School of Environmental and Pharmaceutical Engineering, Taizhou Institute of Science ＆ Technology, Nanjing University of Science & Technology, 8 Meilan East Road, Taizhou City, Jiangsu Province 225300, PR China.
School of Environmental and Pharmaceutical Engineering, Taizhou Institute of Science ＆ Technology, Nanjing University of Science & Technology, 8 Meilan East Road, Taizhou City, Jiangsu Province 225300, PR China.
J Pharm Biomed Anal. 2022 Sep 20;219:114899. doi: 10.1016/j.jpba.2022.114899. Epub 2022 Jun 18.
A comprehensive strategy for quality evaluation of Atractylodis macrocephalae rhizoma by combining quantitative analysis of multi-components by single marker and HPLC fingerprint qualitative analysis was developed and validated in this paper. By analyzing chromatograms of 18 batches of Atractylodis macrocephalae rhizoma, the reference fingerprint of Atractylodis macrocephalae rhizoma was generated and 10 common peaks were identified, of which Atractylenolide I, atractylenolide II, atractylenolide III and atractylone were identified with chemical references. With atractylenolide III as an internal reference substance, the contents of the other three components in 18 batches of Atractylodis macrocephalae rhizoma samples were simultaneously determined by quantitative analysis of multi-components by single marker which were not significantly different from the results determined by external standard method (t test, P>0.839). The accuracy, precision, reproducibility and stability of this method were validated which exhibited satisfactory results, indicating that quantitative analysis of multi-components by single marker could be used for quantitative analysis of Atractylodis macrocephalae rhizoma instead of external standard method. The content of each component in 18 batches of Atractylodis macrocephalae rhizoma was significantly different from each other. There is no Assay specified in the quality standard of Atractylodis macrocephalae rhizoma in Chinese Pharmacopoeia (volume I) (2020 edition). This method combining quantitative analysis of multi-components by single marker and HPLC fingerprint can evaluate quality of Atractylodis macrocephalae rhizoma samples more comprehensively which is beneficial to the application of Atractylodis macrocephalae rhizoma.
本文建立并验证了一种综合评价白术药材质量的策略，该策略结合了单标记多成分定量分析和 HPLC 指纹图谱定性分析。通过分析 18 批白术药材的色谱图，生成了白术药材的参考指纹图谱，鉴定出 10 个共有峰，其中阿魏酸、苍术内酯 I、苍术内酯 II、苍术内酯 III 和苍术酮通过化学对照品进行了鉴定。以苍术内酯 III 为内标物，采用单标记多成分定量分析同时测定了 18 批白术药材样品中另外 3 个成分的含量，与外标法测定结果无显著差异（t 检验，P>0.839）。该方法的准确性、精密度、重现性和稳定性均得到验证，结果令人满意，表明单标记多成分定量分析可替代外标法用于白术药材的定量分析。18 批白术药材中各成分的含量差异显著。《中国药典》（2020 年版一部）白术质量标准中未规定含量测定项。本研究建立的单标记多成分定量分析结合 HPLC 指纹图谱的方法可更全面地评价白术药材样品的质量，有利于白术的应用。
