摘要
目的确定第5批绒促性素国际标准品及其效价。方法以第4批绒促性素国际标准品(编号75/589,Calibrated in International Units)与第1批完整体绒促性素国际参考试剂(编号99/688,Calibratedin Molar Units)为基准,英国国家生物制品检定所组织并邀请包括本实验室在内的来自全球10个国家的18个实验室,采用免疫测定法(包括免疫酶测定法、放射免疫测定法、荧光免疫测定法、酶联免疫吸附法、化学发光免疫测定法)和生物测定法(包括幼小白鼠子宫增重法、幼大白鼠精囊增重法)对第5批绒促性素国际标准品2个候选品(编号:07/364,96/608)效价进行协作标定;采用热加速降解方法研究其稳定性。结果与结论英国国家生物制品检定所最终确定候选品(编号07/364)为第5批绒促性素国际标准品,其效价为177IU.安瓿-1(0.39nmol.安瓿-1),并具有良好的稳定性。
Objective To study the titer of the proposed international 5th standard for chorionic gonadotrophin （CG）. Methods Methods The titer of two candidate standards （coded 07/364, 96/608） was calibrated by 18 laboratories in 10 countries, and were compared by immunoassay （including immunoenzymometric assay, radioimmunoassay, fluoroimmunoassay, enzyme-linked immunosorbent assay, chemiluminescent immunoassay） and bioassay （including uteri weight gain in mice, seminal vesicle weight gain in rats） with the existing International Standard coded 75/589, calibrated in international units, and the WHO Ist Reference Reagent for intact CG coded 99/688, calibrated in molar units. The stability was studied by accelerated thermal degradation. Results and Conclusion Assays of the CG titer of the candidate standard, coded 07/364, by immunoassay and bioassay were in broad agreement and indicated that it would be suitable and stable to serve as a reference preparation with an assigned titer of 177 IU per ampoule （0.39 nmol · ampoule-1）.
出处
《中国药事》
CAS
2013年第4期405-410,共6页
Chinese Pharmaceutical Affairs
关键词
人绒毛膜促性腺激素
标准品
效价
生物测定
免疫测定
human chorionic gonadotrophin （HCG）
standard reference
titer
bioassay
immunoassay
