| Objective:To optimize the conditions of the extraction technology for total flavonoids in Coreopsis tinctoria Flowers, and study on preparation of extraction and purification of total flavonoids; To optimize the optimal formula for flavonoids dispersible tablets of Coreopsis tinctoria Flowers,and establish the quality standards.Methods: Four factors were investigated including the ethanol concentration, the extraction temperature, the extraction time and the ratio of material to liquid by using single factor experiment. Based on the results of single factor experiments, the mathematical model was created by using Box-Behnken software response surface analysis and the regression equation was obtained by using variance analysis.With disintegration time,the surface morphology of tablet or soft materia preparation as indexes,the influences of different kinds of fillers,disintegrating agents,adhesives,lubricants and other accessories as well as the amount of disintegrants and combinationst on Coreopsis tinctoria Flowers total flavonoids dispersible tablets and the best prescription were determined by single factor tests and orthogonal design experiments. Using thin layer chromatography(TLC)to qualitatively IdentifyCoreopsis Tinctoria Flowers Flavonoids Dispersible Tablets,and using ultraviolet-visible to determine the content of total flavonoids in Coreopsis Tinctoria Flowers Flavonoids Dispersible Tablets.Results : According to the results of experiment and data analysis, The best optimum condition was 63% ethanol concentration,extraction 1.6 h, 1:42 ratio of material to liquid and extraction temperature 66 ℃. Under these conditions, the yield of flavonoids was 19.157%.Compared to the theoretical value 19.208%, the relative error was 0.27%. The regression equation fitted well with the actual situation.According to the results of single factor and orthogonal experiment,The optimal formulation was as follows:25%total flavonoids extracts of Coreopsis tinctoria Flowers,64%MCC,5%PVPP,5%L-HPC and 1% magnesium stearate,The disintegration time of dispersible tablet was( 63 ± 5) s. The qualitative identification spots of Coreopsis Tinctoria Flowers Flavonoids dispersible tablets were clear,and the identification results were accurate;The content determination results showed that average content oftotal flavonoids indispersible tablets was 68.10 mg/tablet.Referring to the related standards on dispersible tablets in the second part of CP2010,its weight difference,disintegration time, friability and dispersible uniformity all meeted the Pharmacopoeia;In this paper,the cumulative dissolution analysis method of Coreopsis Tinctoria Flowers flavonoids dispersible tablets was established.The pH=1.0hydrochloric acid solutionã€pH=4.0 acetate bufferã€pH=6.8 phosphate buffer solution and distilled water were investigated to determine the best dissolution medium,the results showed that the best dissolution medium was distilled water,the cumulative dissolution of dispersible tablets reached85% in 5 min,and the cumulative dissolution had reached more than 90% in 10 min.Conclusion:Using single factor combined with Box-Behnken response surface method to optimize the total flavonoids in Coreopsis tinctoria Flowers was feasible,and the model tallies matched to the actual experimental results,the deviation was low which verified the feasibility of the model,and the extraction yield of the total flavonoids could be improved by the best extraction technology;The preparation of Coreopsis Tinctoria Flowers Flavonoids dispersible tablets which had short disintegration time,good dispersible uniformity and fast dissolution rate.The quality standards of Coreopsis Tinctoria Flowers Flavonoids dispersible tablets were established,which method was scientific and reasonable,the operation was simple;The quality of dispersible tablets coud be controled by the quality standards,which made Coreopsis Tinctoria Flowers had good development and utilization value. |