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目的探讨鹿茸多肽-胶原蛋白/壳聚糖复合材料的生物安全性及对骨折愈合的治疗作用,为临床应用提供理论依据。方法胶原蛋白和壳聚糖充分混匀,0.25%戊二醛交联制备含鹿茸多肽(1.0 mg/L)的复合材料。通过扫描电镜观察复合材料的空间结构,溶血实验、急性毒性实验和体内植入实验评价材料的生物安全性和组织相容性。建立家兔下颌骨缺损骨折模型,评价其对骨折愈合的治疗作用。结果戊二醛交联的复合材料呈规则的层状皱褶结构,主要以片状结构为主。材料浸提液无溶血现象,未引起小鼠急性毒性反应,体内植入炎症反应轻微。组织学观察结果显示,同对组相比复合材料能够促进新骨生成,并加速骨折愈合。结论鹿茸多肽-胶原蛋白/壳聚糖复合材料具备良好的生物安全性,并对骨折愈合具有很好的治疗效果,有望成为修复骨缺损、促进骨折愈合的新型材料。
Objective To investigate the biosafety of pilose antler peptide-collagen / chitosan composite and its therapeutic effect on fracture healing, so as to provide a theoretical basis for clinical application. Methods Collagen and chitosan were mixed thoroughly and crosslinked with 0.25% glutaraldehyde to prepare a composite material containing antler polypeptide (1.0 mg / L). The scanning electron microscope (SEM) was used to observe the spatial structure, hemolysis test, acute toxicity test and in vivo implantation test to evaluate the biosafety and histocompatibility of the composites. Rabbit mandibular defect fracture model was established to evaluate its therapeutic effect on fracture healing. Results The glutaraldehyde cross-linked composites showed a regular layered folds structure, which was dominated by lamellar structures. Material leaching solution without hemolysis, did not cause acute toxicity in mice, implanted in vivo inflammatory response to minor. Histological observations showed that composites promoted new bone formation and accelerated fracture healing compared with the control group. Conclusion The antler polypeptide - collagen / chitosan composite has good biosafety and good therapeutic effect on fracture healing. It is expected to become a new material for repairing bone defects and promoting fracture healing.