Physicochemical property and safety of nanometer human demineralized bone matrix composite / 中国组织工程研究

ABSTRACT

BACKGROUND: Demineralized bone matrix and bone morphogenetic protein have been shown to have good bone induction, but less studies concerned nanometer demineralized bone matrix. Its physical and chemical properties and biological security are not yet clear. OBJECTIVE:On the basis of preparing the nanometer human demineralized bone matrix in previous experiment, we mixed the recombinant human bone morphogenetic protein-2 together to obtain the new bone graft substitute and to research its physical and chemical properties and biological security. METHODS:The human demineralized bone matrixes were prepared by the method of modified Urist and nano-processed then mixed with the bone morphogenetic protein-2 in specific proportions in order to be lyophilized to complete the fol owing experiments. (1) Pyrogen experimentthe material extracts were injected in the rabbits by ear intravenous. (2) Toxicity experimentsmaterial extracts and saline were separately injected via the tail vein of mice in vivo. (3) Implantation experimentsexperimental materials andβ-tricalcium phosphate were implanted into rabbits on both sides of the hindlimb muscle. RESULTS AND CONCLUSION:After lyophilized shaping, the nanometer demineralized bone matrix material had dense surface and it’s pore diameter was 100-400μm. The pore distribution was less uniform and the porosity was of less than 30%. The main elements were carbon, oxygen and nitrogen. Nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 did not have pyrogen effect and the rabbits’ body temperature had no significant fluctuations after injection. The acute systemic toxicity test results showed that the nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 complied with the relevant provisions of the State, without obvious toxic reaction. The inflammatory response of nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 was significantly lighter than the reaction ofβ-tricalcium phosphate. The results showed that the nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 is a nanometer al ogeneic bone graft substitutes with nontoxicity, good biocompatibility, high bioavailability, and less inflammatory reaction.