OBJECTIVE: To evaluate the antipruritic effects and safety of compound Fushen cream through animal experiments.METHODS:（1） Fifty KM mice were randomly divided into positive control group and blank control group

low

medium and high dose compound Fushen cream groups

xylene was used to cause swelling in the auricle of mice to investigate the anti-inflammatory effect of compound Fushen cream.（2） Fifty guinea pigs with right hind foot shaved were randomly divided into positive control group and blank control group

low

medium and high dose compound Fushen cream groups

histamine phosphate was used to cause guinea pigs to lick the right hind foot

and the itch-causing threshold was calculated.（3） Forty KM mice with dorsal unhaired were randomly divided into substrate group and compound Fushen cream group

the blank substrate and compound Fushen cream（0.25 g each） were applied to the unhaired area

the toxic reactions and death of mice were continuously observed for 7 d to evaluate the acute toxic effects of cutaneous administration.（4） Sixteen New Zealand rabbits with dorsal unhaired were randomly divided into single administration group and multiple administration group

and then divided into intact skin group and damaged skin group.Each group was given compound Fushen cream（0.5 g

1.0 g） on the left side of unhaired area

and blank substrate（1.0 g） and blank（no application） on the right side of unhaired area

so as to observe the skin condition and to evaluate the safety of cutaneous administration.RESULTS:（1） Compared with the blank control group

the auricular swelling of mice in the low

medium and high dose compound Fushen cream groups was reduced

with statistically significant differences（P<0.05）.（2） Compared with the blank control group

the positive control group and the low

medium and high dose compound Fushen cream groups were able to increase the itch-causing threshold induced by histamine phosphate

with statistically significant differences（P<0.05）.（3） In the acute toxicity test of cutaneous administration

all the mice in each group survived and no abnormalities were observed in major organs

and there was no statistically significant difference in body weight of mice between the substrate group and the compound Fushen cream group（P>0.05）.（4） In the single/multiple skin irritation test

all New Zealand rabbits in the intact/damaged skin groups survived after administration

and their diet

behavioral activities

eyes and mucous membranes were normal

with no obvious erythema or edema on skin

and the damaged areas in the damaged skin group had crusted over in the multiple skin irritation test.CONCLUSIONS: The compound Fushen cream has obvious anti-inflammatory and anti-itching efficacy and good safety in this experimental animal model.