Objective:To optimize the optimal prescription and preparation process of FuFangShenQiKeLi,to study its quality control.Methods:The moisture absorption rate,molding rate,fluidity,and taste of particles were used as evaluation indicators,and comprehensively scoring according to different weights,the comprehensive score as the response value,were combined with response surface methodology analysis,to optimize the prescription and preparation process.Determine The content of Astragaloside IV using high-performance liquid chromatography.Results:The ratio of extract to excipients was 1∶4,the ratio of mannitol to lactose was 4∶3,and the amount of flavor correction agent was 0.20%.The molding rate,moisture absorption rate,and angle of rest were 96.86%,2.52%,and 27.60°,respectively.The particles were slightly sweet and acceptable.The linear regression equation for astragaloside Ⅳ was y=1.321 9x+1.113 3,R2=0.999 6.Astragaloside Ⅳ exhibitsed a good linear relationship within the range of 1.994 to 7.976 μg.Conclusion:This method had good reproducibility and the optimal preparation process for FuFangShenQiKeLi is practical and feasible.The method for determining the content of Astragaloside Ⅳ has a good linear relationship and could be used for its quality control.