龙胆苦苷纳米乳的制备工艺及质量安全性评价  

Preparation and Evaluation of Quality and Security of Gentiopicroside Nanoemulsion

作　　者：夏鹏飞[1,2,3] 马肖 吴国泰 李阳[1,2,3] 樊秦 赵磊[1,2,3] XIA Peng fei;MA Xiao;WU Guo-tai;LI Yang;FAN Qin;ZHAO Lei(Gansu University of Chinese Medicine;Key Laboratory of Chemistry and Quality for Traditional Chinese Medicines of the College of Gansu Province;Gansu province Engineering Laboratory for TCM standardization technology and popularization,Gansu University of Chinese medicine;Second People’s Hospital of Gansu Province;Key Laboratory of Pharmacology and Toxicology of TCM of Gansu Province,Lanzhou 730000,China)

机构地区：[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　　处：《天然产物研究与开发》2017年第11期1824-1830,共7页Natural Product Research and Development

基　　金：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)

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/m L;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。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/EL35/absolute ethyl alcohol/Ultrapure water(1.77∶7.66∶5.94∶11.91∶72.71),the particle size of nanoemulsion was23.08nm;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.

关 键 词：龙胆苦苷 纳米乳 制备工艺 质量评价 

分 类 号：R944.9[医药卫生—药剂学]