中国中药杂志

2016, v.41(19) 3506-3510

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基于近红外光谱技术的“过程轨迹”用于中药制药过程监控的研究进展
Near infrared spectroscopy based process trajectory technology and its application in monitoring and controlling of traditional Chinese medicine manufacturing process

李文龙;瞿海斌;
LI Wen-long;QU Hai-bin;Pharmaceutical Informatics Institute,Zhejiang University;

摘要(Abstract):

该文介绍了基于近红外光谱技术的"过程轨迹"方法的原理,该技术的主要步骤包括:在线采集各工艺过程的在线近红外光谱;对在线采集的三维光谱数据进行展开;确定主成分、Hotelling T2、DMod X等统计量的运行迹线及其正常波动范围;用所建多变量统计过程控制模型监测新批次的运行情况。该文对该技术在生物制药及化学制药领域的应用进行了简要综述,介绍了作者所在的实验室将该技术应用于中药制药过程监控领域所取得的进展,并对该技术的应用前景进行展望。
In this paper,the principle of NIRS( near infrared spectroscopy)-based process trajectory technology was introduced. The main steps of the technique include: 1in-line collection of the processes spectra of different technics; 2unfolding of the3-D process spectra; 3determination of the process trajectories and their normal limits; 4monitoring of the new batches with the established MSPC( multivariate statistical process control) models. Applications of the technology in the chemical and biological medicines were reviewed briefly. By a comprehensive introduction of our feasibility research on the monitoring of traditional Chinese medicine technical process using NIRS-based multivariate process trajectories,several important problems of the practical applications which need urgent solutions are proposed,and also the application prospect of the NIRS-based process trajectory technology is fully discussed and put forward in the end.

关键词(KeyWords): 近红外光谱;过程分析技术;过程轨迹;中药制药;过程监控
near infrared spectroscopy;process analytical technology;process trajectory;traditional Chinese medicine manufacturing;process monitoring and controlling

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基金项目(Foundation): 浙江省中医药科学研究基金项目(2015ZB023)

作者(Author): 李文龙;瞿海斌;
LI Wen-long;QU Hai-bin;Pharmaceutical Informatics Institute,Zhejiang University;

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