辛夷不同组分滴鼻液制剂安全性试验研究

Experimental Study on Safety in Guinea Pig about the Different Components of Flos Magnolia Nose Drop

目的观察比较辛夷不同组分滴鼻液制剂的急性毒性和多次给豚鼠鼻腔滴入所产生的黏膜刺激反应情况,以确定临床用药毒性和有无黏膜刺激性,为辛夷滴鼻液的临床安全使用提供实验依据。方法急性毒性实验:豚鼠随机分成药物不同组分高剂量组,赋形剂组及空白对照组,每组8只,分别滴入辛夷不同组分滴鼻液、赋形剂液适量于豚鼠鼻腔内,持续固定30min,即刻观察豚鼠急性毒性症状谱,连续观察7天。黏膜刺激性实验:豚鼠随机分成辛夷不同组分滴鼻液组、赋形剂组及空白对照组,每组8只,分别滴入辛夷不同组分滴鼻液、赋形剂和蒸馏水适量于豚鼠鼻腔内,连续1周,观察鼻黏膜刺激性程度。结果给豚鼠鼻腔滴入辛夷不同组分滴鼻液相当于临床60kg人日用剂量的60倍时,豚鼠无一死亡,对豚鼠未引起急性毒性反应,并且未出现明显的鼻黏膜刺激性。结论急性毒性实验和黏膜刺激性实验结果表明辛夷不同组分滴鼻液制剂具有较高的安全性。

Objective To study the safety of the different components of Hos Magnolia Nose Drop in guinea pig and to provide experimental data for safe use in clinical. Methods The acute toxicity experiment： The different components of Flos Magnolia Nose Drop were administrated to guinea pig and the acute toxic symptoms were observed. The mucosal irritation experiment： The different components of F]os Magnolia Nose Drop were administrated to guinea pig＂ nasal cavity and the degree of nasal irritation was observed. Results We did not find the chronic toxicity and the mucosal irritation to guinea pig＂ nasal cavity after given Flos Magnolia Nose Drop for 7 days. Conclusion The acute toxicity test and the mucosal irritation test showed that the Flos Magnolia Nose Drop was safe.