| The quality control and evaluation for Traditional Chinese Drugs (TCD) have always been a difficult and focal point in the research of TCD modernization. The current pattern and method of the quality control and evaluation for TCD, which is mainly based on the theory "Only Component", could hardly effectively control and reflect its safety and efficacy. To seek a new breakthrough to settle that problem, the pattern for the quality management of biological products was introduced to refer. TCD Cordyceps was studied as a mould due to its medicinal value,universal usage in clinic and no clarity of chemical components to establish a pattern and method of the quality control and evaluation for TCD. This pattern and method which was based on bioactivity measurement could supplement and consummate the current system of the quality control and evaluation for TCD. The main results of research in this dissertation are as follows:1. Analyze and investigate the contents of 13 nucleosides and 2 oligosaccharide in the different samples of TCD Cordyceps and establish the chemistral fingerprints by using RP-HPLC and RP-HPLC-ELSD. The chemical characteristics about TCD Cordyceps were suggested to be reflected the discrepancy of above-mentioned investigations. On this basis, this chemical quality of pattern recognition methods has been established. Results showed that those chemical characteristics could discriminate TCD Cordyceps for better.2. To investigate the difference of immunologic competence on TCD Cordyceps in vitro by MTT colorimetric method and establish the detection method based on biological activity.the effects of natural Cordyceps sinensis and its cultured mycelia were investigated with lymphocyte proliferation induced by ConA in mice; the test data was studied by cluster analysis. Results:all the samples showed no obvious toxicity to splenic lymphocyte under the concentration of 0.36～11.52 mg/ml, and conspicuous proliferation under high concentration (>0.72mg/ml) (P<0.05).3.The investigation of metabolic action of Cordyceps sinensis and its cultured mycelia on Escherichia colie, stablish the detection method based on bio-thermodynamics method. With index of P1max and effective power(E), the test data was studied by cluster analysis. The results showed that Cordyceps sinensis and its cultured myceli can promote growth and metabolism of Escherichia coli as well as adjust the balance of intestinal microecology efficiently. Compared with the control group,when concentration>6.0 mg/ml, natural Cordyceps sinensis can promote the growth and metabolism of Escherichia coli efficiently (P<0.05)and have better dose-effect relationship with concentration(r> 0.9), its cultured mycelia donot show conspicuous auxoaction (P>0.05)and have no dose-effect relationship with concentration(r<0.6);When concentration<6.0 mg/ml, all samples donot show conspicuous auxoaction(P>0.05). The natural Cordyceps sinensis and its cultured mycelia can be distinguished by cluster analysis. Microcalorimetry show a good application prospect in the quality evaluation of the traditional Chinese medicine.4. The relevance of the test results has been analyzed comprehensively, conducted the chemical characteristics-biopotency information. Biopotency-biopotency information of the relevance analysis showed positive correlation (the correlation coefficient r=0.715, P<0.01) between the chemical characteristics and biopotency information; The biopotency information of MTT colorimetric method and bio-thermokinetics method showed the good correlation and consistency (the correlation coefficient r=0.924,P<0.01), It suggested that the two biopotency measurement methods can be used to supplement and consummate the quality control and evaluation for TCD Cordyceps.5. Compared with the relevance of Chemical analysis and biological evaluation methods, the relevance of different biological evaluation methods, the results showed that biological evaluation method can be used in TCD Cordyceps quality evaluation;The MTT colorimetric method and bio-thermokinetics method both can be used for TCD Cordyceps potency measurement. The systems of TCD Cordyceps quality evaluation and control were established preliminarily. So was the quality evaluation and control for TCD Cordyceps according to the common requirement of pharmacopoeia, analysis of multiple key components, and detection of biopotency. And the biopotency measurement method is the key of the quality control and evaluation for TCD Cordyceps.All above could be concluded that the new pattern and method demonstrated contribution and value to the quality control for TCD Cordyceps preliminarily. And it also offered a new view and technique reference for the quality control of other tonify's TCD. |
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