头孢匹胺注射剂的工艺合理性评价  

The research of process rationality of cefpiramide for injection

作　　者：李雪[1] 肖慧[1] 洪建文[1] 

机构地区：[1]广东省药品检验所,广州510180

出　　处：《中国抗生素杂志》2017年第6期465-469,共5页Chinese Journal of Antibiotics

摘　　要：目的考察头孢匹胺注射剂3种生产工艺的合理性。方法通过考察不同工艺产品中有关物质、溶解时间、固体稳定性、溶液稳定性和添加苯甲酸钠的合理性,结合临床不良反应评价头孢匹胺注射剂的工艺合理性。结果 3种生产工艺产品相比较,混粉法产品在临床使用中存在溶解时间偏长的缺点;冻干法产品的起始杂质含量偏高,在储存过程中最不稳定,且含有一定量的苯甲酸钠,作为静脉给药注射剂,有一定的安全性风险;溶媒结晶法产品纯度较高,稳定性也较好。结论溶媒结晶工艺得到的头孢匹胺钠盐注射剂相对更安全,质量更可控。Objective To investigate three kinds of processes＇ rationality of the cefpiramide for injection. Method To evaluate difference processes＇ rationality of the eefpiramide for injection, by testing the impurities, dissolution time, solid stability, stability of solution, adding pharmaceutical excipient rationality and clinical adverse events of difference processes. Results Cefpiramide for injection, which add anhydrous sodium carbonate in the process, dissolution time was longer; cefpiramide sodium for injection, which add sodium benzoate in the process, impurities growing fast in the solid test, and it would bring some sort of risk; cefpiramide sodium for injection, prepared by solvent crystallization, without adding other materials, not only have a high purity, but also have a better stability. Conclusion Cefpiramide sodium for injection, prepared by solvent crystallization, is relatively safter. And the quality of this process is more controllable.

关 键 词：头孢匹胺注射剂 工艺合理性 有关物质 

分 类 号：R978.1[医药卫生—药品]