| 肾衰宁颗粒指纹图谱研究及3种有效成分含量测定 |
| 投稿时间：2019-11-02 修订日期：2020-03-18 点此下载全文 |
| 引用本文：宋新华,陈旭娇,邓冯沂,高守红,彭辉.肾衰宁颗粒指纹图谱研究及3种有效成分含量测定[J].药学实践杂志,2020,38(3):259~263 |
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| 基金项目:上海市临床药学重点专科建设项目（2016-40044-002）；上海市卫生计生系统重要薄弱学科建设项目（2016ZB0303） |
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| 中文摘要:目的 通过高效液相色谱法建立肾衰宁颗粒的指纹图谱，并测定肾衰宁颗粒中3种有效成分（橙皮苷、丹酚酸B和大黄酚）的含量，为肾衰宁颗粒的质量控制提供依据。方法 采用SunFireTM C18色谱柱，乙腈-0.1%甲酸水溶液为流动相，梯度洗脱，流速1 ml/min，检测波长254 nm，柱温25 ℃，建立肾衰宁颗粒的指纹图谱，并对3种有效成分的含量进行测定。结果 测定10批肾衰宁颗粒的色谱图，确立的标准指纹图谱上有22个共有峰，各批次的指纹图谱与对照图谱之间相似度均不小于0.90，相似度良好。方法学验证结果表明重复性、稳定性、精密度结果均符合要求。结论 本法操作简单、可靠，适用于肾衰宁颗粒指纹图谱的建立及含量测定，为肾衰宁颗粒的质量控制提供依据。 |
| 中文关键词:肾衰宁颗粒 高效液相色谱法 指纹图谱 含量测定 |
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| Research on the fingerprint and three active components assay in Shenshuaining granules by HPLC |
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| Abstract:Objective To establish the fingerprint spectrum and assay three active components (hesperidin, salvianolic acid B and chrysophanol) in Shenshuaining granule by HPLC method.Methods The chromatographic separation was achieved on SunFireTM C18 column with acetonitrile-0.1% formic acid aqueous solution as mobile phase. Gradient elution program was applied with flow rate of 1.0 ml/min, detection wavelength at 254 nm and the column temperature at 25 ℃. The fingerprint spectrum was established and three active components in Shenshuaining granule were assayed.Results There were 22 common peaks on the fingerprints after analyzing chromatograms from 10 batches of Shenshuaining granules. Good fingerprint similarities (≥0.9) between different batches and the control chromatogram were found. This method has great repeatability, stability and precision, which meets all the assay requirements.Conclusion A simple and reliable HPLC method was developed, which is suitable for the fingerprint establishment of Shenshuaining granules. It provides a method for the quality control of Shenshuaining granules. |
| keywords:Shenshuaining granules HPLC fingerprinting content determination |
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