基于红参掺伪检查的大活络丸质量控制研究  

Study on the Quality Control of Dahuoluo Pills Based on Adulteration Detection of Red Ginseng

作　　者：王丽梅 李欣 倪琳 宋平顺 Wang Limei;Li Xin;Ni Lin;Song Pingshun(Gansu Institute for Drug Control,Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces,National Medical Products Administration,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,国家药品监督管理局中药材及饮片质量控制重点实验室,兰州730070

出　　处：《中国药事》2024年第7期796-806,共11页Chinese Pharmaceutical Affairs

基　　金：中药材及饮片质量控制重点实验室项目(编号2023GSMPA-KL08)。

摘　　要：目的:建立大活络丸中红参掺伪西洋参检查方法,以期更好地监测大活络丸的质量。方法:采用超高效液相色谱-串联质谱(UPLC-MS/MS)法,以西洋参特征成分拟人参皂苷F11为检测指标,采用C_(18)(100 mm×2.1 mm,1.8μm)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0.0117~1.167μg·mL^(-1)范围内线性关系良好(R^(2)>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)。96批样品中,37批检出拟人参皂苷F_(11),5批超过拟定限度,涉及1家企业,不合格率5.2%。结论:本研究较全面地开展了大活络丸中红参掺伪西洋参检查方法的研制工作,且方法灵敏、准确,适用于大活络丸的质量监测。Objective:To establish a method for detecting red ginseng adulterated with American ginseng in Dahuoluo Pills to provide an important support for supervising its quality.Methods:Taking pseudo-ginsenoside F_(11),the characteristic component of American ginseng,as the adulteration detection index,an UPLC-MS/MS analysis was performed on C_(18)column(100 mm×2.1 mm,1.8μm),using acetonitrile and 10 mmol·L^(-1)ammonium formate solution as mobile phase for gradient elution at a flow rate of 0.3 mL·min^(-1),and column temperature of 40℃.The analyte was detected by electrospray anion scanning and multiple reaction monitoring mode.Results:There was no obvious matrix eff ect.Pseudo-ginsenoside F_(11)showed a good linearity in the range of 0.0117-1.167μg·mL^(-1)(R^(2)>0.9990),and also has a linear relationship with diff erent adulteration proportion.The average recovery was 95.2%with RSD of 1.73%(n=6).Among the 96 samples,pseudo-ginsenoside F_(11)was detected in 37 samples,and 5 samples from an enterprise exceeded the proposed detection limit,leading to the disqualifi ed rate was 5.2%.Conclusion:This study comprehensively develops a method for detecting red ginseng adulterated with American ginseng in Dahuoluo Pills,and the established method is sensitive and accurate,which can be applied to quality inspection of Dahuoluo Pills.

关 键 词：大活络丸 红参 西洋参 拟人参皂苷F_(11) 质量控制 

分 类 号：R932[医药卫生—生药学] R917[医药卫生—药学]