中药质量实时检测:NIR定量模型的评价参数进展

Real-time detection of quality of Chinese materia medica:strategy of NIR model evaluation

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 ex- ample, which is a rapid analytical technology in pharmaceutical process over the past decade, systematic review is the chemometric pa- rameters 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.