姜黄素自乳化制剂的设计、优化及质量评价  

Design,Optimizition and Quality Evaluation of Curcumin Self-emulsifying Drug Delivery System(SEDDS)

作　　者：王云红[1] 汪圣华[2] 杨荣平[2,3] 马小军[2] 

机构地区：[1]成都中医药大学,四川成都611731 [2]中国科学院大连化学物理研究所,辽宁大连116023 [3]重庆市中药研究院,重庆400065

出　　处：《中药材》2010年第12期1933-1937,共5页Journal of Chinese Medicinal Materials

摘　　要：目的:设计并优化姜黄素自乳化制剂工艺,并对其进行体外质量评价。方法:通过测定姜黄素在不同油、表面活性剂、助表面活性剂中的溶解度选择辅料。采用三元相图和星点设计的方法优化姜黄素自乳化处方,以外观、溶解度、乳化时间、乳化后的粒径和多分散系数为评价指标对姜黄素自乳化制剂进行体外评价。结果:姜黄素自乳化制剂最佳处方为蓖麻油-(吐温-80)-无水乙醇=28∶55∶20,制剂外观透明均一,各指标平均结果:粒径222.2 nm,多分散系数0.171,溶解度1.93 mg/mL,乳化时间10 s。结论:成功制得工艺简单、性质稳定的姜黄素自乳化制剂,且其各项理化性质良好。Objective：To develop the self-emulsifying drug delivery system（SEDDS） of curcumin,and evaluate its quality in vitro.Methods： The excipients of curcumin SEDDS were selected via its solubility study in various oils,surfactants and co-surfactants and the formulation was optimized using ternary phase diagram study and central composite design-response surface methodology（oil,surfactant and co-surfactant percentages as factors;solubility,droplet size,polydispersity index and emulsifying time as responses）.The appearance,droplet size and polydispersity index after emulsifying and the emulsifying time of optimized curcumin SEDDS were studied.The solubility of curcumin in the solution of SEDDS was determined.Results： Castor oil-（tween-80）-ethanol=28∶55∶20（w/w/w） was selected for optimum curcumin SEDDS.The droplet size was 222.2 nm,polydispersity index was 0.171.The time of self-emulsifying was 10 s and the solubility of curcumin in SEDDS was 1.93 mg/mL.Conclusion： Curcumin SEDDS formulation is selected and optimized successfully,and the preparation of curcumin SEDDS is simple,the quality is stable.

关 键 词：姜黄素 自乳化 体外质量评价 三元相图 星点设计 

分 类 号：R294.2[医药卫生—民族医学]