壳聚糖短纤维增强聚己内酯复合材料的体内生物相容性研究

In vivo study of biocompatibility of chitin short fiber reinforced polycaprolactone composite

目的:对壳聚糖短纤维增强聚己内酯复合材料进行体内生物相容性和使用安全性研究,为临床应用提供实验依据。方法:将制备好的纯聚己内酯和壳聚糖增强聚己内酯2种材料放入0.9%生理盐水中获取两者的浸提液,然后进行急性全身毒性试验、溶血试验、热源试验、过敏试验;将2种材料分别植入白兔背部(n=6),术后2、4、8、12、16、24周取材,观察一般组织情况及纤维包膜形态和厚度。结果:壳聚糖短纤维增强聚己内酯复合材料中不存在致敏性物质,浸提液无溶血反应和急性全身毒性反应,无热源反应。复合材料体内植入在初期有轻度的炎症反应,12周后炎症反应基本消失,未见巨噬细胞积聚现象。这些反应与纯聚己内酯无显著差别。结论:壳聚糖短纤维增强聚己内酯组复合材料具有良好的生物相容性,其作为胸壁缺损修补材料应用于临床具有可行性和安全性。

Objective：To investigate the biocompatibility and biological safety of chitin short fiber reinforced polycaprolactone（PCL） composite in vivo so as to provide experimental reference for clinical application. Methods： Pure PCL and chitin short fiber reinforced PCL composite were immersed into 0.9% normal saline separately in order to obtain their extracts. Then the extracts were subjected to acute systemic toxicity test, hemolysis test, pyrogen test and sensitivity test. The 2 materials were implanted into the dorsal muscle of rabbits（n=6）. The animals were killed 2, 4, 8, 12, 16 and 24 weeks after operation to observe the general condition of tissues and the morphology and thickness of the fibrous envelope. Results： There was no potential allergic substance in the chitin short fiber reinforced PCL composite, and no hemolytic reaction, acute systemic toxicity effect or pyrogen reaction was observed. Mild inflammatory reaction was seen in the surrounding tissues in the early implantation stage, which completely disappeared after 12 weeks. Macrophage aggregation was not noted. There was no significant difference in the biocompatibilities between pure PCL and chitin short fiber reinforced PCL composite. Conclusion： Chitin short fiber reinforced PCL composite has fine biocompatibility, which is feasible and safe for clinical reconstruction of chest wall defect.