首页|UPLC-MS/MS检测补肾益脑胶囊中人参掺伪情况

UPLC-MS/MS检测补肾益脑胶囊中人参掺伪情况

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目的:建立一种可测定补肾益脑胶囊制剂中非法添加西洋参的超高效液相色谱-质谱法,考察企业是否存在使用西洋参或其边角料替代人参投料的现象,为中药监管提供技术支持.方法:Phenomenex C18 色谱柱(100 mm×2.1 mm,2.6 μm),以 10 mmoL·L-1 的乙酸铵(A)-乙腈(B)为流动相梯度洗脱;流速为 0.3 mL·min-1;柱温为40℃.采用电喷雾负离子模式进行多反应监测.结果:60 批补肾益脑胶囊中有 29 批检出西洋参的专属成分拟人参皂苷F11,检出率为 48.3%.结论:补肾益脑胶囊中存在人参掺伪的现象,该方法准确可靠,可作为补肾益脑胶囊中人参掺混西洋参的补充检验方法.
Detection of Panax ginseng Adulteration in Bushen Yinao Capsules by UPLC-MS/MS
Objective:This study aims to establish an ultra-high performance liquid chromatography-mass spectrometry(UPLC-MS/MS)method for determining Panax quinquefolium illegally added in Bushen Yinao Capsule preparation and to investigate whether enterprises use P.quinquefolium or its leftover ingredients to replace Panax ginseng,so as to provide technical support for traditional Chinese medicine(TCM)supervision.Methods:Phenomenex C18 column(100 mm×2.1 mm,2.6 μm)was used,with 10 mmoL·L-1 ammonium acetate l(A)-acetonitrile(B)as the mobile phase for gradient elution.The flow rate was 0.3 mL·min-1,and the column temperature was 40℃.Electrospray negative ion mode(ESI-)was employed for multiple reaction monitoring(MRM).Results:Pseudo-ginsenoside F11,a special component of P.quinquefolium,was detected in 29 batches of 60 Bushen Yinao Capsules,with a detection rate of 48.3%.Conclusion:There was P.ginseng C.A.Mey.adulteration in Bushen Yinao Capsules.The method was accurate and reliable and could be used as a supplementary test method for P.quinquefolium illegally added in Bushen Yinao Capsules.

Bushen Yinao CapsulesPanax ginseng C.A.Mey.Panax quinquefoliumpseudo-ginsenoside F11

李欣、高天鹏、张明童、王娟弟、李冬华、杨玲霞

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甘肃省药品检验研究院,甘肃 兰州 730070

国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃 兰州 730070

补肾益脑胶囊 红参 西洋参 拟人参皂苷F11

中药材及饮片质量控制重点实验室项目中药材及饮片质量控制重点实验室项目甘肃省药品科研项目

2022GSMPA-KL122023GSMPA-KL062022GSMPA0075

2024

中国现代中药
中国中药协会,中国医药集团总公司,中国药材公司

中国现代中药

CSTPCD
影响因子:0.65
ISSN:1673-4890
年,卷(期):2024.26(6)
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