五仁醇自乳化释药系统的制备及体外特性评价  

Preparation and in Vitro Evaluation of Self-emulsifying Drug Delivery System for Wurenchun

作　　者：邵兵[1] 唐景玲[2] 纪宏宇[1] 刘红梅[1] 赵红光[1] 兰恭赞[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150086 [2]哈尔滨医科大学药学院药剂教研室,哈尔滨150086

出　　处：《中国药房》2012年第43期4059-4062,共4页China Pharmacy

基　　金：黑龙江省科技计划项目(GC10C210)

摘　　要：目的:研究五仁醇自乳化释药系统的处方及体外特性。方法:通过溶解度试验、处方配伍试验、伪三元相图筛选最优处方;通过研究自乳化效率、乳化后药液的粒度分布、药液体外溶出行为及稳定性对五仁醇自乳化制剂进行体外评价。结果:五仁醇自乳化胶囊的最终处方为油酸:吐温20:二乙二醇单乙基醚=20:65:15(W/W/W),药物为辅料总量的20%;含药乳液的粒径为241nm;自乳化制剂中五味子醇甲在15min溶出即可达到100%,五味子乙素在45min可溶出71.3%,低温和常温下药物稳定性无明显变化。结论:所制备的五仁醇自乳化制剂自乳化能力强、稳定性好、体外溶出率高。OBJECTIVE：To study formulation and in vitro characteristics of self-emulsifying drug delivery system（SEDDS） for Wurenchun.METHODS：Through solubility test,compatibility test and pseudo-ternary phase diagrams,the optimum formation was obtained for wurenchun.The self-emulsifying efficiency,distribution of particle size,the dissolution rate and the stability were studied to evaluate Wurenchun self-emulsifying preparation in vitro.RESULTS：The optimum formulation was as follows：the proportion of oleate,tween-20 and transcutol P were 20：65：15（W/W/W）,the content of wurenchun was 20% of excipients.The particle size of emulsification solution was 241 nm.The release percentage of schisandrin reached to 100% at 15 min and that of schisandrin B reached to 71.3% at 45 min.There was no significant change in stability test at subambient and ambient temperature.CONCLUSION：Prepared Wurenchun SEDDS show high efficiency,characteristic stability and high dissolution in vitro.

关 键 词：五仁醇 自乳化释药系统 伪三元相图 溶出度 

分 类 号：R283.69[医药卫生—中药学] R927.1[医药卫生—中医学]