肤康灵喷雾剂皮肤过敏和毒性试验研究  

Buehler Test and Toxicity Studies by Dermal Administration of FuKangLing Spray

作　　者：李勇 王英英 谢壹科 张斌 曾统英 王三琼 LI Yong;WANG Ying-ying;XIE Yi-ke;ZHANG Bin;ZENG Tong-ying;WANG San-qiong(Institute of Laboratory Animal Sciences,Academy of Medical Sciences&Sichuan Provincial People′s Hospital,Chengdu 610212,China;Sichuan Natural Institute of Pharmacy,Chengdu 610041,China)

机构地区：[1]四川省医学科学院·四川省人民医院实验动物研究所,四川成都610212 [2]四川省天然药物研究所,四川成都610041

出　　处：《海峡药学》2019年第10期18-24,共7页Strait Pharmaceutical Journal

摘　　要：目的通过豚鼠Buehler试验、家兔的单次和重复皮肤给药毒性试验,评价肤康灵喷雾剂的安全性。方法Buehler试验:用1g生药/mL的肤康灵喷雾剂致敏和攻击豚鼠,观察豚鼠皮肤的过敏反应情况。单次给药毒性试验:采用最大给药量法,观察家兔的毒性反应。重复给药毒性试验:将家兔随机分为完整皮肤和破损皮肤1、2g生药/mL剂量组及相应辅料对照组,每组6只,皮肤给药,连续1个月,停药恢复半个月。进行各项毒理学指标检测。结果Buehler试验:肤康灵喷雾剂对豚鼠皮肤无致敏性。单次给药毒性试验:2g生药/mL的肤康灵喷雾剂24h内3次皮肤给药,对家兔完整皮肤具有轻度的刺激性,但未发现有明显的全身毒性反应。重复给药毒性试验:2g生药/mL剂量组动物给药部位皮屑较其他组更明显,但各组动物均未发现其他与药物有关的毒副反应。结论肤康灵喷雾剂皮肤外用是安全的。OBJECTIVE To evaluate the safety of FuKangLing spray in guinea pigs by Buehler test and in rabbits by single dose and repeat doses toxicity studies.METHODS In Buehler test,the allergic reactions of guinea pigs were observed by sensitizing and challenging contact of FuKangLing spray of 1g·mL-1.In single dose toxicity study,maximum feasible dose(MFD)method was applied to observe the toxic reaction of rabbits.In repeat doses toxicity study,rabbits were randomly divided into control,FuKangLing spray 1,2g·mL^-1 groups of intact or damaged skin respectively.All animals was given vehicle or FuKangLing spray by dermal administration for 1 month followed by 15-day recovery.Toxicology parameters were determined.RESULTS In Buehler test,FuKangLing spray of 1g·mL^-1 did not cause skin allergic reactions in guinea pigs by many times sensitization.In single dose toxicity study,FuKangLing spray of 2g·mL^-1 was given to the skin of rabbits for 3 times in 24 hours,no general toxicity was found except mild skin irritation.In repeat doses toxicity study,scurf of rabbits at 2g·mL^-1 group was more obvious than other groups,no other adverse drug reactions were found at all groups.CONCULSION FuKangLing spray was safe when used by dermal adminstration.

关 键 词：肤康灵喷雾剂 皮肤给药 Buehler试验 单次给药毒性试验 重复给药毒性试验 

分 类 号：R965[医药卫生—药理学]