A Study about Long-term Toxicity of Puyi Granules to Rats

Objective:To observe the long-term toxicity of Puyi Granules. Methods:One hundred and twenty SD rats were randomly divided into 4 groups (30 in each group,male:female=1∶1) of which 3 groups orally received high,moderate,and low dosages (4.8,2.4,and 1.2 g/kg of raw drug equal to 50,25,and 12.5 times of those of human dosages) of Puyi granules respectively,and one group received saline as control. The experiment was carried out for consecutive 26 weeks,and general conditions,body weight and food intake of the animals were observed. The hematological and biochemistry parameters,organ coefficients and histomorphological figures were determined in 13 and 16 weeks of the experiment and in 2 weeks after the termination. Results:The general conditions of treated rats were normal during and after the experiment. The body weight,organ coefficients,main hemotology and biochemistry indexes of rats in treated groups were basically the same as those of the controls. The urine analysis results and organ histopathological observation showed no significant difference between experimental rats and controls. Conclusion:Puyi Granules has no immediate or delayed toxicity in long-term administration on rats with dosages within clinical range,and is safe for use.