| 引用本文: | 杨德智,郭永辉,张丽,杨世颖,吕扬.大黄素国家级纯度有证标准物质研制[J].中国现代应用药学,2013,30(9):933-940. |
| YANG Dezhi,GUO Yonghui,ZHANG Li,YANG Shiying,LÜ Yang.Development of National Primary Purity Certified Reference Material of Emodin[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(9):933-940. |
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| 摘要: |
| 目的 通过建立准确的定值分析方法及不确定度的研究，研制具有可溯源性、高准确度量值的大黄素国家级化学纯度有证标准物质。方法 根据我国计量法和一级标准物质研制技术规范与相关技术文件要求，采用高效液相色谱法(HPLC)和差示扫描量热法(DSC)对大黄素纯度标准物质联合定值，并完成不确定度评估。结果 研制的大黄素纯度标准物质符合国家一级有证标准物质要求，其化学纯度标准值与不确定度值为(99.54±0.18)%(k=2, P=0.95)。结论 本实验研制的大黄素国家一级纯度有证标准物质具有量值准确、可溯源的特性，属于国际公认的标准物质，将为我国药品的有效物质和成分标准化与国际化，提供必要的标准物质与物质标准。 |
| 关键词: 大黄素 纯度标准物质 高效液相色谱法 差示扫描量热法 标准值 不确定度 |
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| 基金项目:科技部科技基础性工作专项重点项目(2007FY130100)；天然药物活性物质与功能国家重点实验室自主课题C类-探索性课题(GTZC201229) |
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| Development of National Primary Purity Certified Reference Material of Emodin |
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YANG Dezhi, GUO Yonghui, ZHANG Li, YANG Shiying, LÜ Yang
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Research Center for Pharmaceutical Polymorphism, Peking Union Medical College, Institute of Materia Medica & Chinese Academy of Medical Sciences, Beijing 100050, China
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| Abstract: |
| OBJECTIVE To develop the national primary purity certified reference material(CRM) of emodin which has traceability and high-accuracy quantity value by establishing accurate, reliable analytical method and evaluation of uncertainty. METHODS The CRM of emodin was developed by the joint certification including high performance liquid chromatography (HPLC) and differential scanning calorimetry(DSC) on the basis of Technical Norm of Primary Reference Material and related documents requirements. RESULTS The developed amodin purity CRM in accordance with Technical Norm of Primary Reference Material requirements had the standard value and uncertainty of (99.54±0.18)%(k=2, P=0.95). CONCLUSION The national primary purity CRM of emodin developed in this study possess a high-accuracy value and traceability characteristics which could provide necessary material base for medicines standardization and internationalization. |
| Key words: emodin purity certified reference material HPLC DSC standard value uncertainty |
