Objective To systematically evaluate the effects of soluble excipients on the disintegration behavior of Chinese medicine extract tablets prepared by different processes, thereby providing a scientific basis for the formulation design of Chinese medicine tablets. Methods A total of 11 representative Chinese medicine extract powders were selected, and the impacts of three processes (direct compression, dry granulation compression, and wet granulation compression) on tablet disintegration time and dissolution were compared. On this basis, Rougui (Cinnamomi Cortex) and Quɑnshen (Bistortae Rhizoma) extract tablets with poor disintegration performance were chosen for a factorial experimental design to investigate the modulating effects of soluble excipient type (sugar alcohols, lactose, and starch and its derivatives), proportion (10%, 20%, and 30%), and preparation process (dry granulation compression and wet granulation compression) on tablet disintegration. Results Except for Kushen (Sophorae Flavescentis Radix), the granulation process had minimal impact on the disintegration behavior of single Chinese medicine extract tablets, including Hujisheng (Visci Herba), Dɑnggui (Angelicae Sinensis Radix), Chuɑnxiong (Chuanxiong Rhizoma), Wumei (Mume Fructus), Fuchaocɑngzhu (Atractylodis Rhizoma stir-fried with bran), Zhiheshouwu (Polygoni Multiflori Radix Praeparata), Bohe (Menthae Haplocalycis Herba) with a disintegration time ≤ 30 min. However, for single extract tablets with slower disintegration (> 30 min), such as Xixin (Asari Radix et Rhizoma), Cinnamomi Cortex and Bistortae Rhizoma, granulation prolonged disintegration time and reduced dissolution rate. Under high drug-loading conditions (≥ 70%) sugar alcohols and lactose showed the most significant improvement in disintegration of Cinnamomi Cortex and Bistortae Rhizoma extract tablets, whereas starch and its derivatives exhibited limited effects but enhanced the dissolution of water-soluble components under wet granulation. Wet granulation was more suitable for Cinnamomi Cortex tablets, while dry granulation was preferable for Bistortae Rhizoma tablets. Conclusion In the formulation design of high drug-loading Chinese medicine extract tablets, selecting sugar alcohols or lactose as excipients and optimizing the granulation process based on material properties are effective strategies to enhance disintegration and dissolution. This study provides foundational data for the development of Chinese medicine tablets and related solid dosage forms.

dry granulation compression  /  wet granulation compression  /  disintegration time  /  dissolution behavior during disintegration  /  soluble excipients  /  formulation design  /  Cinnamomi Cortex  /  Bistortae Rhizoma