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医疗机构制剂芪风通窍合剂的系统质量提升研究

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目的 建立定性鉴别和含量测定方法,为芪风通窍合剂质量标准提升提供参考依据。方法 采用薄层色谱法对处方中黄芪、辛夷和广藿香进行定性鉴别;以黄芪甲苷为对照品,通过高效液相色谱法对处方中的主要药味黄芪进行含量测定。结果 在采用的薄层色谱条件下,黄芪、辛夷和广藿香色谱斑点清楚,分离效果好,无干扰;在高效液相色谱含量测定中,黄芪甲苷线性方程为Y=1。411 8X+4。832 6,相关系数R2 = 0。998 4,表明黄芪甲苷在 0。39~3。90 μg的进样量范围内具有良好的线性关系,该方法平均回收率为 99。78%,RSD值为1。02%(n=9)。结论 建立的定性鉴别和含量测定方法比较简便、准确、灵敏、重现性好,可用于芪风通窍合剂质量控制。
Study on the systematic quality improvement of Qifeng Tongqiao Mixture in medical institutions
Objective To establish qualitative identification and content determination methods,and provide reference basis for improving the quality standards of Qifeng Tongqiao Mixture.Methods Thin layer chromatography was used to qualitatively identify Astragalus mongholicus,Flos magnoliae,and Pogostemon in the prescription;Using Astragaloside Ⅳ as the reference content,the content of the main medicinal flavor of Astragalus mongholicus in the prescription was determined by high-performance liquid chromatography.Results Under the thin layer chromatography conditions used,the chromatographic spots of Astragalus mongholicus,Flos magnoliae,and Pogostemon were clear,the separation effect was good,and there was no interference;In the HPLC content determination,the linear equation of Astragaloside Ⅳ is y=1.411 8x+4.832 6,and the correlation coefficient R2=0.998 4,indicating that Astragaloside Ⅳ has a good linear in the injection volume relationship in the range of 0.39~3.90 μg.The average recovery rate of this method is 99.78%,and the RSD value is 1.02%(n=9).Conclusion The established qualitative identification and content determination methods are relatively simple,accurate,sensitive,and reproducible,and can be used for the quality control of Qifeng Tongqiao Mixture.

Qifeng Tongqiao MixtureTLC identificationHigh performance liquid chromatography

陈小锐、余静怡、胡艳华、陈海明、李程瑶

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清远市食品药品检验所,广东清远 511517

清远市中医院,广东清远 511517

芪风通窍合剂 薄层鉴别 高效液相色谱法

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(1)
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