多层非均相制剂技术制备固态花青素面膜及其稳定性评价

Preparation of Solid Anthocyanin Facial Mask Using Multilayer Heterogeneity Technology and Its Stability Evaluation

目的:优化固体花青素面膜多层非均相制备工艺,并考察面膜稳定性。方法:应用Franz透皮试验仪进行透皮试验;应用高效液相色谱法(High performance liquid chromatography,HPLC)测定固体花青素面膜中矢车菊素-3-O-葡萄糖苷(C3G)在猪皮肤表面残留量、皮肤内滞留量和经皮透过量;应用Hunter和全析因实验设计优化工艺变量;应用设计空间确定关键工艺变量的最优值。结果:确定3个关键工艺变量最优值包括面膜中不加入油酸;采用先涂布辅料基质,再涂布花青素原料方式制备;涂布层数为3层。优化工艺后制备的3批面膜长期稳定性显示,C3G在皮肤表面6个月的残留百分率略低于0 d的数据。面膜贴敷20 min去除之后12 h,皮肤表面残留百分率可达8%左右。结论:优化后的多层非均相制备工艺路线可行,制备的固体花青素面膜可长期保存至少6个月。

Objective To optimize the multilayer heterogeneity process of solid anthocyanin masks and examine the stability of the mask.Methods Franz diffusion cell was used for the transdermal test,HPLC was used to determine the content of the residual amount on skin surface,retention amount in skin,and percutaneous permeation amount of Cyanidin-3-O-glucoside(C3G)in solid anthocyanin mask.Hunter and full factorial experimental design were used to optimize the process variables,and design space was used to determine the optimal values of the key process variables.Results The optimal values of 3 key process variables were determined,oleic acid was not added to the mask,the excipient-matrix agents were coatedfirst and then the anthocyanin raw material was coated,the number of coatings was 3 layers.The long-term stability of C3G in the 3 batches of masks prepared after process optimization showed that the residual percentage of C3G on the skin surface for 6 months was slightly lower than the data of 0 d.After the mask was applied for 20 minutes and removed for 12 hours,the residual percentage of C3G on the skin surface could reach about 8%.Conclusion The optimized multilayer heterogeneity process route is feasible,and the solid anthocyanin mask prepared can be stored for at least 6 months.