Objective:To observe the effects of Xu Xiao-pu’s empirical formula in the internal and external treatment for herpetic stomatitis in children with syndrome of accumulated heat in heart and spleen. MethodsSixty subjects were randomly divided into treatment group and control group, 30 cases in each group. The patients in control group were treated with Ribavirin Aerosol combined with Pudilan oral liquid, and the treatment group were treated with Xu Xiao-pu’s empirical formula via internal and external application. Two groups were treated for 6 days. Clinical efficacy and safety were observed, and the time for clinical symptoms relief was compared.  Results:①After treatment for 6 days, the total effective rate was 100% in both groups. The clinical cure rates were 66.67% in the treatment group and 46.67% in the control group, with significant difference between the two groups(P<0.05). ②Compared between two groups, the occurrence of herpes regression, abnormal diet and fever symptoms were significantly different (P<0.05), but there was no significant difference in the time of salivation(P>0.05). ③There were no obvious adverse reactions in two groups.  Conclusion:Xu Xiao-pu’s empirical formula in internal and external treatment is quite effective for herpetic stomatitis in children with syndrome of accumulated heat in heart and spleen,and relieve clinical symptoms.