鼻敏颗粒的临床前药效学研究

Preclinical pharmacodynamic study of Bimin granules

目的通过临床前研究,评价鼻敏颗粒开发成院内制剂的安全性和有效性。方法采用最大给药量法进行急性毒性实验,采用二甲苯致小鼠耳肿胀实验评价其抗炎作用,采用甲苯二异氰酸酯(TDI)致过敏性鼻炎豚鼠模型评价其对过敏性鼻炎的治疗作用。结果急性毒性实验:鼻敏颗粒以86 g生药/kg灌胃给予小鼠,未见明显毒性反应。药效学实验:鼻敏颗粒能明显抑制二甲苯致小鼠耳肿胀;对TDI致过敏性鼻炎豚鼠模型有明显的缓解症状作用,其原因与降低鼻黏膜渗出物和减少炎性细胞产生有关。结论鼻敏颗粒毒性低,有明显的抗炎和治疗过敏性鼻炎的作用,开发成院内制剂前景良好。

Objective To evaluate the safety and effectiveness of Bimin granules developed into hospital preparations through preclinical research.Methods The maximum dose method was used for acute toxicity test,the xylene induced mouse ear swelling test was used to evaluate its anti-inflammatory effect,and the toluene diisocyanate(TDI)induced allergic rhinitis guinea pig model was used to evaluate its therapeutic effect on allergic rhinitis.Results In the acute toxicity tests,Bimin granules were administered to mice by intragastric administration of 86 g crude drug/kg,and no obvious toxicity was observed.In the main pharmacodynamics experiments,Bimin granules could significantly inhibit xylene induced ear swelling in mice;It could significantly relieve symptoms in the guinea pig model of allergic rhinitis caused by TDI,the reason was related to reduce nasal mucosa exudation and inflammatory cells production.Conclusion Bimin granule has low toxicity and high efficacy in anti-inflammatory and treating allergic rhinitis,which exhibiting good prospects for its develop into hospital preparation.