海棠凝胶家兔单次皮肤给药毒性实验

摘要

通过家兔皮肤急性毒性实验,初步评价海棠凝胶对动物完整皮肤及破损皮肤所产生的毒性反应,为后续毒性试验和临床试验提供参考信息.采用最大给药量法,家兔16只,分为4组,即海棠凝胶完整皮肤组及破损皮肤组、赋形剂完整皮肤组及破损皮肤组,每组4只(♀、♂各半),给药前24h用电推剪推去背部两侧毛(约150 cm2),破损皮肤制作:在脱毛区用9号针头划“#”字状,以划破表皮渗血为度,给药量均为2 g/kg凝胶,给药组主药剂量为0.05 g/kg,将供试品和赋形剂涂于脱毛区,用一层称样纸覆盖及兔固定衣固定,并用兔脖套将兔固定,24h后用生理盐水洗去受试物及赋形剂,仔细观察和记录动物出现的毒性反应情况,连续观察14d,并记录体重和进食量情况.结果表明:海棠凝胶完整皮肤组及破损皮肤组无动物死亡,动物体重、进食量与赋形剂组比较无显著性差异(P＞0.05),呼吸、自主活动等均未见中毒反应,动物处死后经对各组家兔系统剖检,对皮肤给药部位及其它组织脏器进行观察,未见明显病理性改变.结论:海棠凝胶单次皮肤给药2 g/kg凝胶(主药剂量为0.05 g/kg),家兔未见明显毒性反应.%Through the acute toxicity test of rabbits,the toxicity of Begonia gel to the skin and damaged skin of the animals was evaluated,which provided reference information for the subsequent toxicity test and clinical trial.A total of 16 rabbits were divided into four groups:namely Begonia gel complete skin group and damaged skin group,excipient complete skin group and damaged skin group;each group has 4 rabbits (♀,♂ half).Before the administration of 24 hours,using the clippers to push the back of the hair on both sides of the hair (about 150 cm2),damaged skin production:in the hair removal area with # 9 needle plan "# " shape to break the epidermal oozing for the degree of administration for amount of 2g/kg gel,the main dose of 0.05 g/kg,the test sample and excipients applied to the hair removal area,covered with a layer of paper and fixed rabbit fixed clothing,and rabbit neck The rabbits were fixed overnight.After 24 hours,the test substance and excipients were washed with physiological saline.The toxicities of the animals were observed and recorded;and the weight and food intake were recorded for 14 days.The results show that there was no significant difference in animal body weight,food intake and excipient group (P＞0.05).There was no poisoning reaction in the respiratory and autonomic activities.After the animals were sacrificed,the animals were sacrificed.The septum of the rabbits in each group was examined;and the organs of the skin and other tissues were observed.No obvious pathological changes were observed.It is concluded that the Begonia gel single skin administration 2g/kg gel (the main dose of 0.05g/kg),no significant toxic effects in rabbits.