Toxicologic Study on Tongmai-huoxueling Capsule

Objective To observe the acute toxicity in mice and the long-period toxicity Tongmaihuoxueling Capsule(TMHXL) in rats.Methodsthe maximum administration dosage(MAD) of TMHXL were determined by iq administration in mice.Body weight,hematological and hematobiochemical parameters,coefficient and histomorphological figure of organs(the heart,liver,spleen,lungs,kidneys,adrenals,testes,prostate,paucreas,uterus,brain,thymus) were examined in 90 days,180 days and 30 days after the cessation of TMHXL.ResultsThe MAD of TMHXL by iq administration was greater than 36.0g/kg in mice.In the long-period toxicity test,after administered repeatedly for 90 days,in 9.0g/kg dose group,Crea increased(P0.01);the epithelium cells edema of proximal convoluted tubule and fat degened,lumens broadend in two,the fat in liver cells were degenerated in two rats.After administerd repeatedly for 180 days,in the 9.0 g/kg dose groups,the TP and Crea increased(P(0.01)orP0.05);The weight coefficients of kidneys and liver were larger in high dose group than that of in control group;the epithelium cells edema of proximal convoluted tubule and fat degened,lumens broadend in three;the fat in liver cells were degenerated in two rats.In the 4.5 g/kg dose groups the Crea increased(P0.05).In 30 days after stopping the drug,the changes of Crea,TP,hematobiochemical,pathological and coefficient of organs could completely recover.ConclusionIt could be concluded that TMHXL is safe to be administrated in the dose prescribed.