(1. 中南大學 醫(yī)用材料與器械研究中心，長沙 410013；2. 中南大學 湘雅三醫(yī)院，長沙 410013；3. 中南大學 生物科學與技術學院，長沙 410013；4. 中南大學 粉末冶金國家重點實驗室，長沙 410083)
摘 要: 采用化學合成法制備用于基因治療的易修飾的氨基化硅納米顆粒和熒光氨基化硅納米顆粒。用透射電鏡和Zeta電位儀對納米顆粒進行分析，并參照ISO7406技術報告中的相關標準，對納米顆粒的生物相容性進行一系列體內及體外實驗，包括細胞毒性實驗、動物急性毒性實驗、動物生殖毒性實驗。結果表明：新研制的氨基化硅納米顆粒的粒徑為40 nm左右；在中性條件下，氨基化硅納米顆粒的表面凈正電荷約為16 mV；納米顆粒對細胞生長無明顯影響，對實驗動物無生長和生殖毒性，與對照組相比無顯著性差異。
關鍵字: 氧化硅；納米顆粒；基因治療；非病毒載體；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
