Objective: To investigate the acute toxicity and chronic toxicity of Fufang Jinling Sini Siwu Shixiao powder (FSXP) and evaluate its safety in clinical applications. Method: The 40 KM mice were randomly divided into FSXP group (192 g·kg-1) and normal group according to their body weight. The maximum tolerated dose (MTD) was determined in mice by oral gavage. In chronic toxicological test

80 SD rats were randomly divided into 4 groups according to their body weight:normal group

FSXP high-dose group

medium-dose group and low-dose group (30.6

15.3

7.65 g·kg-1)

n=20 in each group. The medicine was given intragastrically once a day for consecutive 4 weeks. The changes of general state

body weight

food intake

food utilization rate and organ index were observed respectively

and the histopathological examination of the main organs were determined after 4 weeks of treatment and 2 weeks after drug withdrawal. Result: The maximum tolerated dose for mice was 192 g·kg-1

which was equivalent to 217.4 times of the recommended adult clinical dose. In the chronic study

no death or clinical toxic signs were found. Compared with the normal group

no significant difference was found in body weight

food intake

food utilization rate and organ index of each drug group of FSXP. In addition

no pathological changes related to this drug were observed in the histopathological examination. Conclusion: FSXP has no significant toxicity to mice

and long-term taking has less accumulative toxicity to rats

indicating that the clinical prescribed dose of FSXP is in high safety.