地奈德水性凝胶的制备及透皮研究

Study on preparation and percutaneous penetration of Desonide aqueous gel

目的研制地奈德水性凝胶,建立其质量控制方法并对其体外透皮吸收性能进行观察。方法以地奈德为主药制备凝胶,考察其稳定性并用高效液相色谱法(HPLC)法测定地奈德的含量。采用改进的Franz扩散池,以家兔离体皮肤为透皮模型,使用HPLC法测定药物在透皮接收液中的浓度及皮肤中药物滞留量。结果该制剂具有较好的稳定性,凝胶剂中地奈德的平均回收率为98.5%~101.3%。离体条件下,药物皮肤滞留量可达对照乳膏的1.87倍。结论所制备的地奈德凝胶能显著增加药物在皮肤中的滞留量,有望成为地奈德局部给药的新制剂。

ObjectiveTo develop the Desonide aqueous gel, and establish its quality control method, then observe the in vitro percutaneous absorption properties. MethodsThe gel was prepared, using Desonide as the main drug. The gel’s stability was observed, and the content of Desonide was detected by High performance liquid chromatography （HPLC）. Using improved Franz diffusion cell, and isolated rabbit skin as transdermal model, HPLC was chose to detect the concentration of Desonide in percutaneous absorption liquid and Desonide retained in the skin. ResultsThe preparation has good stability, the average recovery rate of Desonide in the gel is 98.5%-101.3%. Under the condition of in vitro, the amount of drug retention were 1.87 times that of the control emulsifiable paste. ConclusionThe preparation of Desonide gel can significantly increase the retention of the drug in the skin, is expected to become the Desonide local to the new preparation.