煅烧骨的安全性

背景：经高温处理的煅烧骨具有类似自然骨的连续微孔结构,良好的生物相容性和降解性. 目的：观察牛煅烧骨的生物相容性、细胞相容性及毒性. 方法：①细胞相容性实验：将牛煅烧骨与第3代已诱导的Wistar大鼠骨髓间充质干细胞复合培养.②溶血实验：将煅烧骨浸提液、生理盐水与双蒸水加入兔血中.③凝血实验：将煅烧骨加入兔血浆中.④急性毒性实验：在昆明种小鼠尾静脉分别注射煅烧骨浸提液、生理盐水.⑤微核实验：在小鼠腹腔分别注射煅烧骨浸提液、生理盐水与环磷酰胺.⑥局部刺激性实验：将煅烧骨浸提液、生理盐水分别注射于兔两侧脊柱皮下.⑦热源检测实验：在兔耳静脉注射煅烧骨浸提液.⑧皮下植入实验：将煅烧骨材料植入Wistar大鼠背部皮下. 结果与结论：煅烧骨材料无细胞毒性,具有良好的细胞及血液相容性;对皮肤、肌肉无刺激作用;对心、肝、肾重要器官无毒性作用;皮下植入后对周围组织无刺激作用,能够部分降解吸收并被机体组织替代;无致热作用,对凝血功能无影响,对小鼠骨髓细胞无抑制及毒性作用.

Safety of true bone ceramics

BACKGROUND：True bone ceramic treated with high temperature has continuous microporous structure, good biological compatibility and degradation, which are analogous to nature bone. OBJECTIVE：To observe the biocompatibility, cel ular compatibility and acute toxicity of implanted composite made from periosteal-derived osteoblasts and sintered bovine bone （true bone ceramics）. METHODS：Experiment of cel ular compatibility：bovine true bone ceramics were compound cultured with induced passage 3 bone marrow mesenchymal stem cel s of Wistar rats. Hemolysis test：the true bone ceramic water extract, normal saline and double-distil ed water were added into rabbit blood. Blood coagulation test：the true bone ceramics were added into rabbit blood plasma. Systemic acute toxicity test：true bone ceramic water extract and normal saline were injected into the Kunming mice via the tail vein respectively. Micronucleus test：true bone ceramic water extract, normal saline and cyclophosphamide were given into the mice through intraperitoneal injection respectively. Local irritation reaction：true bone ceramic water extract and normal saline were injected at the two sides of the spine respectively. Pyrogen test：true bone ceramic water extract was injected via the ear vein. The subcutaneous implantation test：the true bone ceramic materials were implanted dorsal subcutaneously. RESULTS AND CONCLUSION：True bone ceramics had no cel toxicity, but had good cel ular and blood compatibility;had no stimulation to muscle and skin;had no toxicity on heart, liver and kidney;had no stimulation to the surrounding tissues after subcutaneous implantation, and part of the materials were degraded and replaced by newly developed fibrous tissue;had no pyrogenic action and had no influence on coagulation;had no inhibition and toxic effect on bone marrow cel s.