地塞米松尿素霜皮肤给药安全性研究

Research on safety of Dexamethasone urea cream for enepidermic use

目的探讨地塞米松尿素霜皮肤给药的安全性。方法通过急性毒性试验观察地塞米松尿素霜产生急性毒性的情况;通过皮肤过敏性实验观察其致皮肤过敏情况;通过一次给药和多次给药方法,观察其产生豚鼠皮肤刺激性反应情况。结果地塞米松尿素霜未产生急性毒性反应;反复致敏后使用,无皮肤与全身过敏反应;一次或多次给药对豚鼠正常皮肤刺激的平均反应分值均<0.5分,对破损皮肤刺激的平均反应分值在给药后24h和48h>0.5分,但<2.99分,48h或72h后均<0.5分。结论外用地塞米松尿素霜未产生急性毒性和过敏反应,对豚鼠正常皮肤无刺激性,对破损皮肤有轻度刺激性,但给药后48h或72h,这种刺激性消失,为临床安全用药提供了实验依据。

Objective To explore the safety of Dexamethasone Urea Cream（DUC） for enepidermic use.Methods Observed the acute toxicity situation of DUC by acute toxicity test;Observed the situation of sensitization of skin by cutaneous hypersensitivity test（CHT）;Observed the situation of skin irritation by once and multiple doses.Results DUC didn＇t lead to acute toxicity reaction,and had no skin or systemic allergic reaction when used after repeating sensitization.The average response score of stimulating intensity of once and multiple doses to normal skin of guinea pigs was lower than 0.5 points,while 24h and 48h after admistration,the average response scores to damaged skin were higher than 0.5 points,but lower than 2.99 points;After 48h or 72h,the average response score was lower than 0.5 points.Conclusion DUC doen′t lead to acute toxicity and allergic reactions.It has no skin irritation on normal skin of guinea pig,but have slight irritation on damaged skin,and this irritation disappears 48h or 72h after administration which offers experimental evdience to clinical safe medication.