Wang Xiao-Lei, Lei Rong, Zhao Zhen-Xia, Su Jian, Cheng Xian-Long, Liu Yong-Li, Ma Shuang-Cheng
National Medical Products Administration Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine, Hebei Institute for Drug and Medical Device Control Shijiazhuang 050227, China.
National Institutes for Food and Drug Control Beijing 100050, China.
Zhongguo Zhong Yao Za Zhi. 2024 Oct;49(20):5469-5478. doi: 10.19540/j.cnki.cjcmm.20240715.302.
Ginseng Radix et Rhizoma and its preparations are often adulterated with Panacis Quinquefolii Radix. Based on the research on Ginseng Radix et Rhizoma and Panacis Quinquefolii Radix, the causes and analytical method of adulteration were determined. A UPLC-MS/MS method was developed for the detection of Panacis Quinquefolii Radix mixed in Ginseng Radix et Rhizoma, with pseudoginsenoside F_(11) as the marker. The established method can be applied in the detection of adulteration of the preparations containing Ginseng Radix et Rhizoma. The quality of the medicinal materials, decoction pieces, and preparations of Ginseng Radix et Rhizoma was examined with the limit of 5% adulteration rate. The results showed 22.2% in 27 batches of Ginseng Radix et Rhizoma samples and 15.6% in 32 batches of preparations exceeded the limit. In addition, the theoretical adulteration rates of 7.4% Ginseng Radix et Rhizoma samples and 12.5% preparations were between 3% and 5%. Fourteen supplementary detection methods for adulteration of Panacis Quinquefolii Radix in Ginseng Radix et Rhizoma preparations were classified into 3 types. The application scenarios, drafted methods, and precautions of each type were analyzed and summarized. It was discovered that the medicinal materials, decoction pieces, and powder of Ginseng Radix et Rhizoma were commonly adulterated with those of Panacis Quinquefolii Radix. Taking an adulteration rate of 5% as the limit can combat the adulteration and avoid the misjudgment caused by the high sensitivity of MS. It is suggested the general detection method and limit should be formulated, and supervision and publicity should be strengthened. The findings provide technical and data support for addressing the adulteration from the source.
人参及其制剂常被西洋参掺假。通过对人参和西洋参的研究,确定了掺假的原因及分析方法。建立了以拟人参皂苷F₁₁为指标的UPLC-MS/MS法检测人参中掺入的西洋参。所建立的方法可应用于含人参制剂掺假的检测。以5%的掺假率为限,对人参药材、饮片及制剂的质量进行了检测。结果显示,27批人参样品中有22.2%、32批制剂中有15.6%超过限量。此外,7.4%的人参样品和12.5%的制剂理论掺假率在3%至5%之间。将人参制剂中西洋参掺假的14种补充检测方法分为3类。分析总结了各类方法的应用场景、起草方法及注意事项。发现人参药材、饮片及粉剂常被西洋参掺假。以5%的掺假率为限可打击掺假行为,避免因质谱高灵敏度导致的误判。建议制定通用的检测方法和限量,并加强监管和宣传。研究结果为从源头上解决掺假问题提供了技术和数据支持。