Study On Preparation Technology And Quality Standard Of Compound Danshen Plaster

Coronary heart disease (CHD) is harm for human’s health seriously which is acommon and frequently-occurring disease.With the improvement of people’s livingstandard and working pressure increased, cardiovascular disease, especially CHDmorbidity and mortality increasing, has been become one of the main diseases ofthreating the people’s life and health. Compound DanShen plaster is drug of curingCHD,and its medicinal substances consist of Salvia, Rhodiola, nutmeg,Choerospondias, angelica, Terminalia. It has a good effect to treat the CHD. And theplaster to avoid first-pass effect, reducing adverse drug reactions are topicalformulations of traditional Chinese medicine with good development prospects.In the extraction process of compound DanShen plaster, according to the differentproperty of medicinal effective components, The essential oil of angelica and nutmegwere obtained by steam distillation. Rhodiola was extracted by heating–circumfluence,and Salvia,Choerospondias and Terminalia were extracted by alcohol.Using single-factor experiment/orthogonal experiment and central compositedesign test.The optimum conditions of the extraction were determined by the contentof salidroside and tanshinoneⅡA,The best condition of the volatile oil extraction ofangelica and nutmeg was adding10times amount of water and extracting for2h. TheVolatile oil and extracting solution was obtained to reserve. After filtration, the dregsand Rhodiola were adding22times amount of water and extracting for4h. Whichwere extracted twice, each time adding11times amount of wate for2h.After theliquid was been combined to relative density be0.5by vacuum concentration. Theoptimal technical process for purification of total salidroside was as folllows: theethanol concentration increased from95%to60%,standing for18hours.The optimaltechnical process for extracion of total tanshinones was as follows:added6volumes of75%ethanol,extracted two times and each time for65minutes. The extracta wasobtained by vacuum concentration. In the preparation process of compound DanShen plaster, using single-factorexperiment and central composite design,the optimal preparation prescription andpreparation process were determined by comprehensive score.The optimal conditionswere as follows: the volatile oil been Included by4times β-cyclodextrin for4hours in60℃, acquired inclusion complex to reserve.The optimum proportion ofmatrix for the preparation technology process of Cataplasm is selected by uniformdesign and SPSS regression analysis. Acheck-up for adhibition,peeling strengthnonflowing,content of cream is founded.The best matrix’s prescription isPANA:CMC-Na:glycerol:PVPK90:kaolin:trimethylene glycol:DihydroxyaluminiumAminoacetate:EDTA-2Na:water=2:4.527:4.5:4.5:1.5:0.1:0.1:25.To study quality standard of compound DanShen plaster, the characteristics,qualitative identification, and the content and dissolution test were examined. Thequalitative identification of Salvia,Rhodiola, angelica,nutmeg were set up withoutnegative interference.The content of tanshinoneⅡA was determined by highperformance liquid chromatography, and methodological tests were studied. Thelinearity range of tanshinoneⅡA was0～48.00μg mL-1. The average content of threebatches were4.195mg, RSD=1.01%. So the content of tanshinoneⅡA in this qualitystandard was not less than3.356mg.The quality of compound DanShen plaster preparedwas in conformity with the requirements of Chinese Pharmacopoeia.