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OA

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.