维生素K1冻干标准物质的研制

Development of a Certified Reference Material for Lyophilized Vitamin K1

采用二甲基亚砜（DMSO）作为冻干标准物质的溶剂，以重量法准确配制维生素K1／DMSO溶液，再进行分装、冷冻干燥，经定性分析、定值分析、均匀性检验、稳定性考察和不确定度评定，研制了维生素K1冻干标准物质。以维生素K1纯度标准物质溶液为校准品，对得到的冻干物质进行了高效液相色谱法定值分析，冻干标准物质的准确定值结果为0．96mg／mL，相对扩展不确定度为7％。建立的维生素K1冻干标准物质研制方法，对于临床检验中维生素K1的准确测定和相关疾病的正确诊断治疗以及维生素K1长期保存具有重要意义。

Dimethyl sulfone （DMSO） is firstly applied as the solvent for a lyophilized certified reference material （CRM）. Vitamin K1/DMSO solution is prepared by gravimetry, and is sub-divided and lyophilized, the lyophilized vitamin K1 CRM is developed through qualitative analysis, quantitative analysis, homogeneity study, stability study and uncertainty evaluation. Certified value of lyophilization vitamin K1 is analyzed by high performance liquid chromatography method, using the vitamin K1 purity CRM as a calibrant. The certified value is 0. 96 mg/mL, with the relative expanded uncertainty of 7%. The method of CRM lyophilized vitamin K1 makes great significance for the accurate determination the disease in clinical examination and the long-term preservation of vitamin K1.