【目的】 观察消瘀膏对皮肤的过敏性及刺激性反应，评估消瘀膏在皮肤应用中的安全性。【方法】（1）皮肤过敏性试验： 选用健康豚鼠30只，随机分为空白基质组，阳性药物（2，4-二硝基氯代苯）组，消瘀膏低、中、高剂量组。于第0、7、14天 在豚鼠左侧腹部脱毛给药致敏，于第28天在右侧腹部脱毛给药激发，观察皮肤是否出现过敏反应，进行过敏反应评分及病 理组织学检查。（2）皮肤刺激性试验：选用健康新西兰兔36只，随机分为完整皮肤消瘀膏低、中、高剂量组及破损皮肤消瘀 膏低、中、高剂量组，于每只新西兰兔的左右脊柱两侧分别贴敷消瘀膏和空白基质，连续贴敷15 d，观察皮肤是否出现刺激 反应，进行皮肤刺激强度评分以及病理组织学观察。【结果】 消瘀膏对豚鼠皮肤的致敏性较弱，在完整新西兰兔皮肤上没有 引起刺激反应，但在破损皮肤上呈现出轻微的刺激性。【结论】 消瘀膏的皮肤过敏性较弱并且无明显刺激性，可以进一步进 行临床应用和推广。

Objective To observe the allergic and irritant reactions of Xiaoyu Ointment on the skin and evaluate its safety for topical application. Methods （1）Thirty healthy guinea pigs were randomly divided into a blank base group，a positive drug（2，4-dinitrochlorobenzene） group，and low-，medium-，and high-dose Xiaoyu Ointment groups. On day 0，7，and 14，the left abdominal area of the guinea pigs was shaved and treated with the ointment for sensitization. On day 28，the right abdominal area was shaved and treated to induce an allergic reaction. Skin reactions were observed， and allergy scores and histopathological examinations were performed.（2）Thirty-six healthy New Zealand rabbits were randomly divided into intact skin low- ， medium- ， and high-dose Xiaoyu Ointment groups and damaged skin low-，medium-，and high-dose Xiaoyu Ointment groups. Xiaoyu Ointment and a blank base were applied to both sides of the spine of each rabbit for 15 consecutive days，respectively. Skin reactions were observed， and irritation intensity scores and histopathological examinations were performed. Results Xiaoyu Ointment showed weak sensitization on guinea pig skin and did not cause irritation on intact rabbit skin. However， mild irritation was observed on damaged skin. Conclusion Xiaoyu Ointment has weak skin sensitization and no significant irritation，making it suitable for further clinical application and promotion.

R285.5

国家自然科学基金青年项目（编号：82205301）；深圳市中医重点专科建设项目（编号：P-20240129-0204）