注射用头孢曲松钠晶型与质量关系研究

Study on the relationship between the crystal form and quality of ceftriaxone sodium for injection

目的探索头孢曲松钠晶型对注射用头孢曲松钠产品质量的影响。方法通过比较不同晶型产品长期及加速试验后高分子聚合物含量的变化,分析晶型与产品质量的关系及原因。结果头孢曲松钠不同晶型产品的质量稳定性存在差异。结论生产企业应注重产品生产工艺,选择较优的晶型以提高产品质量。

Objective Exploring the influence of crystal form of ceftriaxone sodium on the quality of ceftriaxone sodium for injection products.Methods Analyze the relationship and reasons between crystal form and product quality by comparing the changes in polymer content of different crystal form products after long-term and accelerated testing.Results There are differences in the quality stability of different crystal forms of ceftriaxone sodium products.Conclusion Production enterprises should pay attention to the production process and choose the optimal crystal form to improve product quality.