腐植酸钠凝胶剂局部用药的安全性评价

The Safety Evaluation of Topical Application of Sodium Humate Gel

为了评价腐植酸钠凝胶剂局部用药的安全性,分别通过家兔的单次给药和多次给药实验、豚鼠的致敏接触和激发接触实验及不同剂量的药物对大鼠的完整皮肤、破损皮肤实验观察腐植酸钠凝胶剂对皮肤的刺激性、致敏性和急性毒性反应。结果表明:腐植酸钠凝胶剂单次、多次家兔完整皮肤和破损皮肤给药,用药局部未见红斑、水肿及其他异常反应,皮肤刺激反应平均分值为0,组织病理学亦未见对家兔完整皮肤和破损皮肤有刺激性;腐植酸钠凝胶剂豚鼠皮肤给药,皮肤未见红斑、水肿及其他过敏反应,皮肤过敏反应平均分值为0,致敏率为0%;腐植酸钠凝胶剂大鼠完整皮肤和破损皮肤给药,在7天观察时间内,未见明显急性毒性反应。可见,腐植酸钠凝胶剂没有明显的刺激性、致敏性和急性毒性,具有较好的安全性。

In order to evaluate the safety of topical application of sodium humate gel,the irritation,anaphylaxis,and acute toxicity of sodium humate gel on the skin were observed by single-dose and multiple-dose tests in rabbits,skin irritation and challenge exposure test in guinea pigs,and different doses of drugs to the complete skin and breakage skin of rats.The results showed that there were no erythema,edema and other abnormal reactions in the test of single-dose and multiple-dose of sodium humate gel to the complete skin and breakage skin of rabbits.The mean value of skin irritation was 0,indicating no irritation to complete skin and breakage skin of rabbits.No erythema,edema and other allergic reactions were observed on guinea pig skin after administration of the sodium humate gel.The mean value of skin anaphylactic reaction and the sensitization rate were both 0.There were no obvious acute toxicity on the complete skin and breakage skin of rats through 7 days observing time after administration of the sodium humate gel.Therefore,sodium humate gel has no obvious irritation,anaphylaxis and acute toxicity,it has better safety.