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    基于多组分分析的复方斑蝥胶囊的质量标准研究

    Study on Quality Standard of Compound Banmao Capsules Based on Multicomponent Analysis

      摘要
    • 摘要:
      目的 提升并完善复方斑蝥胶囊的质量控制方法。
      方法 采用薄层色谱法对人参中人参皂苷Rb1、人参皂苷Re、人参皂苷Rg1、黄芪中黄芪甲苷，刺五加和异嗪皮啶进行定性鉴别；GC对斑蝥素进行限量检查；HPLC同时测定特女贞苷、莫诺苷、马钱苷、野黄芩苷、野黄芩素的含量，采用Cosmosil C18色谱柱(4.6 mm×250 mm，5 μm)，以乙腈-0.3%磷酸溶液为流动相梯度洗脱，流速1.0 mL·min–1，柱温40 ℃，检测波长224、240、335 nm。
      结果 显微特征易于查见；薄层色谱斑点清晰，重现性好；特女贞苷、莫诺苷、马钱苷、野黄芩苷、野黄芩素进样量分别在0.001896~0.5309 μg、0.01998~0.5594 μg、 0.02028~0.5677 μg、0.01946~0.5447 μg、0.008935~0.2502 μg呈良好的线性关系，平均回收率分别为103.87%、97.21%、96.32%、97.52%、98.18%。
      结论 该研究建立的方法稳定可靠，专属性强，简便高效，更全面地控制该制剂的整体质量，为综合评价复方斑蝥胶囊的质量提供了参考。

       

      Abstract:
      OBJECTIVE  To optimize and improve the quality standard of Compound Banmao Capsules.
      METHODS Ginsenoside Rb1, ginsenoside Re, ginsenoside Rg1, astragaloside Ⅳ, acanthopanax senticosus and isofraxidin were identified by thin-layer chromatography(TLC). Limit inspection of cantharidin was detected by GC. Ligustrin, Monoside, Loganin, Scutellarin and Scutellarein were determined simultaneous by HPLC. Cosmosil C18(4.6× 250, 5 μm) column was used with acetonitrile-0.3% phosphoric acid solution as mobile phase in gradient elution at a flow rate of 1.0 mL·min–1, and the detection wavelength were 224 nm, 240 nm, 335 nm, the column temperature was 40 ℃.
      RESULTS Microscopic feature was finded easily. The spots in the TLC were clear with good reproducibility. The linear ranges of ligustrin, monoside, loganin, scutellarin and scutellarein were 0.001896−0.5309 μg, 0.01998−0.5594 μg, 0.02028−0.5677 μg, 0.01946−0.5447 μg and 0.008935−0.2502 μg. The average recoveries were 103.87%, 97.21%, 96.32%, 97.52%, 98.18%.
      CONCLUSION The method developed is simple, stable, repeatable, which can be used for the quality of Compound Banmao Capsules more effective and comprehensively.

       

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