重组人骨形成蛋白-2与生物活性骨水泥复合材料生物相容性评价研究

BIOCOMPATIBILITY STUDY OF RECOMBINENT HUMAN BONE MORPHOGENETIC PROTEIN-2 (rhBMP-2) AND BIOACTIVE BONE CEMENT(α-TCP)COMPLEX MATERIAL

本工作根据卫生部制定的《生物材料和制品的生物学评价标准》(简称《标准),按照标准程序通过溶血试验、对凝血系统影响试验、热原试验、肌肉刺激试验以及细胞毒性试验,系统地研究了重组人骨形成蛋白-2(rhBMP-2)与生物活性骨水泥复合材料的生物学毒性,并参照《标准》对试验结果进行分析和评价。结果表明,重组人骨形成蛋白-2与生物活性骨水泥复合材料具有良好的生物相容性。

According to the standarads for biological evaluation of bio-materials and bio-products,the biocompatibility and,toxicology of the BMP and α-TCP complex material were studied.The results revealed that the BMP and α-TCP complex material had no effects on blood coagulation system,no hemoclasis effects,no febrisgen,no cytotoxicity and no stim- ulation for implantation.All those results indicate that the BMP and α-TCPcomplex mate- rial had good biocompatibilty and can be used in clinic safely.