标准研讨

绞股蓝皂苷A的结构确证和相关质量标准的修订建议

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  • 1.中国食品药品检定研究院, 北京 100050;
    2.军事医学研究院辐射医学研究所, 北京 100071
第一作者 Tel:(010)67095150;E-mail:huxiaoru@nifdc.org.cn
*戴 忠 Tel:(010)67095268;E-mail:daizhong@nifdc.org.cn
马双成 Tel:(010)53852072;E-mail:msc@nifdc.org.cn

收稿日期: 2021-12-04

  网络出版日期: 2024-06-26

Research on structure of gypenoside A and suggestions on revision of relevant quality standards

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  • 1. National Institutes for Food and Drug Control, Beijing 100050, China;
    2. Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing 100071, China

Received date: 2021-12-04

  Online published: 2024-06-26

摘要

为了对绞股蓝皂苷A结构进行确证,对绞股蓝总甙、绞股蓝总甙片等质量标准、档案及相关文献进行了查阅和研究,结果发现绞股蓝总甙片和绞股蓝总甙(苷)胶囊质量标准中使用的绞股蓝皂苷A对照品的结构存在差异。经过调研,发现使用绞股蓝皂苷A名称的化合物存在4种可能的结构(长梗绞股蓝皂苷A、绞股蓝皂苷ⅩⅥ、绞股蓝皂苷XLⅢ和(23S)-19-羰基-21,23-环氧-3β,20,21-三羟基达玛-24-烯-3-O-[α-L-吡喃鼠李糖基-(1→2)][β-D-吡喃木糖基(1→3)]-α-L-吡喃阿拉伯糖苷)。结合绞股蓝及其制剂的研究现状,认为绞股蓝皂苷A的结构应为(23S)-19-羰基-21,23-环氧-3β,20,21-三羟基达玛-24-烯-3-O-[α-L-吡喃鼠李糖基-(1→2)][β-D-吡喃木糖基(1→3)]-α-L-吡喃阿拉伯糖苷,CAS号为157752-01-7。目前,绞股蓝总甙、绞股蓝总甙片、绞股蓝总甙(苷)胶囊等5个药品标准所涉及的绞股蓝皂苷A对照品实际都不是绞股蓝皂苷A化合物本身,建议对相关的质量标准进行修订。

本文引用格式

胡晓茹, 张洁, 肖萌, 刘晶晶, 马百平, 戴忠, 马双成 . 绞股蓝皂苷A的结构确证和相关质量标准的修订建议[J]. 药物分析杂志, 2022 , 42(4) : 714 -719 . DOI: 10.16155/j.0254-1793.2022.04.20

Abstract

To confirm the structure of gypenoside A, the research on quality standards, archives and relevant literature of Jiaogulan Zongdai, Jiaogulan Zongdai tablets and other preparations were carried on. The results showed that the structure of gypenoside A in Jiaogulan Zongdai tablets and Jiaogulan Zongdai(Gan) capsules was different. There were four possible structures of gypenoside A, which were gylongoside A, gypenoside ⅩⅥ, gypenoside XLⅢ and (23S)-19-carbonyl-21, 23-epoxy-3β,20,21-trihydroxydama-24-en-3-O-[α-L-rhamnopyranosyl-(1→2)][β-D-xylopyranosyl-(1→3)]-α-L-pyranoarabinoside, respectively. Due to the research result, it was confirmed that gypenoside A should be (23S)-19-carbonyl-21,23-epoxy-3β, 20, 21-trihydroxydama-24-en-3-O-[α-L-rhamnopyranosyl(1→2)][β-D-xylopyranosyl(1→3)]-α-L-pyranoarabinoside (CAS No.157752-01-7). At present, the reference substance of gypenoside A involved in five drug standards of Jiaogulan Zongdai, Jiaogulan Zongdai tablets and Jiaogulan Zongdai capsules was actually not gypenoside A. It is suggested to revise the relevant quality standards.

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