Abstract: The purpose of this study was to investigate the acute and chronic toxicity of the Regansaibisitan particles.In order to explore the acute toxic reaction of Regansaibisitan particles in two weeks,the maximum tolerable test was performed as follows:the extract of Regansaibisitan particles,as tested drug,was dried,crushed,and then was given to mice by gavage with two dosages (the maximum volume of mice and the maximum concentration of Regansaibisitan particles in mice).In addition,SD rats were randomized into four groups:three testing groups which were treated with 37.50 g/(kg·d),12.50 g/(kg·d) and 3.75 g/(kg·d) of Regansaibisitan particles extract,respectively,and one blank control group which was treated with the same volume of distilled water.Subsequently,at 30 days of medication and 15 days of drug withdrawal,the hemogram index,biochemical index,organ coefficient and pathological sections of main organs were detected respectively.As a result,the maximum tolerable dose of mice to the Regansaibisitan particles extract was 299.70 g/kg.In addition,there was no death,no visible lesion of the main organs which were observed via dissection method,and no statistically significant difference on the weight of the rats during the whole experimental process.As for hemogram index,biochemical index and organ coefficient,there were some differences between the testing groups and the control group,but no toxic significance.In terms of pathological sections of major organs,no obvious pathological change was observed.In conclusion,this study demonstrated that clinical dose of Regansaibisitan particles was far less than its toxic dose,illustrating it had reliable safety.

Key words: Regansaibisitan particles, acute toxicity, maximum tolerated dose, chronic toxicity