清解方雾化吸入剂安全性的实验研究

Experimental study on the safety of Qingjie formula aerosol

目的观察清解方雾化吸入剂的急性毒性和黏膜刺激性。方法采用改良寇氏法观察口服清解方对小鼠的急性毒性,并采用最大耐受量法观察清解方雾化吸入给药对小鼠的急性毒性,同时观察清解方对大鼠口腔及鼻黏膜的刺激性。结果口服清解方对小鼠有一定的急性毒性,其LD50为883.7g生药/kg体重。雾化吸入临床用量24倍的清解方对小鼠没有显著的急性毒性影响。直接接触临床剂量的清解方对大鼠鼻黏膜和口腔黏膜均没有明显的刺激性,但5倍于临床剂量的清解方显著增加口腔黏膜棘层厚度,有轻度刺激性。结论清解方雾化吸入剂的急性毒性很小,且在临床剂量下没有明显的黏膜刺激性,其临床应用的安全性较高。

Objective In this study,the authors target to investigate acute toxicity and mucosa irritation of Qingjie Formula Aerosol. Methods The modified Karber＇s method was used to test the acute toxicity of o-ral Qingjie Formula on mice,the acute toxicity of aerosol inhalation of Qingjie Formula Aerosol on mice was e-valuated by using a maximum tolerance dose method and the effects of Qingjie Formula on irritating the rats＇o-ral and nasal mucosa was observed. Results Oral Qingjie Decoction had some acute toxicity to mice,and its LD50 was 883.7g crude drug/kg body weight.Inhalation 24 times of the clinical dosage of Qingjie formula aero-sol had no significant acute toxicity on mice.Direct contact with the clinical dosage of Qingjie Formula didn＇t have obvious irritation to oral and nasal mucosa of rats,but Qingjie Decoction of 5 times of the clinical dosage increased the thickness of oral mucosa spinous layer significantly,having mild irritation. Conclusion The a-cute toxicity of Qingjie Formula Aerosol is low,and its clinical dosage use has no obvious mucosa irritation,it has high security in clinical application.