OBJECTIVE: To optimize the formulation of Budesonide sustained-release tablet. METHODS: Using the cumulative releases in 2, 4, 8 h as investigation indexes, central composite design-response surface method was used to optimize the amount of hydroxypropylcellulose L (HPC-L), amount of soybean phosphatides, and filler (fixed total 200 mg) lactose - microcrystalline cellulose mass ratio in the formulation of Budesonide sustained-release tablet, and the verification test was conducted. The release behaviors of prepared sustained-release tablet and original preparation in pH 7.2, 7.0, 6.8 phosphate buffer were compared. RESULTS: The optimal formulation was as follow as budesonide of 9 mg, HPC-L of 46.49 mg, soybean phosphatides of 9.23 mg, filler lactose-microcrystalline cellulose mass ratio of 1 ∶ 2.9; the cumulative releases in 2, 4, 8 h were 21.9%, 50.1%, 99.5%, the relative errors with predicted values (22.0%, 50.0%, 98.5%) were 0.45%, 0.20%, 1.02% (n=3), respectively. Compared with cumulative release of original preparation, the f2 was higher than 50. CONCLUSIONS: Budesonide sustained-release tablet is successfully prepared, which shows similar release behavior to original preparations.