一种抗新型冠状病毒灭活血浆的制备及质量标准的建立

Hu Yong; Yu Ding; He Yanlin; Duan Kai; Yang Huichuan; Hou Jifeng; Liang Hong; Peng Yan1; Zhou Zhijun1; Lin Lianzhen; Wu Xiao; Yu Jianhong; Han Ren; Liang Xiaolong; Xing Yantao; Liu Ying.etc

doi:10.3760/cma.j.cn311962-20201018-00098

国际生物制品学杂志 >

2021 , Vol. 44 >Issue 1: 17 - 21

DOI: https://doi.org/10.3760/cma.j.cn311962-20201018-00098

新型冠状病毒专题

一种抗新型冠状病毒灭活血浆的制备及质量标准的建立

Hu Yong ,
Yu Ding ,
He Yanlin ,
Duan Kai ,
Yang Huichuan ,
Hou Jifeng ,
Liang Hong ,
Peng Yan1 ,
Zhou Zhijun1 ,
Lin Lianzhen ,
Wu Xiao ,
Yu Jianhong ,
Han Ren ,
Liang Xiaolong ,
Xing Yantao ,
Liu Ying.etc

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国药集团武汉血液制品有限公司科研开发部 430207；北京天坛生物制品股份有限公司研发中心 100024；武汉生物制品研究所有限责任公司病毒性疫苗研究二室 430207；中国生物技术股份有限公司科研管理部，北京 100029；中国食品药品检定研究院血液制品室，北京 102629；成都蓉生药业有限责任公司科研开发部 610041；

网络出版日期: 2025-08-16

基金资助

“公共安全风险防控与应急技术装备”重点专项（2020YFC0841800）

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

胡勇余鼎何彦林段凯杨汇川侯继锋梁洪彭焱周志军林连珍吴晓喻剑虹韩韧梁小龙邢延涛等

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Research and Development Department, Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd., Wuhan 430207, China; Research and Development Center, Beijing Tiantan Biological Products Co., Ltd., Beijing 100024, China; Laboratory 2 of Viral Vaccine Research, Wuhan Institute of Biological Products Co., Ltd., Wuhan 430207, China; Research and Development Management Department, China National Biotec Group Co. Ltd., Beijing 100029, China; Blood Product Department, National Institutes For Food and Drug Control, Beijing 102629, China；Research and Development Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610041, China;

Online published: 2025-08-16

Supported by

Key Project of Public Security Risk Control and Emergency Technical equipment (2020YFC084180)

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摘要

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。

关键词： 新型冠状病毒肺炎；新型冠状病毒；亚甲蓝；病毒灭活

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Hu Yong , Yu Ding , He Yanlin , Duan Kai , Yang Huichuan , Hou Jifeng , Liang Hong , Peng Yan1 , Zhou Zhijun1 , Lin Lianzhen , Wu Xiao , Yu Jianhong , Han Ren , Liang Xiaolong , Xing Yantao , Liu Ying.etc . 一种抗新型冠状病毒灭活血浆的制备及质量标准的建立[J]. 国际生物制品学杂志, 2021 , 44(1) : 17 -21 . DOI: 10.3760/cma.j.cn311962-20201018-00098

Abstract

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 factor Ⅷ activity 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 factor Ⅷ activity 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.

Key words： COVID-19; 2019 novel coronavirus; Methylene blue;Virus inactivation

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