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钩藤降压方配方颗粒、传统汤剂化学成分一致性评价

张庆刚 孟兆青 张代亮 齐红 丁书文 王玉卓 李运伦 何吉富 郭焕滢 曹桂云

中成药2025,Vol.47Issue(11):3555-3565,11.
中成药2025,Vol.47Issue(11):3555-3565,11.DOI:10.3969/j.issn.1001-1528.2025.11.004

钩藤降压方配方颗粒、传统汤剂化学成分一致性评价

Evaluation of chemical constituent consistency in formula granules and traditional decoctions of Gouteng Jiangya Formula

张庆刚 1孟兆青 2张代亮 1齐红 3丁书文 4王玉卓 2李运伦 4何吉富 4郭焕滢 2曹桂云2

作者信息

  • 1. 山东中医药大学,山东济南 250355||山东宏济堂制药集团股份有限公司,山东济南 250103
  • 2. 山东宏济堂制药集团股份有限公司,山东济南 250103
  • 3. 济南市食品药品检验检测中心,山东济南 250102
  • 4. 山东中医药大学,山东济南 250355||山东中医药大学附属医院,山东济南 250014
  • 折叠

摘要

Abstract

AIM To evaluate the chemical constituent consistency in formula granules and traditional decoctions of Gouteng Jiangya Formula.METHODS HPLC characteristic chromatograms were established,the analysis was performed on a 30 ℃ thermostatic YMC-Triart C18 column(4.6 mm× 250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.2%phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 240 nm.Puerarin was used as an internal standard to calculate the relative correction factors of 3'-methoxy puerarin,puerarin apioside,magnolflorine,paeoniflora,daidzin,baicalin,palmatine,berberine,wogonoside and benzoylpaeoniflorin,after which the content detemination was made by quantitative analysis of multi-components by single-marker(QAMS).RESULTS The characteristic chromatograms of 9 batches of formula granules and 15 bacthes of traditional decoctions demonstrated the similarities of more than 0.90 at the detection wavelengths of 192,210,240,260,280,300,320,360 nm,along with similar total peak areas.Eleven constituents showed good linear relationships within their own ranges(r>0.999 0),whose average recoveries were 97.27%-101.64%with the RSDs of 0.36%-1.11%,the result obtained by QAMS and external standard method demonstrated no significant differences(P>0.05).The contents of various constituents in the formula granules approximated those in the traditional decoctions.CONCLUSION The consistent kinds and contents of various constituents are obversable in formula granules and traditional decoctions of Gouteng Jiangya Formula,which can provide a reference for the reasonable clinical application of this formula.

关键词

钩藤降压方/配方颗粒/传统汤剂/化学成分/一致性/HPLC特征图谱/一测多评

Key words

Gouteng Jiangya Formula/formula granules/traditional decoctions/chemical constituents/consistency/HPLC characteristic chromatograms/quantitative analysis of multi-components by single-marker(QAMS)

分类

医药卫生

引用本文复制引用

张庆刚,孟兆青,张代亮,齐红,丁书文,王玉卓,李运伦,何吉富,郭焕滢,曹桂云..钩藤降压方配方颗粒、传统汤剂化学成分一致性评价[J].中成药,2025,47(11):3555-3565,11.

基金项目

山东省重点研发计划重大科技创新工程项目(2021CXGC010511) (2021CXGC010511)

中成药

OA北大核心

1001-1528

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