The Effects Of Zishe Cream On Experimental Dermatitis And Safety Evaluation

Objective:Determine the safety of Zishe cream.Observe and evaluate the therapeuticeffect of Zishe cream in local lesion in dermatitis model mice, then preliminaryexplore its role in the mechanism of these diseases.Methods:Do safety evaluation,including acute toxicity test and skin allergic test andskin irritation test.Establish xylene induced auricle swelling mouse model,2,4-nitrofluorine benzene induced allergic contact dermatitis mouse model and atopicdermatitis mouse model,then each model are randomly divided into controlgroup,Zishe cream group and hydrocortisone butyrate group.Assess degree ofimprovement in local lesion through lesions observation,measurement and pathologicsections.Using immunohistochemistry,ELISA and other advanced technology andresearch methods,detect level changes of interleukin17(IL-17) and leukotrieneB4(LTB4) in skin lesions.Results:There is no acute toxic and irritant reaction, no erythema, edema, skinallergic reaction and systemic allergic reaction happened in the KM mice after Zishecream is used.In the experiment of mouse auricle swelling induced by xylene, Zishecream and hydrocortisone butyrate cream can obviously reduce the mice ear swellingdegree and the inhibition rates were53.49%and46.51%.In the allergic contactdermatitis mouse model, compared with control group, ear thickness between theZishe cream group and hydrocortisone butyrate group have significant difference(P<0.05).Ear tissue pathological slices reveal that edema was reduced obviously,infiltration of inflammatory cells was also reduced accordingly.After wiping medicinefor3and7days, compared with control group, the Zishe cream significantly reduceexpression level of IL-17and LTB4in the local lesion tissue (P<0.05).In experimentswith atopic dermatitis model mice,we found epidermal layers in skin lesions are moreclear and the thickness of the epidermis become thinner in Zishe cream group(P<0.01),the number of inflammatory cells within the dermis decreased significantly and the hair follicle obviously increased compared with model control group(P<0.01).In hydrocortisone butyrate group,the number of inflammatory cells in the dermis isthe same as that in Zishe cream group,but the hair follicle structure and epidermisthickness change is not obvious. After wiping medicine for1week and2weeks,compared with control group,expression levels of IL-17and LTB4in the locallesion tissue has significant difference in the Zishe cream group(P<0.01).But,thedifference in hydrocortisone butyrate group is not obvious.Conclusion:Zishe cream for external use is safe and reliable.Compared withtraditional medicine, it has no side effects.By reducing the local lesion tissueexpression level of IL-17and LTB4, Zishe cream play its anti-inflammatory andanti-allergic effects.in dermatitis.It is likely to develop a new kind of compoundtraditional Chinese medicine preparation for external use only.