Preparation Of Lithocarpus Olystachyrus Rehd Compound Antidiabetic Tablets Process And Quality Evaluation Research

Diabetes is called "thirst disease" in Chinese medicine theory.Its pathogenesis is mainly loss of yin and fluid,excessive dryness and heat,and the common lesion site is lung,stomach and kidney.Thus,in treatment,the basic methods are to clear away heat and moisturize dryness,nourish the kidney and nourish yin,and strengthen the spleen.Lithocarpus polystachyrus Rehd compound is based on Lithocarpus polystachyrus Rehd,which produces body fluids,nourishes the lungs,clears heat and detoxify,is compatible with Pueraria lobata root to clear heat and moisturize dryness,nourish yin and increase fluid,and use Chinese yam,mulberry leaves,and Huangjing to nourish kidney yin and invigorate spleen,Tortoise Flower Promotes Blood Circulation and Removes Blood Stasis.The functions of nourishing the kidney and yin and invigorating the spleen can regulate abnormal blood sugar in the body.This experiment focuses on the physical and chemical properties of the effective ingredients of traditional Chinese medicines,and mainly studies the extraction process,drying process,preparation molding process and quality evaluation of Lithocarpus polystachyrus Rehd Compound antidiabetic Tablets.It aims to provide research reference for the development of a new,safe and effective hypoglycemic health care product.The main research content and conclusion analysis are as follows:1.In the extraction process research,according to the weight distribution coefficient,use the comprehensive scores of phlorizin transfer rate,puerarin transfer rate and dry paste yield as the inspection index;the weight of the precipitate after alcohol precipitation was used as an indicator,and optimization of alcohol precipitation process by orthogonal design.According to the actual energy consumption in production,the optimal extraction process is determined as follows: soaking for 1 h,adding 12 times of water,extracting for 1.5 h,and extracting 3 times.When the phlorizin content of the compound extract of Lithocarpus polystachyrus Rehd is 1.15,it contains 75% of the alcohol is precipitated,and the precipitation is 12 h.2.in the study of drying process,the thermal stability of the index components in the process of concentration was studied by using the compound extract of Lithocarpus polystachyrus Rehd.The spray rate and water content were taken as the index.The best mixture design of D-optimized was used to screen the best mixture of ingredients in the spray drying.Optimization of spray drying process using Plackett-Burman factor screening experiment and Box-Behnken Design.The results showed that the extraction solution had good thermal stability and there was no significant difference in the content of puerarin and phloridzin;the best proportion of excipients was selected as solid content(a),maltodextrin(b)and β-cyclodextrin(c)=0.717:0.217:0.066;the main factors influencing spray drying were atomization pressure,feeding speed and inlet air temperature;combined with the actual industrial production and application For energy consumption,the optimum spray drying process parameters were determined as: inlet air temperature 160 degree,feed speed 5 ml/min,45 mm Hg.3.In the research of preparation molding process,the pre-prescription powder and preparation process of Lithocarpus polystachyrus Rehd compound-assisted hypoglycemic tablets were studied.First,the powder extract powder extracted from the prescription was studied.Secondly,the formulation prescription was used as the medicine on the basis of the extract powder,and the excipients were screened and optimized,and then the preparation process was optimized,and the preparation of the compound tablet was finally determined.Craft.The results show that the optimized powder’s angle of repose and compression degree are 50° and 1.57 respectively after the mixing design,indicating that the spray-dried powder has poor fluidity.The subsequent formulation process needs to add auxiliary materials to increase its fluidity.The mixing design optimizes the critical relative humidity of the powder 60.0%,the critical relative humidity of the powder without auxiliary materials is 53.0%,which is significantly better than the powder without auxiliary materials.The stability test study on the optimized powder of the mixing design shows that the optimized powder has better stability;Appearance properties,angle of repose,friability,and solubility of the particles as indicators.The final determination of the tablet preparation process is: extract powder: filler(soluble starch:microcrystalline cellulose=1:3)=1:1.5,granulation The conditions are that the speed of the stirring blade is 250 r,the speed of the granulating knife is 2000 r,80% ethanol is used as a wetting agent for wet granulation,and drying is carried out at 60°C for 3 h,0.5% magnesium stearate and 1% PVPP are added and mixed evenly.Press the tablet(adjust the tablet weight to 0.60 g),and control the hardness at about 6 kg.4.In quality evaluation research,with reference to the national food safety standard for health food(GB 16740-2014),a high-performance liquid phase(HPLC)method for the determination of functional index components phlorizin and puerarin as well as the content of Pueraria lobata,Chinese yam,mulberry leaf and Polygonatum Layer identification method.Established a preliminary draft quality standard for the tablet.The sensory,moisture,ash,weight difference,heavy metals,microbial limit and preliminary stability of three batches of pilot samples were investigated.