Objective:To define potential toxicity and reversibility

target organs of toxicity

no adverse effect dosage and medication time of Tongren Anshen pill through the safety evaluation for long-term medication of Tongren Anshen pill

in order to provide basis for clinical safety medication. Method:SD rats were randomly divided into four groups:the control group and high-dose

medium-dose and low-dose Tongren Anshen pill groups (containing 6.4

3.2

1.6 g·kg-1 of medicinal herbs). The rats were administered with the drugs by gavage once daily for 3 months. The blood biochemistry

hematology

urinalysis

relative organ weights (ROWs) and histomorphological indexes were examined in the 1st and 3rd months after administration

and the 2nd month after drug discontinuance. Result:In the study

the results of hematology

biochemistry

urinalysis

ROWs and histopathological examination showed no significant change related to drug toxicity after 1 month of administration; however

the body weights and food consumption of rats in high-dose Tongren Anshen pill group were significantly decreased. After 3 months of administration

aspartate aminotransferase (AST) and creatine kinase (CK) of female rats in the high-dose group significantly increased compared with those in the control group. The histopathological changes in livers and kidneys were observed

including hepatocytes

mild renal tubular degeneration and renal interstitial inflammatory infiltration. There were no significant difference in other indexes

including serum biochemistry

hematology

urinalysis and ROWs. Two months later after drug discontinuance

no significant change in liver function parameters and morphology of liver and kidney was observed in the high-dose group. Conclusion:Long-term administration with high-dose Tongren Anshen pill could induce slight hepatic and renal damages. No observed adverse effect level (NOAEL) is 3.2 g·kg-1·d-1

which was equivalent to 29 times of clinical dosage. Its dosage and medication time shall be strictly controlled in clinic.