关于重组人泌乳素制剂作为推荐的WHO参考试剂的评估  

Evaluation of Recombinant DNA-derive Human Prolactin Preparation As Proposed WHO Reference Reagent

作　　者：黄颖[1] 沈洪征[1] 徐立根[1] 李波[1] 冷炜[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2006年第4期218-222,229,共6页Chinese Pharmaceutical Affairs

摘　　要：本文报告了在国际协作研究中，以泌乳素第3次国际标准品为对照品，用放射免疫分析和免疫放射量度分析试荆盒测定rhPRL97／714、G-PRL98／580和NG-PRL98／582以及泌乳素国家标准品的免疫效价。放射免疫分析法结果：rhPRL97／714、G-PRL98／580和NG-PRL98／582效价的几何均数分别为1275、239和597mIU／安瓿，相当于WHO初步报告中提供的几何均数的100．79，6，103％和97．5％；泌乳素国家标准品与第3次国际标准品的相对效价为0．90。免疫放射量度分析法结果：rhPRL 97／714、G-PRL 98／580和NG-PRL 98／582效价的几何均数分别为956、194和439mIU／安瓿，相当于WHO初步报告中提供的几何均数的75．5％，83．6％和71．7％；泌乳素国家标准品与第3次国际标准品的相对效价为0．92。表明；即使同一个实验室内，不同的免疫分析方法之间也存在一定差异。双份样品精密性测定：泌乳素第3次国际标准品双份样品之间的相对效价为0．95～0．99，rhPRL 97／714双份样品之间的相对效价为1．01～1．04。＋45℃热加速降解样品测定结果符合WHO报告中所述的免疫活性变化趋势。The immunizing potencies of rhPRL 97/714. G-PRL 98/580, NG-PRL98/582 and prolactin of national standard （NS PRL 532-9604） were assayed in the international collaborative study, using RIA and RIMA kits, and with the third IS PRL 84/500 as reference substance. In the RIA experiments, the geometric means of the potencies were 1275mIU/ampoule for rhPRL 97/714. 239mIU/ ampoule for G-PRL 98/580 and 597mIU/ampoule for NG-PRL98/582, and were respectively equal to 100. 7 %, 103 % and 97.5 % of the geometric means supplied by WHO draft report. The Relative potency of NS PRL 532-9604 is 0.90 to the third IS PRL 84/500. In the IRMA experiments, the geometric means of the potencies were 956mIU/ampoule for rhPRL 97/714. 194mIU/ampoule for G-PRL 98/580 and 439mIU/ampoule for NG-PRL98/582, and were respectively equal to 75.5%, 83.6% and 71.7% of the geometric means supplied by WHO draft report. The relative potency of NS PRL 532-9604 is 0. 92 to the third IS PRL 84/500. The results showed method based differences between immunoassays. Precision estimation of duplicates indicated that relative potency ranged from 0. 95 to 0.99 for third IS PRL84/500 and from 1.01 to 1.04 for rhPRL97/714. The determination result of the thermal degradation samples at ＋45℃ was consonant with the trend of immunocompetence change descried in the WHO draft report.

关 键 词：重组DNA衍生的人泌乳素 糖基化泌乳素 非糖基化泌乳素 国际标准品 国家标准品 放射免疫分析 免疫放射量度分析 精密性 

分 类 号：R95[医药卫生—药学]