Abstract: Objective：According to the quality standard of zicao ointment， to study the stability of zicao ointment. Methods：By the influence factor test， accelerated test and long-term test， investigated the change of Zicao ointment′s description， identification， particle size， the load， microbial limit， the content of shikonin and β，β′-dimethylacrylalkannin. Results：After high temperature， high light of the influence factor test， there was no significant change in the zicao ointment， but the content was decreased in the high humidity test. After 6 months of the accelerated test and 12 months of long-term test， the ointment didn′t have obvious change. But after 18 months of long-term test， the content was decreased. Conclusion： Zicao ointment is stable in the room temperature and airtight conditions， and its period of validity was tentatively set as 12 months.