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The Quality Analysis Of Zhibai Dihuang Pills (concentrated Pills)

Posted on:2017-05-30Degree:MasterType:Thesis
Country:ChinaCandidate:H Y XieFull Text:PDF
GTID:2354330491962228Subject:Drug analysis
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This paper mainly study on the application of near-infrared(NIR)spectroscopy and HPLC fingerprinting for the quality analysis of Zhibaidihuang pills(condenseds).Considering the content,this paper is mainly talking about the following several parts:The first part is the quantitative analysis of common Anemarrhena Rhizome and Phellodendron Bark by near-infrared spectroscopy.Scan near-infrared spectral fingerprint of Anemarrhena Rhizome and Phellodendron Bark and examine the content of mangiferin,timosaponin B?,moisture in Anemarrhena Rhizome and berberine,phellodendrine,moisture in Phellodendron Bark according to the 2015 edition of Chinese pharmacopoeia.Associate the content with near-infrared spectral fingerprint and establish a quantitative model of by partial least squares(PLS)of chemometrics.The correlation coefficients(R~2)were 0.96361,0.97515,0.93301,0.99713,0.98923,0.96894.The root-mean-square error of calibration(RMSEC)were 0.0616,0.0942,0.186,0.0823,0.0215,0.132.The root-mean-square error of predication(RMSEP)were 0.0881,0.080 0,0.065,0.071 7,0.016 6,0.171.The root-mean-square error of cross-validation(RMSECV)were 0.11477,0.36920,0.23406,0.22934,0.05657,0.30031.The Performance Index(PI)were 89.6,91.0,90.8,95.6,93.5,98.0.The second part was the application of near-infrared spectroscopy in quantitative and quanlitative analysis of Zhibaidihuang pills(condenseds).In the qualitative aspects,first discriminant analysis model was applied to identify the samples of three different manufacturers of A,B,C.The discriminant analysis model was succesful,it can accurately distinguish the samples of three different manufacturers.Then discriminant analysis model was applied to identify the overdue and not overdue samples Producing by the manufacturer of A.The discriminant analysis model was succesful,it can accurately distinguish the overdue and not overdue samples.In the quatitative aspects,establish a quantitative calibration model of loganin,paeonol and moisture of Zhibaidihuang pills(condenseds).The correlation coefficients(R~2)were 0.97948,0.99122,0.98875.The root-mean-square error of calibration(RMSEC)were 0.0153,0.0305,0.0893.The root-mean-square error of predication(RMSEP)were 0.00972,0.0223,0.0917.The root-mean-square error of cross-validation(RMSECV)were 0.01909,0.04997,0.22816.The Performance Index(PI)were 97.6,94.8,90.0.The third part was the study of HPLC fingerprinting of Zhibaidihuang pills(condenseds).Through the study of the method of extraction,chromatographic conditions,the methods of the analysis of HPLC fingerprinting of Zhibaidihuang pills(condenseds)is determined,and the samples of three different manufacturers of A,B,C were analyzed.The results showed that the similarity of the samples of three different manufacturers was above 0.86,it showed that all of the samples of three different manufacturers were stable.From each HPLC-Reference Chromatogram of the samples of three different manufacturers it showed that there had a certain disparity which was the same as the result of qualitative analysis by NIR,while NIR method was more fast,simple.Analysis the HPLC fingerprinting of the overdue and not overdue samples Producing by the manufacturer of A,it showed that the similarity was above 0.90,so it was difficult to identify the overdue and not overdue samples by HPLC fingerprinting method.However,it can be identified by near-infrared spectroscopy accurately and efficiently.The four part was the study of the stability of Phellodendron Bark.Put Phellodendron Bark in climate chamber,set different temperature,humidity,time and wrapper,and set three levels for each factor,then the orthogonal experiment list of three factors and three levels was set up.According to the changes of the content of Major components and the HPLC fingerprinting of Phellodendron Bark,the influence of temperature,humidity,time and wrapper in Phellodendron Bark was get,and the reference of reasonable reserve of traditional Chinese medicine was presented.
Keywords/Search Tags:Zhibaidihuang pills(condenseds), Anemarrhena Rhizome, Phellodendron Bark, quality analysis
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