咪康唑莫米松皮肤成膜凝胶的稳定性研究

Stability Study of Miconazole Mometasone Skin Film-Forming Gel

目的制备咪康唑莫米松皮肤成膜凝胶并进行稳定性研究。方法选择泊洛沙姆407和泊洛沙姆188为混合基质,以冷溶法制备咪康唑莫米松皮肤成膜凝胶,采用高效液相色谱-二极管阵列检测器(HPLC-DAD)法测定咪康唑及莫米松的含量,并作光照、高温、室温留样的稳定性考察。结果所制凝胶室温下为液体,涂布皮肤即为成膜凝胶。含量测定时,咪康唑与莫米松色谱峰可有效分离,检测质量浓度的线性范围分别为10.0～800.0μg/mL(r=0.998 9,n=6)和1.00～80.0μg/mL(r=0.998 1,n=6),平均回收率分别为98.71%和97.51%,RSD分别为1.41%和2.02%(n=6),2种有效成分对光不稳定。结论该制剂工艺简单、质量可控,宜避光包装、保存。

Objective To prepare Miconazole Mometasone Skin Film-Forming Gel and to study its stability.Methods Miconazole Mometasone Skin Film-Forming Gel was prepared by the cold cut method with poloxamer 407（ P407） and poloxamer 188（ P188） as the mixed matrix.The content of miconazole and mometason was determined by HPLC-DAD,and the stability investigations of light, high temperature and room placement tests were performed.Results The prepared gel was liquid at the room temperature and turned into skin film-forming gel after smearing on the skin.In the content detection,miconazole and mometasone could be effectively separated.The linear ranges of the detection mass concenrttions were 10.0-800.0 μg / mL for miconazole（ r = 0.998 9,n = 6） with the average recovery rate of 98.71%（ RSD = 1.41） and 10.0-80.0 μg / mL for mometasone（ r = 0.998 1,n = 6） with the average recovery rate of 97.51%（ RSD = 2.02%）.Two kinds of effective components were unstable under sunlight.Conclusion This preparation is simple in technology and controllable in quality,which is suitable for packaging and preservation away from light.