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近红外光谱法在兽药生产全过程质量控制中的应用展望

王轩 韩宁宁 陈鑫伟 彭文绣 叶能胜 张秀英

中国兽药杂志2025,Vol.59Issue(1):11-20,10.
中国兽药杂志2025,Vol.59Issue(1):11-20,10.DOI:10.11751/ISSN.1002-1280.2025.1.02

近红外光谱法在兽药生产全过程质量控制中的应用展望

Prospects for the Application of Near-Infrared Spectrometry in Process Quality Control of Veterinary Drugs

王轩 1韩宁宁 1陈鑫伟 2彭文绣 1叶能胜 3张秀英1

作者信息

  • 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京,100081
  • 2. 青岛工程职业学院,山东 青岛,266000
  • 3. 首都师范大学化学系,北京,100048
  • 折叠

摘要

Abstract

Near-Infrared Spectrometry(NIRS),as a key tool of Process Analytical Technology(PAT),has been widely applied in the pharmaceutical field since it was proposed by the U.S.Food and Drug Administration in 2004.However,the application of NIRS in the quality control of veterinary drug production is still insufficient.This paper summarizes the basic principles of NIRS and discusses the current status of its application in the quality control of the whole process of pharmaceutical production.By analyzing the application of NIRS in raw material inspection,production process monitoring and finished product inspection,it shows its potential in improving production efficiency and ensuring drug quality.At the same time,the article looks forward to the future development trend of NIRS technology in veterinary medicine production,including technology optimization,standard establishment and multidisciplinary integration application,with a view to providing technical support for intelligent and precise production in the veterinary medicine industry.

关键词

近红外光谱/药物分析/质量控制/全过程分析技术

Key words

Near-infrared spectrometry(NIRS)/pharmaceutical analysis/quality control/process analytical technology(PAT)

分类

农业科技

引用本文复制引用

王轩,韩宁宁,陈鑫伟,彭文绣,叶能胜,张秀英..近红外光谱法在兽药生产全过程质量控制中的应用展望[J].中国兽药杂志,2025,59(1):11-20,10.

基金项目

国家重点研发计划项目(2022YFD1802105) (2022YFD1802105)

中国兽药杂志

1002-1280

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