Studies On Quality Standards For Yin-ning Tablets

Objective: To establish an eligible qualitative and quantitative analysis system of Yin-ning tablets for better quality control.Methods: radix astrogali,angelicae sinensis,T.hypoglacum(Levl.) Hutch,fructus schisandrae were identified by TLC method .HPLC was developed to determined the astragaloside IV and epicatechin in the main drug of the preperation.IC was used for the content of amino acid in the preparation.The general inspection to this preparation was carried on.Results: In the identification test there is the same colour speck in the preperation chromatograms as that in the reference and the blank test showed no interference. The astragaloside IV showed a good linear relationship in the concentration range of 0.6～7.5μg(r=0.9996). The average recovery rate was up to 98.0 %, RSD was 1.3%. The linearity of epicatechin was good in the concentration range of 5～100μg/ml(r=0.9997). The average recovery rate was 98.0 % with RSD =1.3%. The content of the astragaloside IV in each tablet was not required lower than 70μg and the content of epicatechin not lower than 0.15mg.The content of amino acid in the preparation reached as high as 38%.In the general inspectin,disintegration time limit and tablet weight difference conform to the stipulation.Conclusions: The established methods were simple, reliable, accurate and specific.They can be applied to the quality control for this preparation.The quality...