The Development And Quality Research On Azelastine Hydrochloride Nasal Spray

Allergic rhinitis(AR)is one of the common and frequently diseases in the ear-nose-throat department and serious harm to human health.In recent years,Allergic rhinitis is the global rising disease.The current drugs in the treatment of allergic rhinitis mainly has: glucocorticoids(eg,fluticasone propionate),antihistamines(eg,azelastine hydrochloride),mast cell inhibitors(eg,sodium cromoglycate),vascular convergence drugs(eg,phenylephrine,oxymetazoline),anti-cholinergic drugs(eg,atropine).Because of effects on clinical symptoms of perennial allergic rhinitis is obvious,easy to be carried and used and systemic side effects is low,Azelastine Hydrochloride Nasal Spray is widely used in the treatment of perennial allergic rhinitis.The Azelastine Hydrochloride is treated as the model drug of the Azelastine Hydrochloride nasal spray.Hydroxypropyl methyl cellulose,two sodium hydrogen phosphate,citrate,EDTA,sodium two sodium chloride is the accessories.We developed Azelastine Hydrochloride Nasal Spray preparation.We conducted the following research work on the Azelastine Hydrochloride Nasal Spray.Firstly,the formulation and preparation process about the Azelastine Hydrochloride Nasal Spray was studied.Suitable pH adjusting agents,preservative,thickener were selected.We creened the amount about EDTA-2Na.we determine the optimal prescription,by evaluating the appearance and the properties of the Azelastine Hydrochloride Nasal Spray,pH value and its stability.Secondly,we studied the quality of the Azelastine Hydrochloride Nasal Spray : in accordance with the relevant requirements of Azelastine Hydrochloride Nasal Spray nasal spray imported drug registration standards,we started the related research.The main indexes were the appearance,identification,microbial limit,pH,the related substances,Each spray content and content,etc.The high performance liquid chromatography method to determine the related substance,content and the each spray content of the Azelastine Hydrochloride Nasal Spray were established and the methodology was validated.We established a set of control Azelastine Hydrochloride Nasal Spray quality testing standards,It provided the foundation for the drug’s safety and effectiveness.Experimental results show that the main indicators of Azelastine Hydrochloride Nasal Spray are in line with regulations.Finally,we researched the stability studies of Azelastine Hydrochloride Nasal Spray : the stability research is very important part of the quality research : investigating the physical and chemical changes.we preliminarily studied experimental factors(temperature,humidity,light),accelerated stability,long-term stability of Azelastine Hydrochloride Nasal Spray.The results showed: Azelastine Hydrochloride Nasal Spray had a good stability,its storage conditions is 2~25℃.