各国药典化学计量学相关通用技术要求的概况和应用  

Overview and Application of General Chapters of Chemometrics in Pharmacopoeias

作　　者：徐昕怡 洪小栩[1] XU Xin-yi;HONG Xiao-xu(Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]国家药典委员会,北京100061

出　　处：《中国药学杂志》2023年第11期1049-1056,共8页Chinese Pharmaceutical Journal

基　　金：科技部国家科技基础资源调查专项“中草药毒性药材鉴定标准及共享服务系统建设”项目资助(2018FY00803);国家药典委员会国家药品标准制修订研究课题“用于数据分析的化学计量学指导原则的建立”资助(2022Y09)。

摘　　要：目的为《中国药典》化学计量学相关通用技术要求的制定和化学计量学在我国制药行业中的进一步应用提供参考。方法通过梳理各国药典和有关文献,介绍各国药典化学计量学相关通用技术要求的概况和应用。结果自2016年以来,欧美药典陆续收载与化学计量学相关的指导原则,并在光谱法、过程分析技术和分析方法验证通则中应用或涉及化学计量学技术。结论建议《中国药典》针对化学计量学在我国制药工业水平下的应用需求,借鉴欧美药典的成果和经验,制定《中国药典》化学计量学相关通用技术要求,促进制药行业利用数字技术评估风险和识别目标机会,加速赋能我国药品的研发、生产和质量控制,促进我国医药产业高质量发展。OBJECTIVE To provide a reference for the development of general chapters of chemometrics in the Chinese Pharmacopoeia and the further application of chemometrics in the pharmaceutical industry in China.METHODS By combing the pharmacopoeias and literature,the overview and application of the general chapters of chemometrics in the pharmacopoeias were introduced.RESULTS Since 2016,the European Pharmacopoeia and the United States Pharmacopoeia have successively introduced the general chapters of chemometrics and applied or involved chemometrics technologies in the general chapters of spectroscopy,process analytical technology and validation of compendial procedures.CONCLUSION It is suggested that the Chinese Pharmacopoeia should learn from the achievements and experience of the European Pharmacopoeia and the United States Pharmacopoeia and develop general chapters of chemometrics in the Chinese Pharmacopoeia,aiming at the application needs of chemometrics at the level of the Chinese pharmaceutical industry,and promote the use of digital technology in the pharmaceutical industry to assess risks and identify target opportunities,accelerate and empower the research and development,production and quality control of the pharmaceutical industry in China,and promote the high-quality development of the Chinese pharmaceutical industry.

关 键 词：药典 化学计量学 多变量统计过程控制 光谱法 

分 类 号：R95[医药卫生—药学]