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目的探讨以新型疏水改性的羟丙甲纤维素硬脂醚(Sangelose)作为胶凝剂和乳化剂,用于制备无小分子表面活性剂乳胶剂的应用。方法考察酸、碱和盐对Sangelose凝胶基质动态黏度的影响。以Sangelose、羟丙甲纤维素(hydroxypropylmethylcellulose,HPMC)、卡波姆(Carbomer)或交联聚丙烯酸(Pemulen)为乳胶剂的基质,制备模型药物双氯芬酸钾的乳胶剂或凝胶剂,考察制剂的体外药物释放和经皮透过性及流变学特性,并与市售制剂比较。结果 Sangelose凝胶对电解质,尤其是较高浓度的氯化钠,有良好的相容性;不含小分子表面活性剂的双氯芬酸钾乳胶剂外观良好,具有黏性流体的流变学特性,同时具有较高的药物释放和体外经皮透过性。结论Sangelose作为胶凝剂和乳化剂用于局部用半固体的药品或化妆品具有广泛的应用前景。
Objective To investigate the application of a new hydrophobically modified hydroxypropyl methyl cellulose (Sangelose) as a gelling agent and an emulsifier for the preparation of a surfactant free of small molecule surfactant. Methods The effects of acid, alkali and salt on the dynamic viscosity of Sangelose gel matrix were investigated. The model drug diclofenac potassium emulsion or gel was prepared using Sangelose®, hydroxypropylmethylcellulose (HPMC), Carbomer or Pemulen as a vehicle, and the formulation In vitro drug release and transdermal and rheological properties compared to the commercial formulations. Results Sangelose gel had good compatibility with electrolyte, especially with higher concentration of sodium chloride. Diclofenac free latex with no small molecule surfactant had good appearance and rheological properties of viscous fluid. At the same time with high drug release and transdermal permeability in vitro. Conclusion Sangelose as a gelling agent and emulsifier for topical semi-solid pharmaceuticals or cosmetics has a wide range of applications.