以天然产物双半乳糖基二酰甘油酯为乳化剂的亚微乳的制备及稳定性研究  

Preparation and stability of digalactosyl diglyceride as emulsifier for sub-microemulsion

作　　者：李新刚[1] 胡洁[1] 赵秀丽[1] 胡海洋[1] 赵庆春[2] 陈大为[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳军区总医院药剂科,辽宁沈阳110016

出　　处：《中国中药杂志》2009年第17期2172-2176,共5页China Journal of Chinese Materia Medica

摘　　要：目的：探讨双半乳糖基二酰甘油酯（digalactosyl diglyceride，DGDG）作为一种乳化剂使用的可行性。方法：以香叶油为模型药物，油中乳化法制备初乳，通过单因素考察优化制备工艺，采用星点设计-效应面法（central composite design-response surface methodology，CCD-RSM）对处方进行优化，并对其稳定性进行初步研究。结果：确定的最终制备工艺为，60 ℃，油中乳化法制备初乳，于组织匀浆机中匀浆10 min，高压均质于80 Pa下循环10次，0.22 μm微孔滤膜滤过灭菌，充氮灌封即得。最优处方为：DGDG用量1.6%；大豆油用量1.1%；油酸钠用量0.16%。其中香叶油用量为0.3%。所得亚微乳外观细腻洁白，所制3批样品粒径为168.0～169.3 nm，Zeta电位-25.53～24.90 mV，pH 8.48～8.52，最佳处方的验证结果与预测值相差1.8%。在高温、光照条件下稳定性良好。结论：DGDG可作为香叶油亚微乳的乳化剂使用。Objective： To study the feasibility of digalactosyl diglyceride （DGDG）, which was used as a new type of emulsifier to prepare submicro-emulsion of bay oil. Method： Bay oil was employed as the model drug, emulsifer in oil method was used to prepare foremilk. Through single factor investigation and central composite design-response surface methodology （CCD-RSM）, we optimized the preparation technology and formula respectively. The stability of sub-microemulsion was studied. Result： The optima technology was following： emulsifer in oil method was used to prepare foremilk, temp was 60 ℃, the micro emulsion was prepared by two-step high pressure homogen method with that the pressure was 80 Pa, 10 times, micropore film was used to sterilize, filling and sealing at the preservation of nitrogen. The best formula was following：soybean oil was 1.1%, DGDG was 1.6%, and sodium oleate was 0.16%. The particle size of three batch submicro-emulsions were from 168.0 to 169.3 nm; Zeta potential were from-25.53 to 24.90 mV, pH value were from 8.48 to 8.52. The deviation between measured value and predictive value was 1.8%. It was stable in high temperature and illumination. Conclusion： DGDG can be used as the emulsifier of bay oil sub-microemulsion.

关 键 词：双半乳糖基二酰甘油酯 香叶油 亚微乳 星点设计-效应面法 

分 类 号：R944[医药卫生—药剂学]