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白璐,郭静,伍实花,赵毅,吴梦瑶,陈灿,龚云,李春,张鹏.金樱根质量控制方法提升研究及等级评价体系的建立[J].湖南中医药大学学报英文版,2022,42(2):206-212.[Click to copy
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| 金樱根质量控制方法提升研究及等级评价体系的建立 |
| 白璐,郭静,伍实花,赵毅,吴梦瑶,陈灿,龚云,李春,张鹏 |
| (株洲千金药业股份有限公司, 湖南 株洲 412007;中国中医科学院中药研究所, 北京 100700) |
| 摘要: |
| 目的 提升金樱根药材的质量控制方法，对其进行安全性分析与等级评价。方法 对现行质量标准进行总结，改进薄层鉴别方法，建立特征图谱，并对含量测定方法进行研究；采用电感耦合等离子体质谱法测定其铅、镉、砷、汞、铜的残留量；利用SPSS统计软件对其进行聚类分析。结果 TLC鉴别方法各斑点清晰，分离度良好，可以区分真伪，建立的特征图谱有5个特征峰，指认1个特征峰；不同产地金樱根5种重金属平均含量分别为铅0.7 mg/kg、镉0.1 mg/kg、砷0.1 mg/kg、铜5.0 mg/kg，汞低于0.01 mg/kg；30批样品分为3类：1批特级，9批优质，20批合格。结论 本方法结果准确、简便、客观、重复性好，可用于药材的质量控制；不同产地重金属含量均在中国《药用植物及制剂进出口绿色行业标准》规定范围内，处于安全水平；本研究所提出的3个等级规格药材的不同等级特性区分明显，实践中容易掌握，对药材的采收加工、销售流通及临床应用具有一定的指导和实践意义。 |
| 关键词: 金樱根 薄层色谱 特征图谱 含量测定 安全性评价 等级评价 |
| DOI：10.3969/j.issn.1674-070X.2022.02.007 |
| Received:November 23, 2021 |
| 基金项目:国家中药标准化项目（ZYBZH-C-HUN-21）。 |
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| Improvement of quality control method and establishment of grade evaluation system for Rose cymosa |
| BAI Lu,GUO Jing,WU Shihua,ZHAO Yi,WU Mengyao,CHEN Can,GONG Yun,LI Chun,ZHANG Peng |
| (Zhuzhou Qianjin Pharmaceutical Co., Ltd., Zhuzhou, Hunan 412007, China;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China) |
| Abstract: |
| Objective To improve the quality control method of Rose cymosa, and to carry out safety evalution and grade evaluation. Methods The statutory standard of Rose cymosa were summarized. The thin-layer chromatography (TLC) identification method was improved, the characteristic map was established, and the content determination method was studied. The residues of lead, cadmium, arsenic, mercury and copper in Rose cymosa were determined by inductively coupled plasma mass spectrometry (ICP-MS). Cluster analysis of Rose cymosa was carried out using SPSS statistical software. Results The spots on TLC plate were clear and well-separated, which can be used to identify the authenticity. The established characteristic spectrum identified 5 characteristic peaks and identified 1 components. The average content of lead, cadmium, arsenic and copper was 0.7, 0.1, 0.1, 5.0 mg/kg, respectively, and mercury was less than 0.01 mg/kg. The 30 batches of samples were divided into 3 categories, 1 batch of super grade, 9 batches of high quality and 20 batches of qualified. Conclusion The proposed methods are accurate, simple, and objective, and can be used for quality control of Rose cymosa. The content of heavy metals in Rose cymosa from different areas was all within the limit prescribed in China's Green Thade Standards Importing & Exporting Medicinal plants & Preparation, which was at a safe level. This research proposes three ranks of medicinal materials specifications for different features to distinguish clearly, and easy to master in practice, which has certain guidance and practical significance for the collection, processing, sales, circulation and clinical application of medicinal materials. |
| Key words: Rose cymosa thin-layer chromatography characteristic spectrum content determination safety evaluation grade evaluation |
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