硝矾洗剂皮肤安全性试验研究  

Study on skin safety test of the Xiaofan lotion

作　　者：许曾 皮凤娟[1] 张庆莲[1] 张盛敏[1] 周静[2] XU Zeng

机构地区：[1]泸州市中医医院,四川泸州646000 [2]四川省中医药科学院,四川成都610000

出　　处：《中医临床研究》2023年第22期40-45,共6页Clinical Journal Of Chinese Medicine

基　　金：院内制剂硝矾洗剂的开发研究(2019-LH004);2019年西南医科大学-泸州市中医医院基地项目;硝矾洗剂的皮肤安全性评价和药效学研究(2020年泸州市指导性科技计划项目)。

摘　　要：目的:研究硝矾洗剂的皮肤安全性和急性毒性。方法:通过皮肤急性毒性试验、单次皮肤刺激性试验、多次皮肤刺激性试验、过敏试验,观察硝矾洗剂对新西兰兔皮肤或豚鼠的急性毒性反应、刺激性及致敏性,以期为临床相关应用提供参考。结果:①在本试验条件下给予23.62 g生药/kg以下剂量硝矾洗剂,破损皮肤给药及完整皮肤给药皆无急性毒性反应;②该批次硝矾洗剂单次给药对家兔破损皮肤无明显肉眼可见的刺激反应;③该批硝矾洗剂多次给药对家兔完整皮肤刺激性反应及破损皮肤均无明显肉眼可见的刺激反应;④该批硝矾洗剂对豚鼠激发后未出现皮肤过敏反应,亦未见全身过敏反应症状。对其体质量增长无明显影响。结论:硝矾洗剂主治湿热下注导致的肛门湿疹、内外痔、肛裂、混合痔、肛窦炎;各个肛门术后肛缘疼痛、水肿等及术后预防感染用。主要通过坐浴、熏洗等方式作用于体表皮肤,故有必要通过建立动物模型进行安全性的初步研究。在所设实验条件下,硝矾洗剂特殊安全性试验未见急性毒性反应、刺激反应发生,亦无过敏反应发生,外用安全性好。Objective:To study the skin safety and acute toxicity of the Xiaofan lotion(硝矾洗剂).Methods:The acute toxicity,irritation and sensitization of the Xiaofan lotion on the skin of New Zealand rabbit or guinea pig were observed by skin acute toxicity test,single skin irritation test,multiple skin irritation test and allergy test,in order to provide a reference for clinically relevant applications.Results:①Under the conditions of this test,there were no acute toxic reactions to the administration of broken skin and complete skin administration with less than 23.62 g crude drug/kg dose of nitrate lotion.②The single administration of this batch of the Xiaofan lotion had no obvious visible irritation reaction to the broken skin of rabbits.③The multiple administration of this batch of the Xiaofan lotion had no obvious visible irritation reaction to the complete skin irritation and broken skin of rabbits.④The batch of the Xiaofan lotion did not have skin allergic reactions after being stimulated by guinea pigs,and there were no symptoms of anaphylaxis.There was no significant effect on weight gain.Conclusion:The Xiaofan lotion is mainly used to treat eczema,internal and external hemorrhoids,fissures,mixed hemorrhoids,and sinusitis caused by humid heat bets;It can be used for pain,edema,etc.after surgery and postoperative infection prevention.It mainly acts on the skin of the body surface by sitz bath,fumigation,etc.,so it is necessary to establish animal models for preliminary research on safety.Under the set experimental conditions,there was no acute toxic reaction,stimulation reaction or allergic reaction in the special safety test of the Xiaofan lotion,so it is safe for external use.

关 键 词：硝矾洗剂 皮肤刺激性试验 皮肤过敏性试验 急性毒性试验 

分 类 号：R284.5[医药卫生—中药学]