中药生产过程具有多单元复杂性特点, 制剂生产的各个环节均会影响中药产品的最终质量, 在线近红外光谱技术具有快速、 无损和不污染环境等优势, 能够作为一种快速评价中药生产过程中关键质量属性的分析技术。 以院校相关研究为切入点, 系统阐述了在线近红外光谱技术在中药生产过程分析与控制方面的应用, 并结合院校中药生产在线近红外光谱分析平台搭建为例, 以此为依据阐明中药在线近红外光谱分析技术应用的可行性。 进而, 从企业应用角度出发, 较为全面的综述了目前国内大多数应用在线近红外光谱技术的中药生产企业的研究成果及其中药产品。 按照中药产品的两大剂型(液体制剂与固体制剂)进行分类, 以液体制剂不同生产环节(提取、 浓缩及醇沉等)为区分点, 以固体制剂不同成品剂型(片剂、 胶囊剂及膏剂等)为区分点, 分别对近10年来中药生产过程中在线近红外应用进行系统综述, 阐明中药生产全过程在线近红外技术应用的可靠性, 为中药生产现代化提供有效的技术支撑。

The quality of Chinese materia medica (CMM) is affected by every process in CMM manufacturing. According to multi-unit complex features in the production of CMM, on-line near infrared spectroscopy (NIR) is used as an evaluating technology with its rapid, non-destructive and non-pollution etc. advantages. With the research in institutions, the on-line NIR applied in process analysis and control of CMM was described systematically, and the on-line NIR platform building was used as an example to clarify the feasibility of on-line NIR technology in CMM manufacturing process. Then, from the point of application by pharmaceutical companies, the current on-line NIR research on CMM and its production in pharmaceutical companies was relatively comprehensively summarized. Meanwhile, the types of CMM productions were classified in accordance with two formulations (liquid and solid dosage formulations). The different production processes (extraction, concentration and alcohol precipitation, etc.) were used as liquid formulation diacritical points; the different types (tablets, capsules and plasters, etc.) were used as solid dosage formulation diacritical points, and the reliability of on-line NIR used in the whole process in CMM production was proved in according to the summary of literatures in recent 10 years, which could support the modernization of CMM production.