中文摘要：

目的：对重组人甲状旁腺素rh-PTH（1-34）结构类似物（以下简称rhPTH′）的纯度进行质量控制,为其生产工艺提供实验室研究依据。方法：采用聚丙烯酰胺小肽凝胶电泳（SDS-PAGE）、等电聚焦电泳（IFE）、氨基酸组成分析和反相高效液相色谱法（RP-HPLC）对制备的rhPTH′的纯度等进行质量鉴定,并配合质谱法测定样品的精确相对分子质量。结果：经鉴定酸水解后目的蛋白纯度为89.2%;离子交换层析后样品纯度经电泳和HPLC鉴定分别为100%和94.9%;样品等电点为9.05,与理论值基本一致;氨基酸组成与理论组成相同,质谱鉴定相对分子质量为4663.76,与理论值4664.01相差0.25。结论：用现有生产和纯化工艺制备的rhPTH′具有较高的纯度,质量符合要求。

英文摘要：

Objective：Quality research of rh-PTH （1-34） analog （rhPTH′）,to provide evidence on its purification process and to perform quality control of its purity.Methods：The quality of its purity was determined by SDS-PAGE,isoelectric focusing electrophoresis（IFE）,amino acid composition analysis and RP-HPLC.The precise relative molecular mass of rhPTH′ was measured by electrospray ionization mass spectrometry.Results：The purity of rhPTH′ after acid hydrolysis determined by SDS-PAGE was 89.2%.After CM-52 ion exchange chromatography the purity was 100% and 94.9%,determined by SDS-PAGE and RP-HPLC,respectively.The pI of pure rhPTH′ was 9.05 and amino acid composition analysis of pure rhPTH′ was consistent with theoretical composition.The relative molecular mass was 4663.76,which had a 0.25 difference from theoretical value.Conclusion：The rhPTH′ prepared by existing process has a relatively high purity and its quality is in line with the quality specification.