头孢曲松钠的亚晶型分类及对产品质量的影响

Subtype classification of ceftriaxone sodium and its influence on the quality of product

采用粉末X射线衍射技术结合聚类分析手段,对75批结晶型头孢曲松钠样品进行了亚晶型的分类表征,通过扫描电镜技术获得了各亚型样品的微观晶体形态。通过比较不同亚型样品的成盐率、水分等与结晶工艺相关的指标,研究加速实验过程中不同亚型样品的晶格稳定性差异和与药用丁基胶塞的相容性差异,证明了提高国产头孢曲松钠产品质量的关键应从控制样品的亚晶型入手,改善成盐及结晶工艺,生产稳定性好的Ⅱ亚型样品。

Powder X-ray diffraction（PXRD） technology combined with cluster analysis method was used to classify 75 batches of crystalline ceftriaxone sodium into subtypes, the crystalline characteristics of each subtype were measured with scanning electron microscope（SEM）. By comparing some parameters of these subtypes correlated to crystallization process of ceftriaxone sodium, such as salification rate, water content in different subtypes, as well as by studying different lattice stabilities, different compatibilities with rubber closures during accelerated stability tests, the key point to improve the quality of domestic ceftriaxone sodium was disclosed. The results of this paper indicated that the fine structure of the products could be controlled well by improving the salification and crystallization process. As a result, the subtype II of ceftriaxone sodium with high stability can be produced.