中文摘要：

目的初步评价丝素／β-磷酸三钙（β-TCP）三层一体化高仿生支架的生物安全性。方法以丝素蛋白和β-TCP为支架材料，采用改进的共混／冷冻干燥法制作三层一体化高仿生支架。对该支架行急性毒性试验、亚急性毒性试验、血液相容性试验、CCK-8试验和组织学观察等方法，评价其生物安全性。结果急性与亚急性毒性试验后，动物一般情况良好，2周后体重、血常规等未见明显变化，心、肝、肾等重要器官无异常改变。支架溶血率为2．09％，符合医用材料对溶血试验的要求。CCK-8试验证明支架对软骨细胞无毒性。软骨细胞一支架复合组织块行番红、阿利辛蓝染色可观察到细胞在软骨部分中黏附良好，分布均匀，细胞外基质分泌较多。结论丝素／β-TCP三层一体化高仿生支架具有良好的生物安全性。

英文摘要：

Objective To evaluate the biological safety of a biomimetic three-layered scaffold made by silk fibroin and β-TCP. Methods The scaffold was prepared by the improved commixing and freeze-drying method. It consisted of silk fibroin and β-TCP from the upper to lower layer and the intermediate layer was made by mixed silk fibroin and β-TCP. The biological safety experiments included system toxicity test, sub-acute toxicity test, blood compatibility test, CCK-8 test, HE, safranin O and alcian blue staining. Results After injection and implantation of extracts and scaffolds, general condition of animals remained normal. Weight, red and white blood cells of experimental animals altered slightly two weeks later. HE staining showed that the heart, liver and kidney remained normal. Hemolytic rate of the scaffold was 2.09% ,which met the requirement of hemolysis test standard as a medical material. CCK-8 test showed that the scaffold did not induce any cytotoxicity. Safranin O and alcian blue staining showed that the chondrocytes had good adherent and proliferative ability in the scaffold. Conclusion The biomimetic three-layered silk fibroin/β-TCP scaffold has good biological safety.