Research On Standard Substance And Granule Of Baihu Decoction

Objective Research on the preparation technology and quality range of standard substance of Baihu Decoction from Treatise on cold pathogenic disease and pertinent literature.Optimization of the forming process and quality standard of Baihu Decoction granules,which laid a foundation for the study of Baihu Decoction standard substance and granules.Methods According to the dosage and the amount of water from Treatise on cold pathogenic disease.Optimization of the preparation technology of Baihu Standard substance by Central Composite Design-response Surface Method,to investigate effects of extraction and soaking time on composite score of dry extract rate,the transfer rat of mangiferin,liquiriting,lycyrrhi-zic acid and Ca SO4·2H2O.Fifteen batches of Gypsum Fibrosum,Anemarrhena asphodeloides and Glycyrrhizeae from different localities,which prepares different Baihu Decoctions.The transfer rat,dry extract rate,and fingerprint chromatography are composed of the quality standard range of Baihu Decoction.Optimization of the formation technology of Baihu Decoction Granule by single factor Design and Orthogonal Design,with the ratio of extract powder to adjuvants,the ratio among adjuvants and the concentration of ethanol as the influencing factors;and the forming rate,angle of repose and hygroscopicity as the indices.Establishing the quality standard of Baihu Decoction granules by TLC and HPLC;the preliminary stability of Baihu Decoctions granules was studied by accelerated test.Results The optimum soaking time and extraction time of Baihu Decoction were 45 min and 27 min respectively.Based on the different batches of Baihu Decoction,which concludes the transfer rate of mangiferin,glycyrrhi-zic acid,liquiritin and Ca SO4 ·2H2O were 27.23% ~ 50.56%,19.60% ~36.33%,10.80% ~ 20.05% and 0.61% ~ 1.13%,the range of dry dry extract rate was 8.43% ~15.66%.The similarity results of 21 batches of samples were analyzed and compared,and the results showed that the similarity was all higher than 0.90.The single factor and orthogonal experiments were used to optimize the forming process of Baihu Decoction granules.The total dosage of pharmaceutical excipients was 40 % of Baihu Decoction powder,the ratio of dextrin and soluble starch was 4:1,and 75% alcohol.Six batches of Baihu Decoction granules were identified by TLC and studied by HPLC.The similarity of fingerprints was all higher than 0.90.Baihu Decoction granule is stability within 6 months.Conclusions Establishing the preparation technology and quality range of the material standard of Baihu Decoction.Optimization of the forming technology of Baihu Decoction granules,and establishing its quality standard.