羟基磷灰石涂层与骨组织界面生物相容性与毒理学研究

Experimental Study on the Biocompatibility and Toxicology of Interface Between Hydroxyapatite coating and Bone

依据卫生部新近制定的《生物材料和制品的生物学评价标准》（简称《标准》）［１］，确定五项评价项目，按照标准的生物学试验方法，对目前临床应用的羟基磷灰石制品进行系统研究。结果表明：国产羟基磷灰石制品除有轻微细胞毒性外，其致敏性、溶血性、致突变性和组织相容性均符合《标准》要求，临床应用安全。

According to 'The standards for biological evaluation of bio materials and bio products abbreviated to STANDARDS” newly set by the Ministry of Health,PRC,5 observation indexes were selected to evaluate systematically the biocompatibility and toxicology of China made hydroxyapatite,which is clinicall used.The results revealed no effects of allergy,mutation and hemoclasis reaction except mild cytotoxicity.These indicate that the China made hydroxyapatite meets the demand of STANDADS and thus may be clinically with safety.