多孔纳米钙磷陶瓷支架材料生物相容性评价

Biocompatibility of porous calcium phosphate ceramic nanocomposite

目的评价多孔纳米钙磷陶瓷支架材料的生物相容性。方法将多孔纳米磷酸钙陶瓷材料制成浸提液、混悬液、5 mm×5 mm×1 mm块状等体系,选择健康新西兰兔、昆明小鼠、SD大鼠为宿主,采用溶血试验、凝血试验、急性毒性试验、热原试验、肌内降解来对其生物相容性进行评价。结果材料对新鲜兔血的溶血度为1.1%,小于5%,在允许范围内;血浆中凝血酶原时间、部分凝血活酶凝固时间、凝血酶凝固时间、纤维蛋白原4项指标结果无异常;热原试验显示实验组体温升高分别为0.35、0.40、0.28℃,均小于0.60℃,符合生物医学材料无热原的评价标准;急性毒性试验后小鼠无死亡,未观察到步态不稳、惊厥、瘫痪、呼吸困难等不良反应;肌内埋植后观察见新生纤维组织形成。结论该陶瓷材料是一种安全无毒、无溶血性、对皮肤和肌肉无刺激作用、不含热原物质的组织工程支架材料,其生物相容性良好,具有比普通钙磷陶瓷支架材料更好的降解性能。

Objective To study the biocompatibility of porous calcium phosphate ceramics nanocomposite.Methods The biocompatibility was evaluated via experiments including the hemolysis test,hemopexis test,acute systemic toxicity test,pyrogen test,and intramuscular implant test,in which biphasic calcium phosphate nanocomposite（NanoBCP） presented as leaching solution,suspension or blocks of 5 mm×5 mm×1 mm.Animals including New Zealand Rabbits,Kun-ming mice,SD rats were selected as the host.Results The hemolysis of NanoBCP was 1.1%（5%）.Four coagula-tion index levels were within the normal range.In pyrogen test,the temperature of each experimental rat increased by 0.35,0.40,0.28 ℃（0.60 ℃,in accordance with the pyrogen-free criterion for biomedical materials）.No consequent death,dyspnoea,organ dysfunction,severe peritoneal irritation or ptosis was observed in acute systemic toxic test.Newly-formed fibrous tissue could be found after the implantation.Conclusion The material possesses outstanding biocompatibility and degradability with no toxicity or irritation,contains no pyrogen,as well as better degradation properties than biphasic calcium phosphate.