Quality Evaluation And Control Of Yinhuang Granules By Near Infrared Spectroscopy Technology

The chinese pharmaceutical process analysis technology is important for ensuring thequality of traditional Chinese medicine,and also important for achieving the internationalizationand the modernization of Production process. It is not suitable for traditional methods to analyzeplenty of samples fastly because of the trival pretreatment, the time-consuming and the highrequirement for instrument and operator.Besides,because the traditional methods were Offlineand lagged,so it is difficult to enture the Uniformity and stability of drug and direct practicalproduction.Near infrared spectroscopy(NIR) technology as a kind of new and"green"analysistechnology,Near infrared spectroscopy technology is simple,quick,non-destructive andpollution-free,and also could be used for on-line monitoring.In this paper,with Yinhuanggranules and scutellaria extract as the object,we established Process analysis technology withNear infrared spectroscopy technology as the core,and researched the quick analysis and on-linemonitoring of quality control parameters in TCM production process.There are two parts in thestudy:The first part,with Yinhuang granules as the object,we study the application of nearinfrared spectroscopy technology in the part of quick quantification analysis and manufacturersidentify qualitative analysis.The100Yinhuang granules samples were from19differentpharmaceutical factories.The Spectral date were collected and the content data were determinedwith the method indexed by “Chinese Pharmacopoeia”,and the quantitative analysis models ofbaicalin and chlorogenic were established combining Chemometrics methods. Through thestatistical test,there was no statistical differences between NIR values and HPLC values.Inaddition,we established qualitative analysis models with44Yinhuang granules samples from3different pharmaceutical factories.For the discriminant analysis model,the classificationprecision of calibration set and the forecasting precision of validation set were all100%; for clustering analysis model,44samples were clearly and correctly gather into three categories,andit verified the accuracy of the discriminant analysis model.The result showed that the nearinfrared spectroscopy technology could be used in the quick quantification analysis andmanufacturers identify qualitative analysis of Yinhuang granules.The second part,the100scutellaria extract samples were from11different pharmaceuticalfactories,and the quantitative analysis models of baicalin, baicalein and wogonin wereestablished with the near infrared spectroscopy technology. The correlation coefficients ofcross-validation(R2) of the models were0.9948,0.9987and0.9948, the correlation coefficientsof prediction(r2) were0.9882,0.9966and0.9912.The result showed that the near infraredspectroscopy technology could Comprehensively analyze the overall quality of scutellariaextract.With Yinhuang granules and scutellaria extract as the object,we established，we set up anew method to evaluate TCM combining with the near infrared spectroscopy technology,it issimple,quick,non-destructive and pollution-free.The method could quickly analyze the overallquality, and achieve the Online monitoring and control in TCM production process. Therefore,the near infrared spectroscopy technology has broad development prospects in themodernization of traditional of TCM.