吴志生;史新元;徐冰;戴幸星;乔延江;
WU Zhi-sheng;SHI Xin-yuan;XU Bing;DAI Xing-xing;QIAO Yan-jiang;Beijing University of Chinese Medicine;State Key Laboratory of Dao-di Herbs,National Resource Center for Chinese Materia Medica,China Academy of Chinese Medical Sciences;Key Laboratory of Traditional Chinese Medicine-Information Engineering of State Administration of Traditional Chinese Medicine;

• 1:北京中医药大学
• 2:中国中医科学院中药资源中心道地药材国家重点实验室培育基地
• 3:国家中医药管理局中药信息工程研究中心

摘要(Abstract)：

该文旨在基于顶层设计理念,提出中药关键质量属性概念。结合当今快速分析科学的发展趋势,对中药学一级学科所属的中药分析学二级学科,率先开展中药关键质量属性快速评价研究。以近红外光谱作为近10年来瞩目的中药制药过程快速分析技术范例,系统综述了经典化学计量学参数的近红外模型评价。依据中药复杂性及微量组分分析特点,提出了多元信息融合的中药关键质量属性的近红外模型评价关键技术,为中药关键质量属性的近红外快速可靠性分析提供支撑。
The definition of critical quality attributes of Chinese materia medica( CMM) was put forward based on the top-level design concept. Nowadays,coupled with the development of rapid analytical science,rapid assessment of critical quality attributes of CMM was firstly carried out,which was the secondary discipline branch of CMM. Taking near infrared( NIR) spectroscopy as an example,which is a rapid analytical technology in pharmaceutical process over the past decade,systematic review is the chemometric parameters in NIR model evaluation. According to the characteristics of complexity of CMM and trace components analysis,a multi-source information fusion strategy of NIR model was developed for assessment of critical quality attributes of CMM. The strategy has provided guideline for NIR reliable analysis in critical quality attributes of CMM.

关键词(KeyWords)： 近红外;过程分析技术;模型评价;准确性轮廓;质量源于设计
near infrared;process analytical technology;model evaluation;accuracy profile;quality by design

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81303218);; 高等学校博士学科点专项基金项目(20130013120006);; 国家中医药管理局行业专项(201407003)

作者(Author): 吴志生;史新元;徐冰;戴幸星;乔延江;
WU Zhi-sheng;SHI Xin-yuan;XU Bing;DAI Xing-xing;QIAO Yan-jiang;Beijing University of Chinese Medicine;State Key Laboratory of Dao-di Herbs,National Resource Center for Chinese Materia Medica,China Academy of Chinese Medical Sciences;Key Laboratory of Traditional Chinese Medicine-Information Engineering of State Administration of Traditional Chinese Medicine;

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DOI:

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