The Development And Quality Research On Azelastine Hydrochloride And Futicasone Propionate Nasal Spray

Allergic rhinitis is a allergic disease of nasal mucosa,and can cause a variety of complications,it contains perennial allergic rhinitis(PAR)and clinical seasonal allergic rhinitis(SAR).It mainly type I allergy mediated by IgE.Currently the drug treatment of perennial allergic rhinitis are:glucocorticoids(eg,fluticasone propionate and Budesonide),antihistamines(eg azelastine hydrochloride and olopatadine hydrochloride),mast cell inhibitors(eg cromolyn sodium),vasoconstriction drugs(eg ephedrine,and phenylephrine),anticholinergics(eg atropine).Wherein corticosteroids and antihistamines for AR effects are more obvious,studies have shown that both classes of drugs combined with can meet the effects of anti-inflammatory and anti-histamine,and can rapidly reduce the sensitivity of patient sensory nerve,in turn,causes nasal mucosa tissue reaction decreased and achieved good results in clinical.In this topic,antihistamine azelastine hydrochloride and glucocorticoid fluticasone propionate are the based medicines,microcrystalline cellulose-sodium carboxymethyl cellulose,glycerin,benzylalcohol,benzalkonium,chloride,EDTA-2Na,Tween-80 as accessories,which we used to developed azelastine hydrochloride fluticasone propionate nasal spray and did the following research:First of all,we did the formulation and technology research ofazelastine hydrochloride and fluticasone propionate nasal spray:selected suitable preservatives,wetting agents,and screened the amount of microcrystalline cellulose-sodium carboxymethyl cellulose,glycerin,Tween-80,disodium edetate.We determined the optimal formulation by evaluating the appearance,pH,viscosity,particle size distribution,spray pattern of it.Secondly,we studied the quality of the nasal spray:in accordance with Chp and imported drug registration standards,fluticasone propionate USP standards,we did the related research.The main indexes are character,identification,microbial limits,related substances,the main drug content and drug content per puff.The high-performance liquid chromatography to determine related substances,main drug content and each spray content were established and the methodology was validade.We establish a set of standards to control the quality of the nasal spray and provided the foundation for the drug’s safety and effectiveness.Experimental results show that the main indicators of the nasal spray are meet the requirements.Finally,we did the reasearch of stability studies of the nasal spray,which is a very important part of quality reasearch and is the study of drugs under the influence of temperature,humidity and light the variation with time,the present experiment did the preliminary investigation from factors,accelerated testing and long-term test on the nasal spray and the results show that the azelastine hydrochloride and fluticasone propionate nasal spray had a good stability and storage in a dark,cool place.