中国药业2026，Vol.35Issue(12)：77-82,6.DOI:10.3969/j.issn.1006-4931.2026.12.014
解郁温胆颗粒工艺中间体及制剂的高效液相色谱指纹图谱建立与含量测定
Establishment of HPLC Fingerprint and Content Determination of Intermediate and Preparation of Jieyu Wendan Granules
摘要
Abstract
Objective To establish a high-performance liquid chromatography(HPLC)fingerprint and content determination method for intermediate and preparation of Jieyu Wendan Granules.Methods The chromatographic column was Kromasil 100-5 C18 column(250 mm×4.6 mm,5 μm),the mobile phase was methanol-0.1%formic acid solution(gradient elution),the detection wavelengths were 318 nm(qualitative analysis)and 283 nm(quantitative analysis),the flow rate was 0.6 mL/min,the column temperature was 25 °C,and the injection volume was 5 μL.The Similarity Evaluation Software for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 edition)was used to establish HPLC fingerprints of the traditional decoction,extract solution,thick paste,dry extract,and preparation of the Jieyu Wendan formula.Common peaks were identified,common components were identified,and similarity evaluation was performed.The contents of naringin and hesperidin in the granules were determined.Results A total of 23 common peaks were identified in the HPLC fingerprint of 13 batches of samples,and 14 components were identified by comparison with the reference substances.Except for three batches of dry extract showing relatively low similarity,the similarities of other samples were all above 0.90.The linear ranges of naringin and hesperidin were 21.06-1 053 μg and 20.78-1 039 μg,respectively(r>0.999 9).The RSDs of precision,stability,and repeatability test results were all lower than 2%(n=6).The average recovery rates were 102.76%(RSD=0.87%)and 96.80%(RSD=0.82%),respectively.The average contents were 5.437 mg/g and 5.734 mg/g,respectively.Conclusion The established HPLC fingerprint method exhibits good stability.The established content determination method is simple,sensitive,reproducible,and accurate,which can be used for the quality control of Jieyu Wendan Granules.关键词
解郁温胆颗粒/指纹图谱/柚皮苷/橙皮苷/含量测定/高效液相色谱法Key words
Jieyu Wendan Granule/fingerprint/naringin/hesperidin/content determination/HPLC分类
医药卫生引用本文复制引用
方红城,黄月纯,陈洁,谢纯珠,陈燕霞,丘振文..解郁温胆颗粒工艺中间体及制剂的高效液相色谱指纹图谱建立与含量测定[J].中国药业,2026,35(12):77-82,6.基金项目
广东省中医药管理局中医药科研项目[20231297] （）
广东省宝安市中医药发展基金会—中药制剂研发专项[2022KJCX-KTYJ-10] （）
广东省深圳市引进中医药高层次医学团队立项项目[SZZYSM202106006]. （）
