广东化工2024,Vol.51Issue(17) :164-166,160.DOI:10.3969/j.issn.1007-1865.2024.017.055

痛风金黄凝胶贴膏的质量标准研究

Study on Quality Standard of Tongfeng Jinhuang Gel Plaster

卢勇 章斌 杨亚 赵松梅 李飞
广东化工2024,Vol.51Issue(17) :164-166,160.DOI:10.3969/j.issn.1007-1865.2024.017.055

痛风金黄凝胶贴膏的质量标准研究

Study on Quality Standard of Tongfeng Jinhuang Gel Plaster

卢勇 1章斌 2杨亚 1赵松梅 1李飞2
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作者信息

  • 1. 雅安市中医医院,四川 雅安 625000
  • 2. 雅安职业技术学院,四川 雅安 625000;雅安市食品药品应用开发工程技术研究中心,四川 雅安 625000
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摘要

目的:建立痛风金黄凝胶贴膏的薄层鉴别及含量测定方法,并进行制剂检查.方法:采用薄层色谱法(TLC)建立制剂中冰片、黄柏、大黄的鉴别方法;采用高效液相色谱法(HPLC)建立制剂中盐酸小檗碱的含量测定方法;进行含膏量、赋形性、黏附力和微生物限度检查.结果:薄层色谱鉴别斑点清晰、阴性无干扰、分离度好.盐酸小檗碱质量浓度在7.1469 μg/mL~71.4688 μg/mL范围内与其峰面积线性关系良好(r2=0.9994),平均加样回收率98.49%(RSD 1.46%).含膏量、赋形性、黏附力和微生物限度检查均符合规定.结论:所建立的方法简便可行、准确度高,可用于痛风金黄凝胶贴膏的质量控制.

Abstract

Objective:To establish the methods of thin layer identification and content determination for tongfeng Jinhuang gel plaster.Method:The thin layer chromatography method(TLC)was applied to identify Borneolum Syntheticum,Phellodendri Chinensis Cortex and Rhei Radix et Rhizoma qualitatively.High performance liquid chromatography(HPLC)was used for the content determination of berberine hydrochloride.The plaster-content,formability,adhesion and microbiological limit were also examined.Result:The TLC spots were clear,well separated and good reproducibility.The mass concentration of berberine hydrochloride had a good linear relationship in the range of 7.1469 μg/mL~71.4688 μg/mL(r2=0.9994),and the average recovery rate was 98.49%(RSD 1.46%).The results of the plaster-content,formability,adhesion and microbiological limit inspections were all in compliance with the regulations.Conclusion:This method can be used for the quality control of tongfeng Jinhuang gel plaster.

关键词

痛风金黄散/凝胶贴膏/盐酸小檗碱/TLC/HPLC

Key words

tongfeng jinhuang powder/gel plaster/berberine hydrochloride/TLC/HPLC

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出版年

2024
广东化工
广东省石油化工研究院

广东化工

影响因子:0.288
ISSN:1007-1865
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