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葛根配方颗粒质量评价

张代亮 孟兆青 王春霞 史磊 刘羽康 林永强 王玉卓 张京华 李金鑫 曹桂云

中成药2025,Vol.47Issue(5):1421-1431,11.
中成药2025,Vol.47Issue(5):1421-1431,11.DOI:10.3969/j.issn.1001-1528.2025.05.002

葛根配方颗粒质量评价

Quality evaluation of Gegen Formula Granules

张代亮 1孟兆青 2王春霞 3史磊 1刘羽康 2林永强 4王玉卓 2张京华 2李金鑫 2曹桂云2

作者信息

  • 1. 山东中医药大学,山东济南 250355
  • 2. 山东宏济堂制药集团股份有限公司,山东济南 250103
  • 3. 沂南县人民医院,山东临沂 276300
  • 4. 山东省食品药品检验研究院,山东济南 250101
  • 折叠

摘要

Abstract

AIM To evaluate the quality of Gegen Formula Granules.METHODS Linear calibration with two reference substances(LCTRS)was adopted in the predicting of retention time with puerarin and daidzein as internal standards.UPLC characteristic chromatograms were established.The contents of 3'-hydroxy puerarin,puerarin(internal standard),3'-methoxy puerarin,puerarin 6"-O-xyloside,puerarin apioside and daidzin were determined by quantitative determination analysis multi-components by a single marker(QAMS),after which their transfer rates were calculated.RESULTS Compared with relative retention time method,LCTRS demonstrated higher positional accuracy for characteristic peaks and wider application range for columns.There were 9 characteristic peaks in the characteristic chromatograms for 14 batches of formula granules and 15 batches of standard decoctions with the similarities of more than 0.95.The contents and transfer rates of various constituents in formula granules and standard decoctions were basically consistent.CONCLUSION The chemical constituents in formula granules and their standard decoctions of Puerariae lobatae Radix display good consistency,reliable preparation process is observable in the former.

关键词

葛根/配方颗粒/标准汤剂/质量评价/UPLC特征图谱/双标线性校正/一测多评

Key words

Puerariae lobatae Radix/formula granules/standard decoctions/quality evaluation/UPLC characteristic chromatograms/linear calibration with two reference substances(LCTRS)/quantitative determination analysis multi-components by a single marker(QAMS)

分类

药学

引用本文复制引用

张代亮,孟兆青,王春霞,史磊,刘羽康,林永强,王玉卓,张京华,李金鑫,曹桂云..葛根配方颗粒质量评价[J].中成药,2025,47(5):1421-1431,11.

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)

泉城"5150"引才倍增计划项目(2021) (2021)

中成药

OA北大核心

1001-1528

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