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 base on multicomponent analysis

关键词:  复方斑蝥胶囊  薄层色谱  气相色谱  高效液相色谱  多组分分析  质量标准

Key words:  KEY WORDS: compound banmao capsules, TLC,GC,HPLC, multicomponent analysis, quality standard

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 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，刺五加和异嗪皮定进行定性鉴别；GC法对斑蝥素进行限量检查；HPLC法同时测定特女贞苷、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 nm、240 nm、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内呈良好的线性关系，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:

ABSTRACT:OBJECTIVE To optimize and improve the quality standard of Compound Banmao Capsules.METHODS Ginsenoside Rb1, Genoside Rg1 and Astragaloside -Ⅳ, Acanthopanax senticosus Harms andinsenoside Re, Gins Isoxamidine were identified by thin-layer chromatography(TLC).Limit inspection of Cantharidin by GC. Ligustrin, Monoside, Loganin , Scutellarin and Scutellarein were determined simultaneous by HPLC. COSMOSIL C18 (4.6 mm × 250 mm, 5 μ m) 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 ℃ and the injection volume was 10 μL.RESULTS Microscopic feature was finded easily.The spots in the thin-layer chromatography were clear with good reproducibility and the negative control had no interference.The linear ranges of Ligustrin, Monoside, Loganin, and 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.