Study on the Preparation Process of Shegan Qingwen Fuzheng Oral Liquid

Objective — To investigate the preparation process of Shegan Qingwen Fuzheng Oral Liquid (SQFOL) to fully extract active components, enhance the content and stability of pharmacologically active constituents in the formulation, and ensure clinical efficacy. Methods — The extraction process for volatile components, β-cyclodextrin inclusion process for distillate, and extraction process for distillation residue were investigated separately. Results — The optimal extraction process for volatile components was determined as follows: 8-fold water volume, 1-hour soaking time, and 4-hour distillation time. The optimal β-cyclodextrin inclusion process for distillate was a core-to-shell mass ratio of 1:4, inclusion temperature of 40°C, and inclusion time of 2 hours. The extraction process for distillation residue was adding 8 times the volume of 50% ethanol, performing two extractions: the first for 2 hours and the second for 1.5 hours. Conclusions — The extraction processes were validated to be stable and feasible.