| Chinese materia medica solid preparations (CMMSP) has a long and extensive application history in China. However, lack of effective, reliable quality evaluation technology of traditional Chinese medicine solid preparations at present. In the Chinese Pharmacopoeia, quality control methods are one or several indicators to be selected to detection. For the chemical drug composition and structure is clear, assay results associated with effectiveness and safety. But as Traditional Chinese medicine, only one indicator cannot evaluation of the overall efficacy. So quality control has been one of the most important and difficult issues for the modernization of Chinese materia medica solid preparations.Dissolution can detect ingredients of drugs to control intrinsic quality. It is a necessary quality control program of production processes. There are few studies of CMMSP dissolution and inherent quality. Some indicators are unreasonable. Efficacy biological potency detection method can reflect the efficacy better, but it is not suitable for widely applications.According to its main effect of liver fibrosis, hepatic stellate cells LX-2cell model was Selected.MTT assay was used to obtain the characteristic cell inhibition rate by Compound Biejia Ruangan Tablet (CBRT) dissolving solutions in PBS dissolution medium with pH7.4for different time periods. From these results, the cumulative dissolution of CBRT based on cell inhibitory rate. The dissolution rates of paeoniflorin, phillyrin, and ginsenosides Rg1were determined by HPLC method. A novel approach of self-defined weighting coefficient based on the quality had been created to establish the integrated dissolution rate model. Then f2similar factor method was used to evaluate the relevance of these two methods. Ths f2values for paeoniflorin, phillyrin, and ginsenosides were43,58,61, and59, respectively. It was indicated that the dissolution of multi-component integration could more fully reflect the biological potency of all parties.To explore the chemical-biological assay pattern of CMMSP in vitro dissolution. The biological activity-multicomponents integrated evaluation method of dissolution is expected to be one of the effective means for in vitro dissolution test of CMMSP.CBRT has good curative effects and is widely used. Because of lack Cordyceps, CBRT need to replace it with Cordyceps powder. In order to assess the curative effect of new CBRT and original CBRT. The f2similar factor method was used to evaluate the relevance of these two biological curves. The f2value was65. It state that biological curves could be used to evaluate CMMSP after change the constituent. |
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