黄芩苷-人参总皂苷纳米乳的制备及处方优化研究  

Preparation and optimization of Baicalin-Total Ginsenoside Nanoemulsion

作　　者：邓婕 李晓秋 马茵 龙宇 吴媛媛[1] 胡月 贺小方 冯慧意 吴欠欠 高乐莹 刘昊林 李楠[1] DENG Jie;LI Xiaoqiu;MA Yin;LONG Yu;WU Yuanyuan;HU Yue;HE Xiaofang;FENG Hui Yi;WU Qianqian;GAO Leying;LIU Haolin;LI Nan(State Key Laboratory of Southwestern Chinese Medicine Resources,School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Sichuan Chengdu 61l137,China)

机构地区：[1]西南特色中药资源国家重点实验室,成都中医药大学药学院,四川成都611137

出　　处：《中药与临床》2025年第2期17-22,共6页Pharmacy and Clinics of Chinese Materia Medica

基　　金：成都中医药大学青基进阶人才专项(QJJJ2022014);成都中医药大学乡村振兴专项(XCZX2022007);四川省科学技术厅青年科学基金项目(2022NSFSC1406)。

摘　　要：目的:采用Box-Behnken设计-效应面法优化黄芩苷-人参总皂苷纳米乳的制备工艺。方法:选择超声乳化法制备黄芩苷-人参总皂苷纳米乳。在单因素试验基础上,以油相用量、混合乳化剂用量、混合乳化剂比例为影响因素,粒径、黄芩苷最大载药量和人参总皂苷最大载药量为评价指标,Box-Behnken设计优化制备工艺后,进行工艺验证。结果:纳米乳最佳制备工艺条件为辛癸酸甘油酯用量4.32%,EL40-PEG400比例3:1,混合乳化剂用量30%,此条件下制备得到的黄芩苷-人参总皂苷纳米粒粒径46.25 nm,黄芩苷最大载药量2.38 mg·g^(-1),人参总皂苷最大载药量28.25 mg·g^(-1),外观为淡黄色澄明液体,流动性好。结论:优化的黄芩苷-人参总皂苷纳米乳粒径均一稳定,载药量高,处方工艺稳定,可为相关药物的新剂型的研发提供参考。Objective:To optimize the preparation process of Baicalin-Total Ginsenoside nanoemulsion using Box-Behnken design-effect surface method.Methods:Ultrasonic emulsification was used to prepare Baicalin-Total Ginsenoside nanoemulsion.Based on single-factor experiments,with oil phase amount,mixed emulsifier amount,and mixed emulsifier ratio as influencing factors,particle size,maximum loading capacity of baicalin,and maximum loading capacity of ginsenoside were used as evaluation indicators.After optimizing the preparation process using Box-Behnken design,the process was validated.Results:The optimal preparation conditions for the nanoemulsions included using 4.32%glyceryl caprylate/caprate,EL40 to PEG400 ratio of 3:1,and 30%mixed emulsifier.Under these conditions,the particle size of Baicalin-Total Ginsenoside nanoemulsion was 46.25 nm,the maximum drug load of baicalin was 2.38 mg·g^(-1),and the maximum drug load of total ginsenoside was 28.25 mg·g^(-1).The product appeared as a pale yellow,clear liquid with good fluidity.Conclusion:The optimized Baicalin-Total Ginsenoside nanoemulsion are homogeneous and stable in particle size,high in drug loading,and stable in prescription process,which can provide a reference for the research and development of new dosage forms of related drugs.

关 键 词：黄芩苷 人参总皂苷 纳米乳 超声乳化法 Box-Behnken设计-效应面法 工艺优化 

分 类 号：R284.1[医药卫生—中药学]