Targeted trace ingredients coupled with chemometric analysis for consistency evaluation of Panax notoginseng saponins injectable formulations
文献类型：期刊论文
| 作者 | Zhang, Jingxian3; Zhang, Zijia1,4; Wang, Zhaojun1,4; Zhang, Tengqian1,4; Zhou, Yang1,4; Chen, Ming2; Huang, Zhanwen2; He, Qingqing1,4; Long, Huali1,4; Hou, Jinjun1,4
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| 刊名 | CHINESE JOURNAL OF NATURAL MEDICINES
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| 出版日期 | 2023-08-01 |
| 卷号 | 21期号:8页码:631-640 |
| ISSN号 | 2095-6975 |
| 关键词 | Consistency evaluation Panax notoginseng saponins PCA analysis Xueshuantong Xuesaitong |
| DOI | 10.1016/S1875-5364(23)60396-6 |
| 通讯作者 | Hou, Jinjun(jinjun_hou@simm.ac.cn) ; Wu, Wanying(wanyingwu@simm.ac.cn) ; Guo, Dean(daguo@simm.ac.cn) |
| 英文摘要 | Evaluating the consistency of herb injectable formulations could improve their product quality and clinical safety, particularly concerning the composition and content levels of trace ingredients. Panax notoginseng Saponins Injection (PNSI), widely used in China for treating acute cardiovascular diseases, contains low-abundance (10%-25%) and trace saponins in addition to its five main constituents (notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, and ginsenoside Rd). This study aimed to establish a robust analytical method and assess the variability in trace saponin levels within PNSI from different vendors and formulation types. To achieve this, a liquid chromatography-triple quadrupole mass spectrometry (LC-MS/MS) method employing multiple ions monitoring (MIM) was developed. A "post-column valve switching" strategy was implemented to eliminate highly abundant peaks (NR1, Rg1, and Re) at 26 min. A total of 51 saponins in PNSI were quantified or relatively quantified using 18 saponin standards, with digoxin as the internal standard. This study evaluated 119 batches of PNSI from seven vendors, revealing significant variability in trace saponin levels among different vendors and formulation types. These findings highlight the importance of consistent content in low-abundance and trace saponins to ensure product control and clinical safety. Standardization of these ingredients is crucial for maintaining the quality and effectiveness of PNSI in treating acute cardiovascular diseases. |
| WOS关键词 | LIQUID-CHROMATOGRAPHY ; INJECTION |
| 资助项目 | Science and Technology Service Network Initiative of the Chinese Academy of Sciences (STS)[KFJ-STS-QYZD-2021-03-003] ; Construction Projects of the Research Center for Notoginseng Health Products by the Department of Science and Technology of Guangxi Province[AD20297068] ; Sanming Project of Medicine in Shenzhen[SZZYSM202106004] |
| WOS研究方向 | Integrative & Complementary Medicine ; Pharmacology & Pharmacy |
| 语种 | 英语 |
| 出版者 | CHINESE JOURNAL NATURAL MEDICINES |
| WOS记录号 | WOS:001065077300001 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/307140]  |
| 专题 | 中国科学院上海药物研究所 |
| 通讯作者 | Hou, Jinjun; Wu, Wanying; Guo, Dean |
| 作者单位 | 1.Univ Chinese Acad Sci, Sch Pharm, Beijing 100049, Peoples R China 2.Guangxi Zhongheng Innovat Pharmaceut Res CO LTD, Guangxi Key Lab Comprehens Utilizat Technol Pseudo, Wuzhou 530032, Guangxi, Peoples R China 3.Shanghai Inst Food & Drug Control, NMPA Key Lab Qual Control Tradit Chinese Med, Shanghai 201203, Peoples R China 4.Chinese Acad Sci, Natl Engn Res Ctr TCM Standardizat Technol, Shanghai Inst Mat Med, Shanghai 201203, Peoples R China |
| 推荐引用方式 GB/T 7714 | Zhang, Jingxian,Zhang, Zijia,Wang, Zhaojun,et al. Targeted trace ingredients coupled with chemometric analysis for consistency evaluation of Panax notoginseng saponins injectable formulations[J]. CHINESE JOURNAL OF NATURAL MEDICINES,2023,21(8):631-640. |
| APA | Zhang, Jingxian.,Zhang, Zijia.,Wang, Zhaojun.,Zhang, Tengqian.,Zhou, Yang.,...&Guo, Dean.(2023).Targeted trace ingredients coupled with chemometric analysis for consistency evaluation of Panax notoginseng saponins injectable formulations.CHINESE JOURNAL OF NATURAL MEDICINES,21(8),631-640. |
| MLA | Zhang, Jingxian,et al."Targeted trace ingredients coupled with chemometric analysis for consistency evaluation of Panax notoginseng saponins injectable formulations".CHINESE JOURNAL OF NATURAL MEDICINES 21.8(2023):631-640. |
入库方式： OAI收割
来源：上海药物研究所
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