蒲芩解毒利湿颗粒对小鼠急性毒性和大鼠亚急性毒性的试验研究OA

Objective:This study aimed to evaluate the toxicological safety of Puqin Jiedu Lishi granules through acute and subacute toxicity tests,and to provide a theoretical basis for its safe clinical application.Methods:Forty healthy KM mice(half male and half female)were divided into three groups for the acute toxicity test.All mice received a single intragastric administration,followed by a 7-day observation of body weight,mental state and mortality.Twenty KM mice(half male and half female)were subjected to the maximum tolerated dose test.The drug solution(0.52 g/mL)was administered at 40 mL/kg,with a 14-day observation of toxic reactions and mortality.Eighty healthy SD rats(half male and half female)were randomly assigned to the control group,as well as high-dose(6.4 g/kg),medium-dose(3.2 g/kg),and low-dose(1.6 g/kg)groups.After intragastric administration,the general clinical status of rats was monitored,blood routine parameters and serum biochemical indices were determined,organ coefficients were calculated,and histopathological alterations were examined via HE staining.Results:No death or abnormal manifestations were found in mice during acute toxicity and maximum tolerated dose tests,with a maximum tolerated dose over 20.8 g/kg and no significant inter-group differences(P>0.05).In the subacute toxicity test,all rats survived normally within 4 weeks;blood routine,biochemical indexes and organ coefficients were normal(P>0.05),and no obvious histopathological lesions were observed.Conclusions:Puqin Jiedu Lishi granules show favorable safety with no obvious acute or subacute toxicity,and are worthy of further development as a therapeutic agent for chronic urinary tract infections,providing a new treatment option for patients with such diseases.