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益肾结透合剂质量标准研究

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[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。
Study on Quality Standard of Yishen Jietou Mixture
[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.

Yishen Jietou mixturechlorogenic acidthin layer chromatographyhigh performance liquid chroma-tographyquality standard

任龙艳、杨亮、梁会、曾真、蒋玲、王霞

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贵州中医药大学,贵州 贵阳 550025

贵州中医药大学第二附属医院,贵州 贵阳 550000

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

贵阳市科技计划项目全国中药特色技术传承人才培训项目贵州省第三批中医名医传承工作项目

筑科合同[2019]-9-4-17号国中医药人教函[2023]96号黔中医药函[2021]106号

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
年,卷(期)：2024.27(1)
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