基于过程分析技术和设计空间的金银花醇沉加醇过程终点检测

doi:10.7503/cjcu20130523

高等学校化学学报 ›› 2013, Vol. 34 ›› Issue (10): 2284.doi: 10.7503/cjcu20130523

基于过程分析技术和设计空间的金银花醇沉加醇过程终点检测

徐冰¹, 罗赣¹, 林兆洲¹, 艾路¹, 史新元^1,2, 乔延江^1,2

1. 北京中医药大学中药信息工程研究中心, 北京 100029;
2. 教育部中药制药与新药开发关键技术工程研究中心, 北京 100029

收稿日期:2013-06-03 出版日期:2013-10-10 发布日期:2013-10-10
作者简介:乔延江,男,博士,教授,博士生导师,主要从事中药信息学研究.E-mail:yjqiao@263.net;史新元,女,博士,副教授,主要从事中药过程分析研究.E-mail:shixinyuan01@163.com
基金资助:
国家“重大新药创制”科技重大专项(批准号:2010ZX09502-002)资助.

End-point Detection of the Alcohol Adding Process in Alcohol Precipitation of Lonicerae Japonicae Based on Design Space and Process Analytical Technology

XU Bing¹, LUO Gan¹, LIN Zhao-Zhou¹, AI Lu¹, SHI Xin-Yuan^1,2, QIAO Yan-Jiang^1,2

1. Research Center of TCM Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China;
2. Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development, Ministry of Education, Beijing 100029, China

Received:2013-06-03 Online:2013-10-10 Published:2013-10-10

摘要/Abstract

摘要：

建立了一种新的基于过程分析技术(PAT)和质量源于设计(QbD)设计空间的中药制药过程终点分析与控制方法.以近红外(NIR)光谱技术为PAT工具, 采集正常操作条件下制药过程的多批次NIR光谱; 采用主成分分析结合移动块相对标准偏差(PCA-MBRSD)法, 确定每一批次过程的理想终点样本(DEPs), 由多批DEPs的光谱信息构成过程终点设计空间; 在过程终点设计空间确定的范围内, 建立多变量统计过程控制(MSPC)模型, 利用多变量Hotelling T²和SPE控制图对过程终点进行判断.应用上述方法, 进行了金银花醇沉加醇过程终点检测研究, 结果表明该方法灵敏、准确, 适宜于中药制药过程终点检测.

关键词: 过程分析技术, 设计空间, 近红外光谱法, 醇沉过程, 终点检测

Abstract:

Under the guidance of the FDA's process analytical technology(PAT) initiative and the ICH's quality by design(QbD) principles, a new approach was applied for the end-point detection of the pharmaceutical process of Chinese medicine preparations. Generally, three steps were included in the proposed approach:(1) perform the NIR analysis for the batch process under normal operating conditions(NOCs), and collect the NIR spectra of different batches; (2) determine the desired end-points(DEPs) for every NOCs batch using the PCA based moving window relative standard deviation(PCA-MBRSD) method. Then, the QbD design space was defined, depending on these DEPs; (3) within the area specified by the design space, the multivariate statistical process control(MSPC) strategy was introduced, and the Hotelling T² and SPE control chart were established to monitor and detect the end-point of the manufacturing process. The above methods were tested on the end-point detection of the alcohol adding process of alcohol precipitation of Lonicerae Japonicae water extract. The results demonstrated that the sensitivity and accuracy of the proposed approach were satisfactory.

Key words: Process analytical technology(PAT), Design space, Near infrared spectroscopy(NIRS), Alcohol precipitation process, End-point detection

中图分类号:

O654.9

TrendMD:

徐冰, 罗赣, 林兆洲, 艾路, 史新元, 乔延江. 基于过程分析技术和设计空间的金银花醇沉加醇过程终点检测. 高等学校化学学报, 2013, 34(10): 2284.

XU Bing, LUO Gan, LIN Zhao-Zhou, AI Lu, SHI Xin-Yuan, QIAO Yan-Jiang. End-point Detection of the Alcohol Adding Process in Alcohol Precipitation of Lonicerae Japonicae Based on Design Space and Process Analytical Technology. Chem. J. Chinese Universities, 2013, 34(10): 2284.

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基于过程分析技术和设计空间的金银花醇沉加醇过程终点检测

End-point Detection of the Alcohol Adding Process in Alcohol Precipitation of Lonicerae Japonicae Based on Design Space and Process Analytical Technology

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