穿琥宁自乳化给药系统处方筛选及评价  

Optimization and Preliminary Evaluation the Formulation of Self-microemulsifying Drug Delivery System of Potassium Dehydroandrographolidi Succinas

作　　者：王浩[1] 崔名全[1] 尹蓉莉[1] 慈志敏[1] 余泉毅 

机构地区：[1]成都中医药大学药学院,成都611137

出　　处：《世界科学技术-中医药现代化》2015年第3期712-718,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：四川省教育厅青年基金项目(10ZB076):中药浸膏粉末改性技术在固体制剂中的应用研究;负责人:慈志敏;成都中医药大学校基金项目(ZRYB200936):自乳化给药系统及自乳化效率初步研究;负责人:慈志敏

摘　　要：目的:优选穿琥宁自微乳制剂处方,并对其进行初步评价。方法:通过溶解度试验初步筛选处方辅料种类;以乳化结果和效率、乳滴粒径为标准,采用正交试验设计和伪三元相图法确定最优处方组成及配伍比例;考察该处方形成乳液的外观、粒径、Zeta电位及其稳定性。结果:穿琥宁自乳化制剂最优处方为MCT-Tween-20-甘油(1:4:5),该处方能自发形成具淡蓝色乳光的透明乳液,其乳化时间为31.27 s,平均粒径为37.1±0.06 nm,Zata电位为-17.4 m V,乳液稳定性良好。结论:所得穿琥宁自微乳处方乳化性能良好,乳液较稳定。The self-microemulsion formulation of potassium dehydroandrographolidi succinas （PDS） has been optimized and the performance in vitro has been evaluated preliminary. Kinds of prescription accessories were screened by solubility based on the emulsifying result and efficiency, particle size of emulsions. The optimal formulation composition and compatibility proportion were determined by orthogonal design and pseudo-ternary phase diagrams. The appearance, particle size, Zeta potential and stability of this formulation were also investigated. The optimized prescription of PDS was 10% MCT, 40% Tween-20 and 50% glycerol. It can spontaneously form a transparent pale blue opalescent emulsion with emulsification time 31.27 s, particle size 37.1 nm, Zata potential -17.4 mV and good stability.

关 键 词：穿琥宁 自乳化 三元相图 质量评价 

分 类 号：R283.6[医药卫生—中药学]