Study On The Identification And Quality Evaluation Of Zuogui,Yougui And Jisheng Shenqi Pills

Traditional Chinese compound formula is the maior prescription form for clinical applications in Chinese medicine, and it possesses the advantages of curing complex human diseases and light side effects. It is gradually popular with all people in the world. Traditional Chinese compound formula is a kind of complex biological system. It usually consists of up to tens of herbal medicines, and contains thousands of chemical components which are changeable easily, so its exact quality estimation and control is a difficult and significant subject. On the other hand, traditional Chinese compound formula belongs to black system, since usually different formula products with the same dosage form have no significant difference in their appearance, we can not distinguish them from each other and estimate their quality by their appearances. At present, the identification and quality evaluation study of traditional Chinese compound formulae are of greatly theoretical significance and application value.For the moment, there are many research methods applied to identification and quality evaluation of traditional Chinese compound formulae. In them Visual comparison and Pattern recognition are the two commonly used methods. Pattern recognition method includes supervised pattern recognition and unsupervised pattern recognition. Supervised pattern recognition usually relies on standard samples, reference samples or prior experience. This method is only suitable to white and gray systems, but not suitable to black systems, in which the recognition and quality evaluation study of traditional Chinese compound formulae are involved. Unsupervised pattern recognition does not need standard samples or prior experience, but it can only be applied to clustering samples, is not suitable to classify samples with a certain standard. Dual-index grade sequence cluster analysis method and (?)Sr grade sequence analysis method applied in this paper possess the advantages of both supervised and unsupervised pattern recognition methods. They can perform clustering and classification simultaneously without prior knowledge. In addition, (?)Sr sequence analysis method makes results more accurate and objective, owning to both position information of peaks and content information of components in fingerprints. Therefore, this method has greater distinguish ability than Dual-index grade sequence cluster analysis method which is only according to position information of peaks, and it was more suitably used to analyze chromatographic fingerprints.Zuogui pills, Yougui pills and Jisheng shenqi pills are three well-known traditional Chinese compound formulae which can cure kidney disease. Zuogui pills comprise eight kinds of herbal medicines, Yougui and Jisheng shenqi pills are both constituted of ten kinds of herbal medicines, in which six kind herbal medicines--Radix Rehmanniae Praeparata, Fructus Corni, Radix Aconiti Lateralis Praeparata, Fructus Lycii,Cornu Cervi and Semen Cuscutae are included in both Zuogui and Yougui pills and five kinds of herbal medicines-Radix Rehmanniae Praeparata, Fructus Corni, Radix Aconiti Lateralis Praeparata, Cortex Cinnamomi, Rhizoma Dioscoreae are contained in both Yougui and Jisheng shenqi pills, respectively, which possess high similarity in ingredients. This paper has studied the identification and quality evaluation of these three kind traditional Chinese compound formula products.In this study, the systematic solvents (followed by chloroform, ethanol and water) were employed to extract Zuogui pills, Yougui pills and Jisheng shenqi pills, in order to obtain their extracts existed in different polarity range. The infrared fingerprint of these extracts and original drug powders of the three kind traditional Chinese compound formulae were measured, and HPLC,1H-NMR fingerprints of components extracted with ethanol were carried out. In the analysis of FTIR fingerprint, dual-index grade sequence cluster analysis method was applied to the identification and quality estimation of Zuogui and Yougui pills, Yougui and Jisheng shenqi pills, respectively. In the identification of Yougui and Jisheng shenqi pills, a new Visual comparison was put forward, which improved the traditional Visual comparison method. In this method, the exclusively characteristic peak groups of these two kind formulae were theoretically established based on the normal distribution, and the characteristic radicals, compound species corresponding to each characteristic peak were determined. Meanwhile, EDS fingerprint spectra of the two kind original powders were also measured which can reflect the many kind element species, such as C, O, metal atoms, and their content information. Based on the three kind information (characteristic peak groups, radicals and compound species, different elements), Yougui and Jisheng shenqi pills were identified quickly, precisely and reliably. In the analysis of HPLC and 1H-NMR fingerprints, both dual-index grade sequence cluster analysis method and/or (?)Sr grade sequence analysis method were adopted to identify and evaluate the quality of Zuogui, Yougui and Jisheng shenqi pills. This thesis is divided into five sections:Chapter 1:Both methods, Technical methods of constructing fingerprint and data analysis methods, are reviewed based on about hundred literatures. On the other hand, prescriptions of Zuogui pills, Yougui pills and Jisheng shenqi pills, and the main chemical components of each herbal medicine contained in the prescriptions are outlined. The analysis methods employed in this thesis and innovation in them were introduced.Chapter 2:Dual-index grade sequence cluster analysis method was adopted to analyze infrared fingerprint of Yougui and Jisheng shenqi pills. The results show that this method can accurately distinguish these two kinds of traditional Chinese compound formulae which have the similar composition. The results of three systematic solvents extracts and the original drug powders are all reasonable and reliable. Meanwhile, a new Visual comparison was built up, which improved the traditional one. In this method, based on the characteristic peak groups and radicals and compound species corresponding to each characteristic peak in FTIR fingerprint, and the some kind element species and their content information in EDS fingerprint, Yougui and Jisheng shenqi pills were identified quickly, precisely and reliably.Chapter 3:Dual-index grade sequence cluster analysis method was employed to analyse infrared fingerprint of Yougui and Jisheng shenqi pills. The results show that this method can accurately distinguish these two kinds of traditional Chinese compound formulae which occupy the similar composition. The results of chloroform extracts, ethanol extracts and the original drug powders are more reasonable and reliable, in which the result of the original drug powders is the best.Chapter 4:Dual-index grade sequence cluster analysis method and (?)Sr grade sequence analysis method were used to analyze HPLC fingerprint of ethanol extracts of Zuogui, Yougui and Jisheng shenqi pills. The results show that (?)Sr grade sequence analysis method can more accurately identify these three kind of traditional Chinese compound formulae than dual-index grade sequence cluster analysis method. This method is according to both location information of peaks and content information of components in fingerprints, and it was suitably used to analyze chromatographic fingerprints.Chapter 5:Dual-index grade sequence cluster analysis method was used to analyze 1H-NMR fingerprint of ethanol extracts of Zuogui, Yougui and Jisheng shenqi pills. The results show that this method can accurately identify these three kind of traditional Chinese compound formulae. The results of fingerprints in the range of 8 <4.2 is better than that 8>4.2.