Objective:To observe the response and tolerance of “Xiaoyu Jiangzhi Capsule” on healthy subjects to explore a safe effective dosage  Methods:Randomized, multi-dose and open research was conducted. ①Twenty-four healthy subjects were randomized into six groups by single dosage respectively at 250 mg, 500 mg, 1 000 mg, 1 250 mg, and 1 500 mg; ②Ten healthy subjects were randomized into two groups by accumulative dosage at 1 250 mg and 1 500 mg, twice a day for total 7 days. Some indexes indicating liver and kidney functions were checked before and after administration of “Xiaoyu Jiangzhi Capsule”, and the adverse events were also recorded  Results:The indexes indicating liver and kidney functions before and after treatment were at normal ranges, and no adverse events were found during the whole experiment  Conclusion:“Xiaoyu Jiangzhi Capsule” is safe in clinical application at its recommended dosage.