响应面法优化姜黄素凝胶剂及其稳定性评价

Optimization of Curcumin Gel Formulation by Response Surface Methodology and Estimation of its Stability

凝胶剂是皮肤科常用的一种外用半固体制剂,具有易吸收组织液、可调性强、稳定性好、安全性高等特点.本研究以外观、涂展性、耐寒耐热和离心稳定性等作为感官评分指标,通过单因素实验以及响应面优化实验来探讨姜黄素凝胶剂的制备工艺,并通过牛津杯法检验姜黄素的抑菌性能.结果表明:在本实验条件下,凝胶基质的最优配方为0.5%卡波姆940,0.5%甘油,1.0%三乙醇胺,姜黄素的载药量范围在0.5~2.0 mg/g.该凝胶呈亮黄色,成形性及涂展性良好,其耐寒耐热和离心等稳定性指标均符合《中国药典》2020年版对凝胶剂的质量要求.

Gel is a kind of semi-solid preparation commonly used in dermatology.It has the characteristics of easy absorption of tissue fluid,strong adjustability,good stability and high safety.In this study,appearance,coating malleability,cold and heat resistance,and centrifugal stability were used as sensory indexes.The preparation process of curcumin gel was optimized by single-factor experiment and response surface optimization experiment,and the bacteriostatic performance of curcumin was preliminarily tested by Oxford cup method.The results show that under the said experimental conditions,the optimal formula of the gel matrix was 0.5%carbomer 940,0.5%glycerin,1.0%triethanolamine,and curcumin 0.5~2.0 mg/g.The gel is bright yellow and has good coating ductility.Its stability indexes such as cold resistance,heat resistance and centrifugation all meet the quality requirements of the 2020 edition of Chinese Pharmacopoeia for gels.