纳米羟基磷灰石/羧甲基壳聚糖-海藻酸钠复合骨水泥的生物相容性与体内降解研究

Research on Biocompatibility and In Vivo Degradation of Nono-hydroxyapatite /Carboxymethychitosan-Sodium Alginate Bone Cement Composite Material

对制备的纳米羟基磷灰石/羧甲基壳聚糖-海藻酸钠复合骨水泥的生物相容性及体内降解情况进行研究,为临床提供实验依据。参照GB/T16886医疗器械生物学评价标准和要求,对纳米羟基磷灰石/羧甲基壳聚糖-海藻酸钠复合骨水泥进行急性细胞毒性试验、溶血试验、热源试验、急性全身毒性试验及体内植入试验等系列体内外生物学试验研究,以进行有效的生物相容性和安全性评价。纳米羟基磷灰石/羧甲基壳聚糖-海藻酸钠复合骨水泥的溶血率小于国家规定的5%,在体外不引起溶血反应;浸提液注入动物体内后无死亡,活动进食正常;无细胞毒性反应;热原试验动物体温升高均在0.7℃以下,3只兔体温升高值的总数<1.5℃,无致热作用;材料植入体内初期有轻度炎症反应,随植入时间延长逐渐减轻,材料也逐渐降解吸收。纳米羟基磷灰石/羧甲基壳聚糖-海藻酸钠复合骨水泥具有良好的生物相容性和降解性能,具有临床开发应用前景。

To evaluate the biocompatibility and in vivo degradation of Nano hydroxyapatite /Carboxymethychitosan-sodium alginate bone cement composite material and provide some date for the clinical application.According to the standard for the biological evaluation of the material devices（GB/T16886）,several tests including hemolysis test,pyrogen test,acute systemic toxicity test,acute cellular toxicity test,in vivo degradable test were performed to evaluate biocompatibility and safety of the material.The material had no hemolytic reaction,no acute systemic toxicity,no acute cellular toxicity,and no pyrogen reaction.The results demonstrated that the implanted material had only a mild inflammatory reaction during the early days,which subsided gradually;meanwhile the implanted material were degraded gradually.The nanohydroxyapatite/Carboxymethychitosan-sodium alginate bone cement composite material has good biocompatibility and great biological safety though the surgical application still re quires a future clinical research.