李超;苏晓楠;朱法根;吴菲;步伟全;封亮;贾晓斌;姜梦华;孙娥;
LI Chao;SU Xiao-nan;ZHU Fa-gen;WU Fei;BU Wei-quan;FENG Liang;JIA Xiao-bin;JIANG Meng-hua;SUN E;School of Traditional Chinese Pharmacy, China Pharmaceutical University;Jiangsu Key Laboratory of Chinese Medicine and Characteristic Preparations for Paediatrics, Jumpcan Pharmaceutical Co., Ltd.;Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine;

• 1:中国药科大学中药学院
• 2:济川药业集团有限公司江苏省儿科中药与特色制剂重点实验室
• 3:南京中医药大学附属中西医结合医院

摘要(Abstract)：

蒲地蓝消炎口服液已被广泛用于临床炎症疾病如上呼吸道感染的治疗,蒲公英作为蒲地蓝消炎口服液处方中的君药,其多来源、多产地的特点,以及不同药用部位有效成分含量的差异,是导致不同批次的蒲地蓝消炎口服液质量不稳定性的潜在因素。该文采用Thermo Scientific Vanquish超高效液相系统,利用国家药典委员会"中药色谱指纹图谱相似度评价系统(2012版)"处理分析,通过对照品比对对蒲公英主要共有峰进行指认和含量测定。建立不同产地蒲公英药材指纹图谱,确定了13个共有峰,5个产地共29批次样品相似度均在0.90以上。同时建立测定蒲公英中单咖啡酰酒石酸、绿原酸、咖啡酸、菊苣酸、木犀草素的超高效液相色谱分析方法,定量分析条件通过方法学验证,平均加样回收率在97.30%～101.8%。结果表明同一成分在各产地蒲公英药材、不同药用部位中的含量差异明显,不同成分的波动范围不同。建立不同产地蒲公英超高效液相指纹图谱结合多成分含量测定方法为完善蒲公英药材的质量控制提供了参考,也为蒲地蓝消炎口服液的品质提升提供了源头保证。
Pudilan Xiaoyan Oral Liquid has been widely used in the clinical treatment of inflammatory diseases such as upper respiratory tract infections. Taraxaci Herba, as the monarch medicine in Pudilan Xiaoyan Oral Liquid, due to its multi-source, multi-origin characteristics, and the difference in the content of active ingredients in different medicinal parts, has become a potential factor for the unstable quality among different batches of Pudilan Xiaoyan Oral Liquid. In this paper, Thermo Scientific Vanquish ultra-high-performance liquid chromatography(UPLC) system was used, and the Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2012 Edition) issued by National Pharmacopoeia Commission was used for processing and analysis. The main common peaks were identified and contents were determined by comparison with reference substances. Fingerprints of Taraxaci Herba medicinal materials from different origins were established. 13 common peaks were identified, and 29 batches of samples from five origins had similarities above 0.90. At the same time, an ultra-high performance liquid chromatography method was developed for the determination of monocaffeoyl tartaric acid, chlorogenic acid, caffeic acid, chicoic acid, and luteolin in Taraxaci Herba. The quantitative analysis conditions were verified by methodology, and the average sample recovery was 97.30%-101.8%. The results showed that the content of the same ingredient in Taraxaci Herba from different origins and different medicinal parts was obviously different, and the fluctua-tion range was also different for different ingredients. The establishment of UPLC fingerprints for Taraxaci Herba from different regions combined with multi-component content determination methods provides a reference for improving the quality control of Taraxaci Herba medicinal materials, and also provides a source guarantee for the quality improvement of Pudilan Xiaoyan Oral Liquid.

关键词(KeyWords)： 蒲地蓝消炎口服液;蒲公英;超高效液相指纹图谱;含量测定;质量控制
Pudilan Xiaoyan Oral Liquid;Taraxaci Herba;ultra high performance liquid chromatography fingerprint;content determination;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1706900,2018YFC1706902);; 江苏省博士后项目(1601023C);; 国家博士后基金项目(2016M601864);; 中国药科大学双一流项目(CPU2018GF07,CPU2018PZQ19);; 江苏省中医药管理局项目(YB201819)

作者(Author): 李超;苏晓楠;朱法根;吴菲;步伟全;封亮;贾晓斌;姜梦华;孙娥;
LI Chao;SU Xiao-nan;ZHU Fa-gen;WU Fei;BU Wei-quan;FENG Liang;JIA Xiao-bin;JIANG Meng-hua;SUN E;School of Traditional Chinese Pharmacy, China Pharmaceutical University;Jiangsu Key Laboratory of Chinese Medicine and Characteristic Preparations for Paediatrics, Jumpcan Pharmaceutical Co., Ltd.;Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200802.331

参考文献(References)：

• [1] 王连心,苗青,谢雁鸣,等.蒲地蓝消炎口服液临床应用专家共识[J].中国中药杂志,2019,44(24):5277.
• [2] 蒋喜巧,苗明三.蒲公英现代研究特点及分析[J].中医学报,2015,30(7):1024.
• [3] 张幻诗,杨建宇.蒲公英药用研究进展[J].云南中医中药杂志,2013,34(9):69.
• [4] 国家药典委员会.中华人民共和国药典.一部[S].北京:中国医药科技出版社,2020:374.
• [5] 宁伟,贾庆飞,朱丹,等.东北地区11种蒲公英咖啡酸和绿原酸的含量测定[J].沈阳农业大学学报,2012,43(5):595.
• [6] 师绘敏,李喜凤,孟璐,等.蒲公英中咖啡酸和绿原酸的含量测定[J].河南中医学院学报,2007,22(3):35.
• [7] 邵静媛,郭俊林,郭尚鑫,等.基于质量源于设计理念的三叶糖脂清汤剂定量指纹图谱研究[J].中国中药杂志,2019,44(22):4844.
• [8] 陈夏霖,耿婷,黄文哲,等.基于1H-NMR技术的银杏二萜内酯原料药含量测定和指纹图谱研究[J].中国中药杂志,2018,43(7):1404.
• [9] FENG X,KONG W,WEI J,et al.HPLC fingerprint analysis combined with chemometrics for pattern recognition of ginger[J].Pharm Biol,2014,52(3):362.
• [10] 刘爱朋,郭利霄,薛紫鲸,等.基于指纹图谱和多组分含量测定的蒲公英药材质量控制研究[J].中国中药杂志,2018,43(18):3715.
• [11] 杨挡,姜梦华,顾慧敏,等.基于临床用药的蒲地蓝消炎口服液产品提升与二次开发[J].中国中药杂志,2020,45(18):4285.
• [12] 姜梦华,李超,朱法根,等.基于抗炎活性的蒲地蓝消炎口服液质量标志物的辨识[J].中国中药杂志,2020,45(18):4299.
• [13] 杨挡,姜梦华,李陈子,等.基于网络药理学技术挖掘蒲地蓝消炎口服液的活性组分与作用机制[J].中国中药杂志,2020,45(18):4291.