清湿止痒泡腾片皮肤安全性评价实验研究  

Experimental study on the evaluation of skin safety of Qingshi zhiyang effervescent tablets

作　　者：王友兰 李嘉嘉 陈晨[3] WANG You-lan;LI Jia-jia;CHEN Chen(Kunming Institute of Medical Sciences,Kunming,Yunnan 650011;Third People's Hospital of Yunnan Province,Kunming,Yunnan 650011;Kunming Medical University,Kunming,Yunnan 650500)

机构地区：[1]昆明市医学科学研究所,云南昆明650011 [2]云南省第三人民医院,云南昆明650011 [3]昆明医科大学,云南昆明650500

出　　处：《皮肤病与性病》2020年第5期653-656,共4页Dermatology and Venereology

摘　　要：目的对清湿止痒泡腾片的皮肤急性毒性、刺激性、过敏性进行评价,为临床安全使用提供依据。方法以最大给药量法进行大鼠皮肤急性毒性试验,观察完整皮肤及破损皮肤产生的急性毒性反应及全身性反应;左右侧自身对照法进行豚鼠多次给药皮肤刺激性试验,观察全身状况及局部皮肤的变化;以主动皮肤过敏性试验进行豚鼠皮肤过敏性试验研究。结果多次给予69%的清湿止痒泡腾片混悬液,大鼠未见明显急性毒性反应及全身性反应。涂抹3.2%清湿止痒泡腾片混悬液后,豚鼠破损皮肤组有轻微刺激性,停药(1~2)天皮肤刺激均能恢复正常。涂抹3.2%清湿止痒泡腾片混悬液对豚鼠皮肤无致敏。结论清湿止痒泡腾片混悬液更适合用于完整皮肤,应尽量避免长期使用于破损皮肤,以减少药物对皮肤的刺激性。清湿止痒泡腾片水溶液外用具有较高的安全性。Objective To evaluate the skin acute toxicity,irritation and hypersensitivity of Qingshi zhiyang effervescent tablets in order to provide evidence for safe clinical use.Methods The acute toxicity and systemic reaction of intact skin and amaged skin were observed by the maximum osage method.The skin irritation test of guinea pigs was carried out by the left and right side self-control method.Results Repeatedly giving 69%of the suspension of Qingshi zhiyang effervescent tablets.There was no obvious acute toxicity and systemic reaction in rats.Slight irritation in amaged skin group of guinea pigs after applying 3.2%Qingshi zhiyang effervescent tablets suspension,and the skin irritation could return to normal after 1~2 days of withdrawal.The skin of guinea pigs was not sensitized by applying 3.2%Qingshi zhiyang effervescent tablets suspension.Conclusion The suspension is more suitable for intact skin and should avoid long-term use in amaged skin to reduce the irritation of rugs.It has high safety for external use of water solution of Qingshi zhiyang effervescent tablets.

关 键 词：清湿止痒泡腾片 皮肤 急性毒性 刺激性 过敏性 

分 类 号：R965.3[医药卫生—药理学]