中国当代医药2024,Vol.31Issue(15) :18-23.

天癸苁盈颗粒质量标准研究

Research on quality standard of Tiangui Congying Granules

王珊珊 张哲 夏忠庭 张敏 胡开永 刘军 李艳英 黄能听
中国当代医药2024,Vol.31Issue(15) :18-23.

天癸苁盈颗粒质量标准研究

Research on quality standard of Tiangui Congying Granules

王珊珊 1张哲 1夏忠庭 1张敏 2胡开永 2刘军 3李艳英 3黄能听3
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作者信息

  • 1. 盈科瑞(天津)创新医药研究有限公司,天津 300382
  • 2. 上海鼎辉医药有限公司,上海 201400
  • 3. 北京盈科瑞创新医药股份有限公司,北京 102200
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摘要

目的 建立天癸苁盈颗粒的质量标准.方法 采用薄层色谱(TLC)对天癸苁盈颗粒中肉苁蓉、百合、刘寄奴和女贞子进行定性鉴别;应用高效液相色谱-二极管阵列检测器(HPLC-DAD)双波长法,同时测定松果菊苷、特女贞苷的含量;检测波长为 330 nm(松果菊苷)、224 nm(特女贞苷),柱温 35℃;进样量:10 μl.结果 TLC鉴别图谱中斑点清晰,分离度良好且阴性色谱无干扰;松果菊苷在 0.104 0~2.600 0 μg之间进样量与峰面积线性关系良好(r=0.999 9),特女贞苷在 0.122 6~3.065 0 μg之间进样量与峰面积线性关系良好(r=1.000 0),平均加样回收率分别为 97.52%,104.44%,RSD均小于 3.0%.结论 所建立的质量标准方法专属性强,稳定性好,准确度高且耐用性良好,可用于天癸苁盈颗粒的质量控制.

Abstract

Objective To establish the quality standard of Tiangui Congying Granules.Methods Cistanche deserticola,lily,artemisia anomala and fruit of glossy privet in Tiangui Congying Granules were identified by thin layer chromatography(TLC).High performance liquid chromatography-diode-array detector(HPLC-DAD)was used to simultaneously determine the contents of echinacin and ligustrin.Acetonitrile-0.1%phosphoric acid as mobile phase for gradient elution,and the detection wavelength were 330 nm(echinacea)and 224 nm(ligustrin)respectively.And the column temperature was 35℃.Injection volume was 10 μl.Results The spots in TLC identification chromatogram were clear,the resolution was good,and the negative chromatogram had no interference.The linear relationship between the injection volume and the peak area of echinacin was good between 0.104 0 μg and 2.600 μg(r=0.999 9).The linear relationship between the injection volume and the peak area of ligustroside was good between 0.122 6 μg and 3.065 0 μg(r=1.000 0).Echinacin and ligustrin of the aver-age sample recovery were 97.52%and 104.44%respectively,the RSD were less than 3.0%.Conclusion The established quality standard method has strong specificity,good stability,high accuracy and good durability,and it is used for the quality control of Tiangui Congying Granules.

关键词

天癸苁盈颗粒/特女贞苷/松果菊苷/薄层色谱/高效液相色谱法

Key words

Tiangui Congying Granules/Echinacea/Ligustrin/Thin layer chromatography/High performance liquid chro-matography

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出版年

2024
中国当代医药
中国保健协会 当代创新(北京)医药科学研究院

中国当代医药

影响因子:1.215
ISSN:1674-4721
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