星点设计-效应面法优化熊果苷乳膏配方

Optimization of the Formula of Arbutin Cream by Central Composite Design-response Surface Methodology

目的:优化熊果苷乳膏配方,并建立制剂质量控制方法。方法:采用星点设计-效应面法,以乳膏伸展性为指标,优化十六醇、十二烷基硫酸钠-三乙醇胺(2∶1)和二甲基硅油用量;考察配方优化后制剂的外观性状、粒度、pH、伸展性、稳定性和熊果苷含量。结果:优化的配方是十六醇用量为60g,十二烷基硫酸钠-三乙醇胺(2∶1)用量为10g,二甲基硅油用量为25g;乳膏伸展性较好,延展直径约58.7mm,符合半流体乳膏特性;pH为6.2;稳定性较好;熊果苷含量为标示量的94.5%。结论:星点设计-效应面法优化的熊果苷乳膏配方稳定、可行。

OBJECTIVE：To optimize the formula of Arbutin cream,and to establish its quality control method. METHODS：Using central composite design-response surface methodology,the formula of Arbutin cream was optimized using the spreadability of cream as index and with the amounts of cetyl alcohol,sodium lauryl sulfate-triethanolamine（2 ∶ 1） and dimethicone as independent variables. The appearance characteristic,article size,pH value,spreadability,stability of preparation and the content of arbutin were studied. RESULTS：The optimal conditions were cetyl alcohol 60 g,sodium lauryl sulfate-triethanolamine（2 ∶ 1） 10 g,and dimethicone 25 g. According to the optimal conditions,the diameter of spreadability of prepared cream was about 58.7 mm,and cream suited with the property of semi-fluid cream. The pH value of cream ranged was 6.2. The content of arbutin was 94.5% of labeling amount. CONCLUSION：Central composite design-response surface methodology is stable and feasible.