Study on the preparation process of Tiangui Congying Granules
Objective To study the preparation process of Tiangui Congying Granules and provide a reference for industrial production.Methods The two granulation methods were compared and the optimal granulation method was selected.With the granulation situation and molding rate as evaluation indicators,the type of excipients and the drug loading were selected,the preparation formula and molding process were determined,and the amplification verification was conducted.Results The dry granulation method was selected,with dextrin as the filling agent and 0.1%Aspartame as the corrigent.The drug loading was 65%,resulting in good particle formability and moderate hardness.Conclusion The preparation formula and preparation process determined by the study are reasonable,with controllable process stability and good reproducibility,suitable for industrial production.