The Preparation And Safety Research Of Triamcinolone Econazole Cream

Triamcinolone econazole cream has been used for eczema and dermatitis due to its anti-inflammatory and antiseptic activity. Triamcinolone econazole cream is a compound preparation contained0.1%triamcinolone acetonide and1%econazole nitrate. Triamcinolone acetonide is a potent glucocorticoid which has anti-inflammatory, anti-allergic and anti-virus activity. As an external preparation, it was mainly used for variety non-infectious inflammatory skin disease, since it’s low absorption rate.In the previous study, a HPLC method was established for the determination of related substances. Methodological study results showed that the method has good expression in effectively, respectively and specificity.The HPLC method was used to determine the contents of triamcinolone acetonide and econazole nitrate. It has a good linear relationship between concentration and peak area of triamcinolone acetonide. The calibration curve was linear over the concentration range of30.24～70.56μg/mL, and the linear relationship range of econazole was in0.3012～0.7028mg/mL. At the same time, study results showed that the method precision, recovery were eligible.In addition, the single factor of main process parameters, such as:product characteristics, content, and related substances, was screened in prescription studies. The ptimal prescription was optimized through orthogonal optimization method.At the same time, the quality research of triamcinolone acetonide cream was carried out to determine the quality standards. Then, the stability study showed that the product was stable at40℃±2℃,humidity RH75%±5%for six months or/and at25℃±2℃, humidity RH60%±10%for twelve months.Finally, transdermal character and safety research of triamcinolone econazole cream were studied. Transdermal study indicated that there is a little amount of compound in the accepted solution in24hours, but reserved in skin. It means that the compound can be effective to produce local effects while avoiding systemic effects. We compared our products with commercially available triamcinolone econazole cream for the safety evaluation. The studies showed that they had mild irritation for intact skin and damaged skin of rabbits. The erythema was degraded after8days. There have no difference between our products and commercially available triamcinolone econazole cream. All of these two products do not induce allergic reaction.