石菖蒲挥发油自纳米乳的制备与质量评价  

Preparation and quality evaluation of volatile oil from Acori Tatarinowii Rhizoma self-nanoemulsion

作　　者：钟芮娜 汪小涵[1,2] 王欣桐 申宝德[2] 沈成英[2] 王镜 韩丽[1] 袁海龙[2] WANG Kun;ZHANG Dong;SUN Peng;MA Yue;ZHAO Yi-fan;CHANG Xiao-qiang;YANG Lan;YUAN Hai-long(College ofPharmacy,Chengdu Universtiy of Traditional Chinese Medicine,Chengdu 611137,China;Department of Pharmacy,Air Force General Hospital,PIA,Beijing 100142,China)

机构地区：[1]成都中医药大学药学院,四川成都611137 [2]中国人民解放军空军总医院药学部,北京100142

出　　处：《中国中药杂志》2018年第20期4062-4068,共7页China Journal of Chinese Materia Medica

基　　金：军队后勤科研重点项目(BKJ16J011);全军重大科研计划项目(BKJ16J025);全军医学科技青年培育计划拔尖项目(17QNP028)

摘　　要：为增加石菖蒲挥发油的溶解度,该研究拟将其制成自纳米乳制剂。通过相容性研究、辅料配伍试验、伪三元相图的绘制初步筛选处方,以粒径、载药量为指标,采用Box-Behnken效应面法优化处方,并对最优处方的自纳米乳制剂进行表征、体外溶出评价。结果显示,石菖蒲挥发油自纳米乳的最优处方为:41. 7%石菖蒲挥发油、46. 8%聚氧乙烯脱水山梨醇单油酸酯、11. 5%PEG-400;所制得的自纳米乳澄清透明,载药量为(192. 77±1. 64) mg·g-1,粒径为(53. 20±0. 94) nm,PDI为0. 230±0. 013,Zeta电位为(-12. 2±0. 7) m V;在体外溶出度实验中,石菖蒲挥发油自纳米乳明显高于石菖蒲挥发油。该研究中石菖蒲挥发油直接作为自纳米乳中的油相,处方更简单且载药量更高,制得的自纳米乳符合相关的质量要求,为挥发油的制剂研究提供了一定的参考。In order to increase the solubility of volatile oil from Acori Tatarinowii Rhizoma,this study was to prepare self-nanoemulsion of volatile oil from Acori Tatarinowii Rhizoma. The prescriptions were preliminarily screened by miscibility studies,excipient compatibility tests,and pseudo-ternary phase diagrams,and then the optimal formulation was obtained by using the Box-Behnken response surface method,with particle size and drug-loading rate as the indicators. The self-nanoemulsion prepared by optimal prescription was characterized and evaluated for in vitro dissolution. The results showed that the optimal prescription for this volatile oil self-nanoemulsion was as follows: 41. 7% volatile oil,46. 8% Tween-80,and 11. 5% PEG-400. The prepared self-nanoemulsion was clear and transparent,with drug-loading of(192. 77 ± 1. 64) mg·g-1,particle diameter of(53. 20 ± 0. 94) nm,polydispersity index of0. 230 ± 0. 013,and Zeta potential of(-12. 2 ± 0. 7) m V. The in vitro dissolution of self-nanoemulsion was higher than that of volatile oil. In this research,volatile oil served as the oil phase in self-nanoemulsion,so the prescription was simpler and the drug loading rate was higher. The prepared self-nanoemulsion complied with the relevant quality requirements,providing a reference for the preparation of volatile oil formulations.

关 键 词：石菖蒲挥发油 自纳米乳 伪三元相图 BOX-BEHNKEN效应面法 质量评价 

分 类 号：R283.6[医药卫生—中药学]