白菊湿疹膏安全性实验研究  

Experimental study on the safety of Baiju eczema ointment

作　　者：史向华 续艳 牛丹 薛润苗 杨文彬 柴秋彦 张俊荣 Shi Xianghua;Xu Yan;Niu Dan;Xue Runmiao;Yang Wenbin;Chai Qiuyan;Zhang Junrong(Shanxi Institute of Medicine and Life Sciences,Taiyuan Shanxi 030006;Shanxi University of Chinese Medicine,Jinzhong Shanxi 030619)

机构地区：[1]山西省医药与生命科学研究院,山西太原030006 [2]山西中医药大学,山西晋中030619

出　　处：《山西中医药大学学报》2020年第5期342-344,共3页Journal of Shanxi University of Chinese Medicine

基　　金：山西省科技厅重点研发计划项目(社会发展)(201803D31217)。

摘　　要：目的:观察白菊湿疹膏经皮肤给药的安全性,以为临床实验提供参考。方法:参照文献[1-7],进行白菊湿疹膏口服及皮肤给药对KM小鼠的急性毒性实验、对家兔的皮肤刺激性实验及对豚鼠的皮肤主动过敏反应。结果:安全性实验表明,白菊湿疹膏口服和皮肤给药均不能求得LD50,其最大给药量分别为临床拟用剂量的1600倍和1000倍;对豚鼠的皮肤主动过敏实验为阴性;对家兔的完整与破损皮肤均无刺激性。结论:新型中药制剂白菊湿疹膏在本实验剂量下,对所用实验动物模型是安全的,以上实验结果可为临床进一步观察使用提供参考。Objective:To observe the safety of Baiju eczema cream through skin,and to provide reference for clinical trials.Methods:According to the literature[1-7],the acute toxicity experiment of Baiju eczema ointment on KM mice by oral administration and skin administration was carried out,and the skin irritation experiment on rabbits and the active allergic reaction on guinea pigs were conducted.Results:The safety test showed that the oral and skin administration of Baiju eczema cream could not get LD50,and the maximum dosage was 1600 times and 1000 times as much as the clinical dose.The skin active allergy test of guinea pig was negative,and Baiju eczema cream had no irritation to the intact and damaged skin of rabbits.Conclusion:Baiju eczema cream is safe for the experimental animal model at the experimental dose,which could provide reference for further clinical observation.

关 键 词：白菊湿疹膏 皮肤给药 安全性 

分 类 号：R285.5[医药卫生—中药学]