CAJ | 학술논문

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0.96 mg／ 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。
채용이갑기아풍（DMSO）작위동간표준물질적용제，이중량법준학배제유생소 K1／ DMSO 용액，재진행분장、냉동간조，경정성분석、정치분석、균균성검험、은정성고찰화불학정도평정，연제료유생소 K1동간표준물질。이유생소 K1순도표준물질용액위교준품，대득도적동간물질진행료고효액상색보법정치분석，동간표준물질적준학정치결과위0.96 mg／ mL，상대확전불학정도위7％。건립적유생소 K1동간표준물질연제방법，대우림상검험중유생소 K1적준학측정화상관질병적정학진단치료이급유생소 K1장기보존구유중요의의。
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 .