盐酸千金藤素国家一级有证标准物质的研制

Development of National Primary Certified Reference Material of Cepharanthine Hydrochloride

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。

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.