Quality Control Methods For The Manufacturing Process Of Traditional Chinese Medicine Based On Near Infrarced Spectroscopy

Traditional Chinese Medicine(TCM)industry is now at the crucial period of transformation and upgrading from empirical development towards intelligent production.However,some problems still exist in the manufacturing process of TCM such as the great quality variation of raw materials,the rough production mode and the delayed measurement.And there is lack of effective quality control methods and on-line monitoring techniques.These problems lead to the unstable and uneven quality of TCM products and have seriously restricted the development of the TCM industry.As a high and new technique,the near infrared spectroscopy(NIRS),with the advantages of rapid,economy and non-destructive,has shown its potential in the quality control of manufacturing process of TCM.NIRS can be used for on-line process monitoring,which help us to better understand the key production processes and ensure the TCM quality.Toward the present situation that the TCM quality control level is not high,this thesis introduced NIRS in the TCM manufacture,and comprehensively investigated the application of NIRS coupled with chemometrics or statistical process control(SPC)on the quality control for the manufacturing process of TCM.This study provided a powerful tool for real-time analysis and process monitoring of TCM manufacture.The main works are included as follows:1.Taking the NIR quantitative analyzing method of Radix paeoniae Alba as the study subject,we strictly verified the reliability of NIR quantitative models.The quantitative models were validated in terms of specificity,linearity,accuracy,repeatability,intermediate precision and robustness,according to the guidelines of International Conference on Harmonization(ICH)and Food and Drug Administration(FDA).In addition,the impact of various factors(operational and ambient)including the number of subsamples,sample temperature,ambient temperature,ambient humidity,preheating time and lamp aging on the robustness of NIR quantitative models were examined.Three significant factors were indentified and the robustness of the NIR method was optimized.2.Numerous efficient chemometrics methods have been widely used in many research fields,however,the traditional data-processing software only includes a few common methods.In this thesis,the NIRS combined with novel chemometrics was applied to rapidly detect the quality of Herba Epimedii,on-line monitor the exreaction process of Flos Lonicerae Japonicae,and on-line monitor the concentration process of Wangbi tanblets.The successful applications of on-line NIR for process monitoring were conductive to intelligent quality control of TCM.Furthermore,we explored the algorithms.The effect of the genetic algorithm(GA),competitive adaptive reweighted sampling,synergyi nterval partial least squares(Si-PLS),and support vector machine on the model performance was studied.A new algorithm of Si-PLS with GA(Si-GA-PLS)was proposed for modeling.3.The application of NIRS combined with SPC on the quality control for the manufacturing process of TCM was investigated.First,the influence factors of NIR spectra such as the resolutions,scan numbers,sample particle sizes,and sample drying time were examined.The method for fast quality consistency evaluation of the raw herbal materials based on NIRS was presented.Second,the NIRS and SPC were used for real time release testing of the extraction process of Flos Lonicerae Japonicae.The evaluation criteria of quantitative and qualitative models were constructed,which can accurately identify the normal and abnormal batches.Third,NIRS coupled with MSPC technique were applied to establish the statistical model.Three kinds of multivariate control charts(PC scores,Hottelling T2 and DModX)were used to monitor the abnormal variations caused by the change of starting material quality attributes and abnormal operation conditions.The NIRS combined with MSPC can be successfully applied to the extraction processes of Flos Lonicerae Japonicae,which is of great significance for the improvement of the quality control of TCM.