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金丹附延颗粒挥发油化学成分鉴定及5个主要成分含量测定

朱良辉 刘德鸿 吴倩颖 陈伟康 朱作为 陈希 缪贵忠

化学试剂2026,Vol.48Issue(6):51-56,6.
化学试剂2026,Vol.48Issue(6):51-56,6.DOI:10.13822/j.cnki.hxsj.2026.0100

金丹附延颗粒挥发油化学成分鉴定及5个主要成分含量测定

Identification of Chemical Constituents and Quantitative Determination of Five Major Components in Volatile Oil from Jindan Fuyan Granules

朱良辉 1刘德鸿 1吴倩颖 2陈伟康 1朱作为 1陈希 1缪贵忠3

作者信息

  • 1. 江西省药品检验检测研究院 江西省药品医疗器械质量工程研究中心,江西 南昌 330029
  • 2. 江西省药品检验检测研究院 江西省药品医疗器械质量工程研究中心,江西 南昌 330029||江西中医药大学 药学院,江西 南昌 330004
  • 3. 江西华太药业有限公司,江西 宜丰 336300
  • 折叠

摘要

Abstract

A method for the identification and quantitative determination of chemical components in the volatile oil intermediate of Jindan Fuyan Granules was established to improve preparation quality control.Gas chromatography-mass spectrometry(GC-MS)combined with the NIST spectral library was used to characterize the chemical components of the volatile oil intermediate.Based on the analytical results,the chromatographic conditions for gas chromatography with flame ionization detection(GC-FID)were optimized.The contents of five representative components,namely α-pinene,D-limonene,α-elemene,β-elemene,and cinnamaldehyde,were simultaneously determined,and the method was systematically validated using 17 sample batches.A total of 21 volatile components were identified in the volatile oil intermediate,providing insight into the material basis underlying the efficacy of this traditional Chinese medicine preparation.The five target components exhibited good linear relationships within their respective concentration ranges(R2≥0.9972).The relative standard deviations(RSDs)for instrument precision,sample stability,and method repeatability were all below 2.2%,whereas spike recovery rates ranged from 99.27%to 103.00%with RSDs below 3%.The concentrations of the five components in the 17 sample batches ranged from 15.75 to 24.35,25.12 to 37.86,33.26 to 39.54,24.02 to 28.06,and 58.57 to 66.72 mg/g,respectively.Variations in the contents of these components were mainly attributed to differences in the quality of raw herbal materials and insufficient refinement of the extraction process.The established method demonstrated simple operation,favorable specificity,and high accuracy for the identification and quantitative determination of volatile oil components in Jindan Fuyan Granules.This method fills a gap in the quality control of volatile oil in this preparation and provides a scientific basis for quality evaluation,production process optimization,and whole-process quality control.

关键词

金丹附延颗粒/挥发油/气相色谱-质谱联用/气相色谱法/成分鉴定/含量测定

Key words

Jindan Fuyan Granules/volatile oil/GC-MS/GC/constituent identification/content determination

分类

化学化工

引用本文复制引用

朱良辉,刘德鸿,吴倩颖,陈伟康,朱作为,陈希,缪贵忠..金丹附延颗粒挥发油化学成分鉴定及5个主要成分含量测定[J].化学试剂,2026,48(6):51-56,6.

基金项目

2023年江西省药品监督管理局重点项目(2023JS11). (2023JS11)

化学试剂

0258-3283

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