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医用重组人源胶原蛋白功能敷料体外免疫原性评价

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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.
In Vitro Immunogenicity Evaluation of A Medical Recombinant Human Collagen Product
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.

medical recombinant human collagenbio-compatibilitylymphocyte proliferation testimmunogenicityhuman cell line activation test(h-CLAT)

王国伟、侯丽、秦越、王焱、王鸾鸾、刘成虎

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山东省医疗器械和药品包装检验研究院 国家药品监督管理局生物材料器械安全性评价重点实验室 山东省医疗器械生物学评价重点实验室,山东 济南 250101

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)

山东省医疗器械和药品包装检验研究院基金资助项目

ZX202019

2024

食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子:0.537
ISSN:1672-979X
年,卷(期):2024.26(2)
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