三七总皂苷滴鼻液的制备与质量控制  

Preparation and Quality Control of Panax Notoginseng Saponions Nasal Drops

作　　者：王曙东[1] 乔立业[1] 曹燕丽[1] 苏华[1] 任海祥[1] 

机构地区：[1]南京军区南京总医院制剂科,210002

出　　处：《医药导报》2013年第5期653-655,共3页Herald of Medicine

摘　　要：目的制备三七总皂苷滴鼻液并建立其质量控制方法。方法以三七总皂苷为主药制备三七总皂苷滴鼻液;采用高效液相色谱法测定三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1的含量,色谱柱为Symmetry-C18柱(4.6 mm×250 mm,5μm),流动相为水和乙腈梯度洗脱,流速为1.0 mL·min-1,柱温25℃,检测波长203 nm。结果所制备的三七总皂苷滴鼻液外观澄清;三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1分别在23.36～116.80,85.82～429.10,11.62～58.10,88.24～441.20μg.mL-1范围内具备良好的线性关系,方法重复性及回收率均符合要求。结论该制剂处方及制备方法简单,质量控制方法准确、可靠,便于质量控制。Objective To prepare Panax notoginseng saponions nasal drops and establish a quality control method. Methods The saponions nasal drops were prepared by using panax notoginseng saponions as main componens. The determination was performed on a Symmetry-Cls column （4.6 mm×250mm,5μm） with the mobile phase of water and acetonitrile gradient mode, at 1.0 mL·min^-1 of flow rate, 25 ℃and 203 nm. Results The prepared nasal drops were clear and bright in appearance. The HPLC method showed a good linear relationship within the range of 23.36-116.80μg·mL^-1 for sanchinoside R1 ,85.82-429.10 μg·mL^-1 for ginsenoside Rg1 , 11.62-58.10 μg·mL^-1 for ginsenoside Re, and 88.24-441.20μg·mL^-1 for ginsenoside Rb1. Conclusion The formula and preparation technology are simple and the method of quality control is accurate and reliable, which is very convenient.

关 键 词：三七总皂苷 三七皂苷R1 人参皂苷Rg1 人参皂苷RE 人参皂苷RB1 制备 质量控制 

分 类 号：R286[医药卫生—中药学] R927.1[医药卫生—中医学]