Study On The Identification And Quality Evaluation Of Buzhong Yiqi Pills And Shiquan Dabu Pills

Traditional Chinese compound formulae are the main prescriptions forms for clinical application of Chinese medicine. They are composed of many herbal medicines and have extremely complex components. Their dosage forms mostly are pills, powders, ointments, pellets, and injection agents et cetera. Usually different Traditional Chinese compound formula products with the same dosage form have no significant difference in their appearance. Most herbal medicines are plants, only a small number of components have been identified. Therefore, in a whole, Traditional Chinese compound formulae are complex black systems of biology. Their identification and quality evaluation study is of greatly theoretical significance and application value.Currently, visual comparison, similarity analysis, cluster analysis, principal component analysis, SIMCA and other methods are used in the study of Chinese traditional medicine fingerprint for their identification and quality evaluation. These methods are unable to achieve clustering and classification simultaneously, if there are no learning samples or no empirical knowledge related to samples analyzed.In this study, we established a method called (?) Sr grade sequence analysis method based on dual-index (common peak ratio and variant peak ratio) grade sequence cluster analysis method and (?) Sr sequence analysis method, and it was used to analyze chromatographic fingerprint suitably. This method can perform clustering and classification simultaneously without prior knowledge, as the same as dual-index grade sequence cluster analysis method. In addition, this method makes result more accurate and objective, owing to both location information of peaks and content information of components in fingerprint being used to characterize the similarity between different samples. This method can more accurately reflect the similarities and differences between Traditional Chinese compound formulae, and is able to realize the identification and quality assessment of Traditional Chinese compound formula products. In this thesis, dual-index grade sequence cluster analysis method and (?) Sr grade sequence analysis method were applied to analyzing two kind Traditional Chinese compound formula products-buzhong yiqi pills and shiquan dabu pills, depending on infrared fingerprint and HPLC fingerprint, respectively.Prescriptions of both buzhong yiqi pills and shiquan dabu pills comprise ten kinds of herbal medicines, in which, five kinds of herbal medicines-herbs-astragalus (Honey), licorice (Honey), Codonopsis, Atractylodes (fried) and Chinese angelica, are contained in both of them. Therefore, these two kind Traditional Chinese compound formula products possess high similarity in ingredients. It is more difficult to conduct identification and quality evaluation of them.In this study, the systematic solvents (followed by chloroform, ethanol, water) were employed to extract buzhong yiqi pills and shiquan dabu pills, in order to obtain their extracts existed in different polarity range. The infrared fingerprint of these extracts and original drug powders of the two kinds of Chinese traditional herbal formulae were measured, and HPLC fingerprint of components extracted with ethanol were carried out. Dual-index grade sequence cluster analysis method was used to analyze four categories (chloroform extracts, ethanol extracts, water extracts, the original drug powders) infrared fingerprint of samples. Dual-index grade sequence cluster analysis method and (?) Sr grade sequence analysis method were adopted to analyze the HPLC fingerprint. This thesis is divided into four chapters:Chapter 1:Technical methods of Constructing fingerprint and data analysis methods, are reviewed, which mostly used in the study of Chinese traditional medicine fingerprint. The characteristics of different analysis methods were analyzed, and (?) Sr grade sequence analysis method was established. On the other hand, Prescriptions of buzhong yiqi pills and shiquan dabu pills, and the main chemical components of each herbal medicine contained in the Prescriptions are outlined.Chapter 2: Dual-index grade sequence cluster analysis method was adopted to analyze infrared fingerprint of buzhong yiqi pills and shiquan dabu pills. The results show that this method can distinguish between buzhong yiqi pills and shiquan dabu pills that have high similarity in ingredients, perfectly. The results of chloroform extracts, ethanol extracts and the original drug powders are better. Systematic cluster analysis method was adopted to analyze infrared fingerprint of ethanol extracts of buzhong yiqi pills and shiquan dabu pills, in order to compare the results obtained with Dual-index grade sequence cluster analysis method.Chapter 3:The methods used in chapter two were adopted to analyze shiquan dabu pills from three manufacturers. The results show that, the same kinds of Traditional Chinese compound formula products from different manufacturers can be identified with dual-index grade sequence cluster analysis method, and the systematic cluster analysis method can not give a definite classification of the samples.Chapter 4: Dual-index grade sequence cluster analysis method, (?) Sr grade sequence analysis method and similarity analysis methods were adopted to analyze HPLC fingerprint of ethanol extracts of buzhong yiqi pills and shiquan dabu pills. The results show that, only the (?) Sr grade sequence analysis method can identify these two similar Traditional Chinese compound formula products, more accurately.(?) Sr grade sequence analysis method established in this thesis make use of both the position and area information of chromatographic fingerprint peaks, and is more suitable for the analysis of HPLC fingerprint of Traditional Chinese compound formulae.