医用重组人源胶原蛋白功能敷料体外免疫原性评价

In Vitro Immunogenicity Evaluation of A Medical Recombinant Human Collagen Product

目的对一种医用重组人源胶原蛋白功能敷料的体外免疫原性进行评价。方法以细胞培养液为浸提介质,按0.2 g/ml的比例浸提制备试验液,进行体外淋巴细胞增殖试验、人细胞系激活试验(h-CLAT)、细胞炎症因子含量检测。结果体外淋巴细胞增殖试验中,100%,50%,25%3种浓度试验液的淋巴细胞增殖率分别为105%,111%,86.3%,与阴性对照组比较,差异无统计学意义(P>0.05)。h-CLAT结果显示,试验组THP-1细胞表面分子CD54 RFI值<200,CD86 RFI值<150,判定为阴性结果。试验组细胞上清中肿瘤坏死因子α(TNF-α)、白介素8(IL-8)的含量与阴性对照组比较,差异无统计学意义(P>0.05)。结论医用重组人源胶原蛋白功能敷料有良好的生物相容性。

Objective To evaluate the in vitro immunogenicity of a medical recombinant human collagen product.Methods The test solution for in vitro lymphocyte proliferation assay,human cell line activation test(h-CLAT),and determination of cell inflammatory factors was prepared by leaching at the ratio of 0.2 g/ml,using cell culture medium as leaching medium.Results In the lymphocyte proliferation test,the lymphocyte proliferation rates of 100%,50%,and 25%of test solution were 105%,111%,and 86.3%,respectively,which were not significantly different from those in the negative control group(P>0.05).The RFI value of THP-1 cell surface molecule CD54 was less than 200 and RFI value of CD86 was less than 150,which were judged as negative results.The content of TNF-αand IL-8 in the cellular supernatant of the experimental group was not significantly different from that of the negative control group(P>0.05).Conclusion The medical recombinant human collagen product has good biocompatibility.