A Toxicological Study Of Fuyuan Capsule

Objective:To develop a sort of new Chinese medieine Fuyuan Capasule (FYC)Which can prevent and treat renal deficiency of vital energy and blood stasis,we had the experiment of acute toxicity and the long-period toxicity reaction.In the experiment of toxicology,it would be told whether there was venenous of the compound and degree of it.Accurate and secure datas were got to sever as the clinic from the experiment.Methods:(1)Acute toxicity experiment: 40 mice(Kun Ming kind)were randomly divided into two groups,the drug test group and the control group. The mice were respectively give high dosage and the most volume in a day.The MTD of FYC were determined by iq administration in mice.(2)Chronic toxicity experiment: 80 SD rats were randomly divided into four groups:high,middle,and low dose of FYC and control group.FYC was continuously administrated for 90 days.Rats were given drugs every day. When the experiment was finished and withdrawed for 14 days,the rats were killed and the growth condition,blood cell counting and biochemical targets were measured.Histomorphologieal examination were simultaneously performed.Results:(1)The MTD of FYC by iq administration was greater than 17.4g/kg in mice per giveing high dosage and the most volume. The MTD of FYC by iq administration was greater than 30g/kg in mice per(2)In the long-period toxicity test,after administered repeatedly 90 days,in high dose group AST,ALT and Crea increased(P<0.01);The weight coefficients of liver and kidneys were larger in high dose group than that of in control group(P<0.01).the epithelium cells edema of proximal convoluted tubule and fatdegened ,lumens broadend in two; the fat in liver cells were degenerated in three rats.In 14 days after stopping the drug,the changes of AST,ALT,Crea,hematobiochemical,pathological and coefficient of organs could completely recover.Conclusion:(1)The FYC havn't acute toxicity action by giveing both high dosage and the most volume and the most dosage many times in a day .(2)There would be some effects in liver and renal function,coefficient,histomorphology of the high group rat of FYC.To hint the target organ of toxic action may be liver and renal.(3)During the chronic toxicity experiment,it effected on liver and renal giveing high dosage for long-time.but the effctions would be reversible,both liver and renal function could be reablement . (4)FYC is safe to be administrated in the dose prescribed 6.15g/60kg by total dose daily.