升清解毒微乳凝胶的制备工艺及处方优化研究

Preparation and optimization of Shengqing Jiedu microemulsion gel

目的以挥发油成分为油相、水煎液为水相制备升清解毒微乳凝胶,并对其进行处方优化和质量评价。方法采用伪三元相图法优选微乳处方,再采用D-最优混料设计优化处方,通过单因素法筛选凝胶基质及用量,并对升清解毒微乳凝胶进行质量评价。结果优化后的升清解毒微乳凝胶呈金黄色、半透明、均一稳定的黏稠状半固体,有轻微花椒油气味,均匀细腻,易于涂展,pH值为(6.54±0.08),黏度为(15.33±0.15)Pa·s。处方组成:水相3.49 g,油相0.11 g,EL-350.27 g,1,2-丙二醇0.13 g,卡波姆9400.4 g,三乙醇胺0.5 g。结论优化后的微乳凝胶制备工艺稳定可行,初步质量评价符合皮肤外用制剂的要求。

Objective To prepare Shengqing Jiedu microemulsion gel with volatile oil as the oil phase and water decoction as the water phase,and to optimize its prescription and evaluate its quality.Methods Pseudo-ternary phase diagram was utilized to optimize the microemulsion formulation and D-optimal mixture design was used to screen the optimal formulation.The gel matrix and dosage were screened by single factor method,and the quality of Shengqing Jiedu microemulsion gel was evaluated.Results Shengqing Jiedu microemulsion gel was golden-yellow,translucent,uniform and stable viscous semi-solid,with a slight smell of peppercorn oil,uniform and delicate,and easy to spread.The pH value was(6.54±0.08),and the viscosity was(15.33±0.15)Pa·s.The prescription composition included water phase 3.49 g,oil phase 0.11 g,EL-350.27 g,1,2-propylene glycol 0.13 g,carbomer 9400.4 g,and triethanolamine 0.5 g.Conclusion The optimized preparation of microemulsion gel is stable and feasible,and its preliminary quality meets the requirements of skin topical preparation.