磷酸川芎嗪气雾剂急性毒性及局部刺激性试验研究

目的观察磷酸川芎嗪气雾剂的急性毒性、黏膜刺激性。方法采用最大给药量试验观察鼻腔及腹腔给药后SD大白鼠短期内出现的急性毒性反应及其程度。观察一般情况与解剖显微镜下检查呼吸道黏膜局部刺激性反应。结果鼻腔及腹腔给药后SD大鼠的最大给药量为1%磷酸川芎嗪气雾剂1 mL,短期内未出现急性毒性反应及死亡情况;局部刺激性试验中大鼠一般情况良好,未发生毒副反应,显微镜下观察鼻、喉、气管等呼吸道黏膜未见损伤性变化。结论磷酸川芎嗪气雾剂鼻腔用药无明显毒性及刺激性,可供临床使用。

Experimental Study on Acute Toxicity and Local Irritation of Ligustrazine Aerosol

Objective To observe the acute toxicity and mucosal irritation of ligustrazine aerosol.Methods The maximum administration dosage test was adopted for observing the appearance and degrees of short-term toxicity in SD rat after abdominal cavity and nasal cavity administration.The general condition and the local stimulating reactions of respiratory tract mucosa by microscope were observed.Results The maximum administration dosage by the nasal cavity and abdominal cavity administration in SD rat was 1mL/kg of the test solution 1%ligustrazine aerosol.No acute toxicity reactions and death case occurred in the short term.In the local stimulating experiment,the general condition of the rat was good and no toxic and side-effects could be seen.Similarly,no traumatic changes could be seen in the mucous membrane of nose,larynx and trachea under microscope.Conclusion Ligustrazine aerosol by nasal cavity administration has no obvious toxicity and irritation,which can be used in clinic.