中药质量实时检测：NIR定量模型的评价参数进展.docVIP

中药质量实时检测：NIR定量模型的评价参数进展 　　[摘要]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。 　　[关键词]近红外;过程分析技术;模型评价;准确性轮廓;质量源于设计 　　Real-time detection of quality of Chinese materia medica： 　　strategy of NIR model evaluation 　　WU Zhi-sheng1，2，3， SHI Xin-yuan1，3*， XU Bing1，2， DAI Xing-xing1，3， QIAO Yan-jiang1，3* 　　（1.Beijing University of Chinese Medicine， Beijing 100102， China; 　　2. State Key Laboratory of Dao-di Herbs， National Resource Center for Chinese Materia Medica， 　　China Academy of Chinese Medical Sciences， Beijing 100700， China; 　　3. Key Laboratory of Traditional Chinese Medicine-Information Engineering of State Administration of Traditional 　　Chinese Medicine， Beijing 100102， China） 　　[Abstract]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. 　　[Key words]near infrared; process analytical technology; model evaluation; accuracy profile; quality by design 　　doi：10.4268/cjcm 　　2010年10月9日，国家工业和信息化部、卫生部和国家食品药品监督管理局3部门联合印发了《关于加快医药行业结构调整的指导意见》，其主要任务之一就是调整中药产业技术结构，根据中药特点，以药物效用最大化、安全风险最小化为目标，加快现代技术在中药生产