摘要
配制PLGA/HA复合生物材料,应用3D打印技术制造可移植入体内的骨支架,通过体外物理和生物学方法检测其性能,最后通过动物体内实验对其进行安全性评价。方法:使用3D打印技术打印PLGA/HA复合物立体支架生物材料,参照GB/T 1040和GB/T 9341检测支架材料的拉伸强度和弯曲强度,验证其支持h MSC的增殖及分化能力,并按照医疗器械生物学评价标准(GB/T16886)对支架材料进行体外和体内生物相容性及生物安全性评估。结果:成功制作了PLGA/HA复合材质的多孔3D支架材料;复合材料的机械拉伸强度和弯曲强度分别为38MPa和42MPa,是正常人软骨的5.35倍和5.25倍;体外细胞试验证明3D支架可支持h MSC增殖和分化为软骨细胞,生物安全性试验结果表明支架符合国家医疗器械生物学评价标准。
Scaffold was produced by using 3D printer, its functionality of supporting the differentiation of hMSC and in vivo safety was tested. Method： 3D PLGA/HA composite scaffold was printed with 3D printer, the mechanical strength of the 3D scaffold was tested according to the GB/T1040 and GB/T 9341. Its ability of supporting hMSC multiplication and differentiation was validated in vitro, finally the material was assessed of its in vlvo safety based on the GB/T 16886. Result： Porous PLGA/HA 3D scaffold was successful made, whose tensile-strength and bending strength is 38MPa and 42MPa, which is about 5.35 and 5.25 times more than that of human cartilage. The 3D material supports the Chondrogenic differentiation of hMSC. Biological safety experiment results proved that the 3D material accord with the standard of medical devices.
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2015年第7期55-61,共7页
China Biotechnology
基金
广东省教育部项目(2012B091100408)
深圳市科技创新委项目(JCYJ20140718171752670
CXZZ20120619162250509)资助项目
