| 人参皂苷Re标准样品的研制 |
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| 引用本文： | 宋志博, 陈涛, 王肖波, 王岱杰, 申诚, 王硕, 李洪梅, 海平, 李玉林. 藏药诃子质量标志物诃黎勒酸的标准化分析研究[J]. 分析测试技术与仪器, 2023, 29(2): 140-148. DOI: 10.16495/j.1006-3757.2023.02.002 |
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| 作者姓名： | 宋志博 陈涛 王肖波 王岱杰 申诚 王硕 李洪梅 海平 李玉林 |
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| 作者单位： | 1.中国科学院 西北高原生物研究所，青海 西宁 810001;2.中国科学院 西北生态环境资源研究院，甘肃 兰州 730000;3.山东省分析测试中心，山东 济南 250014;4.青海省药品检验检测院 国家药品监督管理局中药（藏药）质量控制重点实验室，青海 西宁 810016;5.中国科学院大学，北京 100049 |
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| 基金项目： | 青海省重点研发与转化计划：藏药质量标志物发掘和标准化关键技术及应用示范(2023-SF-112) ，甘肃省青年科技基金计划(20JR5RA542) |
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| 摘 要： | 以藏药诃子为原料，研制诃黎勒酸国家标准样品. 诃子经60%乙醇提取，大孔树脂富集，制备液相色谱技术得到诃黎勒酸标准品. 采用高效液相色谱（HPLC）、液相色谱-质谱（LC-MS）和薄层色谱（TLC）等手段进行纯度分析. 采用紫外光谱（UV）、红外光谱（IR）、高分辨质谱（MS）和核磁共振波谱（NMR）技术进行结构确认. 最后进行均匀性、稳定性和联合定值. 结果表明，诃黎勒酸样品均匀性良好，4 ℃储存，24个月内稳定. 联合定值确定诃黎勒酸纯度标准值为99.33%，符合国家标准品的要求. 研制出的诃黎勒酸（GSB 11-3724-2020）国家标准样品，可用于含量测定、检测方法评定、相关产品的检测与质量控制.
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| 关 键 词： | 诃黎勒酸 标准样品 均匀性 稳定性 定值 |
| 收稿时间： | 2023-03-02 |
| 修稿时间： | 2023-05-16 |
Preparation of ginsenoside Re certified reference materials |
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| SONG Zhibo, CHEN Tao, WANG Xiaobo, WANG Daijie, SHEN Cheng, WANG Shuo, LI Hongmei, HAI Ping, LI Yulin. Standardization of Chebulagic Acid as Quality Marker of Tibetan Medicine Terminalia Chebula[J]. Analysis and Testing Technology and Instruments, 2023, 29(2): 140-148. DOI: 10.16495/j.1006-3757.2023.02.002 |
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| Authors: | SONG Zhibo CHEN Tao WANG Xiaobo WANG Daijie SHEN Cheng WANG Shuo LI Hongmei HAI Ping LI Yulin |
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| Affiliation: | 1.Northwest Institute of Plateau Biology, Chinese Academy of Sciences, Xining 810001, China;2.Northwest Institute of Eco-Environment and Resources, Chinese Academy of Sciences, Lanzhou 730000, China;3.Shandong Analysis and Test Center, Jinan 250014, China;4.Qinghai Provincial Drug Inspection and Testing Institute, NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine and Tibentan Medicine, Xining 810016, China;5.University of Chinese Academy of Sciences, Beijing 100049, China |
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| Abstract: | A certified reference material of chebulagic acid has been developed using a Tibetan medicine Terminalia Chebula as the raw material. Terminalia Chebula was extracted with 60% ethanol, enriched by the macroporous resin and through the preparative liquid chromatographic purification to obtain chebulagic acid. The purity analysis was carried out by high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS) and thin-layer chromatography (TLC). The structure was identified using ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, mass spectroscopy (MS) and nuclear magnetic resonance (NMR) spectroscopy. Finally, the homogeneity, stability and cooperative certification were carried out. The results indicated that the chebulagic acid has a good uniformity and a fine stability within 24 months at 4 ℃. The standard value of the purity of chebulagic acid was 99.33%, which was in accordance with the requirements of the certified reference material. The developed chebulagic acid (GSB 11-3724-2020) can be used for the content determination, method evaluation, testing and quality control of related products. |
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| Keywords: | chebulagic acid reference material homogeneity stability certification |
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