Objective To evaluate the in vivo safety of Bushen Qiangjin capsule（BSQJ）through animal experiments，in order to provide scientific and theoretical basis for clinical application. Methods Forty SPF SD rats were randomly divided into Control group and BSQJ group according to the random number table method，with 20 rats in each group，half male and half male. In BSQJ group，the maximum drug volume that the rats could tolerate was 40 mL/（kg·d）as the drug standard，and it was gavaged three times per day，and the drug dose was equivalent to 20 times the clinical adult drug dose，which was 32 g/（kg · d）. The control group was given an equivalent amount of 0.9% sodium chloride solution by intragastric administration. After continuous gavage for 14 days，the acute toxic reaction，body weight，blood routine，biochemical and hemolytic tests，and histopathological changes of the main organs were evaulated before and after administration. Results Compared with control group，the male and female rats in BSQJ group had no mortality and toxicity（P > 0.05）；had no difference in body weight （P > 0.05）；There were no significant differences in blood routine test（WBC，NEUT，NEUT，LY，RBC，HB and PLT）（P > 0.05），and biochemical and hemolytic test（TP，ALT，AST，ALP，Glu，Bun，SCR and UA） （P > 0.05）. No hemolysis or abnormality was found in heart，liver，spleen，lung and kidney. Conclusion Large dose of Bushen Qiangjin capsule had no acute toxic reaction to rats，without affecting blood routine，liver and kidney function，did not produce hemolysis，and caused no pathological damage to the main organs and tissues， which was safe in vivo.