白色ワセリンと混合したステロイド軟膏剤の品質評価―レオロジー特性および安定性―

Abstract

We investigated the uniformity of content, rheological properties and chemical stability for prescription of Kindavate® ointment diluted with white petrolatum. When the ointment was levigated with white petrolatum (Propeto® for dilution) by a pharmacist or mixed by an autorotation/orbital mechanical mixer, a uniform ointment having the precise drug content could be prepared for all conditions. However, as the dilution ratio increased, the hardness of the ointment seemed to decrease based on the yield point measured with a spread meter and apparent absolute viscosity. Also, using a polarizing microscope, we observed a dispersion of oil droplets (consisting of liquid paraffin in clobetasone butyrate) in petrolatum for both Kindavate® ointment and the diluted ointment showing that the internal structure of ointment had not been affected by preparation of the diluted ointment either manually by pharmacists or using the mechanical mixer. When the diluted ointment was stored at 4 or 25°C in tight container in the absence of light, it was chemically stable for at least a month.Since our results showed that Kindavate® ointment diluted with petrolatum had a precise drug content and was stable over time, it should be feasible to prepare the ointment in advance of use.