注射用哌拉西林钠/三唑巴坦钠质量分析

Quality analysis of piperacillin sodium and tazobactam sodium for injection

目的对不同生产工艺注射用哌拉西林钠/三唑巴坦钠的质量进行对比研究及评价。方法运用水活度、水分、酸度、有关物质、聚合物等方法测定不同生产工艺的样品,同时进行加速试验,并将测定结果进行多因素相关分析,综合评价不同生产工艺样品的质量。结果酸混成盐冻干工艺样品的有关物质、水分、水活度、聚合物测定结果均明显低于直接混合工艺和盐混冻干工艺样品,且稳定性较好。结果表明:原料生产工艺是影响制剂质量的关键所在,且水分与样品质量密切相关。结论酸混成盐冻干工艺样品最优,盐混冻干工艺次之,直接混合工艺较差,且更易受温度的影响。说明原料药生产工艺是影响产品质量的重要因素,因此,建议企业首选酸混成盐冻干工艺。

Objective To study and evaluate the quality of different production process of piperacillin sodium and tazobactam sodium for injection. Methods The samples and accelerated samples were analyzed by using the determination of the related substances, water, water activity, pH and polymers. Meanwhile, the quality status of piperacillin sodium and tazobactam sodium for injection was evaluated by multi-factors correlation analysis of the determination results. Results The determination results of related substances, water, water activity and polymers of the production of acid mixed salt freeze-drying were much lower than the direct mixed samples and salt mixed freeze- drying samples. Besides, the production of acid mixed salt freeze-drying was more stable. The results have shown that manufacturing technique of raw materials is the key to the quality of preparation, and water is closely related to the quality of piperacillin sodium and tazobactam sodium. Conclusion The production of acid mixed salt freeze-drying is best, the the direct mixed process is worst and more susceptible to temperature. Therefore, manufacturing technique of raw materials was an important factor to the the quality of preparation, suggested that it is better for enterprise to adapt the preferred acid mixed salt freeze-drying process.