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-α and 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.
关键词
医用重组人源胶原蛋白/生物相容性/淋巴细胞增殖试验/免疫原性/人细胞系激活试验(h-CLAT)
Key words
medical recombinant human collagen/bio-compatibility/lymphocyte proliferation test/immunogenicity/human cell line activation test(h-CLAT)
维普
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