Abstract:This study evaluated the consistency of product quality between modern and traditional preparation processes for Toddalia asiatica formula granules, and aimed to establish a stable and controllable production process. Starting from the concept of quality by design, based on single factor experiments, the key factors affecting the extraction, soaking time, number of extractions, extraction time, and water volume were identified. Hesperidin content, toddaloactone content, nitidine chloride content, characteristic peak similarity, and extract yield were used as evaluation indicators. The extraction process using response surface methodology combined with reference correlation and an AHP-CRITIC comprehensive evaluation method was optimized, and suitable parameters for concentration, drying, and granulation were clarified through single-factor tests. The results indicate that the optimal extraction conditions are adding eight times the amount of water, extracting once, and extracting for 120 minutes. Under these conditions, the comprehensive score reaches 53.620. The suitable concentration density is 1.125-1.250 g/cm3, under a vacuum of 50-200 MPa, and temperature of 50-90 ℃. The study recommends spray drying for the liquid extract, with a feed rate of 8-14 mL/min and inlet temperature of 160-180 ℃. For granulation, dry processing is selected using dextrin as filler, with drug-excipient ratio from 1∶08 to 1∶1. Roller pressure is set at 100-120 bar, feeding speed at 242-262 rad/s, and roller speed at 0.29-0.42 rad/s. The proposed process is reasonable and feasible, which provides a basis for industrial production and quality control of Toddalia asiatica formula granules.