Study On The Preparation And Quality Standards Of Danshen Fufang Capsule

ObjectiveTo develop a new kind of compound preparations.Danshen Fufang capsule,which is made from salviae miltiorrhizae,semen cassiae,cortex Iycii radicis,achyranthes bidentata,eucommia,taxilli,green tea extract,is an effective prescription in treating metabolic hypertension,hyperglycemia,hyperlipidemia and Metabolic disorders.The auther has made a study on its preparation and quality standard.MethodThrough the scientific research method,to determine the route of the extraction of compound preparation,extraction process,molding process and quality standards.ResultIn accordance with properties of medicinal materials and specificit of indications of the prescription,the Capsule was selected as the dosage form of the drug.The extraction efficiency of the tanshinone ?A was taken as evaluating maker,through orthogonal test to select the best alcohol extraction process as follows:90%ethanol extract twice,adding 8 times amount for the first time,refluxing extraction of 1.0 hours,the second 6 times reflux extraction.The extraction efficiency of the Chlorogenic acid was taken as evaluating maker.Through orthogonal test to determine the best water extraction process as follows:use water extract twice,the first water soak 1 hour ahead of extract.Extracting time is 2 hours and 1.5 hours respectively.The water consumption is 8 tines and 6 times resprctively.Contrast research vacuum drying and spray drying,according to the results should choose 60°C vacuum drying.Through the contrast experiment,the capsule of the best selection of molding process conditions,the best molding process is:do not add accessories,dry extract directly crush through 80 mesh sieve.Encapsulated and check.Study on Quality standards.Respectively for the prescription of salvia miltiorrhiza,cassia seed,mulberry parasitism by thin layer chromatography identification,and set up corresponding to identify quality control standard.Gentleman medicine in prescription salvia miltiorrhiza in the HPLC method for determination of tanshinone? A content of research,the results show that the quality control method is reliable.ConclusionThe preparation technology of Fufang Danshen capsule in this study is simple,economical and of high efficiency,therefore it is suitable for the industrial production.And the quality standards can be used to control the quality of Fufang Danshen capsule.