苍辛气雾剂急性毒性、局部刺激性及过敏性实验研究

Experimental study on the acute toxicity and mucosal irritation of Cangxin nasal sprayer

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, potential irritation on respiratory mucous membrane and skin anaphylaxis of Cangxin nasal sprayer. Methods According to the guidance on the research of the new Chinese traditional medicines, the acute toxic reactions of animals were investigated by maximal dosage experiments. The irritative reactions in animals＇ respiratory mucous membrane were systemically observed through physical and histopathological examinations. Patch application to the topical skin of guinea pigs with the solution was used to test whether it might result in skin hypersusceptibility. Results It didn＇t cause acute toxicity and death after being administered to rat＇s nasal cavity at the maximal dosage of 25.6 g/kgod. No whole body reaction and death occurred. The irritative reactions such as erythema and edema were not observed and worse changes including neutrophil leucocyte penetration in respiratory mucous membrane were not discovered by histopathological examinations. Skin anaphylaxis experiments showed that the medicine were not caused skin hypersusceptibility. Conclusions Cangxin nasal sprayer does not induce acute toxicity and mucosal irritation, and it can be used safely in clinical application.