Pharmaceutical Research Of Xinsu Granule

Xinsu granule is a compound preparation consisting of Dansen,Hiiangqi,Gegen and other herbs as ingredients. It is an empirical formula for curing stenocardia and coronary disease.The preparation technique, quality standard, and stability tests have been studied.一、Preparation processIn extraction study, we made content of tanshinone IIA as index to optimize steam distillation,to optimize the extraction way of principal drug Dan shen, The optimized process is to add6times80%ethanol, extract2times and1hours each time.In the water extraction process.we made the content of total puerarin, salvianic acid A sodium and yield rate of dry extract as indexes. The optimized process is to add10times water, extract3times and1.5hours each time.In edulcoration process,treating Xinsu granule solution edulcoration with precipitation, centrifugation and ZTC flocculation, the suitable method was determined.Based on the method, the optimum edulcoration conditions were investigated by single factor experiments with the content of puerarin and salvianic acid A sodium, rate of dried extract as indexes. The appropriate edulcoration method was precipitation. The best technological parameters were as follows: at concentration proportion of1:1, Ethanol concentration of65%.In shaping process study, The shaping process is: to mix powder extract;1.5times the dextrin and1.5%aspartame, then to granulate by extruding with60%ethanol, and to dry under60°C,to size the granulation at last.二、Quality standard study and Preliminary study of stabilityIn order to set up quality standards of the preparation, we used TLC to distinguish Huangqi; Chuanxiong; Shuizhi; Longxuejie, and HPLC to determine tanshinone ⅡA and salvianic acid A sodium in the preparation.The result of the study shows that the preparation technique is scientific, reasonable and practical. Moreover, the quality standard is easy to control and the property of the sample is stable.