苦参总黄酮脂质体凝胶剂的制备工艺研究  

Study on preparation of total flavone liposome gel of Sophora flavescens

作　　者：杨志欣[1] 卞士嘉 王闻文 汲丽丽 王艳宏[1] YANG Zhixin;BIAN Shijia;WANG Wenwen;JI Lili;WANG Yanhong(College of Pharmacy,Heilongjiang University of Chinese Medicine,Harbin 150040,China)

机构地区：[1]黑龙江中医药大学药学院,黑龙江哈尔滨150040

出　　处：《药物评价研究》2020年第11期2201-2206,共6页Drug Evaluation Research

基　　金：黑龙江省自然科学基金(H2016057,H2017066);黑龙江中医药大学“优秀创新人才支持计划”项目(2012,2018)。

摘　　要：目的优化苦参总黄酮脂质体凝胶剂的制备工艺,并进行质量评价。方法薄膜分散制备苦参总黄酮脂质体,以苦参总黄酮的包封率为指标,正交试验优化处方;以脂质体凝胶剂的成型性、涂展性、光泽度、均匀度、pH值及稳定性等综合评分为指标,星点设计-效应面法优化苦参总黄酮脂质体凝胶的处方及制备工艺;通过离心试验、低温试验、热恒温试验考察苦参总黄酮脂质体凝胶剂稳定性,检测其pH值。结果苦参总黄酮脂质体的最佳处方为:卵磷脂与胆固醇比为9∶1,磷酸缓冲盐pH值为7.0,苦参总黄酮的质量为0.05 g;平均包封率83.45%,平均粒径173.00 nm。苦参总黄酮脂质体凝胶剂最佳处方为:卡波姆0.20 g、甘油2.59 g、三乙醇胺0.20 g,其脂质体凝胶剂的稳定性良好,当温度超过60℃时,凝胶剂的颜色变浅,pH值为6.53。结论优化后的苦参总黄酮脂质体凝胶制备工艺简单可行,质量稳定,为苦参总黄酮经皮制剂的开发提供依据。Objective The preparation process of the total flavonoid liposome gel of Sophora flavescens was optimized and the quality was evaluated. Methods Sophora flavescens flavonoid liposomas was preparated by film dispersion, the encapsulation rate of total flavone of sophora flavone was used as an index to optimize the formulation by orthogonal test. Based on the formation of liposome gel, pH and stability as the index, the star point design-effect surface method was used to optimize the formulation and preparation process of the total flavonoid liposome gel of Sophora flavescens. Evaluate the product by its stability(centrifuge test,low temperature test and thermostatic test) and pH value. Results The best prescription for total flavonoids of Sophora flavescens was: lecithin to cholesterol ratio of 9:1, phosphate buffer salt pH of 7.0, the quality of total flavonoids of Sophora flavescens was 0.05 g;average encapsulation efficiency of 83.45%, the particle size was 173 nm;The best prescription of Sophora flavescens total flavonoid liposome gel was: carbomer 0.20 g, glycerol 2.59 g, triethanolamine 0.20 g. Conclusion The optimized preparation process of total flavonoid liposome gel of Sophora flavescens L. was simple and feasible, and provides a basis for the development of this plant transdermal preparation.

关 键 词：苦参总黄酮 脂质体 脂质体凝胶 星点设计效应面 

分 类 号：R944[医药卫生—药剂学]