湖北农业科学 ›› 2021, Vol. 60 ›› Issue (3): 129-133.doi: 10.14088/j.cnki.issn0439-8114.2021.03.025

• 检测分析 • 上一篇    下一篇

一种瑶浴散剂质量标准的试验研究

李金洲1, 陈子隽1, 刘玟君2, 卢惠敏1, 林玉港1, 魏江存3, 陈勇2   

  1. 1.广西中医药大学药学院,南宁 530022;
    2.广西中医药大学科学实验中心,南宁 530022;
    3.广西国际壮医医院壮瑶药研发中心,南宁 530022
  • 收稿日期:2020-05-27 发布日期:2021-02-25
  • 通讯作者: 陈 勇(1961-),男,教授,主要从事药物分析、中药及其制剂质量分析,(电子信箱)cy6381@163.com。
  • 作者简介:李金洲(1995-),男,湖南临澧人,在读硕士研究生,研究方向为药物分析,(电话)15578306053(电子信箱)981530708@qq.com
  • 基金资助:
    国家自然科学基金资助项目(81660701); 广西壮族自治区食品药品监督管理局瑶药材质量评价与标准研究项目(YTT17003); 广西研究生教育创新计划资助项目(YCSY2018006); 广西中药药效研究重点实验室系统性研究课题(17-259-20-A5); 广西壮族自治区食品药品监督管理局课题(YTT16003)

Experimental study on quality control of Yaobath powder

LI Jin-zhou1, CHEN Zi-jun1, LIU Wen-jun2, LU Hui-min1, LIN Yu-gang1, WEI Jiang-cun3, CHEN Yong2   

  1. 1. College of Medicine of Guangxi University of Traditional Chinese Medicine,Nanning 530022,China;
    2. Scientific Experiment Center of Guangxi University of Traditional Chinese Medicine,Nanning 530022,China;
    3. Zhuang Yao Medicine Research and Development Center of Guangxi International Zhuang Medical Hospital,Nanning 530022,China
  • Received:2020-05-27 Published:2021-02-25

摘要: 对瑶浴散剂的水分、灰分、酸不溶性灰分及水溶性浸出物按2015版《中华人民共和国药典》(四部)通则中的方法进行测定;观察瑶浴散剂粉末显微鉴别特征,并对其进行薄层鉴别检查;采用HPLC法测定瑶浴散剂中β-细辛醚的含量。结果表明,瑶浴散剂中的水分含量不得超过9.00%;灰分含量不得大于10.00%,酸不溶性灰分含量不得大于1.30%;水溶性浸出物含量不得低于19.00%;瑶浴散剂中合欢皮、鸡血藤及石菖蒲药材的显微特征明显;TLC鉴别中斑点清晰,阴性无干扰;瑶浴散剂中β-细辛醚的含量在0.71%~0.85%,RSD为2.48%,各批次含量大致相同。所建立瑶浴散剂质量控制方法重复性好,专属性强,可对瑶浴散剂质量进行控制。

关键词: 瑶浴散剂, 质量标准, β-细辛醚;

Abstract: The content of moisture、ash、acid insoluble ash and water-soluble extract of Yaobath powder were determined according to the general principles of “Chinese Pharmacopoeia” (Volume IV),2015; The microscopic identification characteristics of Yaobath powder was observed, and TLC characteristics was identified. The content of β-asarone in Yaobath powder was determinated by HPLC. It was suggested that the water content in Yaobath powder should not exceed 9.00%, ash content should not exceed 10.00%, acid insoluble ash content should not exceed 1.30%, and water-soluble extract content should not be less than 19.00%. The microscopic characteristics of Albizia julibrissin Durazz、Spatholobus suberectus Dunn and Acorus tatarinowii Schott were obvious. The TLC spots were clear and negative without interference. The content of β-asarone in Yaobath powder range from 0.71% to 0.85%, RSD was 2.48%. The content of β-Asaron in Yaobath powder of different batches was basically stable. The established quality control method had good repeatability and specificity, and can be used for the quality control of Yaobath powder.

Key words: Yaobath powder, quality standard, β-asarone;

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