目的:研究蛋白质药物注射剂制备工艺中充氮对产品氧化的影响。方法:对配液搅拌过程中溶氧造成的产品氧化,进行配液过程中充入氮气进行抗氧保护的工艺优化。结果:配液过程中充氮后,配液后半成品氧化程度较之原液无增长。结论:在蛋白质药物注射剂制备过程中,配液充氮工艺可有效改善产品因溶氧而发生不同程度氧化的现象,能有效预防蛋白降解,可提高产品质量和稳定性。 Objective: To study the effect of nitrogen in the preparation process of protein drug injection on the oxidation of the product. Methods: The oxidation of the product caused by dissolved oxygen in the process of mixing with liquid was optimized, and the process optimization of oxygen protection was filled with nitrogen during dosing. Results: After nitrogen was dosed, the degree of oxidation of the semi-finished product after dosing was no longer than that of the original solution. Conclusion: During the process of preparation of protein drug injection, the process of nitrogen filling with solution can effectively improve the oxidation of products due to dissolved oxygen, effectively prevent protein degradation and improve product quality and stability.