中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 397-402.
DOI: 10.19803/j.1672-8629.20220717

• 基础与临床研究 • 上一篇    下一篇

月季花饮片标准汤剂的制备与质量评价研究

李宁1, 姜晓娅1, 张泽昭1, 高乐1, 王鑫国1, 刘晓明2,*   

  1. 1河北中医学院,河北省中药配方颗粒技术创新中心,中药材品质评价与标准化河北省工程研究中心,河北 石家庄 050091;
    2河北省药品审评中心,河北 石家庄 050090
  • 收稿日期:2022-12-12 出版日期:2023-04-15 发布日期:2023-04-20
  • 通讯作者: *刘晓明,女,硕士,副主任药师,药效物质基础。E-mail: 175648404@qq.com
  • 作者简介:李宁,女,硕士,实验师,中药分析。
  • 基金资助:
    河北省自然科学基金重点项目（H2022423335）; 河北省重点研发计划项目（20372502D）; 河北省中医药管理局科研计划项目（2021099）

Preparation and quality evaluation of standard decoctions of Rosa chinensis Jacq.

LI Ning1, JIANG Xiaoya1, ZHANG Zezhao1, GAO Le1, WANG Xinguo1, LIU Xiaoming2,*   

  1. 1University of Chinese Medicine, Hebei Traditional Chinese Medicine Formula Granule Engineering & Technology Innovation Center, Hebei Engineering Research Center for Quality Evaluation & Standardization of Traditional Chinese Medicine, Shijiazhuang Hebei 050091, China;
    2Center for Drug Evaluation, Shijiazhuang Hebei 050090, China
  • Received:2022-12-12 Online:2023-04-15 Published:2023-04-20

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摘要： 目的 建立月季花饮片标准汤剂的质量评价方法,为月季花标准汤剂的应用和质量控制提供参考。方法 采收不同产地的月季花饮片共15批并制备成标准汤剂,将金丝桃苷和异槲皮苷选定为定量检测指标计算出膏率及转移率,建立高效液相色谱（HPLC）特征图谱,并采用中药色谱指纹图谱相似度评价系统（2012版）软件对特征图谱进行分析。结果 15批月季花标准汤剂出膏率范围为16.32%~23.22%,金丝桃苷的转移率为27.57%~45.42%,异槲皮苷的转移率为34.38%~49.71%;11个共有特征峰被标定,其中4个色谱峰被指认,与对照图谱相比较,其相似度均>0.90。结论 建立了简便、稳定、可行的月季花饮片标准汤剂的制备和质量评价方法,可为月季花饮片标准汤剂的制备和质量控制提供参考。

关键词: 月季花饮片, 标准汤剂, 金丝桃苷, 异槲皮苷, 制备工艺, 质量标准, 出膏率, 转移率, 特征图谱

Abstract: Objective To establish a quality evaluation method for the standard decoctions of Rosa chinensis Jacq. so as to provide reference for the use and quality control of the standard decoction of Rosa chinensis Jacq..Methods Fifteen batches of prepared slices of Rosa chinensis Jacq. were collected from different areas of production to prepare standard decoctions. Hypericin and isoquercitrin were selected as indicators of quantitative detection to calculate the transfer rate while HPLC characteristic chromatograms were established and analyzed with the Similarity Evaluation System for Chromatographic Finger-print of Traditional Chinese Medicine (2012). Results Among the standard decoctions made from 15 batches of Rosa chinensis Jacq. samples, the extraction rate of the standard decoction of samples was 16.32%-23.22%. The transfer rates of hypericin and isoquercitrin ranged from 27.57% to 45.42% and from 34.38% to 49.71% respectively. Eleven common peaks were determined with four characteristic peaks identified．Moreover, the similarity was over 0.90. Conclusion A simple, stable and feasible method for the preparation and quality evaluation of standard decoctions of the Rosa chinensis Jacq. is established, which can provide reference for related research.

Key words: Rosa chinensis Jacq. pieces, standard decoction, hypericin, isoquercitrin, preparation process, quality standard, extraction rate, transfer rate, characteristic chromatogram

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