消痤洁肤乳膏皮肤用药安全性实验研究  

Study on the Safety of Xiaocuo Jiefu Cream

作　　者：曾明辉[1] 谭正怀[2] 陈璐[1] 李秀婵[2] 

机构地区：[1]四川省医学科学院/四川省人民医院药剂科,成都市610072 [2]四川省中医药科学院药理毒理研究所国家中医药管理局中药质量生物学评价重点研究室,成都市610041

出　　处：《中国药房》2010年第45期4256-4257,共2页China Pharmacy

摘　　要：目的:评价消痤洁肤乳膏(含螺内酯和盐酸克林霉素)皮肤用药的安全性。方法:采用兔完整皮肤和破损皮肤分组涂布消痤洁肤乳膏和乳膏基质(每只1.0g)进行皮肤刺激实验(n=10);对豚鼠分组涂布消痤洁肤乳膏(每只0.2g)、乳膏基质(每只0.2g)、2,4-二硝基氯苯(每只0.2mL)进行皮肤致敏实验(n=50),2个实验均以红斑和水肿情况为评价指标;对大鼠分组涂布0.65、0.52、0.416g·kg-1的消痤洁肤乳膏和乳膏基质进行完整皮肤和破损皮肤的皮肤急性毒性实验(n=70),并设立对照组,观察各组大鼠7d内体质量变化、中毒反应及死亡情况。结果:消痤洁肤乳膏对兔完整皮肤及破损皮肤刺激强度、豚鼠致敏强度评分均为0,急性毒性实验中大鼠体质量变化无差异,未见死亡及中毒反应发生。结论:消痤洁肤乳膏是一种安全性较好的外用药。OBJECTIVE： To evaluate the safety of Xiaocuo jiefu cream （containing spirolactone and clindamycin hydrochloride）. METHODS： In dermal irritation test, Xiaocuo jiefu cream （1.0 g） and cream matrix （1.0 g） were applied on integral and injured skin of rabbits （n=10）. In dermal sensitivity test, Xiaocuo jiefu cream （0.2 g）, cream matrix （0.2 g） and 2,4-dinitrochloroben （0.2 mL） were applied on skin of guinea pig （n=50）. Erythema and edema were used as evaluation index. In acute dermal toxicity test, Xiaocuo jiefu cream and cream matrix （0.65 g·kg^-1, 0.52 g·kg^-1, 0.416 g·kg^-1） were applied on integral and injured skin of rats （n= 70）, meanwhile compared with control group. The bodyweight, toxicity reaction and death case of rats in 7 days were observed. RESULTS： Xiaocuo jiefu cream had no dermal irritation to integral and injured skin of rabbits and sensitivity to guinea pig. In acute toxicity test, there was no change in body weight of rats and the rats which were used Xiaocuo jiefu cream didn＇ t appear the toxicity reactions. CONCLUSION： Xiaocuo jiefu cream is a safe drug for external use.

关 键 词：消痤洁肤乳膏 刺激实验 皮肤过敏实验 皮肤急性毒性实验 兔 大鼠 豚鼠 

分 类 号：R965.3[医药卫生—药理学] R986[医药卫生—药学]