三碘甲腺原氨酸免疫分析工作标准品的研制  

The Establishment of 3,5,3'-Triiodothyronine Working Standard for Immunoassay

作　　者：孙有香[1] 徐立根[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》2002年第2期83-87,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：制备供免疫分析用的 3,5 ,3 -三碘甲腺原氨酸 (T3 )工作标准品并标定其免疫效价。用每升含 193.2 7mgT3的 4 0mol/LNaOH溶液和去激素血清 ,配制浓度为 10 0 μg/L的T3 溶液。将该溶液按每 1mL分装 ,冻干。以国产现行标准品为对照品 ,标定配制的T3 工作标准品免疫效价为 91.4ng/安瓿 ,95 %的可信限为 88- 95ng/安瓿。并从T3 药盒工作标准曲线上 ,读出本所 16 0 1- 970 3批低、中、高质控血清的T3 值。在以相应的参考值为参照时 ,测定值的偏倚均小于 10 %。总之 ,配制的T3 工作标准品适用于国产T3The working standard of T 3 for immunoassay was prepared and its potency was determinated. T 3 solution of 193.27mg/L in 40mmol/L NaOH was measured by ultra-violet spectrophotometry and diluted to 100μg/L T 3 serum solution with thyroid hormone-free human sera. This serum solution in aliquots of 1 mL(100ng T 3 per ampoule) was distributed and lyophilized. The potency of T 3 working standard was determined by RIA and in terms of present standard of T 3 RIA kits, which were made by chinese manufacturers and T 3 values for a set of T 3 quality control sera (coded as 1601-9703) were measured in terms of T 3 working standard. Mean immunological potency of T 3 working standard to present kit standard was 91.4ng/mL with confident limit of 88-95ng/mL at 95% probability level. In contrast to the reference values for quality control sera, bias of T 3 values measured were less than 10% at three dose levels, when assayed on the dose-response curve of T 3 working standard. T 3 working standard is suitable to study on the kit standard for T 3 RIA and its quality control sera.

关 键 词：3 5 3′-三碘甲腺原氨酸 标准品 放射免疫分析 质控血清 

分 类 号：R94[医药卫生—药剂学]