Pharmaceutical Research Of Hualiao Jiedu Granule

Hualiao Jiedu granule is an auxiliary drug used for the treatment of cancer,which is made in the hospital of chengdu university of taditional Chinese medicine.The preparation process,quality standard and stability tests of the product have been studied in this paper.一、Study of the preparation processIn quashing study,with flour extraction rate as index, the process of Asini corii colla’s quashing is inspected.In extraction study,with calycosin separately glycosidase content,ferulic acid content and dry extract yield as evaluation indexs,the optimum extraction process were studied with orthogonal experiment.The optiize extraction condition was as follows:15times water,extraction time lh,with3times repetition.In purification process, with calycosin separately glycosidase content,ferulic acid content and dry extract yield as indexs,the purification process were investigated by single factor experiment.Filtration,centrifugation and alcohol precipition of different concentrations were used to purificate the liquid.Compared with the concentrate,three ways of purification greately reduced the total of calycosin separately glycosidase content and ferulic acid content.Considering the common methods of deulcoration have larger effects on the main effective components of the prescription,such as flavonoids,organin acids,saponins and higher content polysaccharide composition,so it needn’t to be edulcoratde.In forming process,we choose dextrin as excipient,according to preliminary experimental results. The molding process were studied with orthogonal experiment,with the formation rate,moisture,hygroscopicity and angle of repose as evaluation indexs. The determined molding process was as follows:dertrin is added the same amount of dry power,blend,80%ethanol as wetting agent,the drying temperature is70℃.二、Studies of the quality standard and stabilityTn order to set up quality standards of Hualiao Jiedu granule,TLC were used to identify Astragall Radix, Angelicae sinensis Radix and Asini corii Colla and HPLC to determine ferulic acid in the preparation.In the stability study,samples were packaged by medicinal composite film.According to the proposed quality standards,long-term stability and accelerated stability tests were proceeded.As a result,various indexes meet the requirements.The technology of the preparation is reasonable,quality standards are controllable and samples are stable.