摘要
目的:考察复方透骨草液外用的毒性,为临床应用的安全性提供实验依据。方法:①家兔皮肤急性毒性实验:家兔皮肤1 d内4次涂抹复方透骨草液,观察动物的急性毒性反应,14 d后检测血液生化指标ALT、AST、BUN、CREA、TP和ALB,大体解剖观察心、肝、脾、肾等主要脏器,并计算脏器指数。②家兔皮肤刺激实验:分别采用家兔完整皮肤和破损皮肤模型,连续7 d涂抹复方透骨草液,观察给药期及恢复期皮肤的红斑及水肿情况,记录皮肤刺激反应评分,判断药物是否具有刺激作用及刺激强度。恢复期结束行病理学检查。③豚鼠主动皮肤过敏预实验:豚鼠于第1、7、14天涂抹复方透骨草液进行致敏,以0.9%NaCl溶液为阴性对照,1%1-氯-2,4-二硝基苯溶液为阳性对照;末次致敏后14 d进行激发,激发后连续观察72 h,对皮肤的红斑和水肿情况进行初步评价。结果:①家兔1 d内外用大剂量复方透骨草液无明显急性毒性表现;与对照组相比,各项血液生化指标及主要脏器均无明显异常。②连续7 d涂抹复方透骨草液后,家兔完整皮肤未出现明显的红斑、水肿反应,无刺激性;家兔破损皮肤均出现轻度刺激症状(勉强可见红斑),且随着给药次数增加,药物对皮肤的刺激程度增强,末次给药后呈轻度刺激表现,停药后刺激症状逐渐消失,但部分动物的破损皮肤仍可见局部表皮增厚、真皮内纤维组织增生。③豚鼠外涂复方透骨草液激发后6、24、48、72 h均未出现红斑、水肿反应,无致敏性。结论:家兔外用相当于人临床用量45倍的复方透骨草液后未见急性毒性反应。复方透骨草液对家兔完整皮肤无刺激性,但对破损皮肤有一定的刺激性,对豚鼠无致敏性。
Objective:To evaluate the toxicity of Compound Tougucao Solution with external application,and provide the experimental basis for its clinical application.Methods:①Skin acute toxicity test:Rabbit skin was smeared with Compound Tougucao Solution four times within one day to observe the acute toxicity.After 14 days,the blood biochemical indexes including ALT,AST,BUN,CREA,TP and ALB were detected,the main organs such as heart,liver,spleen and kidney were observed by gross anatomy,and the organ index was calculated.②Skin irritation test:Intact skin and damaged skin model of rabbits were used respectively,and treated with Compound Tougucao Solution by external application for seven consecutive days.The erythema and edema of skin were observed during the administration and recovery period.The skin irritation response score was recorded to determine whether the drug showed the stimulating effect and its intensity.Pathological examination was performed after recovery period.③Active skin allergy pre-test:Guinea pig skin was smeared with Compound Tougucao Solution for sensitization on the 1 st,7 th,14 th day,and 0.9%NaCl solution was taken as the negative control and 1%1-chloro-2,4-dinitrobenzene solution as the positive control.The stimulation was performed on the 14 th day after the last sensitization.The erythema and edema of guinea pigs skin were observed for 72 hours after stimulation.Results:①No acute toxicity was observed in rabbits after external treatment with high-dose Compound Tougucao Solution within one day.Compared with the control group,there were no significant abnormalities in blood biochemical indexes and main organs.②After smearing with Compound Tougucao Solution for seven consecutive days,no obvious erythema and edema were found in rabbit intact skin,which could be considered as no irritation;while the rabbit damaged skin showed mild irritation symptoms(barely visible erythema),and the skin irritation degree was enhanced with the increase of administration times,the mild irritation was observe
作者
羊菲
金若敏
范斌
符胜光
张宁
YANG Fei;JIN Ruomin;FAN Bin;FU Shengguang;ZHANG Ning(Research Center for Drug Safety Evaluation,Shanghai University of Traditional Chinese Medicine,Shanghai201203,China;Department of Dermatology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University ofTraditional Chinese Medicine,Shanghai200437,China;Experiment Center of Science and Technology,Shanghai University ofTraditional Chinese Medicine,Shanghai201203,China)
出处
《上海中医药大学学报》
CAS
2019年第4期78-83,共6页
Academic Journal of Shanghai University of Traditional Chinese Medicine
基金
上海市卫计委科研计划资助项目(201640025)
上海市科委科研计划资助项目(15401972400)
关键词
复方透骨草液
外用
皮肤急性毒性
皮肤刺激性
过敏性
Compound Tougucao Solution
external application
acute skin toxicity
skin irritation
allergy
