Zhang Li, Yuan Peng-Hui, Yang De-Zhi, Bi Yan-Cai, Su Bin, Zhang Bao-Xi, Wang Fu-Qing, Lu Yang, Du Guan-Hua
Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050, People's Republic of China.
Soteria Pharmaceutical Co., Ltd., Laiwu, 271100, People's Republic of China.
Nat Prod Bioprospect. 2020 Oct;10(5):317-324. doi: 10.1007/s13659-020-00261-1. Epub 2020 Aug 18.
Betulin (BE) can be obtained from many plants, such as those belonging Betulaceae family, and pharmacological investigations showed its notable biological properties and good potential for food and pharmaceutical development. We investigated the homogeneity, stability, purity, and uncertainty of a newly certified reference material (CRM) of BE. The certified purity value for the CRM of BE was 99.56% with an extended uncertainty of 0.07% (k = 2, P = 0.95), as determined by differential scanning calorimetry (DSC). In this study, DSC was used for the first time for purity determination of BE. Given its high accuracy, precision, and reproducibility, DSC can be used as an alternative technique for purity determination of CRMs in the pharmaceutical and food industry.
桦木醇(BE)可从多种植物中获得,如桦木科的植物,药理学研究表明其具有显著的生物学特性以及在食品和药物开发方面的良好潜力。我们研究了一种新的BE认证参考物质(CRM)的均匀性、稳定性、纯度和不确定度。通过差示扫描量热法(DSC)测定,BE的CRM认证纯度值为99.56%,扩展不确定度为0.07%(k = 2,P = 0.95)。在本研究中,DSC首次用于BE的纯度测定。鉴于其高准确性、精密度和可重复性,DSC可作为制药和食品行业中CRM纯度测定的替代技术。