Abstract: OBJECTIVE To investigate the acute toxicity of Nanwuweizi softcapsule in mice and rats and to evaluate its safety. METHODS After Nanwuweizi softcapsule was administered intragastrically for 14 days, a series of indexes: symptom, sign, diet, excrement and weight of mice and rats were observed. All mice and rats were put to death at the end of experiment and abnormalities were examined. RESULTS There was no obvious abnormal behavior and weight change for mice and rats of the 14-day feeding experiment. And none was dead. CONCLUSION Nanwuweizi softcapsule with the largest dose has no obvious toxic response to the mice and rats, providing theoretical basis for the new drug development and clinical application of Nanwuweizi softcapsule.