化学计量学指导原则在我国制药行业中的需求分析  

Investigation of the demands of chemometrics guidelines in China′s pharmaceutical industry

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作  者:赵瑜[1] 邵学广[2] 尹利辉[1] ZHAO Yu;SHAO Xueguang;YIN Lihui(National Institutes for Food and Drug Control,Beijing 102629,China;College of Chemistry,Nankai University,Tianjin 300071,China)

机构地区:[1]中国食品药品检定研究院,北京102629 [2]南开大学,天津300071

出  处:《中国药品标准》2024年第1期5-9,共5页Drug Standards of China

基  金:国家药典委标准提高课题(2022Y17)。

摘  要:目的:了解和把握我国制药行业的现状和实际需求,为《中国药典》通则“化学计量学指导原则”的建立提供依据。方法:以网络问卷的形式对制药行业从业人员化学计量学相关背景和需求进行调研。结果:我国制药行业从业人员对化学计量学指导原则具有一定期望和需求,但人才储备情况不容乐观。结论:《中国药典》通则“化学计量学指导原则”的制订极为迫切,其作为法定依据指导分析实践活动中的数据质量控制、分析方法的建立及分析方法的验证,以保障多变量分析方法的科学性和分析结果的可靠性,这将有利于推动我国制药水平的提高。Objective:To understand and grasp the current situation and actual demands of China′s pharmaceutical industry,in order to provide a basis for the establishment of the chemometrics guideline in the Chinese Pharmacopoeia.Methods:Online questionnaire was adopted to investigate the chemometrics backgrounds and demands of pharmaceutical industry practitioners.Results:The practitioners of China′s pharmaceutical industry had certain expectations and demands for the chemometrics guideline,but the situation of talent reserves was not that optimistic.Conclusions:It is extremely urgent to develop the chemometrics guideline,as general chapters of the Chinese Pharmacopoeia,which serve as the legal basis to guide the data quality control,the establishment of analytical methods and the verification of analytical methods in analytical practice,so as to ensure the scientific of multivariate analysis methods and reliability of analytical results,and will be conducive to promoting the improvement of China′s pharmaceutical level.

关 键 词:药典技术通则 化学计量学指导原则 近红外光谱法 过程分析技术 我国制药行业需求 人才储备 

分 类 号:R921.2[医药卫生—药学]

 

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