中国药物警戒 ›› 2025, Vol. 22 ›› Issue (1): 76-83.
DOI: 10.19803/j.1672-8629.20240568

• 基础与临床研究 • 上一篇    下一篇

地黄药材中梓醇的含量测定研究

戴梦茹1,2, 李春1, 张永欣1, 卢宇1, 程博宇1, 冯伟红1,*   

  1. 1中国中医科学院中药研究所,中药质量控制技术国家工程实验室,北京 100700;
    2宜春学院,江西省作物生长发育调控重点实验室,江西 宜春 336000
  • 收稿日期:2024-08-12 出版日期:2025-01-15 发布日期:2025-01-22
  • 通讯作者: *冯伟红,女,研究员, 中药分析。E-mail: weihong_bj@126.com
  • 作者简介:戴梦茹,女,在读硕士,中药分析与质量标准。
  • 基金资助:
    中国中医科学院科技创新工程项目（CI2021A04-206、CI2021A04402、CI2021A04412）; 国家重点研发计划（2023YFC3504000）; 中国中医科学院中药研究所“使命导向改革”重点专项（CI2023E001TS03）

Study on Catalpol Determination in Rehmanniae Radix

DAI Mengru1,2, LI Chun1, ZHANG Yongxin1, LU Yu1, CHENG Boyu1, FENG Weihong1,*   

  1. 1Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Beijing 100700, China;
    2Yichun University, Jiangxi Province Primary Laboratory of Crop Growth and Development Regulation,Yichun Jiangxi 336000, China
  • Received:2024-08-12 Online:2025-01-15 Published:2025-01-22

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摘要： 目的 采用UPLC建立地黄中梓醇的含量测定方法,为提升地黄质量标准提供参考。方法 采用Boltimate LP-C18 色谱柱（4.6 mm×50 mm,2.7μm）,以纯水为流动相和提取溶媒,等度洗脱,检测波长194 nm,流速为0.6 mL·min-1,柱温35℃,进样量1μL。对3批鲜地黄和7批生地黄中的梓醇进行测定,并与《中华人民共和国药典》（2020年版）生地黄中梓醇的【含量测定】项下方法进行比较。结果 所建方法的精密度、重复性、稳定性及加样回收试验的RSD均<0.5,与《中华人民共和国药典》（2020年版）方法相比,灵敏度、重现性和准确度更高。建立的UPLC方法可在15 min内完成供试品溶液的制备,在10 min内可准确测定鲜/生地黄中梓醇。结论 该方法简单易行、绿色环保、节省时间、不需采用任何有机溶剂,可有效避免酸环境下梓醇的降解,准确测定梓醇含量,为地黄药材及其相关制剂的质量控制提供方法参考。

关键词: 地黄, 梓醇, 含量测定, 核壳柱, 超高效液相色谱, 《中华人民共和国药典》

Abstract: Objective To establish a method of UPLC for the determination of catalpol in Rehmanniae Radix so as to improve the quality standard of Rehmanniae Radix. Methods A Boltimate LP-C18 chromatographic column (4.6mm× 50 mm, 2.7μm) was used while pure water was used as the mobile phase and extraction solvent. The detection wavelength was set at 194 nm, the flow rate was 0.6 ml min-1, the column temperature was 35℃, and the sample volume was 1 μL. The contents of catalpol in 3 batches of fresh Rehmanniae Radix and 7 batches of raw Rehmanniae Radix were determined, and the result was compared with the one determined using the method specified in Chinese Pharmacopoeia. Results The RSDs of precision, repeatability, stability and spiked recovery tests of the new method were all below 0.5. Compared with the method specified in the current Chinese Pharmacopoeia, the sensitivity, reproducibility and accuracy of the new method were higher. The new method could complete the preparation of the test solution within 15 min, and accurately determine the content of catalpol in fresh/raw Rehmanniae radix within 10 min. Conclusion This method is simple, environmentally friendly, time-saving, and does not need any organic solvent. It can effectively prevent catalpol degradation in an acid environment, accurately determine catalpol contents, and provide a feasible method for quality control of Rehmanniae Radix. and its related preparations.

Key words: Rehmanniae Radix, Catalpol, Content Determination, Core-Shell Column, Ultra Performance Liquid Chromatography (UPLC), Chinese Pharmacopoeia of the People's Republic of China

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