复方菊冰喷雾剂的毒性试验研究

目的考察复方菊冰喷雾剂的急性毒性、局部刺激性以及蟾蜍口腔黏膜纤毛毒性。方法采用最大给药量试验观察鼻腔给药后动物短期内出现的急性毒性反应,包括呼吸状况、行为活动、精神状态等;参照中药新药指导原则考察复方菊冰喷雾剂的局部刺激性,并对相关组织进行病理切片检查;在光学显微镜下观察在体、离体蟾蜍口腔上腭纤毛在药物溶液作用下的持续摆动时间,考察复方菊冰喷雾剂的纤毛毒性大小。结果复方菊冰喷雾剂以最大给药浓度2.0mL/kg给予大鼠双侧鼻腔滴鼻无明显的急性毒性反应出现;局部刺激性实验中动物一般状况良好,未发生全身反应及死亡情况;组织病理学检查未见异常;对在体和离体蟾蜍口腔黏膜上腭纤毛的功能有一定的损伤作用。结论复方菊冰喷雾剂无明显急性毒性、局部刺激性,但有抑制蟾蜍口腔黏膜纤毛摆动的作用。

Experimental study on the toxicity of compound Jubing spray

Objective To investigate acute toxicity,local irritation and palatine mucosal ciliotoxicity in toad of compound Jubing spray. Method Observed acute toxicity in a short-term after intranasally administrated with compound Jubing spray at a maximum tolerance dose （MTD）,including breathe state,activities,mental state and so on;The local irritation of compound Jubing spray was evaluated by referring to the guiding principle of development of Chinese medicine,and pathological examinations of relevant tissues were also conducted. In vivo palatine mucosal ciliary beating and in vitro palatine mucosal ciliary beating were also observed under light microscopy to investigate the ciliotoxicity of the spray. Results There was no obvious acute toxicity after intranasally administrated with the spray at the maximum tolerance dose of 2.0 mL/kg; all the laboratory animals showed good conditions in the experiment of local irritation,and no abnormality was observed in pathological examination. Certain damages were observed in in vivo palatine mucosal cilia and in vitro palatine mucosal cilia.Conclusion Compound Jubing spray showed no obvious acute toxicity and local irritation,but showed inhibitory effects on the palatine mucosa cilial beating in toad.