巴沙鱼皮脱细胞真皮基质的制备及生物相容性评价

Preparation and Evaluation of Biocompatibility of Acellular Dermal Matrix of Basa Fish (Pangasius bocourti)

摘要: 本研究以巴沙鱼皮为原料，通过脱色、脱脂、脱细胞和交联的方法，制备得到低免疫原性的巴沙鱼皮脱细胞真皮基质(GA-BADM)。通过扫描电镜探究GA-BADM的结构，通过GB/T 16886 医疗器械生物学评价标准规定的血液相容性试验、全身急性毒性试验、皮下植入试验以及细胞相容性试验探究GA-BADM的生物相容性。结果表明：样品呈双层膜结构，一侧疏松多孔，一侧致密光滑；材料溶血率远小于5%，安全性能高；GA-BADM浸提液注射后，大鼠体重呈现增加的现象，无全身急性毒性；材料植入体内，逐渐被降解吸收，具有良好的组织相容性；材料没有细胞毒性，且可以促进细胞增殖生长，具有良好的细胞相容性。本研究证实了GA-BADM材料具有良好的生物相容性，为开展水生生物脱细胞真皮基质的研究提供了理论基础以及技术指导。

Abstract: The low-immunogenic GA-BADM was derived from Basa fish (Pangasius bocourti) and prepared by declorization, degreasing, decellularization and cross-linking. The microstructure of GA-BADM was evaluated by SEM. The biocompatibility of GA-BADM was investigated by blood compatibility, systemic acute toxicity, hypodermic implantation and cell compatibility according to the standards of Biological Evaluation of Medical Devices (GB/T 16886). The results showed that the GA-BADM was made up of double layers with one dense layer and another loose layer. The hemolysis rate of GA-BADM was far less than 5%, which implied high safety performance. After injection of GA-BADM extract, the weight of rats was increased, which meant no acute systemic toxicity. The samples with good histocompatibility, were gradually degraded after implanting in vivo. The samples had no cytotoxicity and could promote cell proliferation, which proved good cell compatibility. This study indicated that the GA-BADM materials had good biocompatibility, which provided a theoretical basis and technical guidance for the study of the acellular dermal matrix of aquatic organisms.