七白散软膏皮肤毒性的动物实验研究

目的:观察七白散软膏对动物皮肤的毒性作用。方法:通过七白散软膏对SD大鼠的皮肤急性毒性实验、单次、多次给药刺激性实验、眼部刺激性实验及皮肤主动过敏实验,以皮肤的刺激性评价分数为指标,对七白散软膏的体外安全性进行评价。结果:单次和多次给予受试药物,水肿和红斑现象在SD大鼠完整皮肤组均未显现;红斑现象在SD大鼠破损皮肤组单次和多次给药时均略有显现,但停用药物后可完全消退。基于皮肤的刺激强度评分标准,单次和多次给药的刺激指数均小于0.5,所以七白散软膏外用对皮肤无刺激性。皮肤主动过敏实验表明,阳性致敏物的致敏率为100%,即称之为极度致敏性;任何红斑和水肿等过敏现象在七白散软膏组和空白软膏组对于致敏接触中和激发接触试验中均未显现,即致敏率为0。结论:通过体外安全性考察,七白散软膏对皮肤无刺激性并不产生过敏现象,作为外用软膏制剂,七白散软膏安全可靠。

Experimental Animal Study on Skin Toxicity of Qibai Powder Ointment

To study the toxicity of Qibai Powder Ointment on animals. Methods:The safety of Qibai Powder Ointment for external use was evaluated with skin irritation scores as indicators through experiments on acute toxicity of Qibai Powder Ointment in SD rats, single or multiple dose active irritation, eye irritation and skin allergic test. Results:After single and multiple drug dose tests, no edema and erythema in SD rats with intact skin group appeared, but erythema appeared in SD rats with damaged skin group of both single and multiple dose and symptoms relieved after cease of the drug. Based on irritant of the skin scale, indexes of single and multiple dose tests were both less than 0.5, indicating that Qibai Powder Ointment on the skin has no irritation. Skin allergy tests showed that the positive allergic sensitization rate was 100%, that is to say, the extreme allergic. No allergic reaction such as erythema and edema appeared in both the Qibai Powder ointment group and blank ointment contrast group in allergenicity and irritant exposure tests and the allergenicity rate was 0. Conclusion:Through in vitro safety study, Qibai Powder Ointment on the skin irritation does not induce allergic reactions and without discomfort and it is safe and reliable as an ointment preparation for external use.