Research on the influence of key process parameters (CPP) of lyophilized powder injection on product appearance and redispersibility
冻干粉针制剂关键工艺参数（CPP）对产品外观及复溶性的影响研究

摘要

冻干粉针制剂作为一种重要的生物制剂形式，其外观质量与复溶性能直接影响产品的稳定性与临床应用效果。本文围绕冻干粉针的关键工艺参数（CPP），系统分析预冻速率、升华温度、干燥时间及压力控制等因素对产品外观结构和复溶时间的影响机制。通过实验设计与数据分析，探讨各参数的最佳控制范围，并提出优化方案以提升产品质量一致性。研究表明，合理调控关键工艺参数不仅能改善冻干产品的物理外观，还能显著提高复溶效率，为冻干粉针制剂的工业化生产提供理论依据和技术支持。

Abstract

As an important form of biological preparations, the appearance quality and redispersibility of lyophilized powder injections directly affect the stability and clinical application effect of products. This paper focuses on the key process parameters (CPP) of lyophilized powder injections, systematically analyzing the influence mechanisms of factors such as pre-freezing rate, sublimation temperature, drying time, and pressure control on the appearance structure and redispersion time of products. Through experimental design and data analysis, the optimal control ranges of each parameter are discussed, and optimization schemes are proposed to improve product quality consistency. The study shows that reasonable regulation of key process parameters can not only improve the physical appearance of lyophilized products but also significantly enhance redispersion efficiency, providing a theoretical basis and technical support for the industrial production of lyophilized powder injections.