实验室，长沙 410083)
摘 要: 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。
关键字: 氧化硅；纳米颗粒；基因治疗；非病毒载体；生物安全性
（1. Research Center for Medical Material and Instruments, Central South University, Changsha 410013, China;2. The Third Xiangya Hospital, Central South University, Changsha 410013, China;3. School of Biological Science and Technology, Central South University, Changsha 410013, China;4. State Key Laboratory of Powder Metallurgy, Central South University, Changsha 410083, China）
Abstract: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 of pH 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.
Key words: silica; nanoparticles; gene therapy; non-viral carrier; biological safety
