Abstract
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 near-infrared (NIR) spectroscopy. NIR spectra in the 4000–10,000-cm[Formula: see text] 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-mean-square 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[Formula: see text]mg[Formula: see text]mL[Formula: see text], and the RMSEP values were 0.711, 1.547, and 3.740[Formula: see text][Formula: see text], respectively. The correlation coefficients [Formula: see text] 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.
Highlights
The safety and e±cacy of herbal medicine (HM) are dependent on the quality of medicinal materials and on the manufacturing processes
NIR spectroscopy has been applied to the in-situ monitoring of a laboratory-scale batch alcohol precipitation process
Fructose, and sucrose were modeled by PLS regression based on the in-situ NIR spectra
Summary
The safety and e±cacy of herbal medicine (HM) are dependent on the quality of medicinal materials and on the manufacturing processes. Owing to the complexity of HM, a number of purication technologies have been used by the pharmaceutical industry to manufacture HMs with high safety standards and e±cacy. Not considered as e±cacy components, saccharides, such as glucose, fructose, and sucrose, are commonly found in HM extracts. These saccharides in HMs can a®ect the drug appearance and stability, and the e±cacy and safety. The production of 5-HMF, which has reported cytotoxicity, genotoxicity, and tumorigenicity, is limited at di®erent safe concentrations in di®erent pharmacopeia.[6] the further reduction and removal of saccharides during manufacturing process is still needed to assure high quality of their end products
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