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目的 :研究乳痛消、乳痛贴的安全性。方法 :口服制剂采用小鼠最大耐受量 ,外用制剂采用完整皮肤、破损皮肤局部刺激试验 ,并与阴性对照同体左右侧对比。结果 :口服制剂小鼠灌胃量相当于成人每日常用量的 1 1 0倍以上 ,小鼠无死亡。外用制剂完整皮肤未发现红斑、水肿等异常反应 ,破损皮肤刺激强度平均分值为 2 5。结论 :研究表明口服及外用制剂均安全可靠。
Objective: To study the safety of Rutongxiao and Daitong stickers. Methods : The maximum dose of mice was used for oral preparations, and the topical stimulation of intact skin and damaged skin was used for external preparations, and compared with the left and right sides of the negative control. RESULTS: Orally administered mice had a gavage amount equivalent to more than 110 times the daily dose in adults and no deaths were observed. No abnormal reactions such as erythema and edema were found on the intact skin of the topical preparation, and the average score of the damaged skin was 25%. Conclusion : Studies have shown that oral and topical preparations are safe and reliable.