均匀设计优化复方螺内酯凝胶基质处方

Optimization of base formula for compound spironolactone gel by uniform design

目的采用均匀设计法优化复方螺内酯凝胶的基质处方。方法采用3因素10水平均匀设计法,以复方螺内酯凝胶的外观性状及粒度、黏度、pH值为评价指标,对处方进行优化。结果优化处方组成为:每100g复方螺内酯凝胶含卡波姆-940 0.70g,山莨菪碱0.65g、丙二醇12g。按照优化的处方制备的复方螺内酯凝胶为无色透明的半固体,质地细腻,pH为7.3,黏度4 300mPa·s。结论按照优化的处方制备的复方螺内酯凝胶外观性状良好,临床应用效果良好。

Objective To optimize the base formula of compound spironolactone gel by the uniform design. Methods The matrix formulation was optimized by a three factor and ten level uniform design, with rheological parameters such as appearance and particle size,viscosity,and pH value. Results The optimum matrix formulation was composed of 0.70 g carbomer -940, 0.65 g anisodamine and 12 g propylene glycol in 100 g compound spironolactone gel. According to the optimal prescription, the compound spironolactone gel is a clear, colorless semi-solid, fine texture, with the pH value was 7.3 and the viscosity 4 300 mPa · s. Conclusion The compound spironolactone gel prepared by the method has characteristics such as good appearance and good clinical effect.