Objective:To study on the preparation technology of Chuanmingshen buccal tablets and evaluate the physical quality of intermediate particles based on idea of quality by design(QbD). Method:Taking Chuanmingshen extract as the main component

and the single factor experiments were used to screen excipients;and the forming rate

tablet weight difference

hardness

friability and disintegration time were used as indicators to optimize prescription of Chuanmingshen buccal tablets prepared by wet granulation process.Physical indicators in the granules were characterized by micromeritics evaluation method.The physical fingerprint of the granules was constructed by 9 indexes

including relative homogeneity index

interparticle porosity

Carr index

bulk density

tap density

loss on drying

hygroscopicity

Hausner ratio and angle of repose.The physical fingerprint was adopted to evaluate the quality consistency of different batches of Chuanmingshen granules and analyze the compressibility of the granules

and according to the requirements in the 2015 edition of Chinese Pharmacopoeia

the quality of Chuanmingshen buccal tablets was evaluated. Result:The optimum formula was 30% of Chuanmingshen extract

23% of microcrystalline cellulose

46% of lactose

0.7% of magnesium stearate and proper amount of 70% ethanol.The preparation process conditions were as follows:granulated with 16 mesh sieve

dried at 55℃ for 1 h

and unified with 18 mesh sieve for granulation.The similarities of physical fingerprint of five batches of Chuanmingshen granules were >0.944

the compressibility parameters were within acceptable limits

the tablet weight difference and hardness of Chuanmingshen buccal tablets met the requirements. Conclusion:This optimized preparation technology of Chuanmingshen buccal tablets and the physical quality of intermediate particles are scientific and reasonable

which can provide ideas and methods for the research and development of other Chinese medicine buccal tablets.