Study On Preparation Technology And Quality Standard Of Xiaoer Yinshu Granules

ObjectivesResearch and develop a new health food that promotes digestion(tentatively named Xiaoer Yinshu Keli).Optimize the preparation process of Xiaoer Yinshu granules and study its quality standards.MethodsThe topic mainly contains three parts:extraction process,forming process,and quality standards of Xiaoer Yinshu Keli.1.Extraction technology research:According to material properties in the prescription,charred fructus crataegi and charred germinated barley use the method of water extract.The amount of water,decocting time,decocting times are factors affecting the extraction technology of water.Total flavonoids content and yield of dry extract are index of alcohol extracting process.2.Forming process research:This study detersmines to use wet granulation according to process results and practical situation.With the molding rate and moisture absorption as the index and refer to liquidity of granules,this study determined the impact of types of supplementary material,ethanol concentration on the molding process.Through the experiment,the study optimizes the best molding process.3.Quality standards research:In order to guarantee the quality of the granules,this carried out the routine examination and studied the quality standard from qualitative and quantitative aspects.This study identified charred fructus crataegi,charred germinated barley and stir-baked rhizoma dioscoreae with soil by TLC method and determined the content of chlorogenic acid and protein by Using high performance liquid chromatography(HPLC)and UV-visible spectrophotometer method,then established the quality standard initially.Results1.Extraction process result:Water extraction process conditions:The optimal conditions of water extraction are adding E times water boiling for F times,each time T1h.2.Forming process results:According to the proportion of prescription to take four flavor powder to G r/min speed mixing T3 minutes,the choice of and citric acid as excipients,mixed with H%of the total amount of drug 1%ethanol Wetting agent,stir quickly after M mesh sieve granulation,the wet particles placed in K? oven drying T4 hours,with M mesh sieve.Put the particles into the granula to get the finished product3.Establish quality standards:Set up the TLC qualitative identification method for charred fructus crataegi,charred germinated barley and stir-baked rhizoma dioscoreae with soil.The high performance liquid content determination method for chlorogenic acid.Chromatographc conditions for chlorogenic acid:Thermo C18(4.6 mm×250 mm,5 ?m)chromatographic column;mobile phase was Acetonitrile(A)-5%Acetic acid solution(B),and the elution conditions was A-B(1:9),the flow rate of 1.0 mL/min.detection wavelength of 327 nm.And the content of chlorogenic acid,and protein in each granula cannot be less than 0.5298 mg and 0.3575 g,respectively.ConclusionBy analyzing the the preparation process of Xiaoer Yinshu Keli,a stable and feasible molding process was established,and a batch of qualified granulas was prepared,This study carried out qualitative identification and content determination as well,and set up quality standards to ensure the good quality of the granulas.