静脉注射用人SARS特异性免疫球蛋白的研制

中国生物工程杂志

2006, Vol. 26

Issue (0): 20-23

专稿

静脉注射用人SARS特异性免疫球蛋白的研制

张战洪计灵张信郭采平李昆成张剑平李冲之杨海峰丁玉江黄肖武

深圳市卫武光明生物制品有限公司

Preparation of Human SARS Immunoglobulin for Intravenous Injection

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摘要：

目的从康复期患者血浆中制备静脉注射用人SARS特异性免疫球蛋白。方法采用低温乙醇和离子交换层析相结合的蛋白纯化工艺，在分离纯化过程中对血浆进行S/D处理，对原液进行低pH孵放和纳米膜过滤去除病毒。结果产品纯度达到99.0％、IgG单体+二聚体为100％，ACA为11％、PKA未检出，其他的各项质量指标符合《中国生物制品规程》中静脉注射用人免疫球蛋白（pH4）的要求，产品中SARS抗体效价经ELISA法检测为1:83、经免疫荧光法检测为1：1600、经中和抗体法检测为1：200。结论本蛋白纯化工艺可操作性强，产品中含有高效价的SARS抗体，质量符合静脉注射要求。

关键词： 严重急性呼吸系统综合症; 康复期血浆; 特异性免疫球蛋白

Abstract:

Objective To produce the SARS immunoglobulin for intravenous injection from convalescent plasma. Methods Combination of the protein purification process of cold ethanol with ion exchange chromatography.Treat the source plasma with S/D，incubate the bulk at low pH and filtrate the bulk with nanofilter. Results The purity of the product was 99.0%,the monomer and dimmer contents of IgG was 100%,the ACA was 11%,the PKA wasn’t detected,the sterlity,safety,pyrogen and stability tests met the Chinese Requirements of Biological Products. the product was specific to SARS antigen and the titers of the product was1:83(ELISA),1:1600(IFA) and 1:200(NT)。Conclusion The process was feasible, the product had high titer SARS-antibody and the quality of product met the standard of Intravenous Injection.

Key words: severe acute respiratory syndrome convalescent plasma hyperimmunoglobulin

收稿日期: 2006-02-20 出版日期: 2006-06-15

通讯作者: 张战

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	洪计灵
	郭采平
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	李冲之
	李昆成
	张信
	张战
	杨海峰
	丁玉江
	黄肖武

引用本文:

张战,洪计灵,张信,郭采平,李昆成,张剑平,李冲之,杨海峰,丁玉江,黄肖武. 静脉注射用人SARS特异性免疫球蛋白的研制[J]. 中国生物工程杂志, 2006, 26(0): 20-23.

. Preparation of Human SARS Immunoglobulin for Intravenous Injection. China Biotechnology, 2006, 26(0): 20-23.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/ 或 https://manu60.magtech.com.cn/biotech/CN/Y2006/V26/I0/20

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