Chem. J. Chinese Universities ›› 2013, Vol. 34 ›› Issue (10): 2284.doi: 10.7503/cjcu20130523

• Analytical Chemistry • Previous Articles     Next Articles

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-Yuan1,2, QIAO Yan-Jiang1,2   

  1. 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

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

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