基于"药辅合一"的辛夷油亚微乳的制备及评价
Preparation and evaluation of Magnolia Flos oil-loaded submicron emulsion based on the unification of drugs and excipients
孟扬 1徐丽芝 2王欣茹 1冯向阳 1刘彤 3叶田田 4杨瑞 5王淑君6
作者信息
- 1. 江西中医药大学药学院,南昌 330004;长三角药物高等研究院,江苏 南通 226133;江苏艾迪纳米生物医药有限公司,江苏 南通 226100
- 2. 长三角药物高等研究院,江苏 南通 226133;江苏艾迪纳米生物医药有限公司,江苏 南通 226100;安徽中医药大学药学院,合肥 230012
- 3. 辽宁省药品检验检测院,沈阳 110032
- 4. 江西中医药大学药学院,南昌 330004;沈阳药科大学,沈阳 110016
- 5. 辽宁中医药大学附属第二医院,沈阳 110034
- 6. 沈阳药科大学,沈阳 110016
- 折叠
摘要
目的 基于"药辅合一"理念优化辛夷油亚微乳的处方与制备工艺,并对其进行表征和体外释放动力学研究.方法 以离心稳定性常数Ke、粒径、ζ电位的综合评分为指标,采用Box-Behnken效应面法优化辛夷油亚微乳处方工艺,透析法研究其体外释放桉油精的情况.结果 辛夷油亚微乳的最优处方:辛夷油5％、大豆磷脂1.2％、泊洛沙姆188 1.8％、油酸1.3％,最佳制备工艺条件:乳化时间10 min,乳化温度60 ℃,超声时间10 min.辛夷油亚微乳的桉油精含量为(2.43±0.04)mg·mL-1,粒径为(156.93±1.53)nm,多分散指数(PDI)为(0.16±0.02),ζ电位为(一 24.87±1.67)mV,体外释放符合一级动力学方程特征,释放机制为Fick扩散.结论 成功制备辛夷油亚微乳并优化了处方工艺,所得制剂的稳定性良好,并且具有缓释作用.
Abstract
Objective To optimize the prescription and preparation of Magnolia Flos oil-loaded submicron emulsion based on unification of drugs and excipients,characterize its preparation and determine the vitro release kinetics.Methods Box-Behnken response surface method was used to optimize the formulation and process variables of Magnolia Flos oil-loaded submicron emulsion using the comprehensive score of Ke,particle size,and zeta potential as indexes.The dialysis method was used to determine the in vitro release of eucalyptol.Results The optimal formulation of Magnolia Flos oil-loaded submicron emulsion was as follows:5％Magnolia Flos oil,1.2％soybean lecithin,1.8％poloxamer 188,and l.3％oleic acid.The optimal preparation conditions:emulsification for 10 min,at 60 ℃,ultrasonic time of 10 min.The content of eucalyptol in the Magnolia Flos oil-loaded submicron emulsion was(2.43±0.04)mg·mL-1,mean particle size was(156.93±1.53)nm,polymer dispersity index(PDI)was(0.16±0.02)and zeta potential was(-24.87±1.67)mV The in vitro release study exhibited the characteristics of the first-order kinetic equation,and the release mechanism was Fick diffusion.Conclusion Magnolia Flos oil-loaded submicron emulsion is successfully prepared and the formulation is optimized.The preparation has good stability and sustained release effect.
关键词
辛夷油/药辅合一/响应面法/亚微乳/体外释药Key words
Magnolia Flos oil/unification of drug and excipient/response surface method/submicron emulsion/in vitro release引用本文复制引用
出版年
2024
NETL
NSTL
万方数据