中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 52-56.
DOI: 10.19803/j.1672-8629.2022.01.11

• 基础与临床研究 • 上一篇    下一篇

抗新型冠状病毒候选药物法维拉韦首批国家对照品的研制

熊婧, 严菁, 刘毅, 刘阳, 何兰*   

  1. 中国食品药品检定研究院,化学药品质量研究与评价重点实验室,北京102629
  • 收稿日期:2021-05-14 出版日期:2022-01-15 发布日期:2022-01-20
  • 通讯作者: *何兰,女,博士,教授,药物质量分析。E-mail：helan1961@aliyun.com。#为共同通信作者。
  • 作者简介:熊婧,女,硕士,副研究员,药物质量分析。
  • 基金资助:
    国家重点研发计划（2016YFE0205400）; 国家自然基金青年科学基金项目（21801020）

Development of the first national reference substance of favipiravir as a candidate drug against COVID-19

XIONG Jing, YAN Jing, LIU Yi, LIU Yang, HE Lan*   

  1. National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China
  • Received:2021-05-14 Online:2022-01-15 Published:2022-01-20

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摘要： 目的 为有效控制法维拉韦片的产品质量,满足企业注册上市及生产的需要,研制法维拉韦首批含量测定用于国家化学对照品。方法 采用质谱、核磁共振谱和红外光谱进行结构确证,利用高效液相色谱法进行有关物质分析及均匀性、稳定性考察,采用气相色谱法、水分测定法、动态蒸气吸附法和炽灼残渣检查法对其他理化性质进行检查,采用质量平衡法进行含量赋值,并通过氟核磁共振定量法、进口对照品外标法以及差示扫描量热法对含量结果的准确性进行验证。结果 确证了法维拉韦首批国家对照品的结构,并确定其含量为99.7%。结论 法维拉韦首批国家对照品具备纯度高、量值准确、稳定性好的特性,可有效控制产品质量。

关键词: 法维拉韦, 新型冠状病毒肺炎, 对照品, 标准物质, 质量平衡法, 核磁共振定量, 动态蒸气吸附法

Abstract: Objective To establish the first national reference standard for content determination of favipiravir in order to ensure the quality of favipiravir tablets. Methods MS, 1H-NMR, 13C-NMR, and FTIR were used to confirm the structure. HPLC was used to analyze the related substances, uniformity and stability of favipiravir. Other physical and chemical properties were examined by GC, water determination, dynamic vapor sorption(DVS) and residue on ignition test. The content was assigned using the mass balance method and verified by 19F-NMR, HPLC, DSC. Results The structure of the national reference substance for favipiravir was confirmed, and the content was 99.7%. Conclusion The first national reference substance for favipiravir is characterized by high purity, good accuracy and stability, which can effectively control the quality of this product.

Key words: favipiravir, COVID-19, reference substance, reference standard, mass balance method, quantitative nuclear magnetic resonance, DVS

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