Study On Preparation Technology And Quality Standard Of Jiedu Tongluo Yishen Concentrated Pill

Objective: To optimize the preparation technology of Jiedu Tongluo Yishen concentrated pill and establish the quality standard.Methods: 1.To sum up the previous work and literature,design the preparation technology of Jiedu Tongluo Yishen concentrated pill,and optimize the extraction technology by response surface curve analysis,and the best preparation technology of Jiedu Tongluo Yishen concentrated pill was determined by the small-scale test in laboratory and the pilot test in pharmaceutical factory.2.Refer to pharmacopoeia of the people’s Republic of China,2015 edition and standard issued by the Ministry,qualitative analysis methods were used to analyze the appearance,disintegration,water content,weight variation,content uniformity,TLC and content determination of the capsules,and to formulate the standard quality standard of Jiedu Tongluo Yishen concentrated pill.Results: 1.To determine the total anthraquinone(calculated by emodin,Rhein)and total flavone(calculated by rutin)as response values,and to analyze 17 batches of decocting technology samples by response surface curve method.2.The best preparation technology was determined to be ten kinds of drugs,such as hazelnut flower and rhubarb,8 times of water,decocting twice,each time for 1.5h.The solution was concentrated to thick paste(density 1.2),dried(60 ℃),crushed(paste yield: 24.33%),Salvia miltiorrhiza and Dragon’s blood were crushed into fine powder,mixed with dry paste powder,and 70% ethanol was used as binder to prepare the pill.3.Check the water content,disintegration,weight variation,content uniformity of concentrated pills.In the thin layer chromatography,the identification methods of Dragon’s blood,Rhubarb,Motherwort,Chinese wolfberry,Dried tangerine peel and Salvia miltiorrhiza are determined.It is determined by HPLC that the content of dragon’s blood in the concentrated pills should be no less than 0.0530 mg/g in terms of dragon’s blood element perchlorate and no less than 0.1062 mg/g in terms of rhubarb acid.Conclusion: The best preparation technology of Jiedu Tongluo Yishen concentrated pill was selected and the quality standard of the preparation was established.The preparationtechnology of screening is simple,reasonable and feasible;the TLC identification method in the quality standard is simple,the content determination method is stable and feasible,the specificity is strong,the reproducibility is good,and the quality of the preparation can be effectively controlled.