RESUMO
Objective:To explore the chemical and biological assay pattern for the quality control and evaluation of Chinese mate-ria medica solid preparations ( CMMSP) . Methods:Compound berberine tablets were used as the model drug, the inhibition against sensitive strains of the dissolution solution at different time points was studied with water as the dissolution medium, and the cumulative dissolution of compound berberine tablets was obtained based on the bacterial inhibitory rate. The dissolution of hydrochloric acid ber-berine was also determined by HPLC, and a f2 similar factor method was used to evaluate the relevance of the two methods. Results:The antimicrobial test showed that berberine was sensitive to escherichia coli,staphylococcus aureus, bacillus subtilis, micrococcus luteus and candida albicans etc, and among them, the antibacterial circle edge of bacillus subtilis was clear with higher sensitivity. The disso-lution curve of compound berberine tablets determined by HPLC as the reference, the similarity factor f2 of bio-dissolution curve of com-pound berberine tablets from 7 different manufactures was greater than 50, which suggested that the dissolution determination method based on biological titer determination could comprehensively reflect the bioavailability of compound berberine tablets. Conclusion:The biological activity evaluation method for dissolution is expected to be one of the effective means for in vitro dissolution test of CMMSP.
RESUMO
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.