水飞蓟宾磷脂复合物自乳化片的制备及体外溶出度考察  

Preparation of self microemulsifying tablet for silybin phospholipid complex and its dissolution

作　　者：卫世杰[1] 霍务贞[2] 李晓芳[1] 方泽浩[1] 

机构地区：[1]广东药学院药剂系,广东广州510006 [2]广东药学院中药开发研究所,广东广州510006

出　　处：《中成药》2010年第10期1688-1691,共4页Chinese Traditional Patent Medicine

基　　金：广东药学院科研启动基金项目(2006yxk06)

摘　　要：目的:研制高溶出度的水飞蓟宾磷脂复合物自乳化片,并对其体外溶出度进行考察。方法:通过溶解度试验、伪三元相图的制备、体外乳化效率和稳定性筛选处方;采用干法制粒压片法制备水飞蓟宾磷脂复合物自乳化片,并考察其乳化后微乳的粒径、形态和体外溶出情况。结果:以辛癸酸三甘油酯为油相,Cremophor RH40为表面活性剂,异丙醇为助表面活性剂,制备自微乳化溶液,其比例为20:60:20,稀释后测定粒径为73.2nm;自乳化片中水飞蓟宾溶出度可达90%以上,而市售益肝灵薄膜衣片不足50%。结论:与市售片相比,水飞蓟宾磷脂复合物自微乳化片能显著提高其体外溶出。AIM：To develop the formulation of self-microemulsifying tablet for silybin phospholipid complex（SPCMET） and to investigate its dissolution property.METHODS：Through solubility experiment,pseudoternary phase diagram,self-microemulsification in vitro and the stability of solution,the optimum formulation was selected.SPCMET was prepared by dry granulation.The particle size distribution,particle shape and dissolution of SPCMET were measured taking the commercial tablet as reference.RESULTS：In the selected formulation,octyl decyl acid triglycerate,cremophor RH40 and isopropyl alcohol were screened as oil phase,emulsifier and co-emulsifier,respectively.The optimal proportion was 20：6：20.The average particle size was 73.2 nm after dilution.The dissolution of silybin in SPCMET was more than 90 percent in 45 min,while the dissolution of the commercial tablet was less than 50 percent in 45 min.CONCLUSION：The dissolution of SPCMET is sufficiently improved in comparison with the commercial tablet.

关 键 词：水飞蓟宾 磷脂复合物 自乳化片 溶出度 

分 类 号：R944[医药卫生—药剂学]