基于伪三元相图的壬二酸微乳液的制备与评价

Preparation and Evaluation of Azelaic Acid Microemulsion Based on Pseudo Ternary Phase Diagram

制备稳定的壬二酸祛痘微乳。方法:借助伪三元相图,通过不同表面活性剂的复配筛选壬二酸微乳区,并进行处方筛选及工艺优化。选取3种壬二酸微乳体系进行粒径、理化性质、稳定性及试用评价。结果:筛选出3种壬二酸微乳的粒径分别为(1247.6±13.29) nm、(381.85±0.92) nm、(520.8±16.97)nm,经过稳定性测试表明制备的壬二酸微乳均一稳定,粒径及PDI差异无统计学意义。试用人群77%反馈有祛痘效果,基本无刺激性。结论:本研究通过筛选出壬二酸微乳液区域并成功制备了6%壬二酸微乳液,开发并优化了微乳纳米体系,可作为壬二酸的载体,提高其治疗效果。

Objective: To prepare stable azelaic acid( AzA) anti-acne microemulsion(ME). Methods: Through the distribution of different surfactants, with the aid of pseudo ternary phase diagram screening of azelaic acid microemulsion area, and three azelaic acid microemulsion systems were selected for particle size, physical and chemical properties, stability and trial evaluation. Results:The particle sizes of three azelaic acid microemulsions were screened out to be 1247.6±13.29 nm, 381.85±0.92 nm and 520.8±16.97nm. The preparation process of a new formulation of AzA microemulsions is feasible and its quality could be stable. There were no significant differences in appearance, particle size and PDI. And results suggested that the optimal ME exhibited a prominent therapeutic effect, without any irritant response. Conclusion: In this study, the microemulsion region of AzA was screened out, and 6% azelaic acid microemulsion was successfully prepared. As a topical carrier for AzA, the development and optimization of a microemulsion(ME) Nano carrier system could improve its therapeutic efficacy..