摘要
目的通过肽图谱分析,鉴定重组人甲状旁腺素1-34产品一级结构的完整性和准确性。方法采用胰蛋白酶裂解-反相高效液相色谱法测定肽图;用LC-MS/MS和N端氨基酸测序鉴定产品氨基酸序列。结果建立重组人甲状旁腺素1-34产品肽图测定法,并鉴定出肽图异常产品的氨基酸序列。结论肽图分析能有效地控制重组人甲状旁腺素1-34产品一级结构的完整性和准确性,对该产品的质量控制具有重要意义。
Abstract
OBJECTIVE To identify the integrity and accuracy of the primary structure of Recombinant Human Parathyriod Hormone 1-34(rhPTH134) products by peptide mapping analysis.METHODS The peptide mapping was analyzed by trypsin digestion and RP-HPLC analysis.The amino acid sequences of product were measured by LC-MS/MS and N-terminal sequence determination.RESULTS The peptide mapping analysis of rhPTH1-34 products was established.The amino acid sequences of rhPTH1-34 product with a different peptide mapping were measured.CONCLUSION The peptide mapping analysis can be used for the control of the integrity and accuracy of the primary structure of rhPTH1-34 products effectively.It has an important significance for the quality control of the products.
关键词
肽图谱分析 /
重组人甲状旁腺素1-34 /
胰蛋白酶裂解-反相高效液相色谱法
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Key words
peptide mapping analysis /
rhPTH1-34 /
trypsin digestion and RP-HPLC analysis /
LC-MS/MS /
amino acid sequences
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曾文珊;廖海明;杨仲元;徐康森.
肽图分析在重组人甲状旁腺素1-34产品质量控制中的应用[J]. 中国药学杂志, 2006, 41(13): 1020-1022
ZENG Wen-shn;LIO Hi-ming;YNG Zhong- yun;XU Kng-sen.
Significance of Peptide Mapping in the Quality Control of Recombinant Human Parathyriod Hormone 1-34 Products [J]. Chinese Pharmaceutical Journal, 2006, 41(13): 1020-1022
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参考文献
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脚注
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