克癣净乳膏外用安全性评价实验研究

【目的】对克癣净乳膏进行临床前安全性评价。【方法】进行豚鼠皮肤过敏实验、家兔皮肤刺激性实验和家兔皮肤急性毒性实验。将豚鼠分为克癣净乳膏组20只、空白基质组5只和阳性致敏对照组5只，经致敏接触和激发接触，观察皮肤过敏反应情况，按出现红斑程度评分。将家兔16只分为克癣净乳膏完整皮肤组和破损皮肤组、空白基质完整皮肤组和破损皮肤组，分别外涂受试物，每组4只，观察皮肤刺激反应强度。将不同剂量的克癣净乳膏用于家兔背部正常和破损去毛区皮肤，观察其产生急性毒性情况。【结果】克癣净乳膏对反复致敏后的豚鼠无皮肤过敏与全身过敏反应，皮肤刺激性强度对家兔正常皮肤和破损皮肤平均反应分值在给药后24、48h或72h后均低于0．49分，也未产生急性毒性反应。【结论】克癣净乳膏用于临床前实验中未产生明显的过敏反应、皮肤刺激反应和毒性反应，使用安全。

Experimental study on KeXuanJing Cream in safety evaluation

[Objective]To investigate the pre-clinical safety evaluation of KeXuanJing Cream. [Methods]G：uinea pig skin allergy test, rabbit skin hypersensitive test and rabbit skin acute toxicity test are been taken. Thirty Guinea pigs were randomly divided into 3 groups, 20 as KeXuanJing Cream group, 5 as blank matrix group and 5 as positive sensitized control group, after the allergic contact and excited contact, we have observed the condition of skin allergic reaction and given evaluation according to the reaction degree. The domestic rabbits were randomly divided into groups of KeXuanJing Cream intact skin and abraded skin and groups of blank matrix intact skin and abraded skin, and then all these groups are coated with test samples to observe the degree of skin irritation and the reaction of systematic poisoning. Smearing different doses of KeXuanJing Cream on the normal and damaged back skin of rabbits＇ skin, the acute toxicity reactions of KeXuanJing Cream were abserved. [ Result] KeXuanJing Cream cannot arouse skin irritation or general allergicalIy reaction on those repeated sensitization guinea pigs. Skin irritation intensity on intact skin and abraded skin of domestic rabbit is under 0.49 averagely after administration for 24 h, 48 h or 72 h, and there is no acute toxicity reaction either. [Conclusion] Owing to there is no any obvious anaphylaxis, skin irritation or toxic reaction of KeXuanJing Cream, it is safety for application.