Objective:To optimize the formulation and preparation process of sophora suppositories.Methods:Sophora suppositories were prepared by hot melt method,Tween-80,lanolin and mixed fatty acid glycerides were the influencing factors,and the appearance and melting time of sophora were taken as the investigation indexes,and the optimal formulation and preparation process of sophora suppositories were optimized by orthogonal test method.In accordance with the 2020 edition of the Chinese pharmacopoeia,the quality inspection of the prepared sophora suppositories was carried out.Results:The optimal process conditions of sophora radix suppositories were as follows:V(Tween-80)∶m(lanolin)∶m(mixed fatty acid glycerides)were 0.4∶1∶15(mL∶g∶g),the optimal drug-loading ratio m(sophora spp.)∶m(white and polysaccharide)was 2∶1,the perfusion temperature was 50 ℃,and the freezer was placed for 20 min,and the molding effect was the best.Conclusion:The optimal process method of sophora radix suppositories in this study is simple and feasible,and the quality is controllable.
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