市售消炎镇痛膏皮肤刺激性和过敏性试验评价  

Experimental Evaluation of Skin Irritation and Hypersensitivity of Xiaoyan Zhentong Ointment

作　　者：郑洋滨 刘宁 艾力奇 刘波 洪燕 任琦 ZHENG Yangbin;LIU Ning;AI Liqi;LIU Bo;HONG Yan;REN Qi(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;The First Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330029,China.)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]南昌大学第一附属医院,江西南昌330029

出　　处：《药品评价》2021年第7期409-411,共3页Drug Evaluation

基　　金：江西省重点研发计划项目(20202BBGL73007)。

摘　　要：目的:对市售消炎镇痛膏进行皮肤刺激性过敏性进行安全性评价。方法:参照《中药、天然药物局部刺激和溶血性研究的技术指导原则》《中药天然药物免疫毒性(过敏性、光过敏反应)研究技术指导原则》中皮肤刺激性及皮肤过敏性试验,取不同厂家18批样品、原料和辅料分别进行家兔单次皮肤刺激性试验、多次皮肤刺激性试验和豚鼠皮肤过敏性试验。结果:所有样品均未出现单次皮肤刺激和过敏反应。在多次皮肤刺激试验中,4个厂家样品出现轻度皮肤刺激反应,4种原料和辅料分别出现轻度和中度皮肤刺激反应。结论:市售消炎镇痛膏有较好的安全性。Objective:To evaluate the safety of Antiphlogistic and analgesic cream for skin irritation and hypersensitivity.Methods:Refer to"the technical guidelines for the study of local irritation and hemolysis of traditional Chinese medicine and natural medicine",and"the technical guidelines for the study of immunotoxicity of natural Chinese medicine(allergic and photoallergic reactions)In the anaphylaxis experiment",18 batches of samples,raw materials and auxiliary materials from different manufacturers were used for single skin irritation test,multiple skin irritation test and guinea pig skin anaphylaxis test.Results:There was no single skin irritation and allergic reaction in all samples.In many skin irritation experiments,four samples from four manufacturers showed mild skin irritation,and four kinds of raw materials and auxiliary materials showed mild and moderate skin irritation respectively.Conclusion:Antiphlogistic and analgesic cream is safe.

关 键 词：经皮贴片 消炎镇痛膏 皮肤刺激试验 皮肤过敏试验 

分 类 号：R965[医药卫生—药理学]