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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 design and optimize curcumin self-emulsifying preparation technology and to evaluate its in vitro quality. Methods: The excipients were selected by measuring the solubility of curcumin in different oils, surfactants and cosurfactants. The curcumin self-emulsifying formulation was optimized by ternary phase diagram and star point design. The appearance, solubility, emulsifying time, particle size after emulsification and polydispersity index were used as evaluation indexes to evaluate curcumin self-emulsifying formulation in vitro. Results: The optimum formulation of curcumin self-emulsifying preparation was castor oil - (Tween -80) - absolute ethanol = 28:55:20. The appearance of the preparation was transparent and homogeneous. The average results of each index were 222.2 nm and polydispersity 0.171 , Solubility 1.93 mg / mL, emulsification time 10 s. CONCLUSION: Curcumin self-emulsifying preparation with simple technology and stable properties has been successfully prepared, and its physical and chemical properties are good.