维生素K2固体自乳化制剂的处方优化  

Prescription Optimization of Vitamin K2 Solid Self-emulsifying Preparation

作　　者：赵运双 陈洁 金小红 梅兴国 ZHAO Yun-shuang;CHEN Jie;JIN Xiao-hong(School of Pharmacy,Hubei University of Science and Technology,Xianning Hubei 437100,China)

机构地区：[1]湖北科技学院药学院,湖北咸宁437100 [2]军事科学院军事医学研究院,北京100850

出　　处：《湖北科技学院学报（医学版）》2020年第5期381-385,F0002,共6页Journal of Hubei University of Science and Technology(Medical Sciences)

摘　　要：目的对维生素K 2(VK 2)固体自乳化药物传递系统进行处方优化,制备载药固体自乳化制剂。方法筛选油相、表面活性剂和助表面活性剂,在37℃条件下绘制空白三元相图,并通过星点设计-效应面,以粒径、电位以及分散系数为指标优化自乳化处方。以自乳化辅料与微晶纤维素为载体,采用喷雾干燥法,制备VK 2自乳化固体粉末。结果固体自乳化制剂最佳处方组成为:VK 2∶油酸乙酯∶聚氧乙烯40氢化蓖麻油∶甘油∶微晶纤维素,比例为0.05∶2∶2∶1∶30。结论处方优化成功制得工艺简单、性质稳定的VK 2自乳化制剂,且其各项理化性质良好。Objective To optimize the formulation of vitamin K 2 solid self-emulsifying drug delivery system.Methods The oil phase,surfactant and cosurfactant were screened,the blank ternary phase diagram was drawn at 37℃,and the self-emulsification prescription was optimized by star-point design-effect surface with particle size,potential and dispersion coefficient as indexes.Vitamin K 2 self-emulsifying solid powder was prepared by spray drying with microcrystalline cellulose as the carrier.Results The optimal formulation of solid self-emulsifying preparation was as follows:vitamin K 2∶ethyl oleate∶polyoxyethylene 40 hydrogenated castor oil∶glycerin∶microcrystalline cellulose 0.05∶2∶2∶1∶30.Conclusion Vitamin K 2 self-emulsifying preparation with simple technology and stable properties was successfully prepared.

关 键 词：处方优化 维生素K 2 固体自乳化药物传递系统 三元相图 

分 类 号：R917[医药卫生—药物分析学]