Pharmaceutical Research Of Teng Cha Shen Capsule

Teng cha shen capsule is traditional Chinese medicine compound Preparation based on Tencha,with effect of reducing blood fat,lowering blood sugar,blood pressure,enhancing immunity,and anti-aging.The subject is guided by traditional Chinese medicine theory,applying modern science and technology and methods,studying systemly experimentally on the preparation process and quality standards of the preparation,providing a scientific basis for the development of new lipid-lowering drugs.Study are as follows:一,Study on preparation processStudy on extraction process:polysaccharide is as the evaluating indicator of lanceolata and barbarum,optimizing for the extraction process:after complement 1.75 times absorption as lanceolata and barbarum,Adding 8 times the amount of water soaking 1h,refluxingly extract 3 times,each time 1 hour.Study on purification process:the content of polysaccharide and the extract yield are as the evaluating indicator of lanceolata and barbarum, investigating that the concentration and the adding amount of chitosan,the concentrate ratio of liquid medicine and the time of repose impact on the effect of clarification,and optimize for the clarification process by single-factor test.So,the clarification process of chitosan:the total extract as crude drug:water extract=1:10,is put in a water bath at 60℃,into which the amount of chitosan is added by 3.5%(chitosan:crude drug g/g),and1%acetic acid solution of chitosan is slowly added,stired to even dispersion,keeped warm by 5～10min and placed by 24h,then leach the supematant of it.Study on dry process:the content of polysaccharide and the dry condition of materials are as the evaluating indicator,investigating that the amount of accessory and the relative density of the extract impact on the effect of dry,and optimize for the dry process by single-factor test.So,the dry process: polysaccharide purified extract is concentrated to a relative density of 1.26～1.28(60℃),into which starch as weighed as 60%crude drug is added, stirred evenly,then it is put into vacuum drying oven at 60℃(-0.1MPa), drying to constant weight.Study on forming process:investigate that the moisture absorption changes after extract powder is mixed with Tencha extract,and that the concentration and the amount of wetting agent ethanol impact on granulating process.Result:after extract powder is mixed with Tencha extract,the moisture absorption reduced significantly;With 95%ethanol as wetting agent,consumpting for 5%of the amount of powder,particles are made,put into blast drying oven at 60℃,turned once half an hour and dried 4h,so,the moisture absorption is low,the mobility is better,and the critical relative humidity is about 63%.二,Study on quality standardsCharacters:the product is capsules and light brown powder in it,with special Ampelopsis fragrance and sweet with slightly astringency.Study on TCL qualitative:identify the 3 species of crude drug Tencha lanceolata and barbarum in the preparation by TLC.Test results show that the location of the reference substance or reference crude drug show the same color spots,while the negative control did not interfere in the appropriate location.And after numerous tests,the reproducibility is good. Study on determination:determine the content of Ampelopsin in the preparation by HPLC;determine the content of Polysaccharides and total flavonoids in the preparation by HPLC and UV.the methodological studys of HPLC and UV show that the methods are reasonably practicable and nicely reproducible,which can be used for the quality control of the preparation.The content of Ampelopsin is not less than 24.22mg in each cap.The content of total flavonoids is not less than 43.55mg in each cap.The content of Polysaccharides is not less than 12.52mg in each cap.