Studies On Quality Control Methods For Chinese Medicinal Materials And Macroporous Resin Purification Process Based On Near Infrared Spectrometry

Currently,traditional Chinese medicine(TCM)industry is in the transition stage from empirical development towards engineering production,and a number of problems are arising,such as the different quality of raw materials,the lack of quality control standards and scientific techniques during the whole manufacturing process.Those problems have seriously restricted the development of the TCM industry.Therefore,there are impressive needs to improve the quality control means and establish rapid quality evaluation standards for TCM production process.The quality control of raw materials is the starting work of production processes.However,Chinese medicinal materials are susceptible to species,origin,harvesting season and other natural factors.Traditional quality control method,including morphological identification and physical and chemical test methods,demand high personnel abilities,and can not achieve rapid analysis of effective compositions.Macroporous resin purification process is an important refining method in purifying TCM preparation,guaranteeing the good quality of intermediate products,thus ensuring qualified final products.However,the start and end points determination of elution process is usually based on empirical foundations,lacking a real-time detection of the main quality indexes during processes,as well as scientific quality assessment.Process analytical technology(PAT)combined with chemometrics have been widely used in the quality control of raw materials and the whole manufacturing process in recent years.In this study,Rhizoma paridis,Panax notoginseng,toad skin and macroporous resin elution process of Panax notoginseng were taken as research objects,and analytical methods based on near-infrared spectroscopy(NIRS)were developed to ensure the quality of raw and in-process materials,which was meaningful for enhancing the quality of final products.The main research contents and achievements are as follows:(1)NIRS was applied to establish the quantitative models for determining saponins and moisture in Rhizoma paridis.The results showed that the methods could rapidly and accurately detect the contents of Rhizoma Paridis saponins and moisture,relative standard errors of prediction(RSEP)values for both models were less than 10%.Meanwhile,the methods were employed to the real-time release testing(RTRT)of Rhizoma paridis with 100%accuracy.(2)NIRS was used for quantitative analysis of notoginsenoside R1,ginsenoside Rgi,ginsenoside Rb2,and moisture in Panax notoginseng.The results showed that the established models could rapidly and accurately detect the contents of index components in Panax notoginseng,RSEP values for all five models were less than 13%.Meanwhile,the models for moisture and the total contents of three saponins were helpful to distinguish the qualified and unqualified samples,the accuracy of RTRT was 100%.(3)A high performance liquid chromatography(HPLC)and spectrophotometry methods for determination of main effective components in toad skin were established.Meanwhile,NIRS was employed to establish overall models and hierarchical models for total toad lactone and indole alkaloid.The results showed that the prediction accuracy of hierarchical models was superior to overall models,R2 of hierarchical models were higher than 0.95.(4)NIRS was applied for detecting the content of Panax notoginseng saponins:(PNS)during macroporous resin elution process.The results showed that the established method could reflect PNS concentration change and help determine the·start and end points of elution process,R2 of PNS model was higher than 0.98,residual predictive deviation(RPD)value was higher than 8,which contributing to achieving the automation control of manufacturing processes.