痛风金黄凝胶贴膏对皮肤急性毒性、刺激性和过敏性研究  

Study on the skin acute toxicity,irritation and anaphylaxis of Tongfeng Jinhuang gel plaster

作　　者：卢勇 赵松梅 杨亚 郑泽连 章斌[2,3] LU Yong;ZHAO Songmei;YANG Ya(Ya'an Hospital of Traditional Chinese Medicine,Ya'an 625000,China)

机构地区：[1]雅安市中医医院,四川雅安625000 [2]雅安职业技术学院,四川雅安625000 [3]雅安市食品药品应用开发工程技术研究中心,四川雅安625000

出　　处：《四川中医》2025年第3期177-181,共5页Journal of Sichuan of Traditional Chinese Medicine

基　　金：雅安市科学技术局2021年省级转移支付项目(编号:22ZYZF0003);雅安职业技术学院高层次人才中药制剂研究工作室科研项目(编号:Yzygcky202219)。

摘　　要：目的:观察痛风金黄凝胶贴膏经皮给药的急性毒性、刺激性和过敏性反应。方法:急性毒性实验给予家兔痛风金黄凝胶贴膏贴敷给药[0.5001g/(cm~2·d)],给药14天,观察家兔精神状况和身体状况;刺激性实验中家兔敷贴痛风金黄凝胶贴膏[0.5001g/(cm~2·d)],连续14天,观察敷药局部皮肤是否出现红斑、水肿等刺激反应,进行皮肤刺激实验反应评分和刺激强度评价;过敏性实验中豚鼠于第1、7、14、28天敷贴痛风金黄凝胶贴膏[0.5001g/(cm~2·d)],观察皮肤过敏反应及全身性过敏反应。结果:急性毒性实验,家兔精神状况和身体状况未见明显异常,也无死亡发生;刺激性实验,家兔精神状况和身体状况未见异常,第3天开始给药局部出现轻微红斑,在去除药物24h后红斑逐渐消失,皮肤未出现水肿;过敏性实验,该贴膏对豚鼠无皮肤过敏现象,致敏率为0。结论:痛风金黄凝胶贴膏经皮给药无明显的急性毒性、刺激性和过敏性,患者可在临床医师指导下安全使用痛风金黄凝胶贴膏。Objective: To evaluate the acute toxicity,irritation and anaphylaxis of transdermal administration of Tongfeng Jinhuang gel plaster. Method: In the acute toxicity test,rabbits were administered Tongfeng Jinhuang gel plaster [0.5001g/(cm 2 ·d)] for 14days,and the mental and physical conditions of the rabbits were observed. In the irritation test,rabbits applied gel plaster [0.5001g/(cm 2 ·d)] for 14days. The skin was observed every day for erythema,edema and other irritation reactions,and the skin irritation experiment reaction score and stimulation intensity were evaluated. In the allergy test,guinea pigs applied gel plaster [0.5001g/(cm 2 ·d)] on days 1,7,14,and 28to observe skin allergic reactions and systemic allergic reactions. Results: In the acute toxicity test,no obvious abnormalities were found in the mental and physical conditions of the rabbits,and no deaths occurred. In the irritation test,no abnormalities were found in the mental and physical conditions of the rabbits. On the third day,slight erythema appeared in the local area after the drug was administered. The erythema gradually disappeared 24hours after the drug was removed,and there was no edema on the skin. Allergy test showed that the gel plaster had no skin allergies on guinea pigs and the sensitization rate was 0. Conclusion: Tongfeng Jinhuang gel plaster has no obvious acute toxicity,irritation or anaphylaxis when administered transdermally. Patients can safely use it under the guidance of clinicians.

关 键 词：痛风金黄凝胶贴膏 经皮给药 急性毒性 刺激性 过敏性 

分 类 号：R275.9[医药卫生—中西医结合]