Research On Preparation Technology And Quality Standard Of Kangyan Granules

ObjectivesTo develop a new dietary supplement with anti-oxidation function(tentatively named Kangyan Keli),optimize the production process of Kangyan Keli,and determine the main indicators of its quality standards.MethodsThis study focuses on the study of Kangyan Keli in three aspects:extraction process,forming process research,and quality standards.1.Extraction process research:In the study of Polygonatum odoratum(Mill.)Druce that water extraction technology,Puerarin transfer rate and yield of dry extract are evaluation of water extracting process.The amount of water,decocting time,decocting times are factors affecting the extraction technology of water.In the process of the extraction of Angelicae Dahuricae Radix and Chaenomeles speciosa(Sweet)Nakai total saponins content and yield of dry extract are index of alcohol extracting process.The amount of alcohol,refluxing time,refluxing times are factors affecting the extraction technology of alcohol.2.Forming process research:According to the results of the process and the actual conditions,the process of granulation,degree of granulation,rate of particle formation,moisture absorption,particle flow,content of index components and other indicators to optimize the auxiliary materials,wetting agents,drying temperature and time parameter.In addition,the critical relative humidity of powders and granules was also investigated,which provided a basis for the control of the production environment.3.Quality standard study:The qualitative and differential determination of Kangyan Keli was carried out using thin layer chromatography,high performance liquid chromatography,and UV-Vis spectrophotometry,and the corresponding quality standards were formulated.Results1.Extraction process results:The best water extraction process for Polygonatum odoratum(Mill.)Druceis as follows:Polygonatum odoratum(Mill.)Druce is soaked in 10 times the amount of water for 60 minutes,reflux extraction is performed 3 times,each extraction is performed for 2 hours,and the filtrate is combined and concentrated under reduced pressure to a thick paste.Dry extract was dried under reduced pressure.The best alcohol extraction technology of Angelicae Dahuricae Radix and Chaenomeles speciosa(Sweet)Nakai was as follows:Angelica dahurica,Papaya herb plus 10 times the amount of 90%ethanol,reflux extraction twice,extraction for 1.5 h each time,combined extraction,filtration,filtrate recovery of ethanol,concentration to thick Ointment,dry extract with reduced pressure to dry.2.Molding process results:Weigh the powder according to the proportion of each compound in the compound and mix at a rate of 60 r/min for 15 min.The dextrin is used as an excipient and the drug-assisted ratio is 2:1.25%of the drug-assisted total amount of 90%ethanol made of soft material,sieved through a 12-mesh sieve,wet granulation set at 50? in an oven for 2 h,sieved with No.1 and No.5 sieves,and the resulting pellets were made of double-layer aluminum-plastic composites.Film packaging,that is,finished products.3.Establishment of quality standards:Established a thin layer identification method for ginseng,white peony,royal jelly lyophilized powder and papaya in Kangyan granules;established the use of high performance liquid chromatography for 10-hydroxy-2-decenoic acid in Kangyan granules The determination method of content;The method of determining the total saponin content in Kangyan granules by UV-Vis spectrophotometry was established.The lyophilized powder of Royal Jelly containing 10 hydroxy-2-decenoic acid(C10H18O3)per bag of this product should not be less than 6.22 mg.The total saponins contained in ginsenoside Re(C48H82O18)should not be less than 39.60 mg.ConclusionThis topic studies the preparation process and quality standards of Kangyan Keli,establishes a stable and feasible extraction and molding process and quality standards,and provides a strong basis for ensuring the quality of dietary supplement.