人胎盘泌乳素免疫测定用国家标准品的研制  

Preparation of Human Placental Lactogen (HPL) National Standard for Immunoassay

作　　者：沈洪征[1] 黄颖[1] 焦岩[1] 徐立根[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《同位素》2003年第4期180-185,共6页Journal of Isotopes

摘　　要：人胎盘泌乳素原料经聚丙烯酰胺凝胶电泳分析在相对分子量为21 000～22 000处有两条显色相近的主带,在5 000～80 000处有数条微弱杂质色带,蛋白定量分析为1.06 g/L,用放射免疫分析方法标定其免疫活性为2.187 g/L,其剂量-反应曲线与人胎盘泌乳素国际参考品(编号73/545)平行,表明该原料适于制作标准品。用含0.2％(w/V)人血清白蛋白、1％甘露醇的磷酸盐缓冲液(0.01 mol/L,pH7.4)配制的30mg/L人胎盘泌乳素溶液按每安瓿0.5 mL分装,经冷冻干燥制备成标准品。以人胎盘泌乳素国际参考品为对照品,用放射免疫分析法对其免疫活性进行标定,均值为14.19 μg/支,95％可信限为13.50～14.88 μg/支。分别以国际标准品和本标准品为对照品测定同一套人胎盘泌乳素质控血清,证明对不同剂量水平的质控血清测定均值非常接近,统计学分析上无显著差异,P>0.05。The raw material is analyzed for preparation of HPL national standard (NS) for im-munoassay. Impure zone is not found by polyacrylamide gel electrophoresis,protein amount is 1. 06 g/L and immunoactivity is 2.187 g/L by RIA.with its dose-response curve being parallel to that of HPL International Reference Preparation(IRP) coded (73/545). The results demonstrate that this material is suitable to be prepared as HPL NS. 2. 06 mL of raw material diluted in 0.01mol/L phosphate buffer (pH7. 4) containing 0. 2% human serum albumin and 1% mannitol is distributed into aliquot of 0. 5 mL (15μg per ampoule) ,lyophilized and assayed by RIA. The mean value of the NS is 14.19μg per ampoule in terms of IRP. Similar values are obtained for the HPL contents of quality control serum samples at different dose levels when ether the IS or NS is used as the assay calibrator. It indicats that there is no statistically significant difference between the serum sample values at the same levels.

关 键 词：人胎盘泌乳素(HPL) 国际参考品(IRP) 国家标准品(NS) 放射免疫分析(RIA) 

分 类 号：R817.9[医药卫生—影像医学与核医学]