骨康宁洗剂皮肤刺激性和过敏性实验研究  

Skin Irritation and Hypersensitivity of Gukangning Lotion

作　　者：张晓萌 王康俊 陈国彪 王巨才 ZHANG Xiaomeng;WANG Kangjun;CHEN Guobiao;WANG Jucai(Hainan Institute for Drug Control·Hainan Key Laboratory for Pharmaceutical Quality Research,Haikou,Hainan,China 570216)

机构地区：[1]海南省药品检验所·海南省药物质量研究重点实验室,海南海口570216

出　　处：《中国药业》2021年第16期59-61,共3页China Pharmaceuticals

基　　金：国家科技支撑计划项目[2007BAI27B00]。

摘　　要：目的探讨骨康宁洗剂的皮肤刺激性和过敏性。方法取家兔8只,随机分为完整皮肤组和破损皮肤组,每组4只,雌雄各半。以无菌针头划破制备破损皮肤。采用同体左右侧自身对比法,脱毛后,左侧以纱布浸骨康宁洗剂原液20 m L贴敷,右侧同法贴敷等体积纯水,单次药物刺激1,24,48,72 h及多次药物刺激1 h后,观察贴敷部位的红斑、水肿、色素沉着、出血点、皮肤粗糙、皮肤菲薄等情况,以及发生和消退时间。取豚鼠40只,随机分为药物组(20只)、空白对照组(10只)和模型组(10只),脱毛,致敏,激发。激发给药后24,48 h时观察豚鼠皮肤红斑、水肿等过敏反应症状并评分,以及是否有哮喘、站立不稳、休克等严重全身性过敏反应出现。结果单次给药后,两组家兔的受试皮肤未见明显异常;多次给药后,破损皮肤组有2只家兔的受试皮肤出现不规律的轻度红斑(24 h后消失),其余家兔皮肤未见明显异常。激发给药24,48 h后,模型组豚鼠皮肤出现重度红斑、中度水肿,致敏率100%,药物组和空白对照组豚鼠未见过敏反应及严重的全身性过敏反应。结论骨康宁洗剂的皮肤刺激性和皮肤过敏性均较低。Objective To investigate the skin irritation and hypersensitivity of Gukangning Lotion.Methods Eight rabbits were randomly divided into intact skin group and damaged skin group,four rabbits in each group with half male and half female.The damaged skin was prepared by cutting with a sterile needle.The homobody left and right sides self-comparison method was adopted.After depilation,20 m L of Gukangning Lotion was applied on the left side of the rabbit with gauze,and an equal volume of pure water was applied on the right side of the rabbit with the same method.After single drug stimulation for 1,24,48,72 h and multiple drug stimulation for 1 h,the erythema,edema,pigmentation,bleeding point,rough skin and thin skin at the application site were observed,as well as the occurrence and regression time.A total of 40 guinea pigs were randomly divided into the drug group(20 guinea pigs),blank control group(10 guinea pigs)and model group(10 guinea pigs),and they were depilated,sensitized and stimulated.After 24 h and 48 h of stimulation,the hypersensitivity reactions symptoms such as skin erythema and edema of guinea pigs were observed and scored.Meanwhile,whether there were severe systemic hypersensitivity such as asthma,instability or shock were closely observed.Results After a single administration,there was no obvious abnormality in the tested skin of rabbits in the two groups.After repeated administration,irregular mild erythema appeared on the skin of two rabbits in the damaged skin group(disappeared after 24 h),and no obvious abnormality was found on the skin of other rabbits.After 24 h and 48 h of stimulation,severe erythema and toxic edema appeared on the skin of guinea pigs in the model group,and the sensitization rate was 100%.Guinea pigs in the drug group and the blank control group had no allergy and severe systemic hypersensitivity reactions.Conclusion Gukangning Lotion has a low risk of skin irritation and hypersensitivity.

关 键 词：骨康宁洗剂 皮肤刺激性 皮肤过敏性 动物实验 家兔 

分 类 号：R932[医药卫生—生药学] R285.5[医药卫生—药学]