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作 者:赵曼曼 侯田田 耿兴超[1] 周晓冰[1] Zhao Manman;Hou Tiantian;Geng Xingchao;Zhou Xiaobing(National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing 100176,China)
机构地区:[1]中国食品药品检定研究院国家药物安全评价监测中心药物非临床安全评价研究北京市重点实验室,北京100176
出 处:《中国药事》2020年第10期1180-1185,共6页Chinese Pharmaceutical Affairs
基 金:国家“重大新药创制”科技重大专项(编号2018ZX09201017-001)。
摘 要:纳米材料是物质结构在三维空间中至少有一维处于纳米尺度的新型材料,具有比表面效应、小尺寸效应、宏观量子隧道效应等独特的性质,在生物医药领域应用广泛。随着纳米技术的飞速发展,纳米材料的生殖发育毒性问题受到越来越多的关注。金属纳米材料可引起大鼠生殖器官结构改变、功能受损,还可进入胎儿体内直接影响或通过干扰胎盘的生长发育间接影响胎儿发育。而纳米载体药物相比于普通药物,生物分布特征的改变可能使其生殖器官及胚胎毒性减弱。随着动物福利3R原则的推行,国内外已建立多种体外替代方法用于生殖发育毒性评价,其中,胚胎干细胞试验(EST)、全胚胎培养技术(WEC)、斑马鱼模型、线虫在纳米材料生殖发育毒性评估中有良好的适用性。Nanomaterials are new materials with at least one dimension of the material structure out of the three-dimensional space belonging to the nanoscale.They manifest unique properties such as surface effect,small size effect and macroscopic quantum tunneling effect,and they have been widely used in the biological fields.With the rapid development of nanotechnology,more and more attention has been paid to the reproductive and developmental toxicity of nanomaterials.Metal nanomaterials may cause structural changes and functional impairment of reproductive organs in rats,and they can also directly affect fetal development by entering the fetus or indirectly affecting placenta functions.The toxicity of reproductive organs or embryos of nanomedicines may reduce because of the altered biological distribution compared with ordinary medicines.A variety of alternative test systems for reproductive toxicity evaluation have been established with the implementation of the 3 R principle of animal welfare,among which embryonic stem cell test(EST),whole embryo culture(WEC),zebrafish model and caenorhabditis elegans showed good applicability in the evaluation of nanomaterials.
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