FUNCTION AND SAFETY EVALUATION OF 3D TECHNOLOGY TO PREPARE BONE REPAIR BIOMATERIALS

Abstract

PLGA/HA composite biomaterials are prepared, and 3D printing technology is used to make bone scaffolds that can be implanted in the body. Its performance is tested by in vitro physical and biological methods, and its safety is evaluated by animal experiments. Methods: 3D printing technology was used to print the PLGA/HA composite three-dimensional stent biomaterial, and the tensile strength and bending strength of the stent material were tested with reference to GB/T1040 and GB/T9341 to verify its ability to support the proliferation and differentiation of hMSC. The biological evaluation standard (GB/T16886) evaluates the biocompatibility and biosafety of scaffoldmaterials in vitro and in vivo. Results: The porous 3D scaffold made of PLGA/HA composite material was successfully fabricated; the mechanical tensile strength and flexuralstrength of the composite material were 38 MPa and 42 MPa respectively, which were5.35 times and 5.25 times that of normal human cartilage; in vitro cell test It is proved that the 3D scaffold can support the proliferation and differentiation of hMSC into chondrocytes. The results of the biosafety test show that the scaffold meets the national medical device biological evaluation standards.