In vitro dissolution of Chinese materia medica solid preparation based on biological activity-multicomponents integration / 中草药

ABSTRACT

Objective: To explore the chemical-biological assay pattern for quanlity control and evaluation of Chinese materia medica solid preparations (CMMSP). Methods: MTT assay was used to obtain the characteristic cell inhibitory rate on LX-2 hepatic stellate cells by Compound Biejia Ruangan Tablet (CBRT) dissolving solutions in PBS dissolution medium with pH 7.4 for different time periods. From these results, the cumulative dissolution of CBRT was obtained based on the cell inhibitory rate. The dissolution rates of paeoniflorin, phillyrin, and ginsenosides Rg1 were 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 f2 similar factor method was used to evaluate the relevance of these two methods. Results: The f2 values for paeoniflorin, phillyrin, ginsenosides, and the integration dissolution were 43, 58, 61, and 59, respectively. It was indicated that the dissolution of multicomponent integration could fully reflect the biological potency of all parties. Conclusion: 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.