【摘要】 目的 :对重组人甲状旁腺素 1- 34进行肽图谱测定 ,以确证一级结构和比较不同批产品间一级结构的一致性。方法 :运用梯度洗脱 /反相高效液相色谱法对样品进行纯度检查和肽图谱测定。结果 :建立了重组人甲状旁腺素 1 -34的胰蛋白酶水解肽图谱HPLC测定方法 ,3批样品的肽图谱均与对照品一致。结论 :建立的肽图测定方法简便、准确、重现性好 ,适用于产品的质量控制。更多还原

【Abstract】 AIM:To establish a method of peptide mapping analysis for primary structure identification of recombinant human parathyriod hormone 1-34(rhPTH 1-34)and consistency validation among different batches.METHOD:Gradient elution/RP-HPLC was applied to check the purity of rhPTH1-34 and peptide mapping analysis.RESULT:The method for tryptic peptide mapping of rhPTH1-34 has been established.The tryptic peptide mapping of samples with different batch were accorded with the reference.CONCLUSION:This method proves to be simple,accurate and reproducible,and it is suitable for the quality control of products.更多还原