Abstract: PURPOSE: To prepare Koukuining granules and observe its efficiency in the treatment of recurrent aphthas ulce (RAU). METHODS: In accordance with the theories of traditional Chinese medicine, the prescriptions of Koukuining granules were composed of rhizoma coptidis, radix scutellariae and other Chinese herbs, and the preparation procedure was conducted by means of wet granulation technology. One hundred patients with RAU were randomly divided into experimental group and control group equally. Patients in the experimental group took particles orally after a meal, 3 times a day, 1 bag each time, for successive 10 days as one treatment course. The treatment was repeated after 3 days of interval. Patients in the control group took vitamin C, compound vitamin B2, orally for 2 courses. The treatment effect was evaluated. Data analysis was performed using SPSS 11.5 software package. RESULTS: The preparation process was controllable and the quality of the products was stable. The overall effective rate of the experimental group was 88.4% and there was a significant difference compared with the control group. CONCLUSIONS: The preparation of Koukuining granules was feasible with stable quality of final products. Treatment of RAU with the granules was effective and worthy of clinical application.

Key words: Koukuining granules, Recurrent aphthous ulcer, Clinical effect