新型可注射可降解磷酸钙骨水泥的生物相容性的实验研究

目的:研究新研制的一种可注射可降解磷酸钙骨水泥材料生物相容性,为材料的最终临床应用提供实验依据.方法:根据国际标准化组织(ISO)颁布的ISO10993系列标准和国内的国家医药管理局颁布的GB/T16886系列标准,对这种磷酸钙骨水泥材料进行体外溶血试验、细胞毒性试验、急性毒性试验、热原试验、微核试验、皮肤过敏性试验和体内肌内埋置试验.结果:该磷酸钙骨水泥材料原液对健康人血红细胞溶血率为1.82%,无溶血现象.对小鼠的体外L929细胞毒性分级为0级,无细胞毒性.材料原液未引起小鼠急性毒性反应、新西兰白兔热原反应、小鼠遗传毒性及豚鼠过敏反应.小鼠肌内埋置后植入部位无肌肉坏死,炎症反应轻,无纤维包裹.结论:新型可注射可降解磷酸钙骨水泥材料的生物相容性符合国际和国内规定的体内植入物的生物学评价标准,可适用于临床治疗相关疾病.

An Experimental Study on the Biocompatibility of a Novel Injectable and Degradable Calcium Phosphate Cement

Objective:To evaluate the biocompatibility of a novel injectable and degradable calcium phosphate cement to provide basic data for its clinical application.Methods: The in vitro hemolyzation,cytotoxicity,acute systemic toxicity,pyrogenicity,micronucleus and hypersensitivity tests,as well as intramuscular implantation test were performed on the novel injectable and degradable calcium phosphate cement according to the requirements given in Biological Standards for Implanted Biomaterials ISO10993 by International Organization for Standardization(ISO) and GB/T16886 by National Food and Drug Administration(NFDA).Results: The hemolysis rate of the cement-extracted liquid in human was 1.82%.The in vitro cytotoxicity index of the L929 cell was graded zero.The cement-extracted liquid induced no acute toxicity in mice,pyrogenic reaction in rabbits,genetic toxicity in mice or allergic reaction in guinea pigs.The intramuscular implantation in mice induced no muscular necrosis or fibrous capsule formation,except for slight inflammatory reaction.Conclusion: the biocompatibility of the novel injectable and degradable calcium phosphate cement met the requirements in above-mentioned two Standards,suggesting that it could be used for clinical trial.