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Study On Anti-fatigue Granules

Posted on:2022-12-04Degree:MasterType:Thesis
Country:ChinaCandidate:S K LiFull Text:PDF
GTID:2491306758990939Subject:Pharmaceutics
Abstract/Summary:PDF Full Text Request
Fatigue affects people’s normal study,work and life,it is a typical sub-health state.About 80%of white-collar workers in my country are in a state of overwork.The number of the fatigue population is increasing and degree of fatigue is getting worse.Thus developed a kind of health food for people to take daily to delay the generation of fatigue and promote the fatigue disappear,known as fatigue resistance,it is very necessary.Based on the research of relevant literatures,ancient recipes and anti-fatigue health food,this topic developed ginseng,Astragalus membranaceus,Lycii Fructus extracts as the main medicine,with appropriate auxiliary materials mixed evenly,by wet granula made compound granules,used for anti-fatigue,in order to improve the quality of people’s work,life and study.Refer to the relevant literature to determine the extraction process of this topic is water extraction.The response surface experiment was designed with design-Export V8.0.6.1 software to optimize the extraction process.The extraction time,times and solid-liquid ratio were taken as independent variables,the dry extract yield and the comprehensive score of astragaloside IV,total ginsenoside and total polysaccharide contents were taken as response values to investigate the influence of independent variables on the response values.The response surface optimization results were combined with the actual production to determine the optimal extraction conditions:extraction times of 2 times,extraction time of 2 hours,8 times of solid-liquid ratio;The optimal extraction process was verified and the results showed that the extraction process was stable and could be used for the extraction of three Chinese medicinal materials in this topic.To optimize the preparation technology,firstly,through hygroscopicity test,draw the balance curve of humidity absorption and fit the experimental data to the binomial regression curve to obtain the hygroscopicity equation,calculate the balance hygroscopicity,dextrin was determined as diluent by comprehensive evaluation.The optimum level of the ratio of extract to excipients,the mass fraction of ethanol and wetting agent dosage were determined by single factor experiment.The forming rate,hygroscopicity and angle of repose was used as response surface evaluation index.Using SPSSAU to conduct AHP analysis hierarchy process on the forming rate,hygroscopicity and angle of repose,the calculation formula of comprehensive score was obtained.Box-behnken design method and AHP were combined to establish response surface model to optimize preparation process.Next,the correctives are screened to improve the taste of the granules,and the optimal preparation process was obtained.Finally this topic with Qb D concept as a guide,starting from the concept of product design level to ensure drug quality,then the stackability,homogeneity,flowability and stability of granules were characterized by using micromeritics evaluation method to construct physics fingerprint.The results showed that the particle quality was basically stable,indicating that the preparation process was stable and controllable,which provided a good foundation for large-scale industrial production.The quality standard of anti-fatigue particles was established.(1)Routine inspection of particles;(2)Thin layer identification of three herbs in anti-fatigue granules was carried out.(3)The contents of ginsenosides(Rg1,Rb1,Re,Rc,Rd)in granules were determined by HPLC.The content of astragaloside IV in granules was determined by HPLC-ELSD method.In order to avoid the influence of excipients on the determination of total polysaccharide content of main medicine powder,the total polysaccharide content of dry cream powder was determined by ultraviolet spectrophotometry.The content standards of three landmark components were established,namely,astragaloside IV≥20mg/100g,total ginsenosides(calculated by the sum of Rg1,Rb1,Re,Rc and Rd)≥27mg/100g,total polysaccharide in dry cream≥0.98g/100g.A preliminary stability check was carried out on the finally produced granules.The results show that the particle is stable,which can provide a scientific basis for its production,storage,transportation conditions and the establishment of shelf life.
Keywords/Search Tags:Anti-fatigue, granules, physical fingerprint, response surface methodology, quality standard
PDF Full Text Request
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