血清中皮质醇成分分析标准物质的研制

摘要

Hydrocortisone is animportant kind of adrenocortical hormone,as well as an important kind of clinical diagnosis marker. For the purpose of the traceability,comparability and accuracy of detection results,hydrocortisone reference material was developed. Serum was filtrated, mingled and packed, and the value determination, homogeneity examination and stability investigation were conducted. The certified value of reference material was determined by ultra high performance liquid chromatography-isotope dilution tandem mass spectrometry (HPLC-ID-MS/MS). The content of hydrocortisone in healthy male and health female serum determined by this method were 107.63 ng/g (U=1.44 ng/g, k=2) and 92.24 ng/g (U=1.68 ng/g,k=2),respectively. Meanwhile, the method was verified by the comparison sample of CCQM-K63a and the measured value was within the range of uncertainty of this comparison's reference value. Experimental results showed that, serum hydrocortisone component analysis reference material met the requirements of technical norm of national primary reference material.%皮质醇是一种重要的肾上腺皮质激素,同时也是一种重要的临床诊断标志物,为保证检测结果具有溯源性、可比性和准确性,研制了血清中皮质醇成分分析标准物质.对血清样品进行分离、过滤、混匀、分装,进行均匀性检验、稳定性考察和定值分析.采用超高效液相色谱-同位素稀释串联质谱(UPLC-ID-MS/MS)法进行定值,混合健康男性血清和健康女性血清中皮质醇的定值结果分别为107.63 ng/g(U=1.44 ng/g,k=2),92.24 ng/g(U=1.68 ng/g,k=2).采用CCQM-K63a比对样品对定值方法进行验证,测量结果在该比对参考值的不确定度范围内.研制的皮质醇成分分析标准物质符合国家一级标准物质技术要求.