生物植入剂的“去免疫原性”处方正交设计优化研究

Study on optimization of“deimmunogenicity”process and quality of biological implants by orthogonal design

目的通过对实验试剂的筛选,获得生物植入剂去免疫原性的最佳工艺条件,使中间产品的免疫原性物质达到质量标准的限定范围内,对机体的免疫反应降至最低。方法选用“猪小肠黏膜下层”为原料,根据细胞与支架材料的连接特点,采用乙二胺四乙酸二钠进行鳌合,在碱性条件下断裂细胞与支架的连接蛋白,将细胞及细胞器清洗出来。结果经过该工艺的设计,能够较好的去除DNA残留。结论该工艺的设计较好的去除了产品的免疫原性物质,在植入人体后能够发挥细胞外基质的药理作用。

Objective By meticulously scrutinizing and selecting experimental reagents,we have successfully identified the optimal procedural conditions for mitigating the immunogenicity of biologic implants.This ensures that the immunogenic substances in intermediate products adhere to the defined boundaries of quality standards,thereby minimizing immune responses within the organism to their utmost extent.Methods The submucosa of porcine small intestine was designed as the raw material.According to the connection characteristics of cells and ECM,EDTA was used for chelation,and the cells and organelles were washed out after the connection proteins between cells and ECM were broken under alkaline conditions.Result After the orthogonal design of this process,the residual cells and DNA of biological implants can be better removed.Conclusion The design of this process can better remove the immunogenic substances of the biological implants,which can play the pharmacological appointment of the extracellular matrix after implantation in the human body.