Abstract: The toxicity test is compulsory for the drugs to get the clinical approval. In recent years, the cases of poisoning and adverse reactions associated with traditional Chinese medicine are commonly reported, indicating that it is necessary to conduct toxicological evaluation on traditional Chinese medicine. In order to ensure the safety and reliability of the traditional Chinese medicine compound preparation Wenshenyijing Powder in clinical use and to objectively evaluate its safety, toxicity tests were designed and conducted in this study. The acute toxicity of Wenshenyijing Powder was assessed in accordance with the protocol recommended by ′ Veterinary Drug Acute Toxicity Test（LD50 Determination） Guidelines′. The long-term toxicity test was performed on rats which were assigned to four groups. Three experimental groups fed the basil diet containing 0.45, 0.15, 0.045 kg/kg of Wenshenyijing Powder respectively, and one control group fed the basil diet. The long-term toxicity test lasted for 30 days, and at the end of the test, the physiological and biochemical indexes of the male and female rats were determined. The results showed that Wenshenyijing Powder exhibited no toxic effect to rats.