水解氨基酸法测定注射用促肝细胞生长素中肽的含量

Determination of peptide contents of hepatocyte growth-promoting factor for injection by acid hydrolytic method

摘要: 探讨注射用促肝细胞生长素中肽含量的测定方法并比较不同厂家产品的质量差异。采用盐酸水解多肽方法，利用AccQ-Tag氨基酸衍生技术，使用Kromasil 100-5 C₁₈色谱柱（250 mm×4.6 mm，5 μm）进行液相色谱分析，水解后游离氨基酸总量扣除水解前氨基酸总量即为肽含量。各氨基酸测定结果具有良好线性（r＝0.999 1~0.999 9，n=6），游离氨基酸回收率为101.1％~104.6%，水解氨基酸平均回收率为101.8%~104.1%。本方法可作为注射用促肝细胞生长素中肽含量测定的方法补充和完善。

Abstract: To investigate the analytic method for the determination of the peptide contents in hepatocyte growth-promoting factor for injection and compare the product quality differences in different factories.An AccQ-Tag method coupled with an HPLC using Kromasil 100-5 C₁₈column (250 mm×4.6 mm，5 μm) was established for the determination of amino acids in acid hydrolytic samples.The contents of peptide was calculated by subtracting the amino acid amout in the non-hydrolytic samples from the total amino acids amount in the hydrolytic sample.The linearly dependent coefficient of each amino acid was in the range of 0.999 1-0.999 9（n=6）.The recove-ries of non-hydrolytic amino acids were 101.1%-104.6%，The recoveries of total amino acids were 101.8%-104.1%.The method is suitable for the determination of peptide contents in drug.