吴茱萸凝胶贴膏的质量标准研究

Study on Quality Standard of Wuzhuyu Gel Paste(吴茱萸凝胶贴膏)

冯金鹰 ¹卢立欣 ¹纪康康 ¹冉令超¹

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作者信息

1. 山东省立第三医院,山东济南 250031
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摘要

目的:建立吴茱萸凝胶贴膏的质量标准.方法:采用薄层色谱(TLC)法对吴茱萸凝胶贴膏中的吴茱萸进行定性鉴别;采用高效液相色谱(HPLC)法测定吴茱萸凝胶贴膏中吴茱萸碱和吴茱萸次碱的含量.色谱柱为Inertsil ODS-3色谱柱,流动相为乙腈-水(53∶47),流速为1 mL/min,柱温为28℃,检测波长为215 nm.对吴茱萸凝胶贴膏进行含膏量、赋形性、黏附性检查.结果:TLC定性鉴别中检出吴茱萸,且斑点清晰,分离度好,阴性对照无干扰.吴茱萸碱和吴茱萸次碱的进样量线性范围分别为0.156 8～0.940 8 μg(r=0.999 5)、0.103 2～0.619 2 μg(r=0.999 1);精密度、稳定性、重复性试验的RSD值均小于3.0％;平均加样回收率分别为100.20％、100.85％,RSD值分别为2.05％、2.16％(n=6).制剂通则检查符合要求.结论:所建质量标准方法准确、可靠,可用于吴茱萸凝胶贴膏的质量控制.

Abstract

Objective:To establish quality standards for Wuzhuyu Gel paste.Methods:TLC was adopted to identify Wuzhuyu(Evodia rutaecarpa)in Wuzhuyu Gel Paste.HPLC was used to determine evodiamine and rutecarpine in Wuzhuyu Gel paste.The chromatographic column was Inertsil ODS-3.The mobile phase,acetonitrile-H20(53∶47)was used at a rate of 1 mUmin.The column temperature was 28 ℃ and the detection wavelength was set at 215 nm.The paste content,formedness,adhesiveness in Wuzhuyu Gel paste was examined.Results:Wuzhuyu(Evodia rutaecarpa)was identified by TLC,and the TLC spots were clear and negative without interference.There was a good linear relationship for evodiamine and rutecarpinein the range of 0.156 8-0.940 8 μg(r=0.999 5)and 0.103 2-0.619 2 μg(r=0.999 1).RSD of precision,stability and repeatability test was less than 3.0％.The average recoveries were respectively 100.20％and 100.85％with the RSD of 2.05％and 2.16％(n=6).General inspection of preparations meet the requirements.Conclusion:The established qualitative and quantitative analysis method is applicable quality control of Wuzhuyu Gel paste.

关键词

吴茱萸凝胶贴膏/薄层色谱法/高效液相色谱法/含量测定/质量标准

Key words

Wuzhuyu Gel paste/TLC/HPLC/content determination/quality standard

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基金项目

山东省中医药科技发展计划项目(2019-0330)

出版年

2024

中医药导报

湖南省中医药学会湖南省中医管理局

中医药导报

CSTPCD

影响因子：0.952

ISSN：1672-951X

参考文献量16

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