The Study Of Oil/Water Gel Of Triamcinolone Acetonide And Econazole Nitrate

Triamcinolone Acetonide and Econazole Cream is a compound skinexternal preparation developed by Janssen-Cilag N.V.，the manufacturer inChina is Xi’an-Janssen Pharmaceutical CO，LTD. It mainly used in thetreatment of fungal skin disease，such as dermatitis，eczema，tinea corporis，tinea manus，etc. The compound preparation only have cream at present，and don’t have oil-in-water gel with carbomer as gel bases. In order todiversify dosage form, this article changed the original dosage form creaminto oil-in-water gel，the appearance，greasy feeling improved a lot, andalso more aesthetics after applied to skin. This improved compliance ofpatients.The main content of the paper includes:（1）to screen the formulationand preparation process of oil/water gel of triamcinolone acetonide andeconazole nitrate；(2)to study the quality of oil/water gel of triamcinoloneacetonide and econazole nitrate；(3)to investigate the stability of oil/watergel of triamcinolone acetonide and econazole nitrate；（4）to study in vitropercutaneous permeability and irritancy of oil/water gel of triamcinolone acetonide and econazole nitrate.Prescription design was taken by refered to Triamcinolone Acetonideand Econazole Cream，the type and amount of raw material and excipientswere screened and selected. According to the results of single factorexperiments，the amount of propylene glycol，ethanol，liquid petrolatum，Labrasol and Span80were the main factors that influence results. Theformulation of oil/water gel of triamcinolone acetonide and econazolenitrate were optimized by orthogonal design by index of appearance，centrifugal test and crystal precipitation. Homogenized speed，temperatureand time were also investigated to optimize preparation process.High-performance liquid chromatography(HPLC) method wasestablished for the determination of triamcinolone acetonide and econazolenitrate. Triamcinolone acetonide and econazole nitrate showed a goodlinear relationship in concentration of4.78～86.04μg/ml and49.86～897.48μg/ml，respectively. Recovery，precision and stability meet therequirement. The quality of oil/water gel of triamcinolone acetonide andeconazole nitrate were evaluated. The oil/water gel of triamcinoloneacetonide and econazole nitrate appear as a whitish gel，the average pHvalue of it was5.63，with a average dynamic viscosity40.5Pa·S at25℃.The results of content，particle size，content uniformity，heat and freezingresistance tests all conformed to the requirements.To evaluate stability，influence stress testing，accelerated testing and long-term testing were taken on the oil/water gel of triamcinolone acetonideand econazole nitrate. The gel was unstable at the temperature of60℃andin light，so it should be stored at a dark and cool place. The change of contentand related substances of the gel in accelerated testing were within therecommended limits. With commercial packaging，all the index had nosignificant change under the condition of dark and cool for6months，thisshowed the prescription and preparation process were valuable forproduction and study.The transdermal delivery of oil/water gel of triamcinolone acetonideand econazole nitrate was studied. There were no significant differencebetween gel and cream on the market in every sample points cumulativepermeation amounts and average cumulative permeation amounts. So wepreliminary estimated that there was no obvious difference in curativeeffect between gel and cream on the market. The irritancy of oil/water gelof triamcinolone acetonide and econazole nitrate was studied meanwhile，The results showed that the oil/water gel of triamcinolone acetonide andeconazole nitrate has no irritancy on skin，it is good in safety.