摘要
目的:研究国产仿制药丁酸氯倍他松乳膏的皮肤刺激性和过敏性,并与市售品(原研药品)进行对比。方法:采用家兔进行皮肤刺激性实验,将24只家兔随机分为供试品完整皮肤组、供试品破损皮肤组、市售品完整皮肤组和市售品破损皮肤组,每组6只。在家兔背部左侧完整或破损皮肤给予0.5 mL供试品或市售品,右侧给予等量的赋形剂,每天给药2次,连续7 d。观察药物对家兔皮肤的刺激性,对皮肤红斑和水肿进行评分,并在末次给药结束后72 h及停药7 d后取给药部位皮肤进行组织病理学检查。采用豚鼠进行皮肤过敏性实验(Buehler实验),将60只豚鼠随机分为供试品组(20只)、市售品组(20只)、阳性对照组(10只)和赋形剂对照组(10只)。分别于第0、7、14天对豚鼠左侧肋腹部皮肤给予相应受试物(0.2 mL/只)进行致敏,第28天在右侧肋腹部给予相应受试物(0.2 mL/只)进行激发。激发后24、48 h观察豚鼠皮肤红斑、水肿等过敏反应症状并进行评分,同时计算过敏反应发生率。结果:在家兔皮肤刺激性实验中,供试品和市售品对家兔完整皮肤均未引起红斑和水肿等刺激性症状,皮肤刺激评分为0,皮肤刺激强度为无刺激性;供试品和市售品均引起个别家兔破损皮肤出现短暂性轻微的红斑,皮肤刺激评分为0~0.33分,皮肤刺激强度为无刺激性;各组之间无统计学差异;病理检查均未见组织病理学改变。在豚鼠皮肤过敏性实验中,供试品和市售品激发给药后豚鼠皮肤未见红斑和水肿等过敏反应,评分均为0,过敏反应发生率为0;与赋形剂对照组比较,供试品组和市售品组的评分和过敏反应发生率差异无统计学意义。结论:在家兔皮肤刺激性实验和豚鼠皮肤过敏性实验中,丁酸氯倍他松乳膏仿制药与原研药评价结果一致,对家兔皮肤无刺激性,对豚鼠皮肤无过敏性。
OBJECTIVE:To study the skin irritation and sensitization of domestic generic drug Clobetasone butyrate cream,and to compare it with commercial drug(original drugs).METHODS:The skin irritation test was conducted on rabbits.Totally 24 rabbits were randomly divided into test preparation intact skin group,test preparation abraded skin group,commercial drug intact skin group and commercial drug abraded skin group,with 6 rabbits in each group.0.5 mL test preparation or commercial drug was administered to the left side of intact or abraded skin and the same amount of excipient on the right side of each rabbit twice a day for consecutive 7 days.The irritation of the drug to the rabbit skin was observed,and the erythema and edema of the skin were scored;the skin of administration site was taken at 72 h after last administration and the end of 7 d after drug withdrawal for histopathological examination.The skin sensitization test(Buehler test)was carried out on guinea pigs.Totally 60 guinea pigs were randomly divided into test preparation group(n=20),commercial drug group(n=20),positive control group(n=10)and excipient control group(n=10).0.2 mL test preparation or commercial drug was administrated to the left side of the rib abdomen skin of each guinea pig at the 0,7th,14th day to induce model,and an equal amount of corresponding preparation was administered to the right side in the same way at the 28th day for stimulation.Hypersensitive response such as erythema and edema were observed and scored at 24 h and 48 h after the stimulation.The incidence of hypersensitive response was then calculated.RESULTS:In skin irritation test of rabbits,no erythema and edema was caused by the test preparation or commercial drug on intact skin of rabbits;scores of skin irritation was 0;there was no dermal irritation.Both test preparation and commercial drug caused transient slight erythema on abraded skin of a few rabbits;scores of intact and abraded skin irritation were 0-0.33;there was no dermal irritation.There was no statistical signi
作者
向翠英
杨刚
杨冰
郑传博
周静思
李正平
XIANG Cuiying;YANG Gang;YANG Bing;ZHENG Chuanbo;ZHOU Jingsi;LI Zhengping(Center of Research&Development,Huapont Pharm Co.,Ltd.,Chongqing 401121,China;Chengdu Baikang Pharmaceutical Industry Pharmacology and Toxicology Research Institute,Chengdu 610046,China)
出处
《中国药房》
CAS
北大核心
2020年第3期330-334,共5页
China Pharmacy
基金
重庆市科技计划项目-社会事业与民生保障科技创新专项(No.cstc2016shmszx130055)
关键词
丁酸氯倍他松乳膏
仿制药
原研药
皮肤刺激性
皮肤过敏性
家兔
豚鼠
Clobetasone butyrate cream
Generic drug
Original drug
Skin irritation
Skin sensitization
Rabbit
Guinea pigs
