广西中医药大学学报2024,Vol.27Issue(1) :58-61,69.

益肾结透合剂质量标准研究

Study on Quality Standard of Yishen Jietou Mixture

任龙艳 杨亮 梁会 曾真 蒋玲 王霞
广西中医药大学学报2024,Vol.27Issue(1) :58-61,69.

益肾结透合剂质量标准研究

Study on Quality Standard of Yishen Jietou Mixture

任龙艳 1杨亮 2梁会 2曾真 2蒋玲 2王霞2
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作者信息

  • 1. 贵州中医药大学,贵州 贵阳 550025
  • 2. 贵州中医药大学第二附属医院,贵州 贵阳 550000
  • 折叠

摘要

[目的]建立益肾结透合剂的质量标准.[方法]采用薄层色谱法对益肾结透合剂中白茅根、生大黄和荷叶进行定性鉴别;采用高效液相色谱法测定制剂中绿原酸的含量,色谱柱为Welch Ultimate PolarRP C18柱(4.6 mm×250 mm,5 μm),流动相为乙腈-0.05%磷酸水溶液(95:5),检测波长为326 nm,柱温为30℃,流速为0.8 ml/min,进样量为10 μl.[结果]白茅根、荷叶、生大黄的薄层色谱图斑点清晰,且与阴性对照相互无干扰;绿原酸的进样量在0.3~2.0 μg之间线性关系良好,回归方程为Y=65 304X+62 016(r=0.999 8);且重复性试验、精密度试验、稳定性试验的相对标准偏差(RSD)均≤3%;平均加样回收率为100.73%,RSD为1.75%(n=6);绿原酸平均含量为3.86 mg/ml.[结论]本研究建立的定性、定量方法重复性好,专属性强,结果准确,可用于益肾结透合剂的质量控制.

Abstract

[Objective]To establish the quality standard of Yishen Jietou mixture.[Methods]Thin layer chromatog-raphy(TLC)was used for qualitative identification of Rhizoma Imperatae,Rhei Radix et Rhizoma and Nelumbinis Foli-um in Yishen Jietou mixture.The content of chlorogenic acid in the preparation was determined by high performance liq-uid chromatography.The chromatographic column was Welch Ultimate PolarRP C18 column(4.6 mm×250 mm,5μm),the mobile phase was acetonitrile-0.05%phosphoric acid aqueous solution(95:5),the detection wavelength was 326 nm,the column temperature was 30℃,the flow rate was 0.8 ml/min,and the injection volume was 10 μl.[Results]The TLC spots of Rhizoma Imperatae,Rhei Radix et Rhizoma and Nelumbinis Folium were clear,and there was no interfer-ence with the negative control.The linear range of chlorogenic acid was 0.3~2.0μg,and the regression equation was Y = 65 304X+62 016(r=0.999 8).The RSD of repeatability test,precision test and stability test were all less than 3%.The average recovery was 100.73%and RSD was 1.75%(n=6).The average content of chlorogenic acid was 3.86 mg/ml.[Conclusion]The qualitative and quantitative methods applied in this study have good repeatability,strong specificity and accurate results,which can be used for the quality control of Yishen Jietoumixture.

关键词

益肾结透合剂/绿原酸/薄层色谱法/高效液相色谱法/质量标准

Key words

Yishen Jietou mixture/chlorogenic acid/thin layer chromatography/high performance liquid chroma-tography/quality standard

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基金项目

贵阳市科技计划项目(筑科合同[2019]-9-4-17号)

全国中药特色技术传承人才培训项目(国中医药人教函[2023]96号)

贵州省第三批中医名医传承工作项目(黔中医药函[2021]106号)

出版年

2024
广西中医药大学学报
广西中医药大学

广西中医药大学学报

影响因子:0.558
ISSN:2095-4441
参考文献量11
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