With Berberine Quality Of Chinese Herbs Biological Evaluation And Control Of A Preliminary Study

The quality control and evaluation for Traditional Chinese Drugs (TCD) have always been a difficult and focal point in the research of TCD Modernization. However, 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 which contained berberine was studied as a mould due to its universal usage in clinic and relative 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 biopotency measurement could supplement and consummate the current system of the quality control and evaluation for TCD.Objective:Based on biopotency measurement, to establish a method of the quality control and evaluation for TCD which contained berberine could supplement and consummate the current system of the quality control and evaluation.Methods:1. The contents of three kinds of alkaloids such as berberine and the chemistral fingerprints in the different samples of Cortex Phellodendri, Cortex Phellodendri Amurene, Coptis Chinensis and Radix Berberidis were analyzed and investigated by using RP-HPLC.2. The cup-plate method and bio-thermokinetics method were used to comparatively detect the antiblastic activity of the samples which contained berberine. And the antibacterial potency testing methods of TCD have been established.Results:1. The chemical characteristics about TCD which contained berberine 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 be applied in the research of the quality control and evaluation for TCD which contained berberine.2. The reference materials of berberine hydrochloride and the samples of TCD with berberine within certain concentration range, between the dose and the parameters of antibacterial circle diameter D and the parameter T_max² showed good dose-effect relationship (r>0.99). It could be concluded that bioactivity or biopotency of TCD which contained berberine could be evaluated and control according to the cup-plate method and the bio-thermokinetics method as objective and effective means. The biopotency of Cortex Phellodendri, Cortex Phellodendri Amurene, Coptis Chinensis and Radix Berberidis under the limits were 70 U/g, 15 U/g, 440 U/g and 30 U/g tentatively, and the confidence rate should not exceed 10 percent.3. The relevance of the test results has been analyzed comprehensively, conducted the chemical characteristics-biopotency information, biopotency - biopotency information of the relevance analysis showed that: between the chemical characteristics and biopotency information showed significantly positive correlation (the correlation coefficient r=0.8517, P<0.01); The biopotency information of cup-plate method and bio-thermokinetics method showed the good correlation and consistency (the correlation coefficient r=0.9861, 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 which contained berberine.4. 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 which contained berberine quality evaluation; The cup-plate method and bio-thermokinetics method both can be used for TCD antimicrobial potency measurement. The systems of TCD which contained berberine quality evaluation and control were established preliminarily. So was the quality evaluation and control for TCD which contained berberine according to the common requirement of pharmacopoeia, analysis of multiple key components, and detection of biopotency. And the biopotency measurement method is the core of the quality control and evaluation for TCD.Conclusion:According to above-mentioned results, it could be concluded that this new pattern and method demonstrated its contribution and valued for the quality control for TCD which contained berberine preliminarily. And it also offered a new view and technique for the quality control of other TCD.Innovation:In this article, TCD which contained berberine was studied as a mould to detect this antibacterial potency by the cup-plate method and the bio-thermokinetics method firstly. The biological evaluation method of TCD has been established preliminarily. And it offered a view and technique for supplement and consummate the current system of the quality control and evaluation for TCD.