缓释 PDGF-BB 的纳米珍珠层/聚乳酸/纤维蛋白胶复合支架生物安全性评价简

目的探讨缓释PDGF—BB的纳米珍珠层／聚乳酸，纤维蛋白胶复合支架的生物安全性，为临床应用提供理论依据。方法采用支架材料浸取液进行急性毒性试验、皮内刺激试验以及热原实验。根据实验数据评价其安全性；同时采用皮下置入试验，观察其对周围组织的反应，对复合材料组织相容性进行评价。结果该支架材料无毒性作用，不引起皮内刺激反应。不具有致热原作用；皮下置人试验术后病理组织学切片证实该材料置入兔体内后炎性细胞反应逐渐减轻，材料周围组织纤维囊壁逐渐变薄。结论缓释PDGF—BB的纳米珍珠层，聚乳酸，纤维蛋白胶复合支架具备良好的生物安全性和组织相容性．符合作为骨组织工程材料的基本条件。

Biological security evaluation of PDGF-BB releasing nano-nacrUPDLLA/FG composite scaffold

Objective To evaluate the biological safety of PDGF-BB releasing nano-nacre/PDLLA/FG composite scaffolds for providing the scientific and experimental basis for clinical application. Methods Scaffold was immersed into normal saline in order to obtain extracts. Then the extracts were subjected to acute systemic toxicity test, intradermal stimulation test and pyrogen test to evaluate the biological safety. Additionally, the scaffolds were implanted in back subcutaneous tissue to observe its surrounding tissue reaction and evaluate its histocompatibility. Results The results showed that the scaffold was non-toxic, non-stimulation, no pyrogen. After scaffolds were implanted in subcutaneous tissue, the histopathology biopsy confrrmed that after the material was implanted in rabbits, the inflammatory cells gradually reduced and surrounding tissue fibers cyst gradually thinned. Conclusion The PDGF-BB releasing nano-nacre/PDLLA/FG composite scaffold possesses good biological safety and histocompatibility and match the basic conditions of bone tissue engineering materials.