基于UPLC指纹图谱的西洋参灵芝口服液质量及批次一致性评价  

Study onthe Quality and Batch Consistency Evaluation Techniques of American Ginseng Ganoderma Lucidum Oral Solution Based on UPLC Fingerprint

作　　者：陈银彬 钟永生 曾莉 邵小宇 万承波 Chen Yinbin;Zhong Yongsheng;Zeng Li;Shao xiaoyu;Wan Chengbo(Jiangxi Provincial Produce Quality Supervision Testing Institute,Jiangxi Nanchang 33000)

机构地区：[1]江西省产品质量监督检测院,江西南昌330000

出　　处：《江西化工》2021年第3期91-96,共6页Jiangxi Chemical Industry

基　　金：江西省市场监督管理局科技项目(GSJKZC201927)。

摘　　要：目的,通过建立保健食品西洋参灵芝口服液中25种皂苷成分的检测方法和多批次样品的指纹图谱,来对西洋参灵芝口服液的质量和批次一致性进行评价研究。方法,采用超高效液相色谱仪,以乙腈-0.005%磷酸(v/v)和超纯水-0.005%磷酸溶液(v/v)为流动相进行梯度洗脱,柱温35℃,流速为0.5 mL/min对样品进行检测;并采用“中药色谱指纹图谱相似度评价系统”(2012版)对16批样品进行相似度评价。结果建立了西洋参灵芝口服液中25种皂苷类成分的检测方法和指纹图谱,标示出了23个共有峰,指认出了16个皂苷特征峰。16批次样品相似度均≥0.913。结论本实验所建立的检测方法稳定简便,在相同条件下能够同时检测多种皂苷成分,可用于西洋参类保健食品的质量控制,防止以次充好;同时指纹图谱的建立可以更加全面系统地对产品批次一致性进行评价,为保健食品质量控制提供借鉴。Objective The quality and batch consistency of American ginseng and Ganoderma lucidum oral liquid were evaluated by establishing the detection method of 25 kinds of saponins in the health foodof American ginseng Ganoderma lucidum oral liquid and the fingerprint of multiple batches of samples.Methods UPLC was performed with the mobile phase consisted of acetonitrile-0.005%phosphoric acid solution(v/v)and deionized water-0.005%phosphoric acid solution(v/v)in gradient mode.The flow rate was 0.5 mL/min under the temperature of 35℃;The similarity evaluation of 16 batches of samples was carried out by Similarity Evaluation System for TCM Chromatographic Fingerprint(2012 Edition).Results The detection method of 25 kinds of saponins in American ginseng ganoderma lucidum oral solution was established,and the UPLC fingerprint of American ginseng ganoderma lucidum oral solution with 23 commons peaks,and 16 of them were identified by comparing with reference substances.The similarity was≥0.913 in 16 batches of sample.Conclusion The established method was stable and simple,and could detect a variety of components at the same time under the same condition,which could be used for the quality control of American ginseng ganoderma lucidum oral solution and prevent the shoddy products;at the same time,the establishment of fingerprint couldbe more comprehensive and systematic evaluation of batch consistency,the study also provided a reference for the research on quality control of health food.

关 键 词：西洋参类保健食品 指纹图谱 质量控制 一致性评价 

分 类 号：O657.72[理学—分析化学] TS218[理学—化学]