舒乳凝胶的毒理学研究

Toxicologic Research of Shuru Gel

目的:分析舒乳凝胶的毒理学,为制定相关的卫生标准和防治措施提供理论依据。方法:把健康家兔分成5组,包括1组空白对照组(空白凝胶)和4组试验组(完整皮肤和破损皮肤组,分别使用高、低剂量舒乳凝胶),对舒乳凝胶的急性毒性、皮肤刺激性和长期毒性进行分析。结果:所有家兔均未出现死亡及明显的中毒症状,饮食情况正常,体质量正常增加,活动自如,给药期间各试验组动物体质量与对照组的差异无统计学意义(P>0.05);舒乳凝胶低、高剂量组家兔单次给药后,完整皮肤和破损皮肤均未形成局部红斑和水肿,均未见刺激性,与对照组的差异无统计学意义(P>0.05);对各组进行长期毒性反应试验可见,试验组家兔的体质量、血液学指标、血液生化指标和脏器系数、脏器组织形态学变化情况与对照组的差异均无统计学意义(P>0.05)。结论:不同剂量的舒乳凝胶对家兔无急性毒性、皮肤刺激性和长期毒性,为比较安全的外用药物。

OBJECTIVE： To analyze the toxicology of shuru gel,and to provide theoretical basis for the formulation of hygienic standard and control measures. METHODS： Health rabbits were divided into 5 groups,including one blank control group（ blank gel） and 4 experimental groups（ intact-skin and damaged-skin model group,respectively with high and low doses of shuru gel）. The acute toxicity,skin irritation and long-term toricity were analyzed. RESULTS： All of the rats had no death and obviously toxic symptoms,with normal diet and freely activity,the body mass had an normal increase,there was no statistically significant difference of body mass between the control group and observation group（ P〉0. 05）. After administration of shuru gel of high dose and low dose in the rabbits,there were no local erythema,edema and irritation in intact-skin and damaged-skin,and with no statistically significant difference compared with the control group（ P〉0. 05）. From the long-term toxicity test of these groups,there was no statistically significant difference of the body mass,blood routine examination,blood biochemical indexes and coefficient of organs between the control group and observation group（ P〉0. 05）. CONCLUSIONS： Shuru gel of different dose has no acute toxicity,skin irritation and long-term toxicity in rabbits,it is safe for external medication.