甲状腺素工作标准品的研制  

The Establishment of Thyroxine Working Standard for Immunoassay

作　　者：徐立根[1] 孙有香[1] 焦岩[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《标记免疫分析与临床》2003年第1期25-28,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：制备供免疫分析用的甲状腺素工作标准品并标定其免疫效价。用每升含 95 1.2 2mgT4的 4 0mmol/LNaOH溶液和甲状腺素基础值为零的去激素血清配制浓度为 10 0 0 μg/L的T4血清溶液。将该血清溶液按每安瓿1mL分装 (10 0 0ng/安瓿 )、冻干。以国产T4RIA药盒现行标准品为对照品标定T4工作标准品效价 ,并从工作标准品的剂量 -反应曲线上读出本所制备的 16 0 1- 970 3质控血清的T4测定值。以T4药盒标准品为对照品 ,工作标准品平均免疫效价为 94 6ng/安瓿 ,95 %概率水平的可信限为 915 - 976ng/安瓿。从工作标准品的剂量 -反应曲线上读出低、中、高值质控血清的T4测定值 ,在以相应的参考值为参照时 ,测定值的偏倚均小于 10 %。新制备的T4工作标准品适用于国产T4放射免疫分析药盒标准品的核对工作及其质控血清的标定工作。In order to make the working standard of thyroxine (T 4) for immunoassay and determinate its potency, T 4 serum solution of 1000μg/L was prepared by using T 4 solution of 951.22mg/L in 40 mmol/L NaOH and T 4-free human sera.T 4 solution was measured by ultra-violet spectrophotometry and by radioimmunoassay, then an aliquot of 1000ng T 4 per mL was distributed and lyophilized. The potency of T 4 working standard was determinated in terms of present standard of T 4 RIA kits made by chinese manufacturers and a set of T 4 quality control sera (coded as 1601-9703) for chinese manufacturers. The results showed that mean immunological potency of T 4 working standard to present kit standard is 946 ng per ampoule with confident limit of 915-976 ng at 95% probability level. In contrast to the reference values for quality control sera, bias of measured T 4 values is less than 10% at three dose levels when assayed on the dose-response curve of T 4 working standard. T 4 working standard is suitbale to check the kit standard for T 4 RIA and its quality control sera.

关 键 词：甲状腺素 标准品 研制 放射免疫分析 

分 类 号：R944[医药卫生—药剂学]