盐蒺藜质量标准提升研究
Improvement of Quality Standard of Tribuli Fructus Stir-baked with Salt Water
吕西雨 1李静娜 1韩冰 1王帅 1刘坤琳 1张超1
作者信息
- 1. 山东中医药大学药学院,山东济南 250355
- 折叠
摘要
目的 修订并提高盐蒺藜的质量标准.方法 以10批盐蒺藜为研究对象,对其外观性状、粉末显微特征进行观察,采用薄层色谱法对其中蒺藜皂苷K进行定性鉴别,参照2020年版《中国药典》通则相关方法测定其水分、总灰分、酸不溶性灰分和水溶性浸出物,采用HPLC-ELSD法测定其中蒺藜皂苷K的含量并建立盐蒺藜特征图谱.结果 明确了盐蒺藜外观性状、粉末显微特征的描述,10批盐蒺藜薄层色谱中均可定性出蒺藜皂苷K,取消了酸不溶性灰分的检查,修订了水分、总灰分的限度,新增了水溶性浸出物、蒺藜皂苷K含量限度和盐蒺藜特征图谱,方法学考察结果显示所建立的HPLC-ELSD检测方法符合含量测定要求.结论 建立的方法简便可行、专属性强、重复性好,可用于盐蒺藜的质量控制.
Abstract
Objective To revise and improve the quality standard of Tribuli Fructus stir-baked with salt water.Methods 10 batches of Tribuli Fructus stir-baked with salt water were selected as research object,which the appearance characters and mi-croscopic identification of powder were observed.The Terrestrosin K was identified by the thin-layer chromatography(TLC).The moisture,total ash,acid-insoluble ash and water-soluble extracts were detected according to the method stated in 2020 e-dition of Chinese Pharmacopoeia.The content of Terrestrosin K was determined and the characteristic spectrum was established by HPLC-ELSD.Results The appearance characters and microscopic identification of powder were clarified.The Terrestrosin K could be identified by TLC in 10 batches of Tribuli Fructus stir-baked with salt water.The inspection of acid-insoluble ash was canceled,the limits of moisture and total ash were revised,and the limits of water-soluble extract,the content of Terrestrosin K and the characteristic spectrum were added.The results of HPLC-ELSD methodological investigation of showed that the method meet the requirements of content determination.Conclusion The established method is simple,feasible,specific and reproduci-ble,which can be used for the quality control of Tribuli Fructus stir-baked with salt water.
关键词
盐蒺藜/质量标准/蒺藜皂苷K/含量测定/特征图谱Key words
Tribuli Fructus stir-baked with salt water/Quality standard/Terrestrosin K/Content determination/Char-acteristic spectrum引用本文复制引用
出版年
2024
NETL
NSTL
万方数据