Fluticasone Propionate Nasal Spray Prescription Technology Was Studied

Fluticasone propionate is a new type of glucocorticoid drugs, Clinical application in the treatment of asthma, allergic rhinitis, chronic obstructive pneumonia, atopic dermatitis. The medicine has very strong effect and less adverse reaction. Fluticasone propionate nasal sprays is free in the domestie market,so it is valuable to research. For domestic pharmaceutical enterprises to develop a new product, in order to bring new business opportunities, increased pharmaceutical enterprise’s comprehensive strength, make Chinese patients using relatively cheap price and import drug efficacy of the same drug. At the same time as the imitation of other imported preparation process research.First of all, according to the quality standards of imported drugs and prescription of accessories categories, the fluticasone propionate nasal spray prescription screening, with the quality of imported drugs contrast as evaluation basis, the main screening help suspension agent Avicel RC-591and osmotic pressure regulator the amount of glucose. The screening of fluticasone propionate nasal spray for the prescription: Fluticasone propionate (0.05%w/w),benzalkonium chloride (0.020%w/w), Twain-80(0.005%w/w), microcrystalline cellulose, sodium carboxymethyl cellulose (1.50%w/w), phenyl ethyl alcohol (0.25%v/w), anhydrous glucose (5%w/w), hydrochloric acid (amount), purified water (add to100%)Secondly,through the droplets size, spray model, spray geometry of this a few aspects of imported drugs and contrast analysis, screening the spray pump type for VP7spray pump. Through each spray spray quantity, each spray content uniformity of the investigation and comparison, determine the charge control in every bottle of15.0-16.0g can get mark between spray number (120spray).Finally, according to the pharmaceutical enterprise current production condition determine the process, and the three batch of pilot scale production.the fluticasone propionate nasal spray on the quality of the system research. The establishment of product effective component and the related substances determination method and system methodology.Influence factors of experimental results show that the fluticasone propionate nasal spray in strong light, high temperature, high humidity under both stability; Accelerated and long-term test results show that the sample in the12months not altered obviously.