Study On Preparation Technology And Quality Standard Of Compound Badanren Granule

Objects:(1):To evaluate the antitussive and antipyretic effects of compound Badanren extract granules and alcohol extract,and to determine the extraction site of compound Badanren.(2):Optimize the extraction process of compound Badanren.(3):Study on the molding process of compound Badanren granule.(4)Improve the quality standard of compound Badanren granule.Methods:(1):The antitussive and expectorant effects of compound Badanren water extract and alcohol extract in different doses were investigated by using the mouse model of ammonia-induced cough,sulfur dioxide induced cough,and mice model of tracheal phenol red emission.The antipyretic effects of different dosages of compound Badanren water extract and alcohol extract were investigated in rats with yeast-induced fever.(2):The extraction rate and gallic acid content were used for comprehensive evaluation,and using the single factor and orthogonal experiment to optimize the extraction process of compound Badanren.(3):According to the granulation situation,particle size and moisture absorption percentage,the best auxiliary materials,the best proportion of auxiliary materials,the best wetting agent and the binder were screened out by the single factor method,and the optimal prescription proportion was finally determined.(4):The free amino acids in granules were identified by indene trione chromogenic assay,the liquorice in granules were identified by TLC,and the contents of ammonium glycyrrhizate and gallic acid were determined by HPLC.Results:(1):Low,medium and high doses of compound Badanren both water extract and ethanol extract can significantly reduce the number of cough caused by ammonia water and sulfur dioxide in mice(P<0.05).The high doses of compound Badanren water extract can significantly increase the amount of tracheal phenol red excretion in mice(P<0.05).The low,medium and high doses of compound Badanren ethanol extrac can significantly increase the amount of tracheal phenol red excretion in mice(P<0.05).The high dose group of compound Badanren kernel water extract can significantly reduce the rats'fever caused by yeast(p<0.05),but the cooling effect of the water extract medium dose group,the alcohol extract medium dose group and the alcohol extract high dose group is not significant.(2):The optimal extraction process for screening is as follows:water is used as the extraction solvent,reflux extraction,material liquid ratio is 1:12,extraction twice,each extraction time is 2 hours,extraction solution is filtered,combined with decompression and concentrated to the right amount,obtained.(3):Determine granule molding process is as follows:dry extract powder and liquorice extract,gum Arabic powder blending,mixed with equal proportions of excipients(starch,sucrose=1:1),mixed evenly,with 75%ethanol as moistening agent,4%PVP for adhesive,soft material,16 mesh granulating,55?drying 3 hours,12 mesh granulation.(4):In the aspect of quality control,indene trione chromogenic experiment was established for the qualitative identification of free amino acids in granules,which can quickly determine whether there is any medicine of granules such as Badanren and Althaea seeds.TLC identification method for glycyrrhiza was established.The content of Ammonium glycyrrhetate in granules was determined by HPLC.The standard curve was Y=8873.9 x-25182(r~2=0.9996).The linearity range was 19.92?g/ml~199.2?g/ml.The minimum content of Ammonium glycyrrhetate in the preparation shall not be less than 60mg/bag.The content of gallic acid in granules was determined by HPLC.The linear regression equation was Y=35315X+2328.5(r~2=0.9999),with a linear range of 5.140?g/ml~51.39?g/ml.It was stipulated that the minimum content of gallic acid in granules should not be lower than 4.8mg/bag.The relevant indexes of granule were all met under the provisions of the Chinese pharmacopoeia,so the standards of the Chinese pharmacopoeia were implemented.Conclusion:(1):The effective part of compound Badanren was determined as water extraction part by pharmacodynamics experiment.(2):The optimized extraction process is stable and feasible.(3):The optimized molding process is simple,stable and feasible.(4):The quality control scheme determined in this study can quickly,accurately and truly control the quality of compound Badanren granules,meet the quality control requirements of this preparation,and ensure the safety and effectiveness of medication.