Author Affiliations
Abstract
1 School of Medicine, Zhejiang University City College Hangzhou, Zhejiang 310015, P. R. China
2 Pharmaceutical Informatics Institute, Zhejiang University Hangzhou, Zhejiang 310058, P. R. China
As unsafe components in herbal medicine (HM), saccharides can affect not only the drug appearance and stabilization, but also the drug efficacy and safety. The present study focuses on the in-line monitoring of batch alcohol precipitation processes for saccharide removal using nearinfrared (NIR) spectroscopy. NIR spectra in the 4000–10,000-cm-1 wavelength range are acquired in situ using a transflectance probe. These directly acquired spectra allow characterization of the dynamic variation tendency of saccharides during alcohol precipitation. Calibration models based on partial least squares (PLS) regression have been developed for the three saccharide impurities, namely glucose, fructose, and sucrose. Model errors are estimated as the root-meansquare errors of cross-validation (RMSECVs) of internal validation and root-mean-square errors of prediction (RMSEPs) of external validation. The RMSECV values of glucose, fructose, and sucrose were 1.150, 1.535, and 3.067 mgmL-11, and the RMSEP values were 0.711, 1.547, and 3.740 mg mL-11, respectively. The correlation coefficients (r) between the NIR predictive and the reference measurement values were all above 0.94. Furthermore, NIR predictions based on the constructed models improved our understanding of sugar removal and helped develop a control strategy for alcohol precipitation. The results demonstrate that, as an alternative process analytical technology (PAT) tool for monitoring batch alcohol precipitation processes, NIR spectroscopy is advantageous for both efficient determination of quality characteristics (fast, in situ, and requiring no toxic reagents) and process stability, and evaluating the repeatability.
Herbal medicine alcohol precipitation near-infrared spectroscopy saccharides removal process analytical technology Journal of Innovative Optical Health Sciences
2018, 11(5): 1850027