金雀异黄素自乳化释药系统的制备及质量评价  

Preparation and Quality Evaluation of Genistein Self-emulsifying Drug Delivery System

作　　者：宋笑丹[1,2] 唐景玲[3] 邸哲婷[1] 吴琳华[1] 

机构地区：[1]哈尔滨医科大学附属第二医院药学部黑龙江省高校重点实验室,哈尔滨市150086 [2]哈尔滨医科大学附属第一医院药学部,哈尔滨市150001 [3]哈尔滨医科大学药学院,哈尔滨市150081

出　　处：《中国药房》2011年第47期4441-4443,共3页China Pharmacy

基　　金：黑龙江省自然科学基金项目(D201009)

摘　　要：目的:研究金雀异黄素自乳化释药系统的处方,并对其进行质量评价。方法:通过溶解度试验,辅料配伍选择并结合伪三元相图确定金雀异黄素自乳化释药系统的最佳处方;考察该释药系统经水稀释后形成微乳的外观、形态、粒径和Zeta电位,并测定载药量。结果:该自乳化释药系统中油相为油酸乙酯,乳化剂为聚氧乙烯蓖麻油,助乳化剂为二乙二醇单乙基醚;最佳比例为3∶12∶5。金雀异黄素自乳化释药系统稀释1000倍后所得微乳为澄清透明液体,透射电镜下呈球形,分布均匀,粒径为(227.9±93.8)nm,Zeta电位为(-18.6±4.8)mV,载药量为5.16%。结论:确定了金雀异黄素自乳化释药系统的最佳处方,制得的自乳化释药系统质量稳定、可靠。OBJECTIVE： To study the formulation of Genistein self-emulsifying drug delivery system and evaluate its quality. METHODS： Through equilibrium solubility experiment, the compatible combination of excipients and drawing pseudo-ternary phase diagram, the optimum formulation of Genistein self-emulsifying drug delivery system was determined. The morphology, parti- cle size, zeta potential of microemulsion were investigated after diluted by water and drug-loading amount was determined. RE- SULTS： In the optimum formulation, ethyl oleate, cremophor EL, transcutol P were screened as oil phase, emulsifier and co-emul- sifier, respectively. The optimum proportion was 3 ： 12 ： 5. After being 1 000 times diluted with water, the morphology of micro- emulsion was clear and transparent homogeneous small spherical drops observed under the electron microscope. The particle size and the zeta potential were （227.9 ＋ 93.8） nm and （ -- 18.6 ＋ 4.8） mV, respectively. The content of drug in self-emulsifying drug delivery system was 5.16%. CONCLUSION： The optimum formulation of Genistein self-emulsifying drug delivery system is deter- mined, and the quality of it is reliable and steady.

关 键 词：金雀异黄素 自乳化释药系统 制备 质量评价 

分 类 号：R944.9[医药卫生—药剂学] R928.6[医药卫生—药学]