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目的观察苍辛气雾剂急性毒性、局部刺激性反应及皮肤过敏反应,为其临床应用提供安全性参考依据。方法以最大给药量法观察大鼠鼻腔给药后出现的急性毒性反应及其程度;以大鼠鼻腔给药,根据一般情况观察与组织病理学检查综合判断呼吸道粘膜发生的局部刺激性反应;进行豚鼠皮肤给药致敏试验,观察其过敏反应。结果苍辛气雾剂以最大给药量25.6g/kg·d鼻腔给药,并连续观察14d,均未见死亡及明显急性毒性反应。以8.6g/kg·d连续给药7d,无一例死亡,且未见局部刺激反应,病理组织学检查亦未见异常。豚鼠主动皮肤过敏实验中,亦未见豚鼠过敏症状。结论苍辛气雾剂在本次试验的剂量范围内未出现急性毒性、局部刺激性及过敏性反应,结果提示其临床使用安全。
Objective To observe the acute toxicity, local irritant reaction and skin allergic reaction of Cangxin aerosol, and provide safety reference for clinical application. Methods The maximum dose was used to observe the acute toxicity and its degree after nasal administration in rats. Rats were given intranasally. According to the general observation and histopathological examination, the local irritative reactions of respiratory mucosa occurred. Guinea pig skin sensitization test was performed to observe allergic reactions. RESULTS Cangxin aerosol was administered into the nasal cavity with the maximum dose of 25.6g/kg·d and observed continuously for 14 days. No death or significant acute toxicity was observed. At the dose of 8.6g/kg·d for 7 days, there was no case of death, and no local irritative reaction was found. Histopathological examination showed no abnormality. No guinea pig allergy symptoms were found in the guinea pig active skin allergy test. Conclusion Cangxin aerosol did not show acute toxicity, local irritation and allergic reactions within the dose range of this trial. The results suggest that its clinical use is safe.