中国中药杂志

2016, v.41(19) 3574-3578

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近红外光谱分析技术在复方阿胶浆生产全程中的应用进展及相关思考
Construction of NIRS-based total quality control system for compound Ejiao oral liquid and relative thinking

张淹;张路;田守生;周祥山;李文龙;瞿海斌;
ZHANG Yan;ZHANG Lu;TIAN Shou-sheng;ZHOU Xiang-shan;LI Wen-long;QU Hai-bin;Dong'e Ejiao Co.,Ltd.;Pharmaceutical Informatics Institute,Zhejiang University;

摘要(Abstract):

该文报道了东阿阿胶股份有限公司将近红外(NIR)光谱技术应用于复方阿胶浆生产全程质量控制中的实例。具体应用包括原料药材的质量控制、提取工艺和碱沉工艺的在线监控、以及复方阿胶浆成品的快速分析和不开瓶检验技术。通过以上技术的应用,初步实现了复方阿胶浆生产过程的可视化,增强了生产过程的可控性,有助于提高不同批次产品之间的质量一致性。同时还对NIR光谱技术用于复方阿胶浆生产过程的相关问题进行了相关思考,以期为其他中药品种开展类似研究提供参考。
In this paper,near infrared spectroscopy( NIRS)-based total quality control system of compound Ejiao oral liquid is introduced briefly,including the quality control of raw traditional Chinese medicine( TCM) materials,monitoring and control of the extract and the alkaline precipitation technics,and also the inspection of finished products in both open bottle and non-opening modes.By analyzing and summing up the significance and difficulties,several important problems in the practical applications of NIRS technology are proposed,which will provide references for the similar studies of other TCM products.

关键词(KeyWords): 近红外光谱;复方阿胶浆;过程分析技术;质量控制
near infrared spectroscopy;compound Ejiao oral liquid;process analytical technology;quality control

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基金项目(Foundation): 国家“重大新药创制”科技重大专项(2011ZX09201-201-10)

作者(Author): 张淹;张路;田守生;周祥山;李文龙;瞿海斌;
ZHANG Yan;ZHANG Lu;TIAN Shou-sheng;ZHOU Xiang-shan;LI Wen-long;QU Hai-bin;Dong'e Ejiao Co.,Ltd.;Pharmaceutical Informatics Institute,Zhejiang University;

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