Objective: To observe the acute toxicity and the long-period toxicity reaction of Fuyuan Capsule(FYC) to provide the reference dosage for human beings. Methods:Tests of acute oral toxicity: 40 mice (Kun Ming kind) were randomly divided into two groups

the drug test group and the control group. The maximum administration dosage(MAD) of FYC were determined by iq administration in mice. Tests of long oral toxicity:80 SD rats were randomly divided into four groups:high

middle

and low dose of FYC group and control group.FYC was continuously administered for 90 days.Rats were given drugs every day. When the experiment was finished and withdrawed for 14 days

rats were killed and the growth condition

blood cell counting and biochemical targets were measured.Histomorphologieal examination were simultaneously performed. Results:The MAD of FYC by iq administration was greater than 30g/kg in mice.In the long-period toxicity test

after administered repeatedly for 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 in control group(P<0.01). Edema of the epithelium cells in proximal convoluted tubule

degeneration of fat

broadening of lumens occured in two rats;Fat in liver cells was degenerated in one rat.14 days after stopping the drug

the values of AST

ALT

Crea

hematobiochemical

and pathological findings and coefficient of organs could completely return to nomorl. Conclusion: FYC is safe to be administered in the dose prescribed.