Research Of Spectrum-Effect Related Evaluation System Based On Alkaloid Components In Tong Bi Capsule

Objective: To evaluate the quality of TongBi Capsule more scientificly,the spectrum-effect related quality evaluation model was applied to study the correlation between HPLC fingerprint of alkaloid components in TongBi Capsule and the inhibiting effect on the synovial fibroblasts. The data of HPLC fingerprint was related analyzed with the data of pharmacodynamic. The mathematical model of TongBi Capsule was established by related analysis, to evaluate the quality of TongBi Capsule scientificly from the perspective of alkaloid components.Methods:Alkaloid components in TongBi Capsule was piecewise processed by the difference of chemical polarity wih the use of silica gel column chromatography. The HPLC fingerprint of alkaloid components in TongBi Capsule was built by high performance liquid chromatography technique. The synovial fibroblasts were cultured in vitro, and the growth inhibition model of MH7 A cells was established. The content of rheumatoid factor(RF) in the supernatant of cell culture was determined, and the content of RF as an index was used to evaluate the pharmacodynamic effect of alkaloid components in TongBi Capsule.Using the method of least squares vector machine, HPLC fingerprint of alkaloid components in TongBi Capsule was related analyzed with pharmacodynamic data, and the model was established and verified. From the perspective of alkaloid components, the quality evaluation system was established. The pharmacodynamics effect of TongBi Capsule can be evaluated by the determination of HPLC fingerprint through the system.Result: 13 batches of samples were collected. The samples were prepared with ammonia solution and ethyl ether as solvent. The test solution was flushed in alkaline silica gei column,gathering part of ethyl acetate flushing.The method of HPLC fingerprint of alkaloid components were established by researching methodology. The HPLC fingerprints of 13 batches of samples were measured and 22 peaks were selected as the common peaks. The growth inhibition model of MH7 A cells was established, and the content of RF in the supernatant of the 13 groups was measured. Using method of least squares vector machine, the data of pharmacodynamic were correlated with the data of HPLC fingerprint in TongBi Capsule, and the mathematical model of spectrum-effect was established. Through the mathematic model, when the data of the HPLC fingerprint of alkaloid components in TongBi Capsule were inputed, the data of efficacy can be obtained.Conclusion: Through the mathematical model of spectrum-effect, The quality of TongBi Capsule can be predicted by measuring the chemical constituents of the drug, and the aim of scientific, objective, comprehensive evaluation can be realized. The establishment of the mathematical model of alkaloid components is the scientific basis and data support for the establishment of the comprehensive establishment of the spectral-effect quality evaluation system of TongBi Capsule.