Research on the Preparation Process of Mahuang Xixin Fuzi Decoction Granules

Abstract Objective The objective of this study was to investigate the preparation process of Mahuang Xixin Fuzi decoction granules based on the clinical pharmacological effects of the classic formulas and to control the quality of the product. Methods An orthogonal experimental design was used, with extraction yield and transfer rate of key ingredients as evaluation indicators, to optimize the extraction process of Mahuang Xixin Fuzi decoction. The granulation process was optimized based on indicators such as granule formation rate, dissolution rate, and moisture absorption rate. Results The optimal extraction process for Mahuang Xixin Fuzi decoction was determined as the following: using 10 times the amount of water to soak for 30 minutes, extracting three times, each for 60 minutes, with a concentrated extract relative density of 1.3 g/mL. A mixture of dextrin and starch at a 1:2 ratio was used as a binder for wet granulation. The granule formation rate, dissolution time, and dilution rate of three repeated batches showed relative standard deviation (RSD) values of 1.48, 2.83, and 1.55%. Conclusion This method is stable and feasible, providing valuable data for the industrial production of Mahuang Xixin Fuzi decoction granules and further research on this formulation.