天然产物研究与开发 ›› 2017, Vol. 29 ›› Issue (11): 1824-1830.doi: 10.16333/j.1001-6880.2017.11.003

• 研究论文 • 上一篇    下一篇

龙胆苦苷纳米乳的制备工艺及质量安全性评价

夏鹏飞1,2,3,马肖4,吴国泰1,5,李阳1,2,3,樊秦1,2,3,赵磊1,2,3*   

  1. 1甘肃中医药大学;2甘肃省高校中(藏)药化学与质量研究省级重点实验室;3甘肃省道地药材质量标准化技术研究与推广工程实验室; 4甘肃省第二人民医院; 5甘肃省中药药理与毒理学重点实验室,兰州730000
  • 出版日期:2017-11-29 发布日期:2017-11-30
  • 基金资助:

    国家自然科学基金(81660577);2014年度中医学院中青年科研基金(ZQ2014-2);甘肃省科技计划(148RJZA064);甘肃省中药药理与毒理学重点实验室自主基金(ZDSYS-KJ-2016-008);西北民族大学科研项目(31920160115);甘肃省科技计划(148RJZA064)

Preparation and Evaluation of Quality and Security of Gentiopicroside Nanoemulsion

XIA Peng-fei1,2,3, MA Xiao4, WU Guo-tai1,5, LI Yang1,2,3, FAN Qin1,2,3, ZHAO Lei1,2,3*   

  1. 1Gansu University of Chinese Medicine; 2 Key Laboratory of Chemistry and Quality for Traditional Chinese Medicines of the College of Gansu Province; 3 Gansu province Engineering Laboratory for TCM standardization technology and popularization, Gansu University of Chinese medicine; 4Second People’s Hospital of Gansu Province; 5Key Laboratory of Pharmacology and Toxicology of TCM of Gansu Province, Lanzhou 730000, China
  • Online:2017-11-29 Published:2017-11-30

摘要: 通过筛选最佳处方制备龙胆苦苷纳米乳,并对其质量安全性进行评价;基于单因素考察及伪三元相图法,筛选得到龙胆苦苷纳米乳制剂的处方为:龙胆苦苷,乙酸乙酯,聚氧乙烯醚(35)蓖麻油,无水乙醇,水,其质量比为1.77∶ 7.66∶ 5.94∶ 11.91∶ 72.71,龙胆苦苷纳米乳平均粒径为23.08 nm;建立高效液相色谱法测定龙胆苦苷纳米乳中龙胆苦苷的含量,方法的专属性良好,线性范围0.00428~0.214 mg/mL;不同温度、光照和湿度条件下含量无明显变化,稳定性良好;小鼠急性毒性实验结果表明属于实际无毒范围;本研究研制的龙胆苦苷纳米乳制备工艺简单,为提升龙胆苦苷口服生物利用度及扩大临床应用前景提供参考依据。

关键词: 龙胆苦苷, 纳米乳, 制备工艺, 质量评价

Abstract: The aim of this study was to optimize prescription of gentiopicroside nanoemulsion and evaluate its quality and security.Single-factor test and pseudo-ternary phase diagram were adopted to optimize prescription,optimal prescription was gentiopicroside/ethyl acetate/EL-35/absolute ethyl alcohol/Ultrapure water (1.77∶7.66∶5.94∶11.91∶72.71),the particle size of nanoemulsion was 23.08 nm;The content of gentiopicroside was determined by HPLC;Stability of prepared gentiopicroside nanoemulsion was good in the state of different temperatures,illumination intensity and humidity conditions;The security test demonstrated that there was no acute toxicity;The optimized preparation technology of gentiopicroside nanoemulsion was simple,repeatable and stable.It provided the possibility to improve the bioavailability and clinical application.

Key words: gentiopicroside, nanoemulsion, preparation technology, quality evaluation

中图分类号: 

R944.9