医药导报2026，Vol.45Issue(5)：796-802,7.DOI:10.3870/j.issn.1004-0781.2026.05.009
市售人纤维蛋白原质量评价
Quality Evaluation of Commercially Available Human Fibrinogen
摘要
Abstract
Objective To evaluate the quality status of commercially available fibrinogen and compare the inherent differences in products from different enterprises.Methods A total of 21 batches of samples from 7 companies were inspected accord legal quality standards,and research was conducted on four aspects:residual investigation of borne viruses(human parvo-virus B19 and cytomegalovirus),stability,protein composition,and aluminum ion residue.Conduct statistical analysis on the results of testing according to legal standards and exploratory comprehensively evaluate the quality status of human fibrinogen.Results The legal standard inspection pass rate of 21 batches of samples was 100%.The exploratory research results showed that the re-sidual DNA of human cytomegalovirus was negative,and 38%of the samples were detected to have residual DNA of human parvo-virus B19.The thermal stability of products from different enterprises varies greatly,which may be related to protective agents,with higher purity observed in products exhibiting better thermal stability.A total of 3 to 10 heteroproteins were identified across the 7 manufacturers,with low levels of fibronectin and plasminogen in all products.One enterprise used aluminum hydroxide gel for adsorption,and the residual aluminum ion was significantly higher of other enterprises.Conclusions The overall quality of this product is good,but there is still a need to strengthen control of human parvovirus B19 load and gradually improve and process to enhance product stabilityrisks of impurities and aluminum ion residues.The research can provid technical support for enhancing the quality of commercially available human fibrinogen.关键词
人纤维蛋白原/质量评价/血源性病毒残留/热稳定性/铝离子残留Key words
Human fibrinogen/Quality evaluation/Residual blood borne viruses/Thermal stability/Aluminum ion resi-dues分类
医药卫生引用本文复制引用
王文晞,郭江红,王德蓉,李世兴,程梦兰,谢育媛,胡敏..市售人纤维蛋白原质量评价[J].医药导报,2026,45(5):796-802,7.基金项目
国家药品抽检计划项目. （）
