文章摘要
基于红参掺伪检查的大活络丸质量控制
Study on the Quality Control of Dahuoluo Pills Based on Adulteration Detection of Red Ginseng
投稿时间:2024-02-28  修订日期:2024-06-18
DOI:
中文关键词: 大活络丸  红参  西洋参  拟人参皂苷F11  质量控制
英文关键词: Dahuoluo pill  red ginseng  steamed American ginseng  supplementary testing method  pseudo-ginsenoside F11
基金项目:中药材及饮片质量控制重点实验室项目
作者单位邮编
王丽梅 甘肃省药品检验研究院 730013
李欣 甘肃省药品检验研究院 
倪 琳 甘肃省药品检验研究院 
宋平顺* 甘肃省药品检验研究院 730013
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中文摘要:
      目的:建立大活络丸中红参掺伪西洋参的检查方法,以期提高大活络丸质量。方法:采用超高效液相色谱-串联质谱(UPLC-MSMS),以西洋参特征成分拟人参皂苷F11为检测指标,采用C18(100 mm×2.1 mm,1.8 μm)色谱柱,以乙腈、10 mmol·L-1甲酸铵溶液为流动相,梯度洗脱,流速0.3 mL·min-1,柱温40 ℃;电喷雾负离子扫描,多反应监测模式。结果:制剂基质效应不明显;拟人参皂苷F11在0.0117~1.167 μg·mL-1范围内线性关系良好(R2>0.9990),并与不同掺伪比例呈线性相关;平均回收率为95.2%,RSD=1.73%(n=6)。98批样品中,37批检出拟人参皂苷F11,5批超过拟定限度,涉及1家企业,不合格率5.1%。结论:相较于目前已报道研究,本研究较全面的开展了补充检验方法的研制工作,且起草方法灵敏、准确,可作为大活络丸质量控制的补充检验。
英文摘要:
      Objective: Establish a method for detecting red ginseng adulterated with steamed American ginseng in Dahuoluo Pills to provide an important support for supervising its quality. Method: Taking pseudo-ginsenoside F11, the characteristic component of American ginseng, as the adulteration detection index, an UPLC-MSMS analysis was performed on C18 column (100 mm×2.1 mm, 1.8 μm), using acetonitrile and 10 mmol.L-1 ammonium formate solution as mobile phase for gradient elution at a ?ow rate 0.3 mL.min-1, and column temperature was 40 ℃. The analyte was detected by electrospray anion scanning and multiple reaction monitoring mode. Results: The preparation has a non-obvious matrix effect; pseudo-ginsenoside F11 showed a good linearity in the range of 0.0117~1.167 μg.mL-1 (R20.999), and also has a linear relationship with different adulteration proportion. The average recovery was 95.2% with RSD=1.7% (n=6). Among the 98 samples, pseudo-ginsenoside F11 was detected in 37 samples, and 5 samples from an enterprise exceededSthe proposed detection limit, leading to the disqualified rate was 5.1%. Conclusion: Compared to the reported literatures, this study launched the supplementary testing method more comprehensively, and the established method was sensitive and accurate, which can be applied to be a supplementary inspection of Dahuoluo Pills.
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