Objective: To observe the long-term toxicity of compound Lingzhi Jiangtang capsule after the six-month administration and the accumulative toxicity after the drug discontinuance. Method: Totally 120 clean-grade Wistar rats were randomly divided into four groups:the normal group (equal volume of distilled water) and compound Lingzhi Jiangtang capsule high

medium and low doses groups (4.14

2.07

0.69 g·kg-1)

with 30 rats in each group. Each group was intragastrically administered with drugs once every day for consecutively 180 days and then stopped giving drugs for one month for observation. The general status

haematological indexes: reticulocyte

erythrocyte total(RBC)

blood platelet count(PLT)

total hemoglobin(Hb)

total white blood cells(WBC) and blood clotting time

blood biochemical indexes:alanine aminotransferase(ALT)

aspartate amino transferase(AST)

alkaline phosphatase(ALP)

urea nitrogen(BUN)

creatinine(Cr)

blood glucose(GLU)

total bilrubin(T-BIL)

total protein(TP)

total cholesterol(T-CHO)

triglyceride (TG)

γ-glutamyltransferase(γ-GGT) and creatine phosphokinase(CK)

were measured

and heart

liver

spleen

lung

kidney

adrenal gland

thyroid gland

testis

uterus

brain

prostate

ovarian

thymus and epididymis were weighed

in order to calculate organ coefficients. Subsequently

25 organ tissues:pancreas

stomach

duodenum

ileum

colon

pituitary

spinal cord

sternum (bone and bone marrow)

lymph nodes

bladder and optic nerve

were collected for a histopathologic examination

in order to evaluate the safety of long-term administration of compound Lingzhi Jiangtang capsule. Result: According to the result in the mid-stage of the experiment (90 days after the administration)

the late stage of the experiment (180 days after the administration) and the recovery period (30 days of after the discontinuation)

compared with the normal group

compound Lingzhi Jiangtang capsule groups showed no significant effect on the development

general situation

hematological indexes

blood biochemical indexes

organ coefficients and organ pathological morphology of rats. Conclusion: The long-term administration with high dose of compound Lingzhi Jiangtang capsule shows a very low toxicity

with no cumulative toxicity reaction after the discontinuation

and can be taken safe.