论文部分内容阅读
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 To develop a national standard reference substance of acinarine hydrochloride and to establish a method for the purity determination of acteostilbene hydrochloride and to evaluate the uncertainty. Methods According to the requirements of the technical standards for the development of a Chinese standard reference material and the relevant guidelines of the International Organization for Standardization (ISO), the purity of cepharanthine hydrochloride was determined by differential scanning calorimetry and mass balance method, and its uncertainty was evaluated. Results The purity of cepharanthine hydrochloride standard was 99.6% with an uncertainty of 0.4%, including a factor of 2 and a confidence interval of 0.95. Conclusion Cefotaxime hydrochloride developed by the State Administration of Quality Supervision, Inspection and Quarantine as a national standard material, number GBW09578. The development of this standard material provides the material standards and standard methods for the quality control research of related pharmaceutical products and also provides scientific basis for the research of other natural product standard materials.