Study On Fluticasone Propionate Cream Based On O/W Emulsions Matrix

Skin disease such as eczema and the keloid the Common frequently-occurringdisease,seriously affect patient’s quality of life,bring enormous spirit suffering topatients.So to develop new drugs with non-infectious and non-inflammatory has goodmarket prospects.Fluticasone propionate as a topical glucocorticoid for dermatologytreatment is suitable for long-term treatment of chronic and recurrent inflammatory skindisease, has the advantage of good clinical efficacy and little adverse reaction while treatingnon-infectious and non-inflammatory skin disease.We prepared fluticasone propionatecream with the carrier of O/W emulsion matrix and fluticasone propionate as the modeldrug.We have confirmed the prescription and the preparation process of fluticasonepropionate cream,established quality standard of fluticasone propionate cream,examinedthe stability of fluticasone propionate cream.We have laid the foundation for the declarationfor new drug of treating chronic and easily recurrent inflammatory skin disease by the studyof the prescription、 preparation process and the stability of propionate fluticasonecream.The main study can be summarized as follows:(1) The study on screening the prescription and the preparation process of fluticasonepropionate cream.Objective:To screen the prescription and to optimize the preparation process offluticasone propionate cream.Methods: To screen the material and its amount by singlefactor method,containing oil phase、water phase and emulsifier,to optimize the bestpreparation process of cream by investigating the process parameters, includingemulsifying equipments、emulsifying ways、emulsifying temperature、emulsifying time、emulsifying speed and ways of adding drugs.Results:The best prescription: polysorbateesters-80as the emulsifier,glycerol monostearate as a secondary emulsifier, stearylalcohol、white petrolatum as oil phase,propylene glycol as the humectant,ethylparaben asthe preservative, DMSO as the solvent and transdermal penetration enhancer.The bestpreparation process:To preparate the cream by using reversed-phase method and the emulsifier respectly added to the oil and water phase,emulsifying temperature80℃,emulsifying time20min,emulsifying speed600r/m,the drug added to the matrix bysolving in DMSO,at45℃.Conclusion:The formulation is reasonable and the preparationprocess is feasible,the good appearance and stability of cream can meet the industialproduction needs.(2) The study on quality standards of fluticasone propionate creamObjective:To control the quality of fluticasone propionate cream.Methods:Establishand investigate HLPC method to determinate the content of Fluticasone propionate. Results:Method for determination the content of Fluticasone propionate:column: The C18columnwas used with the mobile phase of0.02M phosphoric acid solution (adjusted to pH4.5withtriethylamine)-methanol (24:76) and with the flow rate of1.0mL.min-1at the detectionwavelength of240nm. The detection temperature was35℃and the injection volume was20ul.Conclusion: The method is simple、rapid、accurate、reliable and could be used as themethod of quality control of futicasone propionate cream.(3) The study on the stability of fluticasone propionate creamObjective:Investigate the stability of fluticasone propionate cream. Methods:Investigate the stability of preparations with influence factor test, accelerated test andlong-term test.Results: The appearance and the content of preparations didn’t changesignificantly and was in line with the relevant provisions of the Chinese pharmacopoeia.Conclusion:The good stability of preparation can provide basis for packaging options anddrawing up quality standards.