Application Of Near Infrared Spectroscopy To On-line Quality Analysis Of Traditional Chinese Medicine Manufacturing Process

Technics of Traditional Chinese Medicine (TCM) manufacturing process is under-developed, and process has been monitored with experience. The absence of effective on-line monitoring techniques will affect the quality of TCM manufacturing process directly, and the quality of TCM farther. As a fast, non-destructive process analysis method, Near Infrared Spectroscopy (NIRS) technique has been applied in fields of industry, but little in TCM manufacturing process. In this thesis, the application of NIRS technique in on-line quality analysis of TCM manufacturing process had been researched. The main works can be summarized as follow.1. Taken ethanol extraction process of Red Ginseng as an example, the method of fast analysis of ethanol extraction process by NIRS had been investigated. Samples were collected during extraction process, and then the spectra of samples were scanned. The gensenosides concentrations of samples were measured by colorimetric assays as reference values. The interference information in the spectra was deleted by orthogonal signal correction method. A calibration model between spectra and reference values was built by partial least squares regression method. The root mean square error of calibration set and validation set were 0.15mg/mL, 0.16mg/mL, and correlation coefficient were all 0.99. The results showed that the predictive accuracy of NIRS calibration model used for determination of ginsenosides concentrations was good.2. The method of on-line analysis of ethanol extraction process of Red Ginseng by NIRS had been built. Spectra were on-line collected with flowcell. Gensenosides concentrations of samples were measured by colorimetric assays as reference values. First derivative combined with standard normal variate was used to pretreat spectra, and calibration model for ginsenosides had been built by partial least squares regression method. The root mean square error of calibration set and validation set were 0.15mg/mL, 0.17mg/mL, and correlation coefficient were 0.99, 0.98.3. The method of on-line analysis of industrial water extraction process of Radix Salviae Miltiorrhizae by NIRS had been studied. Spectra of extract were obtained with industrial flowcell in the course of manufacturing process. Partial least squares regression method was used to build the calibration models with HPLC as a reference method for each component. Root mean square error of prediction for Danshensu and salvianolic acid B were 0.0282mg/mL,0.00448mg/mL,correlation coefficient were 0.87, 0.88 <>4. NIRS was used in on-line analysis of concentration process of Red Ginseng alcohol extract. The standard samples were prepared by diluting concentrated Red Ginseng extract proportionally with anhydrous ethanol, and their reference measurements of alcohol and ginsenosides concentration and spectra were obtained. The calibration models for alcohol and ginsenosides were built. Models had root mean square error of prediction of 1.81 mg/mL, 1.58%, and correlation coefficient of 0.983, 0.997 for ginsenosides and alcohol.5. NIRS had been explored for fast analysis of decolourisation process of Red Ginseng concentrated extract. Spectra were pretreated with orthogonal signal correction method, and wavelength was selected by genetic algorithm. Calibration models were developed by partial least squares regression to measure gensenosides concentrations and transparency. Root mean square error of prediction for gensenosides and transparency were 0.96 mg/mL, 1.13%.As those works shown, the NIRS technique could be applied in on-line quality analysis of TCM manufacturing process, and developed to be a new method of monitoring the quality of TCM manufacturing process.