The ginsenoside in Ciqishen capsule was detected by using HPLC,and the polysaccharide was determined by UV. The safety of Ciqishen capsule were evaluated by the acute toxicity test in rats and mice, with the mutation tests of salmonella test (Ames test),the micronucleus tests of mice bone marrow polychromatic erythrocytes and the experiment of mouse sperm deformity, and the 30-day feeding test was used for toxicological study. The results showed that the average contents of ginsenoside and polysaccharide in Ciqishen capsule were 0.273,3.190 g/100 g. The acute toxicity result showed that the biggest tolerance dose of Ciqishen capsule on rats and mice was more than 24.0 g/kg·BW. The results fell into the scale of non- toxicity, and the three genotoxicity tests were all found negative. The results of test on feeding for 30 days showed that there were no evident influence on the clinic experiment, hematology, biochemistry, the weight and coefficient of visceral organ and several indexes of pathological organization under the experiment dosage range. Our results show that Ciqishen capsule is a safe and non-toxic product with good food safety.