Development Of Guarana Effervescent Based On QbD Concept

Guarana,also known as Brazilian fragrant cocoa,is a vine-like shrub of the Sapindus family.It mainly grows in the tropical rain forests of the Amazon River in northern Brazil and has the title of "Mysterious Eyes".Contains caffeine,amino acids,vitamins,proteins,tannins and other active ingredients.It has the effects of anti-fatigue,anti-oxidation,anti-aging,improving memory,fat loss,anti-tumor and so on.In recent years,due to the influence of factors such as living conditions,social environment,work pressure,etc.,the number of people in sub-healthy states such as fatigue has been increasing.With the continuous in-depth research on the effective ingredients of Guarana at home and abroad,the development of anti-fatigue functions of Guarana has become a trend.Effervescent tablets are favored by more and more consumers at home and abroad because of their rapid disintegration,convenient taking,and quick onset of action.Combining with the current domestic situation,it is planned to develop a guarana effervescent tablet with anti-fatigue effect.This project takes Guarana as the research object,uses network pharmacology and molecular docking technology to explore the mechanism of the anti-fatigue effect of Guarana,and verifies it with the preliminary anti-fatigue effect experiment of Guarana;Based on the QbD concept,starting with the key parameters of the preparation of Guarana effervescent tablets,the preparation process of Guarana is optimized to ensure the quality of effervescent tablets.1 Exploring the mechanism of anti-fatigue effect of Guarana based on network pharmacology and molecular docking technologyThe anti-fatigue mechanism of Guarana was explored based on the method of network pharmacology,and the results obtained were verified by molecular docking technology.Collect the chemical constituents of guarana through the chemistry database and TCMSP database,and predict its target,build a constituent-target network diagram,protein interaction network diagram(PPI)and target-pathway diagram,and screen guarana and anti-Common target of fatigue;GO and KEGG analysis of common targets: The component-target network contains fifteen drug-like components and ninety eight corresponding targets.Two of the core targets may be the core targets of the anti-fatigue efficacy of Guarana.Through the analysis of its core network and the verification of molecular docking,it was found that Guarana exerts an anti-fatigue effect through multiple targets and multiple pathways,and has a good effect on fighting fatigue.2 Preliminary study on the anti-fatigue effect of GuaranaThe anti-fatigue efficacy of Guarana was studied by the mouse swimming experiment with weight.Take the exhaustion time of the mice as an indicator,set up a blank group,a low-dose group and a high-dose group,The experimental results showed that compared with the blank group,the exhaustion time of mice in the low-dose group was significantly increased on the 6th and 9th days(P<0.05),and the exhaustion time of the mice on seventh,eleventh,and twelfth days were all significantly increased.(P<0.01);while in the high-dose group,the exhaustion time of mice on seventh,ninth,tenth,eleventh,and twelfth days was extremely significantly increased(P<0.01).Experiments show that low and high doses of guarana extract can extend the swimming time of mice,verifying the anti-fatigue effect of guarana.3 Study on the physical properties of guarana powder in different drying processesUsing a texture analyzer,the fluidity and compressibility of the guarana powder were used as the key quality attributes(CQAs),and the powder physical properties of the guarana powder with different drying processes were studied.The powder’s flow stability,cohesion coefficient,agglomeration strength,compressibility,etc.were compared,and the fluidity of guarana powder with different drying processes was investigated;The water content,solubility,angle of repose,bulk density,tap density,compression index,and Hauners ratio of the powder were tested and compared,and the compressibility of guarana powder with different drying processes was investigated.The experimental results show that the guarana powder prepared by the vacuum drying process has good fluidity and compressibility.4 Study on the preparation process of Guarana effervescent tabletsUsing the concept of quality by design(QbD),the pH value,foaming volume,and disintegration time limit of guarana effervescent tablets are used as evaluation indicators.Selection of fillers,disintegrants,acid-base sources,lubricants and other factors for single-factor screening to determine the main preparation key process parameters(CPPs),Orthogonal experiment method was used to optimize the composition of the prescription and determine the best preparation process parameters with sensory evaluation as an indicator.The hardness,friability,foaming amount,pH value,and pH value of the effervescent tablet made by the best composition were determined.Checked the difference in film weight,disintegration time limit,etc.The content of guarana caffeine in effervescent tablets was determined and methodologically investigated by HPLC.To determine the scientificity and feasibility of the process and ensure the quality of effervescent tablets.Experimental results show that the best excipients for effervescent tablets: acid source is citric acid,sodium bicarbonate is used as disintegrant alkali source,lactose is used as filler,and PEG6000 is used as lubricant.The best formula is: disintegrant content of fifty percent,disintegrant acid-base ratio of 0.6 to one,guarana content of fifteen percent,and the quality of effervescent tablets prepared under the conditions of optimal prescription and optimal process parameters is consistent with the quality of tablets.Provisions for effervescent tablets under the item.