一测多评法同时测定无敌丹胶囊中7种成分的含量*
作者：李晴红1，王 娟2，张晓平3，计 飞1，杨兴波1，张文平1
单位：1.云南中医药大学中药学院，云南 昆明 650500； 2.云南无敌制药有限责任公司技术中心，云南 昆明 650216； 3.山东中医药大学药学院，山东 青岛 250355
引用：引用：李晴红，王娟，张晓平，计飞，杨兴波，张文平.一测多评法同时测定无敌丹胶囊中7种成分的含量[J].中医药导报,2025,31(4):83-88.
DOI：10.13862/j.cn43-1446/r.2025.04.014
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摘要：目的：建立一测多评法同时测定无敌丹胶囊中松脂醇二葡萄糖苷、毛蕊异黄酮葡萄糖苷、三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、川续断皂苷Ⅵ及补骨脂素的含量。方法：采用WondaSil C18 Superb色谱柱（250.0 mm×4.6 mm，5.0 μm )，以乙腈-0.05%磷酸水为流动相，梯度洗脱；流速为1.0 mL/min；柱温为30 ℃；检测波长为203 nm。以毛蕊异黄酮葡萄糖苷为内参物，计算其他6种成分的相对校正因子，测定其含量。结果：7种成分在各自范围内呈现良好的线性关系（r≥0.999 1），平均加样回收率为98.84%～101.33%（RSD＜3%），一测多评法与外标法的含量测定结果无明显的差异（RSD＜2%）。结论：建立的方法准确可靠，可用于同时测定无敌丹胶囊中松脂醇二葡萄糖苷、毛蕊异黄酮葡萄糖苷、三七皂苷R1、人参皂苷Rg1、川续断皂苷Ⅵ、人参皂苷Rb1及补骨脂素的含量。
关键词：无敌丹胶囊；一测多评法；毛蕊异黄酮葡萄糖苷；质量控制；含量测定
Abstract：
Objective: To establish a quantitative analysis method of multi-components by single marker (QAMS) for simultaneous determination of pinoresinol diglucoside, calycosin glucoside, notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1, asperosaponin Ⅵ, and psoralen in Wudidan capsules. Methods: Using octadecylsilane bonded silica gel as a filler, use a WondaSil C18 Superb chromatography column (250.0 mm×4.6 mm, 5 μm), using acetonitrile-0.05% phosphoric acid water as the mobile phase, gradient elution; volume flow rate of 1.0 mL/min; column temperature of 30 ℃; detection wavelength of 203 nm. Calculate the relative correction factors of the other six components using the flavonoid glucoside from Fructus Mori as the internal standard, and determine their content. Results: The seven components showed good linear relationships within their respective ranges (r≥0.9991), with an average recovery rate of 98.84% to 101.33% (RSD<3%). There was no significant difference in the content determination results between the one test multiple evaluation method and the external standard method (RSD<2%). Conclusion: The established method was accurate and reliable and could be applied for the simultaneous determination of pinoresinol diglucoside, calycosin glucoside, notoginsenoside R1, ginsenoside Rg1, asperosaponin Ⅵ, ginsenoside Rb1, and psoralen in Wudidan capsules.
Key words：Wudidan capsules; QAMS; calycosin glucoside; quality control; content determination
发布时间：2025-12-20
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