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 C_(18)色谱柱(4.6 mm×250 mm,5μm),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0.001896~0.5309μg、0.01998~0.5594μg、0.02028~0.5677μg、0.01946~0.5447μg、0.008935~0.2502μg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,能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。
OBJECTIVE To optimize and improve the quality standard of compound Banmao capsules.METHODS Ginsenoside Rb1,ginsenoside Re,ginsenoside Rg1 in Ginseng Radix et Rhizoma,astragalosideⅣin Astragali Radix,Acanthopanacis Senticosi Radix et Rhizoma Seu Caulis 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 C_(18)(4.6 mm×250 mm,5μm)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 224,240,335 nm,the column temperature was 40℃.RESULTS Microscopic feature was found easily.The spots in the TLC were clear with good reproducibility.The linear ranges of ligustrin,monoside,loganin,scutellarin and scutellarein were 0.001896−0.5309μg,0.01998−0.5594μg,0.02028−0.5677μg,0.01946−0.5447μg and 0.008935−0.2502μg.The average recoveries were 103.87%,97.21%,96.32%,97.52%,98.18%.CONCLUSION The established method is stable reliable,highly specific,simple,efficient,and more comprehensive control of the overall quality of compound Banmao capsules,which provides reference for its quality evaluation.
作者
陈思妮
李铮
王萌萌
马千
傅欣彤
王京辉
CHEN Sini;LI Zheng;WANG Mengmeng;MA Qian;FU Xintong;WANG Jinghui(Beijing Institute for Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)
出处
《中国现代应用药学》
北大核心
2025年第14期2425-2430,共6页
Chinese Journal of Modern Applied Pharmacy
基金
2021年国家药品标准提高项目(2021Z046)。
