丹红注射液提取过程轨迹及质量在线监控研究(3)
[5] Xiong H S， Gong， X C， Qu H B. Monitoring batch-to-batch reproducibility of liquid-liquid extraction process using in-line near-infrared spectroscopy combined with multivariate analysis [J]. J Pharm Biomed Anal， 2012， 70：178.
[6] Huang J， Helle W， Karasten B Q， et al. Multi-way methods in image analysis——relationships and applications [J]. Chemometr Intell Lab Syst， 2003， 66：141.
[7] MacGregor J F， Kourti T. Statistical process control of multivariate processes[J]. Control Eng Pract， 1995， 3(3)：403.
Implementation of extraction process trajectory for in-line
quality control of Danhong injection
HUANG Hong-xia1， LI Wen-long1， QU Hai-bin1*， ZHAO Bu-chang2， ZHAO Tao2
(1. Pharmaceutical Informatics Institute， Zhejiang University， Hangzhou 310058， China；
2. Heze Buchang Pharma Co.， Ltd.， Heze 274000， China)
[Abstract] Extraction process trajectory of Danhong injection by near-infrared (NIR) spectroscopy in conjunction with multivariate data analysis techniques was developed for in-line monitoring of extraction process. To capture the variation of batch process， the use of score， Hotelling T2 and DModX control charts was investigated for real-time monitoring of extraction process. Various abnormal behaviors of the test batches were detected in time by comparing the extraction process trajectory. It was concluded that the process trajectory for in-line quality control based on NIR spectroscopy was a feasible technology tool of the total process quality control during traditional Chinese medicine (TCM) manufacturing process.
[Key words] near-infrared (NIR) spectroscopy； process trajectory； traditional Chinese medicine (TCM) manufacuring； extration process monitoring； Danhong injection
doi：10.4268/cjcmm20131103
[责任编辑 曹阳阳], http://www.100md.com(黄红霞， 李文龙， 瞿海斌， 赵步长， 赵涛)
[6] Huang J， Helle W， Karasten B Q， et al. Multi-way methods in image analysis——relationships and applications [J]. Chemometr Intell Lab Syst， 2003， 66：141.
[7] MacGregor J F， Kourti T. Statistical process control of multivariate processes[J]. Control Eng Pract， 1995， 3(3)：403.
Implementation of extraction process trajectory for in-line
quality control of Danhong injection
HUANG Hong-xia1， LI Wen-long1， QU Hai-bin1*， ZHAO Bu-chang2， ZHAO Tao2
(1. Pharmaceutical Informatics Institute， Zhejiang University， Hangzhou 310058， China；
2. Heze Buchang Pharma Co.， Ltd.， Heze 274000， China)
[Abstract] Extraction process trajectory of Danhong injection by near-infrared (NIR) spectroscopy in conjunction with multivariate data analysis techniques was developed for in-line monitoring of extraction process. To capture the variation of batch process， the use of score， Hotelling T2 and DModX control charts was investigated for real-time monitoring of extraction process. Various abnormal behaviors of the test batches were detected in time by comparing the extraction process trajectory. It was concluded that the process trajectory for in-line quality control based on NIR spectroscopy was a feasible technology tool of the total process quality control during traditional Chinese medicine (TCM) manufacturing process.
[Key words] near-infrared (NIR) spectroscopy； process trajectory； traditional Chinese medicine (TCM) manufacuring； extration process monitoring； Danhong injection
doi：10.4268/cjcmm20131103
[责任编辑 曹阳阳], http://www.100md.com(黄红霞， 李文龙， 瞿海斌， 赵步长， 赵涛)