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目的:进行豚鼠皮肤给药过敏性试验、急性毒性试验及长期毒性试验,观察雄竭烫烧伤膏皮肤用药的安全性。方法:将空白基质、阳性致敏物(2,4-二硝基氯苯)和雄竭烫烧伤膏涂于豚鼠背部皮肤进行皮肤过敏性试验;豚鼠完整皮肤及破损皮肤一日内涂药4次后观察至14天,进行急性毒性试验;豚鼠完整皮肤及破损皮肤连续涂药3个月,部分动物停药后观察1个月,观察其对动物体重、血细胞、生化指标、肝肾功能、病理切片等指标的影响,进行长期毒性试验。结果:雄竭烫烧伤膏皮肤给药未见过敏性反应;完整及破损皮肤豚鼠未产生急性毒性反应;长期毒性试验时,完整及破损皮肤豚鼠的一般状态、体重、血常规及生化、组织病理学指标等均未出现异常。结论:雄竭烫烧伤膏皮肤给药未出现毒副反应,安全性试验显示其安全、无毒。
OBJECTIVE: To study the skin allergy test, acute toxicity test and long-term toxicity test of guinea pig skin to observe the safety of the drug of the skin radix abdomen. Methods: Blank matrix, positive sensitizer (2,4-dinitrochlorobenzene) and abscess cream were applied to the skin of guinea pigs for skin allergy test. Guinea pigs with intact skin and damaged skin were treated 4 times a day Observed to 14 days, acute toxicity test; Guinea pigs intact skin and damaged skin continuous application of 3 months, some animals were observed after stopping for 1 month to observe the animal body weight, blood cells, biochemical parameters, liver and kidney function, pathological sections And other indicators of the impact of long-term toxicity test. Results: There was no anaphylactic reaction in the skin of Guizhen scald ointment. Guinea pigs in intact and damaged skin did not produce acute toxic reaction. In the long-term toxicity test, the general condition, body weight, blood and biochemical, histopathological Neo-Confucianism norms and other abnormalities. Conclusion: There is no toxic or side effect on the skin of Oxygen burn burn cream. The safety test shows it is safe and non-toxic.