黄红霞;李文龙;瞿海斌;赵步长;赵涛;
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)

• 1:浙江大学药物信息学研究所
• 2:菏泽步长制药有限公司

摘要(Abstract)：

目的:建立丹红注射液提取过程轨迹并用于提取过程质量在线监控。方法:采用近红外(near-infrared,NIR)光谱仪在线采集过程光谱数据,结合多变量数据分析技术,建立提取过程轨迹,并采用主成分得分、Hotelling T2和DModX监控图实时监控提取过程质量。结果:应用建立的丹红注射液提取过程轨迹,能及时发现提取过程异常情况。结论:基于NIR光谱技术的过程轨迹在线质量监控方法为实现中药生产全程质量控制提供了技术。
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.

关键词(KeyWords)： 近红外光谱;过程轨迹;中药生产;提取过程监控;丹红注射液
near-infrared(NIR) spectroscopy;process trajectory;traditional Chinese medicine(TCM) manufacuring;extration process monitoring;Danhong injection

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 黄红霞;李文龙;瞿海斌;赵步长;赵涛;
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)

Email:

DOI:

参考文献(References)：

• [1]Li W L,Xing L H,Fang L M,et al.Application of near infraredspectroscopy for rapid analysis of intermediates of Tanreqing injec-tion[J].J Pharm Biomed Anal,2010,53(3):350.
• [2]Li W L,Qu H B.Rapid quantification of phenolic acids in RadixSalvia Miltrorrhiza extract solutions by FT-NIR spectroscopy intransflective mode[J].J Pharm Biomed Anal,2010,52(4):425.
• [3]李文龙,邢丽红,薛东升,等.一种基于近红外光谱技术的熊胆粉鉴别方法[J].光谱学与光谱分析,2011(3):673.
• [4]Huang H X,Qu H B.In-line monitoring of alcohol precipitationby near-infrared spectroscopy in conjunction with multivariatebatch modeling[J].Anal Chim Acta,2011,707:47.
• [5]Xiong H S,Gong,X C,Qu H B.Monitoring batch-to-batch re-producibility 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 inimage analysis——relationships and applications[J].ChemometrIntell Lab Syst,2003,66:141.
• [7]MacGregor J F,Kourti T.Statistical process control of multivariateprocesses[J].Control Eng Pract,1995,3(3):403.