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盐蒺藜质量标准提升研究

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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。
Improvement of Quality Standard of Tribuli Fructus Stir-baked with Salt Water
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.

Tribuli Fructus stir-baked with salt waterQuality standardTerrestrosin KContent determinationChar-acteristic spectrum

吕西雨、李静娜、韩冰、王帅、刘坤琳、张超

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山东中医药大学药学院,山东济南 250355

盐蒺藜 质量标准 蒺藜皂苷K 含量测定 特征图谱

2024

时珍国医国药
时珍国医国药杂志社

时珍国医国药

北大核心
影响因子:0.887
ISSN:1008-0805
年,卷(期):2024.35(3)