人凝血酶国家标准增订概况  

Overview of updates and amendments of the national standard for human thrombin

作　　者：蒋玉辉[1] 梁蔚阳[1] 黄瑶 赵沁 曹琰[3] JIANG Yuhui;LIANG Weiyang;HUANG Yao;ZHAO Qin;CAO Yan(Guangdong Institute for Drug Control,NMPA Key Laboratory of Blood Products Quality Control,Guangzhou 510663,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Biological Products Division,Chinese Pharmacopoeia Committee,Beijing 100061,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局血液制品质量控制重点实验室,广州510663 [2]上海市食品药品检验研究院,上海201203 [3]国家药典委员会生物制品处,北京100061

出　　处：《中国药品标准》2023年第2期117-121,共5页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题(354#);广东省药品监督管理局科技创新项目(2021ZDZ02);广东省医学科学技术研究基金项目(B2022285)。

摘　　要：目的:正确理解和使用2020年版《中国药典》新增各论品种“人凝血酶”,为本品种的国家标准的顺利实施提供应用指南。方法:从新增背景、国内外标准比较、关键质量属性制定过程几方面对人凝血酶各论增订情况进行简述。结果与结论:将人凝血酶企业注册标准上升为国家药典标准,有利于血液制品的科学监管。Objective:To Correctly understand and use the new variety“human thrombin”in the Chinese Pharmacopoeia 2020,and provide application guidelines for the smooth implementation of national standards for this variety.Methods:The revision of the monotheory of human thrombin was summarized from the new background,the comparison of domestic and foreign standards and the formulation process of key quality attributes.Results and Conclusion:Raising the registration standard of human thrombin enterprises to the national pharmacopoeia standard is conducive to the scientific supervision of blood products.

关 键 词：人凝血酶 2020年版《中国药典》 国家标准 药典各论 质量控制 血液制品 

分 类 号：R921.2[医药卫生—药学]