| 引用本文: | 杨德智,胡堃,张燕,吕扬.盐酸千金藤素国家一级有证标准物质的研制[J].中国现代应用药学,2016,33(3):266-271. |
| YANG Dezhi,HU Kun,ZHANG Yan,LYU Yang.Development of National Primary Certified Reference Material of Cepharanthine Hydrochloride[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(3):266-271. |
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| 摘要: |
| 目的 开展盐酸千金藤素国家一级标准物质的研制，建立盐酸千金藤素纯度测量方法，并进行不确定度的评定。方法 根据我国一级标准物质研制技术规范及国际标准化组织相关导则的要求，采用差示扫描量热法与质量平衡法测定盐酸千金藤素的纯度，并对其不确定度进行评定。结果 研制的盐酸千金藤素标准物质的纯度值为99.6%，不确定度为0.4%，其中包含因子为2，置信区间为0.95。结论 研制的盐酸千金藤素被国家质量监督检验检疫总局评为国家一级标准物质，编号GBW09578。该标准物质的研制为相关药物产品的质量控制研究提供物质标准与标准方法，亦为其他天然产物标准物质的研究提供科学依据。 |
| 关键词: 盐酸千金藤素 有证标准物质 差示扫描量热法 质量平衡法 不确定度 |
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| 基金项目:“重大新药创制”科技重大专项(2012ZX09301-002-001)；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(GTZC201229) |
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| Development of National Primary Certified Reference Material of Cepharanthine Hydrochloride |
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YANG Dezhi,HU Kun,ZHANG Yan,LYU Yang
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1.Peking Union Medical College, Chinese Academy of Medical Sciences, Research Center for Pharmaceutical Polymorphism, Institute of Materia Medica;2.State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China
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| Abstract: |
| OBJECTIVE Through establishing accurate, reliable analytical method and evaluation of uncertainty, to develop the national primary certified reference material(CRM) of cepharanthine hydrochloride. METHODS The purity of cepharanthine hydrochloride CRM was certified by the joint certification including mass balance method and differential scanning calorimetry (DSC) and the uncertainty was carefully evaluated on the basis of Technical Norm of Primary Reference Material and related documents requirements of International Standards of the International Organization for Standardization. RESULTS The purity of cepharanthine hydrochloride CRM was 99.6% and the uncertainty was 0.4% with k=2, P=0.95. CONCLUSION The national primary CRM of cepharanthine hydrochloride developed in this study has been approved and assigned as a grade primary reference material by the General Administration of Quality Supervision, Inspection, and Quarantine of the People’s Republic of China, which was numbered GBW09578. The CRM provides quality control of related pharmaceutical products with standard material and method and also provides reference for purity determination and uncertainty evaluation of other medicines and natural products. |
| Key words: cepharanthine hydrochloride certified reference material differential scanning calorimetry mass balance method uncertainty |
