Abstract: BACKGROUND ＆ AIM: To study mutagenicity and acute toxicity of Yushengtang capsule safety. MATERIAL AND METHODS: Mutagenicity and acute toxicity of Yushengtang capsule were studied by using LD50 in mice,Ames test,micronucleus in mice, sperm shape abnormality test and thirty days feeding study in rats. RESULTS: Acute toxicity test: LD50>215 000 mg/kg. Ames test:Yushengtang at four concentration of 1.0,2.0,3.0,4.0 mg/plate were studied by TA97(a),TA98,TA100,TA102 bacterial,at the same time mutagenic were used as the control groups. The test were repeated under the action of metabolic activated enzyme. The bacterial numbers at every concentrations of Yushengtang had no significant differences from the control groups. Micronucleus and sperm shape abnormality test in mice: Micronucleus rate at 5 000, 10 000, 20 000 mg/kg and positive were 2.0 ‰,1.6 ‰,1.8 ‰,2.0 ‰ and 32.6 ‰ respectively. Sperm shape abnormality rate at 5 000,10 000,20 000 mg/kg and positive were 19.4 ‰,19.8 ‰,19.8 ‰,22.4 ‰ and 128.4 ‰. Thirty days feeding test: The rats were feed thirty days. All index were normal. CONCLUSION: Yushengtang had no potential mutagenicity.

Key words: Yushengtang capsule, mutagenicity, acute toxicity, feeding test