| 蒋玉辉,梁蔚阳,黄瑶,赵沁,曹琰.人凝血酶国家标准增订概况[J].中国药品标准,2023,24(2): |
| 人凝血酶国家标准增订概况 |
| Updates and amendments of the monograph for human thrombin |
| 投稿时间：2022-07-17 修订日期：2023-04-03 |
| DOI： |
| 中文关键词: 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 |
| 英文关键词: human thrombin Chinese Pharmacopoeia 2020 national standards pharmacopoeia monographs quality control blood products |
| 基金项目:广东省医学科学技术研究基金项目（B2022285） |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: to correctly understand and use the new monograph "human thrombin" in the Chinese Pharmacopoeia 2020, and provide application guidance for the smooth implementation of this national standard. Methods: the revision of “human thrombin” monographs was briefly described from the revision background, the comparison of domestic and foreign standards, and the formulation process of key quality attributes. Conclusion: improveing the enterprise registration standard of human thrombin to the national pharmacopoeia standard is beneficial to the scientific supervision of blood products. |
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