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重组人甲状旁腺激素1-34的氨基酸组成分析

Analyse the Amino Acid Composition of Recombinant Human Parathyroid Hormone 1-34

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【作者】 曾文珊廖海明杨昭鹏杨仲元刘景晶徐康森

【Author】 ZENG Wen-shan 1, LIAO Hai-ming 2, YANG Zhao-peng 2, YANG Zhong - yuan 1, LIU Jing-jing 3, XU Kang-sen 2 (1. Guangzhou Institute for Drug Control, Guangzhou 510160; 2.National Inst it ute for the Control of Pharmaceutical and Biological Products, Beijing 100050; 3.China Pharmaceutical University, Nanjing 210009)

【机构】 广州市药品检验所中国药品生物制品检定所中国药科大学中国药品生物制品检定所 广州510160北京100050广州510160南京210009北京100050

【摘要】 分析重组人甲状旁腺激素 1-3 4的氨基酸组成 ,为该品种的结构鉴定提供依据。水解条件含 1%苯酚的6mol L盐酸 ,10 5℃水解 2 4h ;衍生方法异硫氰酸苯酯 (PITC)柱前衍生法 ;氨基酸测定色谱条件色谱柱为PhenomenexprodigyODS 10 0A。 (4 .6mm× 2 5cm ,5 μm) ;流动相A为 0 .1mol L醋酸钠 (pH6.5 ) -乙腈 (93 :7) ,B为水 -乙腈 (1:4) ;二元梯度洗脱 ;检测波长为 2 5 4nm ;流速为 1ml min ;柱温为 40℃。结果 :实验值与理论值一致 ,偏差小于 10 %。本法准确、可靠、重现性好 ,可用于该产品的质量控制。

【Abstract】 To analyse the amino acid composition of Recombinant Human Parathyriod Hormone 1-34(PTH1-34) so as to provide the basis for the characterization o f PTH1-34 structure. The Hydrolysis conditions were 1% Phenol and 6 mol /LHCl at 105℃for 24 hours.The derivatization method was phenylisothiocyanate(PITC) preco lum derivatization. The amino acids determination conditions:The column was Phen omenex prodigy ODS 100A?(4.6mm×25cm,5μm).The mobile phase A were 0.1mol/Ls odium acetate solution(pH6.5) and acetonitrile(93:7). The mobile phase B wer e water and acetonitrile(1:4).Gradient elution was used.The detective waveleng th was 254nm. The flow rate was 1ml/min.The column temperature was 40℃. The mea sured value is identical with the theoretical value and error is less than 10%. This method is accurate ,reliable, reproducible and suitable for the quality c ontrol of the drug.

  • 【文献出处】 药物生物技术 ,Pharmaceutical Biotechnology , 编辑部邮箱 ,2003年02期
  • 【分类号】R917
  • 【被引频次】10
  • 【下载频次】187
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