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目的:对重组胰高血糖素样肽-1受体激动剂(r Exendin-4)原液进行质量研究。方法:采用紫外光谱、肽图、飞行时间质谱及N端氨基酸序列分析对r Exendin-4原液进行结构确证;采用凯氏定氮法、BCA法及氨基酸分析法测定r Exendin-4原液的蛋白含量,建立高效液相色谱法测定原液纯度,通过纯度校正计算原液中r Exendin-4含量。结果:确证了r Exendin-4原液的结构,测得原液含量为2.21 mg·m L-1。结论:本研究所用的r Exendin-4原液结构正确、测定含量结果准确可靠,可作为HPLC外标法含量测定用对照品,用于r Exendin-4同质对照品的赋值,也可作为理化对照品用于r Exendin-4工艺中间体的评价和原液放行检验。
OBJECTIVE: To study the quality of recombinant human Exendin-4 (PG-1) agonist. Methods: The structure of r Exendin-4 was confirmed by ultraviolet spectrum, peptide map, time of flight mass spectrometry and N-terminal amino acid sequence analysis. The protein content of r Exendin-4 stock solution was determined by Kjeldahl method, BCA method and amino acid analysis , The establishment of high-performance liquid chromatography to determine the purity of the original solution, calculated by the purity of r Exendin-4 content in the solution. Results: The structure of r Exendin-4 stock solution was confirmed. The stock solution was 2.21 mg · mL-1. Conclusion: The structure of r-Exendin-4 stock solution used in this study is correct, and the content of r Exendin-4 is accurate and reliable. It can be used as reference substance for determination of HPLC external standard method, and can be used for evaluation of r Exendin-4 homogeneous reference substance. The product was used for the evaluation of r Exendin-4 process intermediates and for the release of stock solutions.