一种抗新型冠状病毒灭活血浆的制备及质量标准的建立

Preparation and establishment of quality standard for an anti 2019- novel coronavirus inactivated plasma

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 screend for pathogens including 2019-nCoV,HIV,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 factorⅧactivity and other tests,the effect of methylene blue light inactivation on plasma was determined and the quality standard was dstablished.Results Protein content of inactivated plasma did not change significantly before and after methylene blue irradiation inactivation,coagulation factorⅧactivity was≥≥0.50 I U/ml.Antibody titer did not show a significant decrease.All test results met the queality requeirement.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.