关节止痛膏改进基质辅料前后的安全性实验研究

Skin Safety Evaluation of Arthralgia Plaster Before and After Matrix Amelioration

目的:比较关节止痛膏改进橡胶膏基质辅料前后对皮肤刺激性及导致皮肤过敏2者是否存在差异。方法:1)分别在家兔一侧完整或破损的皮肤上贴两种不同胶布,并以另一侧完整或破损的皮肤作空白对照观察不同时段的刺激性;2)豚鼠用阳性药及受试药接触致敏3次,于末次接触后第14天激发接触,观察除去药物时及时间段的过敏反应情况。结果:原有基质辅料配方的关节止痛膏对豚鼠皮肤有轻度刺激性,改变基质辅料配方的关节止痛膏也使少数豚鼠出现红斑,经χ2检验后发现原有基质辅料配方的关节止痛膏对豚鼠皮肤的刺激性比改变基质辅料配方的关节止痛膏大,2者间存在着显著性差异(P<0.05)。过敏试验表明,关节止痛膏改进橡胶膏基质辅料前后的样品24h、48h、72h均无过敏反应,2者间不存在显著性差异。结论:可以使用改变基质辅料配方的关节止痛膏胶布代替原有基质辅料配方的关节止痛膏胶布。

Objective：To evaluate and compare impact of Arthralgia Plaster on skin （i.e. irritation,allergy） before and after amelioration of rubber matrix.Methods：1） Skin irritation test：Plasters with original or ameliorated matrix were applied on complete or damaged rabbit skin on one side,controlled by skin of same condition on the other side,to observe skin irritation at different time points; 2） Skin sensitization test：Guinea Pig skin was sensitized with positive drug and investigational drug for 3 times,received stimulating contact on Day 14 from last sensitization contact,then observed skin allergic reaction at the time of drug removal and different time points.Results：The original plaster was mildly skin sensitive,the ameliorated plaster caused erythema on a few subjects. Square test showed original plaster was more skin sensitive than ameliorated plaster （P〈0.05）. In sensitization test,none of two plasters caused skin allergy at 24、48、72h （P〉0.05）.Conclusion：Matrix-ameliorated Arthralgia Plaster can substitute Arthralgia Plaster with original matrix.