Objective To investigate the preparation process of Acanthopanax trifoliatus(L.)Merr polysaccharides granules.Methods:The granules were prepared using a wet granulation technique.Shaping rate,angle of repose,and solubility were used as indicative parameters to optimize the preparation process.The single factor method was used to investigate the effects of the ratio of A.trifoliatus(L.)Merr polysaccharides to diluents,the concentration of wetting agents,the volume of wetting agent,drying temperature and drying duration on the quality of granules.The central composite design-response surface methodology was employed to optimize the formula by the ratio of A.trifoliatus(L.)Merr polysaccharides to diluents,the concentration of wetting agents and the volume of wetting agent as factors,followed by three batches of process validation.A comprehensive score was calculated to evaluate the feasibility of the preparation process.Results The optimal formula consisted of a 3.22:1 ratio of erythritol to A.trifoliatus(L.)Merr polysaccharides,a wetting agent with an ethanol concentration of 73.68%,and ethanol volume usage of 17.51%.Under these conditions,the A.trifoliatus(L.)Merr polysaccharides granules achieved a 93.60%shaping rate,a 28.20° angle of repose,and a 98.12%dissolution rate,with an average comprehensive score of 97.24.The prepared Acanthopanax trifoliatus(L.)Merr polysaccharides granules meet the requirements of the 2020 edition of the Chinese Pharmacopoeia in terms of appearance,particle size,moisture content,and total sugar content.Conclusion The preparation process is stable and feasible with reliable quality.
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