Study And Application Of Critical Technologies For Fast Quality Control System Construction During The Manufacturing Processes Of Two Characteristic Traditional Chinese Medicine

As Tu won the 2015 Nobel prize,the internationalization of traditional Chinese medicine(TCM)has promoted by the national strategic layout of "Belt and Road".Despite the rapid development of the TCM industry,the quality detection and control methods of TCM are relatively backward due to the complexity and instability of the TCM production process.Therefore,it’s hard for the quality assurance of TCM.So to some extent the internationalization of the TCM industry is restricted.Hence,it is a major scientific frontier issue how to apply modern scientific theories and high-technology tools for TCM research,especially comprehensive study of TCM quality control system.The key factors of TCM quality control,from raw medicine to production,include strengthening basic research,improving the quality control techniques and establishing the quality control system of TCM.In recent years,the rapid analysis techniques,such as spectroscopic technique combined with chemometrics methods,especially near-infrared spectroscopy(NIRS).NIRS technique is relatively mature and reliable for the quality control of TCM.This study specifically includes the following aspects:(1)Take the manufacturing process of Shu-Xue-Tong(SXT)injection as one of research objects,NIRS was applied for the rapid construction of quality control system of the production process.Mahalanobis distance(MD),studentized residual-leverage value(LD)and principal component scores diagnostic(PCSD)methods were used for outliers detection.The contents of soluble solids(SSC),hypoxanthine(HX),polysaccharide(PS)and polypeptide(PP)were as the quality control indicators.The quality control systems of the raw materials of leech and earthworm,the extraction process,the freezing and thawing(F&T)process and the membrane filtration process were built respectively.This paper was about the research of animal medicines(leech and earthworm),which was relatively backward compared with the study of plant medicines.Using modern science and technology to control the quality of animal medicine was better to make animal medicines modernization and internationalization.The result showed that the combination of MD,LD and PCSD can be used to diagnose outliers comprehensively.The established NIRS models can be used for the quantitative analysis of the quality control indexes,and the models were stable and reliable.(2)The rapid quality control system for the production process of Qi Jiao Sheng Bai(QJSB)capsule was studied.With icariin,astragaloside IV,total flavonoids(TF)and total saponins(TS)as the quality control indexes,the rapid quality control systems of raw materials of epimedium and astragalus,extraction and concentration process were established,respectively.For the quality control of raw materials,based on NIRS and middle infrared spectroscopy(MIRS)technologies,the contents of icariin,astragaloside IV,TF and TS were analyzed.Consequently,models established from the data integration of NIR and MIR(NIR+MIR)were more excellent,which correlation coefficient were all above 0.99.MIRS was not suitable for samples with water as solvent,so the rapid quality control system of extraction process was constructed by NIRS only.The rapid quality control system of concentration process was constructed by NIRS and MIRS,based on the contents of density,icariin,TF and TS as the quality control indexes.The results showed that the performance of the NIR+MIR models was better than NIR models and MIR models,which was in accordance with the conclusion of the quality control system of epimedium and astragalus.