| 引用本文:王璐，黄鲁，汪玥，乔立业，苏华.抗敏颗粒质量标准提升研究[J].世界中医药,2020,(16):. |
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| 抗敏颗粒质量标准提升研究 |
| Study on the Improvement of Quality Standard of Kangmin Granules |
| 投稿时间：2019-05-30 |
| DOI：10.3969/j.issn.1673-7202.2020.16.002 |
| 中文关键词: 抗敏颗粒 质量标准 薄层色谱 高效液相色谱 苦参碱 苦参 地肤子 甘草 赤芍 |
| English Keywords:Kangmin Granules Quality standard TLC HPLC Matrine Sophora Flavescens Fructus kochiae scoparuae Radix grycyrrhizae Radix paeoniae rubra |
| 基金项目:全军医疗机构制剂标准提高科研专项课题重点项目（14ZJZ08） |
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| 中文摘要: |
| 目的：提升抗敏颗粒制剂的质量标准。方法：利用薄层色谱法（TLC）对抗敏颗粒中苦参、地肤子、甘草、赤芍4种组分进行定性鉴别，运用高效液相色谱法（HPLC）测定制剂中苦参碱的含量。色谱条件：Agilent NH2色谱柱（4.6 mm×250 mm，5 μm），流动相条件：乙腈-无水乙醇-3%磷酸（80:10:10），利用220 nm波长进行检测，流速1.0 mL/min，柱温25 ℃，进样量为10 μL。结果：建立的苦参、地肤子、甘草、赤芍的TLC鉴别中，成分斑点清晰，分离度好，且阴性对照样品无干扰。苦参碱质量浓度在11.31～180.96 μg/mL范围内，与峰面积线性关系良好，R2=1；平均加样回收率为100.88%，RSD为2.31%（n=9）。结论：该方法准确易行，精密度、稳定、重复性均较好，可用作抗敏颗粒制剂的质量标准。 |
| English Summary: |
| To improve the quality standard of Kangmin Granules.Methods:Sophora flavescens，Fructus Kochiae Scoparuae，Radix Grycyrrhizae and Radix Paeoniae Rubra were identified by thin-layer chromatography(TLC).The content of matrine in the preparation was determined by high performance liquid chromatography(HPLC).Chromatographic conditions:Agilent NH2 column(4.6 mm×250 mm，5 μm)，mobile phase conditions:acetonitrile-anhydrous ethanol-3% phosphoric acid(80:10:10)，detection at 220 nm wavelength，flow rate 1.0 mL/ min，column temperature 25 ℃，injection volume 10 L.Results:In the established TLC identification of Sophora flavescens，Radix Rhizoma，Radix Glycyrrhizae，and Radix Paeoniae Alba，the component spots were clear，the separation was good，and the negative control sample had no interference.The concentration of Sophora flavescens was in the range of 11.31~180.96 μg/mL，which has a good linear relationship with the peak area，R2=1; the average sample recovery rate was 100.88%，and the RSD was 2.31%(n=9).Conclusion:The method is accurate and easy to perform，with good precision，stability and repeatability，and can be used as a quality standard for Kangmin Granules. |
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