Onuki Yoshinori, Funatani Chiaki, Yokawa Takashi, Yamamoto Yoshihisa, Fukami Toshiro, Koide Tatsuo, Obata Yasuko, Takayama Kozo
Department of Pharmaceutics, Hoshi University.
Chem Pharm Bull (Tokyo). 2015;63(5):377-83. doi: 10.1248/cpb.c15-00088.
A mixed preparation consisting of a water-in-oil emulsion-type moisturizing cream and a steroid ointment is frequently prescribed for the treatment of atopic dermatitis. We have investigated the compatibility of moisturizing creams and ointments because there are concerns regarding the physical stability of these mixed preparations. The key technology used in this study was magnetic resonance imaging (MRI). A commercial moisturizing cream and white petrolatum or clobetasone butyrate (CLB) ointment samples were mixed in a weight ratio of 1 : 1. A centrifugation test protocol (20000×g for 3 min) was implemented to accelerate the destabilization processes in the samples. After centrifugation, the mixed preparations separated into three distinct layers (upper, middle, and lower), while no phase separation was observed using moisturizing cream alone. The phase separation was monitored using chemical shift selective images of water and oil and quantitative T2 maps. In addition, MR and near-infrared spectroscopy were employed for component analysis of each phase-separated layer. Collectively, it was confirmed that the lower layer contained water, oils, and organic solvent, while the upper and middle layers were composed solely of oils. Furthermore, this study investigated the distribution of CLB in the phase-separated samples and showed that a heterogeneous distribution existed. From our results, it was confirmed that the mixed preparation became unstable because of the incompatibility of the moisturizing cream and ointment.
一种由油包水乳液型保湿霜和类固醇软膏组成的混合制剂常用于治疗特应性皮炎。由于人们对这些混合制剂的物理稳定性存在担忧,我们对保湿霜和软膏的相容性进行了研究。本研究使用的关键技术是磁共振成像(MRI)。将市售保湿霜与白凡士林或丁酸氯倍他索(CLB)软膏样品按1:1的重量比混合。实施离心试验方案(20000×g,3分钟)以加速样品中的不稳定过程。离心后,混合制剂分离为三个不同的层(上层、中层和下层),而单独使用保湿霜时未观察到相分离。使用水和油的化学位移选择性图像以及定量T2图监测相分离。此外,采用磁共振和近红外光谱对每个相分离层进行成分分析。总体而言,证实下层含有水、油和有机溶剂,而上层和中层仅由油组成。此外,本研究调查了CLB在相分离样品中的分布,结果表明存在不均匀分布。根据我们的结果,证实由于保湿霜和软膏不相容,混合制剂变得不稳定。