| 摘要 |
[Objectives] To optimize the crystallization process of ceftriaxone sodium using response surface methodology (RSM) for enhancing both the crystallization rate and the quality of the final product. [Methods] Four key factors, including crystallization temperature, stirring speed, solvent drop rate, and seed crystal content, were employed as independent variables, while the crystallization rate served as the response variable. The Box-Behnken response surface method was utilized for the optimization design. [Results] The optimal parameters for the crystallization process, determined through optimization, were as follows: a temperature of 10.6 ℃, a stirring rate of 150 rpm, a solvent drop rate of 1.50 mL/min, and a seed crystal content of 0.12 g. Validation tests conducted under these conditions yielded an average crystallization rate of 94.38% for the refined product. [Conclusions] The crystallization efficiency of ceftriaxone sodium is markedly enhanced, thereby offering substantial support for its industrial production and clinical application. |
