To observe the long-term toxiciy t of Jianpizhixiening granule (JPZX) on rats to provide a scientific experimental basis for clinical treatment. Methods: The rats were randomly divided into four groups: a high, medium and low dose group of JPZX with 187.1, 119.3, 51.07 g crude drug · kg-1· day-1 respectively, equal to 55, 35 and 15 times of clinic dose, and a control group. Parameters were examined, including general condition, body weight, the indexes of hematology, blood biochemistry and the related organ histopathology after successive administration of 92 days and 14 days' recovery. Results: In each group, there was no significant changes in the outer appearance and behavior, the indexes of hematology, blood biochemistry, organ weight and coefficient, gross anatomical observation and histopathological examination. Conclusion: In the 55 times of clinical dose, JPZX has no significant long-term toxicity, no toxicity target organ and is relatively safe under clinical proposed dose.