复方雷琐辛搽剂(Ⅰ)急性毒性试验

Acute Toxity Experiment of Compound Resorcinol Liniment(Ⅰ)

目的:为复方雷琐辛搽剂(Ⅰ)成品制剂的临床安全使用提供实验依据。方法:观察大鼠完整皮肤及破损皮肤一次性涂抹最大耐受量(MLD)的复方雷琐辛搽剂(Ⅰ)所产生的毒性反应情况。从给药0时起至7 d连续观察记录动物的毒理反应,以皮肤刺激反应标准进行评分作毒理等级评价;对存活动物在观察结束时进行高位脱椎处死采血检测外周血常规和血清生化,解剖后裸眼和病理切片观察心、脑、肝、肾等主要脏器的病理变化。实验数据以Bliss法处理计算LD_(50)。结果:未测出LD_(50)值;皮肤完好与破损组动物均产生轻度刺激反应;外周血常规和血清生化均未见明显改变;心、脑、肝、肾等重要脏器裸眼和病理切片均未见明显病理改变。结论:复方雷琐辛搽剂(Ⅰ)在小于MLD40 ml·kg^(-1)·d^(-1)(2000 mg·kg^(-1)·d^(-1))剂量下一次性涂大鼠皮肤后(该剂量相当于临床剂量的800倍),未产生明显毒副反应。

Objective： To provid scientific fundation for Safety using drug of compound resorcinol liniment （ Ⅰ ）. Method： Integrated and disrepaired skins in the albino rats were smeared with compound resorcinol liniment（ Ⅰ ） by the maximum tolerated dose （MLD） only. The toxic reaction of the animals were observed and recorded continuously from the beginning of using the drug to 7d, and evaluated by using the general standard of the reaction of skin stimulation in pharmacology. Execute animal by take off acanthi and collect blood to check up the periphery blood routine and serum biochemistry was used at the end of the observation of the euritherkophilic rats, and after the dissection, the pathological change of main visceras, such as heart, brain, liver, and kidney were observed with bore hole and pathological slices. The data of this experiment was used to calculat the value of LD50 by using Bliss rule. Result： The value of LD50 was unavaliable to be calculated. Low - grade stimulation was appeared in integrated and disrepaired groups. There was no obvious changes after the periphery blood routine and serum biochemistry and pathological slices in the main visceras （heart, brain, liver, and kidney）. Conclusion： There are no obvious toxic reactions occurred to the albino rats by smearing compound resorcinol liniment （ Ⅰ ）only, whose dose was lower than MLD 40ml·kg^-1·d^-1（2000 mg·kg^-1·d^-1）, and the value of LD50 is more than 2000 mg·kg^-1·d^-1