The Development And Quality Research On Fluticasone Propionate Lotion

Fluticasone propionate is a sort of external glucocorticoid with moderate efficacy,which chemical name is S-(fluoromethyl)6(alpha),9-difluoro-11(beta),17-dihydroxy-16(al pha)-methyl-3-oxoandrosta-1,4-diene-17(beta)-carbothioate,17-pr opionate.It is odorless white powder,free soluble in familiar solvent DMSO and dimethylformamide.It can dissolve in dichloromethane,and Slightly Soluble in ethyl alcohol,almost practically insoluble in water.Fluticasone propionate has Strong lipotropy,it combines the glucocorticoid receptor well as a external medicine,so it's used to do clinic treatment of various kinds of skin diseases constantly,such as eczematous dermatitis and psoriasis.It stops the Chronic allergic inflammatory of epithelial cells with variety approaches,so that it improves the patients' symptoms.In the in the preliminary stage of the experiment,I looked up the pertinent literature of fluticasone propionate lotion,comprehensively understood the character,composition and all kinds of components of fluticasone propionate lotion,established the standard of the prescription,related substances,content determination and stability,and designed a reasonable experiment project,so I had a holistic grasp of thefluticasone propionate lotion research.I established the way of measuring the components by means of the study before prescription of fluticasonepropionate lotion,and inspected the influence factors of Fluticasone propionate's stability,to provide the basis for the stability study of the preparation.This experiment referenced 2015 Chinese pharmacopoeia standard of lotion,fluticasone propionatebulk drug USP38 and EP8.0 quality standard,fluticasone propionate cream USP38 quality standard,fluticasone propionate lotion USP41 quality standard,and the standard of fluticasone propionate cream import registration.This task used fluticasone propionate as the main drug,CETETH-20,cetostearyl alcohol,isopropyl myristate,dimeticone350,propanediol,methylparaben,imidazole,sodium citrate,anhydrous citric acid as the pharmaceutical excipients to develop a sort of lotion——fluticasone propionate lotion.And the following research was carried out:Firstly,the experiment aimed at the quality control of fluticasone propionate's source.In this study,the bulk drug was independent synthetic of my graduate student internship company,the preparation process,synthesis process,degradation pathway and related literatures(including current edition BP,USP)were studied of the impurity profile comprehensive analysis,found out the constructions and the sources of impurities,the degradation products and impurities were pointedly controlled,the method of impurity analysis was verified by High Performance Liquid Chromatography,studied systematicallyresidual solvents that may exist in the bulk drug by gas chromatographic method.The quality control of fluticasone propionate lotion was further studied by the quality control of bulk drug.Secondly,this study focused on the prescription of targeted drugs,the optimal prescription andprocess were determined by comparing the characteristics of foreign listed drugs.Finally,a comprehensive quality control study was carried out for the production of fluticasone propionate lotion in the study,the main indexes were character,content,relative substance,relative density,viscosity,pH and so on.Through the indexes above,a set of testing standards can be established to control the quality of finished products.The experimental results show that the self-made fluticasone propionate lotion can be consistent with foreign market samples both in character and quality.