Research On Preparation Technology And Quality Standard Of Baihu Decoction Granules

Objective The extraction,purification and molding technology of Jingfang Baihu decoction were studied.The granules were prepared,and the quality standard of Baihu decoction was studied,which laid a foundation for the research and development of Jingfang Baihu decoction.Methods Taking the yield of new mangiferin,mangiferin and dry extract as the index,single factor experiment and orthogonal test were used to screen the water extraction technology of Baihu decoction.The retention rate of Ca SO4·2H20,the retention rate of new mangiferin,the retention rate of mangiferin and the rate of impurity removal were used as the indexes.The purification process of carboxymethyl chitosan was selected by orthogonal test.The yield of qualified particles,the time of dissolution,the angle of repose and the moisture absorption rate were used as the indexes.The optimum forming process was optimized by star design-effect surface method and the quality standard of Baihu decoction was studied.By acceleration test and retention observation method respectively were used for 6 months accelerated test and 6 months preliminary stability test.Results Take gypsum,Anemarrhena,licorice and rice 4 herbs,first times with 8 times amount of water,soaking for 0.5 h,2nd and 3rd respectively,adding 6 times amount of water,decocting 3 times,0.5 h each time,filtration,and the filtrate for three times,the liquid is concentrated to the relative density of 1.02,in the under the condition of 60 ℃,20 m L-100 m L-1 according to the liquid ratio of carboxymethyl chitosan solution into 0.5%,stirring after 20 min standing for 12 h,centrifugation,filtration,the filtrate was concentrated to the relative density of the paste 1.10~1.12(60 ℃),by dextrin soluble starch for the ratio of 3:2,adding appropriate amount of mixed excipients to dry at 60 ℃,crushing them into fine powder,adding the remaining excipients according to the amount of excipient as 0.3 times of the thickening paste,adding 88% ethanol to prepare the soft materials,packing 12 g/bag with 12 mesh sieve granulation,drying at 60 ℃.In the study of quality standard,TLC method was used to identify Radix Anemarrhenae and Radix Glycyrrhizae in prescription by TLC,the content of new mangiferin,mangiferin,glycyrrhizin and mono-ammonium glycyrrhizinate in Baihu decoction granules were determined by HPLC,and the fingerprint of Baihu decoction granules was established.The results of 6 months accelerated test and preliminary stability test showed that the indexes had no obvious change and the quality was stable.Conclusions The optimum preparation technology of white tiger soup granules was determined.The quality standard of white tiger soup granules was studied and the fingerprint was established.The preliminary stability of the granule was good.