医用臭氧油皮肤安全性评价

目的：开展医用臭氧油皮肤刺激性、急性毒性、过敏性评价，为临床安全使用提供依据。方法：以左右 侧自身对照法进行豚鼠单次或多次皮肤刺激性试验，观察全身状况及局部皮肤的变化；以最大给药量法进行大鼠皮 肤急性毒性试验，观察完整皮肤及破损皮肤产生的急性毒性反应；以主动皮肤过敏性试验进行豚鼠皮肤过敏性试验 研究。结果：多次给予高浓度(臭氧耗量为150 g/L)医用臭氧油后豚鼠破损皮肤组有轻度刺激性，其他剂量无皮肤刺 激性或皮肤刺激均能恢复正常；医用臭氧油对大鼠未见明显急性毒性；医用臭氧油与基质油均对豚鼠皮肤有轻度致 敏。结论：医用臭氧油皮肤刺激性与其浓度有关，采用合适的浓度和疗程，临床使用安全。

Safety evaluation for medical ozone oil on skin

Objective: To evaluate skin irritation, acute toxicity, and allergy of medical ozone oil for clinical application. Methods: In contrast to their left and right side irritation, one or more skin irritation tests were performed on the intact and damaged skins of guinea pigs. With the maximum concentration, acute skin toxicity test was applied on the intact and damaged skins of rats.Active cutaneous anaphylaxis was applied to the guinea pigs. Results: High concentration (ozone consumption: 150 g/L) of medical ozone oil showed a slight irritation on the broken skin of guinea pigs, while low concentrations did not show skin irritation.Medical ozone oil had no obvious acute toxicity to rats. The medical ozone oil and base oil showed mildallergy for the skin of guinea pig. Conclusion: The irritation of medical ozone oil is related to its concentration. With appropriateconcentration and duration of treatment, medical ozone oil is safe.