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一测多评法同时测定肾康宁胶囊中5种酚酸

Simultaneous determination of five phenolic acids in Shenkangning Capsules by QAMS

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【作者】 刘世欣陈良妮王晗雪程雪梅季莉莉李小锋刘胜康兴东尉小慧王长虹

【Author】 LIU Shi-xin;CHEN Liang-ni;WANG Han-xue;CHENG Xue-mei;JI Li-li;LI Xiao-feng;LIU Sheng;KANG Xing-dong;WEI Xiao-hui;WANG Chang-hong;Institute of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine;Shanghai Municipal Key Laboratory for Compound Chinese Medicines;Ministry of Education Key Laboratory for Standardization of Chinese Medicines;Jiangxi Puzheng Pharmaceutical Co., Ltd.;

【通讯作者】 尉小慧;王长虹;

【机构】 上海中医药大学中药研究所上海市复方中药重点实验室中药标准化教育部重点实验室江西普正制药股份有限公司

【摘要】 目的 建立一测多评法同时测定肾康宁胶囊中丹参素、迷迭香酸、原儿茶醛、紫草酸、丹酚酸B的含量。方法 该药物50%甲醇提取液的分析采用DIKMA Diamonsil Plus C18-A色谱柱(250 mm×4.6 mm, 5μm);流动相甲醇-乙腈-0.1%磷酸,梯度洗脱;体积流量1.0 mL/min;柱温30℃;检测波长230 nm。以迷迭香酸为内标,计算其他4种酚酸的相对校正因子,测定其含量。结果 5种酚酸在各自范围内线性关系良好(r≥0.999 5),平均加样回收率98.29%~102.9%,RSD 0.11%~1.99%,一测多评法所得结果与外标法一致。结论 该方法简便稳定,重复性好,可用于肾康宁胶囊的质量控制。

【Abstract】 AIM To establish a quantitative analysis of multi-components by single-marker(QAMS) method for the simultaneous content determination of danshensu, rosmarinic acid, protocatechuic aldehyde, lithospermic acid and salvianolic acid B in Shenkangning Capsules. METHODS The analysis of 50% methanol extract of this drug was performed on a 30 ℃ thermostatic DIKMA Diamonsil Plus C18-A column(4.6 mm×250 mm, 5 μm), with the mobile phase comprising of methanol-acetonitrile-0.1% phosphoric acid flowing at 1.0 mL/min in a gradient elution manner, and the detection wavelength was set at 230 nm. Rosmarinic acid was used as an internal standard to calculate the relative correction factors of the other four phenolic acids, after which the content determination was made.RESULTS Five phenolic acids showed good linear relationships within their own ranges(r≥0.999 5), whose average recoveries were 98.29%-102.9% with the RSDs of 0.11%-1.99%. The result obtained by QAMS approximated those obtained by external standard method.CONCLUSION This simple, stable and reproducible method can be used for the quality control of Shenkangning Capsules.

【基金】 国家重点研发计划资助(2018YFC1707302,2018YFC1707303)
  • 【文献出处】 中成药 ,Chinese Traditional Patent Medicine , 编辑部邮箱 ,2023年07期
  • 【分类号】R286.0
  • 【下载频次】74
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