| 昆仙胶囊的质量标准提升研究 |
| 投稿时间：2021-06-18 修订日期：2021-10-19 点此下载全文 |
| 引用本文：许春芳,李泽璇,邹洛颖,张倪,杨宏,陶霞.昆仙胶囊的质量标准提升研究[J].药学实践杂志,2022,40(2):152~156 |
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| 基金项目:国家重点研发项目（2018YFC1707300） |
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| 中文摘要:目的 提升昆仙胶囊质量标准，以有效地控制产品质量。方法 以雷公藤甲素、淫羊藿苷、金丝桃苷为指标性成分，增加或改进昆明山海棠、淫羊藿及菟丝子的薄层鉴别方法；以Agilent ZORBA SB-C18（4.6 mm×250 mm, 5 μm）为色谱柱，以乙腈-0.1%甲酸水溶液为流动相，以220 nm为检测波长，改良雷公藤甲素的HPLC含量测定方法。结果 昆明山海棠、淫羊藿及菟丝子的TCL法鉴别专属性强，特征斑点分离度良好、清晰，阴性无干扰；定量分析结果显示雷公藤甲素的质量浓度在40.16～502.00 μg/ml范围内与峰面积呈良好线性关系（r=0.999 5），平均加样回收率为98.12%，RSD为8.25%，准确度良好。结论 本实验所建立的TLC鉴别方法和HPLC含量测定方法专属性强、重现性好，能有效地控制昆仙胶囊的质量。 |
| 中文关键词:昆仙胶囊 薄层色谱法 雷公藤甲素 高效液相色谱法 质量标准 |
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| Improvement of the quality standard for Kunxian capsules |
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| Abstract:Objective To improve the quality standards of Kunxian capsules (KC) and effectively control the product quality. Methods Triptolide, icariin and hypericin were used as the indicator components, to increase or improve the thin layer chromatography (TLC) identification methods of Kunming begonia, epimedium and dodder. Agilent ZORBA SB-C18 (4.6 mm×250 mm, 5 μm) as a chromatographic column, the HPLC method for the determination of triptolide was improved with acetonitrile-0.1% formic acid solution as the mobile phase and 220 nm as the detection wavelength. Results The spots in the TLC method of Kunming begonia, epimedium and dodder has strong specificity, good and clear separation of characteristic spots, negative and no interference. The quantitative analysis of the content of triptolide in KC showed that there is a good linear relationship (r=0.9995) between the mass concentration of triptolide and the peak area in the range of 40.16-502.00 μg/ml, the average recovery was 98.12%, RSD was 8.25%, and the accuracy was good. Conclusion The TLC identification method and HPLC method established in this experiment have strong specificity and good reproducibility, and can effectively control the quality of KC. |
| keywords:Kunxian capsules TLC triptolide HPLC quality standards |
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