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目的:建立一种以新型冠状病毒肺炎(COVID-19)康复者恢复期血浆为原料制备抗新型冠状病毒(2019 novel coronavirus, 2019-nCoV)灭活血浆的工艺及其质量标准。方法:采集2020年1—3月期间中国武汉441人份COVID-19康复者捐献的恢复期血浆，开展2019-nCoV、HIV和梅毒螺旋体等病原体的筛查，进行亚甲蓝光照灭活，并通过检测蛋白含量、抗2019-nCoV抗体、凝血因子Ⅷ活性等，判断亚甲蓝光照灭活对血浆的影响并建立质量标准。结果:亚甲蓝光照灭活前后灭活血浆的蛋白含量没有发生明显变化，血浆的凝血因子Ⅷ含量≥0.50 IU/ml，抗体滴度未出现明显下降，各项检测结果均符合质量要求。结论:确立了以COVID-19康复者恢复期血浆制备抗2019-nCoV灭活血浆的关键质量控制及工艺参数。“,”Objective:To explore the production and quality standard of an inactivated plasma of anti-2019 novel coronavirus (2019-nCoV) prepared from convalescent plasma of COVID-19 patients.Methods:Four hundred and forty-one convalescent samples were collected from COVID-19 patients in Wuhan, China from January to March 2020, and screened for pathogens including 2019-nCoV, HIV, n Treponema pallidum and so on. Qualified plasma samples were inactivated by methylene blue light. By carrying out protein content of plasma, anti-2019-nCoV antibody, coagulation factor Ⅷ activity and other tests, the effect of methylene blue light inactivation on plasma was determined and the quality standard was established.n Results:Protein content of inactivated plasma did not change significantly before and after methylene blue irradiation inactivation, Coagulation facctor Ⅷ activity was ≥0.50 IU/ml. Antibody titer did not show a significant decrease. All test results met the quality requirements.Conclusion:The key quality control and process parameters of anti-2019-nCoV inactivated plasma prepared from the plasma of COVID-19 convalescent patients are established.