血液制品生产用血浆国内外监管的异同  

Similarities and Differences of Regulation of Plasma Used in the Production of Blood Products at Home and Abroad

作　　者：杨敬鹏 徐晓楠 Yang Jingpeng;Xu Xiaonan(Henan Province Food and Drug Evaluation and Inspection Center, Zhengzhou 450018, China;Food Inspection and Testing Institute of Henan Province, Zhengzhou 450018, China)

机构地区：[1]河南省食品药品审评查验中心,郑州450018 [2]河南省口岸食品检验检测所,郑州450018

出　　处：《中国药事》2019年第7期732-736,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:分析国内外血液制品生产企业用原料血浆管理的差异,为优化国内血浆管理模式提出合理化、建设性的意见和建议。方法:本文运用文献资料法、比较研究法和描述性研究法,梳理血液制品行业原料血浆管理的国内外差异,了解行业现状,分析目前存在的问题。结果与结论:目前,我国血液制品企业原料血浆投浆量低,血浆综合利用度不高,建议通过实施上市许可持有人制度、推进原料血浆集中检测及综合利用临床分离富余血浆等措施,缓解国内血浆蛋白制品紧缺的现状。Objective: To analyze the differences of management of plasma used in blood products manufacturers at home and abroad and provide rational and constructive opinions and suggestions for optimizing domestic plasma management modes. Methods: In this paper, the methods of literature review, comparative study and descriptive study were used to sort out the differences of raw material plasma management in the blood product industry at home and abroad. Current situation of the industry and the existing problems were analyzed. Results and Conclusion: At present, the raw material plasma of blood product enterprises in China is low in plasma volume and in comprehensive utilization. It is suggested the current situation of the shortage of plasma protein products in China be alleviated by implementing the system of listing permit holders, promoting the centralized detection of raw material plasma and comprehensively utilizing the surplus plasma separated from clinical samples.

关 键 词：血液制品 血浆 管理模式 差异 建议 

分 类 号：R95[医药卫生—药学]