摘要
目的:建立可用于质量控制的 rh-PTH(1-34)的标准胰酶肽图分析方法,并确定其理论肽图。方法:用胰酶动态酶切rh-PTH(1-34)探索最佳肽图分析条件,利用氨基酸特征吸收波长色谱分析结合 LC-MS 相对分子质量分析确证理论肽图。结果:多批 rh-PTH(1-34)原液经胰酶解、RP-HPLC 分析后,可产生4个主要肽段,其图谱与人工合成的 hPTH(1-34)对照品一致;确定其理论肽图为:T_1—HLNSMER、T_2—LQDVHNF、L_3—VEWLR、T_4—SVSEIQLMHNLGK。结论:建立的胰肽图分析方法可用于 rh—FFH(1—34)产品的质量控制,用氨基酸特征吸收波长分析辅助 LC-MS 相对分子质量分析可有效用于 rh-PTH(1-34)的标准肽图确定。
Objective：To establish the method of tryptic peptide mapping for recombinant human parathyroid hormone [ rh -PTH（ 1 -34） ] and then determine its peptide map. Methods： Optimizing the appropriate digest conditions by dynamic digestion and RP - HPLC analysis. By characteristic wavelength chromatogram combination with LC - MS analysis, the peptide map of rh - PTH （ 1 - 34） was determined. Results： Peptide map showed mainly four peptide fragments clearly and the result was consistent with that of the synthesized h - PTH （ 1 - 34）. Their amino acids composition were ： T1-HLNSMER, TE-LQDVHNF, T3-VEWLR and T4-SVSEIQLMHNLGK, respectively. Conclusion ：The method developed here may be served as routine method in quality control for tryptic mapping of rh- PTH（ 1 -34）. The attempt by combination the characteristic wavelength chromatogram with LC -MS analysis can be adopted for determine the peptide map of peptide products.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第8期949-951,共3页
Chinese Journal of Pharmaceutical Analysis
基金
国家863重大专项
课题编号:2003AA2Z3480
