Journal of Chemistry and Chemical Research

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.

Lyophilized powder injection; Key process parameters; Product appearance; Redispersibility; Pre-freezing rate