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目的:研究蛋白质药物注射剂制备工艺中灌装方式对产品稳定性的影响。方法:对剪切力敏感的蛋白质分子,考察不同灌装方式对产品稳定性的影响。结果:使用蠕动泵灌装的产品,较之活塞泵灌装的产品,可见异物及稳定性相关指标均明显改善。结论:在蛋白质药物注射剂制备过程中,蠕动泵灌装工艺可尽量降低剪切力对蛋白质的伤害,能有效预防蛋白聚集,可提高产品质量和稳定性。
Objective: To study the influence of filling method on the stability of the product in the preparation of protein drug injection. Methods: Shear-sensitive protein molecules were investigated to investigate the influence of different filling methods on product stability. Results: Compared with the products filled with peristaltic pumps, the products filled with peristaltic pumps showed that the indexes of foreign materials and stability were significantly improved. CONCLUSION: During the preparation of protein drug injection, peristaltic pump filling process can minimize the damage of shearing force to protein, effectively prevent protein aggregation and improve product quality and stability.