人参及其制剂中违法掺加西洋参补充检验方法与监管策略分析  

A supplementary detection method and supervision strategy for adulteration of Panacis Quinquefoli Radix in Ginseng Radix et Rhizoma and its preparations

作　　者：王晓蕾 雷蓉 赵振霞 苏建 程显隆[2] 刘永利 马双成 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,Shjiazhuang 050227,China;National Institutes for Food and Drug Control,Beijing 100050,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]河北省药品医疗器械检验研究院/国家药品监督管理局/中药材质量监测评价重点实验室,河北石家庄050227 [2]中国食品药品检定研究院,北京100050 [3]国家药典委员会,北京100061

出　　处：《中国中药杂志》2024年第20期5469-5478,共10页China Journal of Chinese Materia Medica

基　　金：河北省省级科技计划项目(21372502D);中国药品监管科学行动计划第二批重点项目(NMPAJGKX-2023-026)。

摘　　要：针对人参及含人参中成药违法掺加西洋参现象,该研究基于对人参、西洋参的基础研究,确定掺伪原因及监测方法,以拟人参皂苷F_(11)为检测指标,制定人参药材及饮片中违法添加西洋参的UPLC-MS/MS检测方法,建立的方法可同时应用于含人参中成药的掺伪检查。以掺伪率5%为限度分析市场药材及饮片、常见中成药中人参质量状况,27批人参掺伪检出率为22.2%,32批中成药按人参处方量折算,掺伪检出率为15.6%;此外,7.4%人参、12.5%中成药的理论掺伪率介于3%~5%。对比现有14种含人参中成药西洋参掺伪补充检验方法的优劣势及限度原则,将方法划分为3种模式,分析应用场景,总结方法起草及应用注意事项。明确人参药材掺伪多为劣等西洋参替代,人参饮片及人参粉是掺加部分西洋参饮片或粉,将掺伪率5%作为限度,既能实现对故意掺加行为的打击,又可规避质谱高灵敏度引起的误判。建议制定通用检测方法及限度制定原则并加强监管与宣传,为从源头解决人参中西洋参的掺伪问题提供技术支持及数据支撑。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 F11 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.

关 键 词：人参 西洋参 掺伪 拟人参皂苷F_(11) 检查 补充检验方法 

分 类 号：R284.1[医药卫生—中药学]