Applications and Prospects of On-Line Near Infrared Spectroscopy Technology in Manufacturing of Chinese Materia Medica
LI Yang, WU Zhi-sheng*, PAN Xiao-ning, SHI Xin-yuan, GUO Ming-ye, XU Bing, QIAO Yan-jiang*
Beijing University of Chinese Medicine, Pharmaceutical Engineering and New Drug Development of TCM of Ministry of Education，Key Laboratory of TCM-information Engineering of State Administration of TCM, Beijing Key Laboratory for Basic and Development Research on Chinese Medicine, Beijing 100102, China
Abstract：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.
Key words：On-line NIR;Critical quality attributes;Quality control;Chinese materia medica;Production process
李 洋，吴志生*，潘晓宁，史新元，郭明晔，徐 冰，乔延江* . 在线近红外光谱在我国中药研究和生产中应用现状与展望 [J]. 光谱学与光谱分析, 2014, 34(10): 2632-2638.
LI Yang, WU Zhi-sheng*, PAN Xiao-ning, SHI Xin-yuan, GUO Ming-ye, XU Bing, QIAO Yan-jiang* . Applications and Prospects of On-Line Near Infrared Spectroscopy Technology in Manufacturing of Chinese Materia Medica. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2014, 34(10): 2632-2638.
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