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, cellular compatibility and acute toxicity of implanted composite made from periosteal-derived osteoblasts and sintered bovine bone (true bone ceramics). METHODS:Experiment of cellular compatibility: bovine true bone ceramics were compound cultured with induced passage 3 bone marrow mesenchymal stem cells of Wistar rats. Hemolysis test: the true bone ceramic water extract, normal saline and double-distilled 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 cell toxicity, but had good cellular 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 cells.