Objective:

2

To study the acute toxicity of Shizaotang in rats

in order to provide reference for clinical drug safety and subsequent toxicological efficacy experiments.

Method:

2

Totally 40 SPF SD rats were randomly divided into control group and Shizaotang group

with 20 rats in each group (10 males and 10 females). By the maximum dose method

the Shizaotang group was given the maximum concentration of Shizaotang suspension 0.3 g·mL

-1

for 2 consecutive times in the maximum dosage volume within 24 h

and the control group was given normal saline. The toxicity (death

poisoning symptoms) and its severity and recovery of the rats were observed within 14 days

and the changes in body weight and feeding before and after administration were recorded. After 14 days

the rats were put to death

and serum alanine aminotransferase (ALT)

aspartate aminotransferase (AST)

urea nitrogen (BUN)

creatinine (SCr)

and interleukin-2 (IL-2)

tumor necrosis factor-alpha (TNF-

α

) and nuclear factor-

κ

B (NF-

κ

B) levels were measured

each tissue was weighed

and organ coefficients were calculated. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of various organs

and evaluate the acute toxicity.

Result:

2

No animal death

obvious poisoning symptom

and visible organ abnormality were observed. Compared with the control group

there was no significant change in body weight and food consumption in the drug-administered group. There was no significant difference in the organ coefficients of rats. Serum ALT

AST

BUN

SCr

IL-2

TNF-

α

and NF-

κ

B did not change significantly

and no abnormality was observed in pathological sections of each tissue.

Conclusion:

2

The maximum oral dosage of Shizaotang in rats is 12 g·kg

-1

which is 480 times of daily dosage for adults

with a good safety. This suggests that Shizaotang has a certain safety range.