Abstract: OBJECTIVE To provide evidence for the safety of clinical medication through the test on the acute toxicity, maximum tolerance and subacute toxicity of Tangzhi pill. METHODS In the acute toxicity experiment, three dose groups were set up, once for the first administration, the effects of Tangzhi pill on body weight and food intake of mice were observed continuously for 7 d. In the maximum tolerance test of mice, Tangzhi pill was prepared at a concentration of 225 mg·mL^-1 according to its maximum solubility. The drug was administered by gavage at 40 mL·kg^-1, toxic symptoms and deaths were observed and recorded after administration. In the subacute toxicity test, Tangzhi pill were prepared into high, medium and low dose group solutions at 2.25, 1.50 and 1.00 g·kg^-1, respectively, and 10 mL·kg^-1 were administered by gavage to observe the subacute toxicity reaction of rats. RESULTS No death of mice was observed in the acute toxicity test of Tangzhi pill for 7 d after administration for once, and LD₅₀ could not be measured. According to the toxicological evaluation standard, the substance with LD₅₀>1 g·kg^-1 had no toxicity. However, no toxicity was found when the dose was increased to 9 g·kg^-1 in maximum tolerance test, indicating that Tangzhi pill was safe and had no toxicity to mice. In the subacute toxicity experiment, there was no significant difference in signs and physiological indexes between the blank control group and the high, medium and low doses groups which were continuously administered for 30 d. CONCLUSION Tangzhi pill has good safety and can be further prepared into the preparation for the development of new drugs for the treatment of diabetes.