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目的综合评价注射用美洛西林钠/舒巴坦钠的质量现状。方法采用现行法定标准结合探索性研究对市场上4家生产企业的102批注射用美洛西林钠/舒巴坦钠的质量进行系统比较,通过对原料药和制剂有关物质、聚合物及杂质谱等的考察,结合加速稳定性试验,分析不同企业产品注射用美洛西林钠/舒巴坦钠的质量差异。结果法定标准检验102批注射用美洛西林钠/舒巴坦钠,合格率为100%;探索性研究揭示现行标准中有关物质检查方法欠缺和聚合物杂质检查缺失,导致质量控制不到位。结论国内注射用美洛西林钠/舒巴坦钠整体质量一般,质量标准有待统一和提高。
Objective To comprehensively evaluate the quality status of mezlocillin sodium / sulbactam sodium for injection. Methods The quality standards of mezlocillin sodium / sulbactam sodium for injection in 102 batches of 4 manufacturing enterprises in the market were systematically compared with the existing statutory standards and exploratory studies. The quality of raw materials and preparations related substances, polymers and impurity spectra And other inspection, combined with accelerated stability test, analysis of different products for the injection of mezlocillin sodium / sulbactam sodium quality differences. Results A total of 102 batches of mezlocillin sodium / sulbactam sodium for injection were tested by the statutory standard, with a pass rate of 100%. Exploratory studies revealed that the existing standards lacked methods for checking substances and missing polymer impurities, resulting in poor quality control. Conclusion The overall quality of the domestic injection of mezlocillin sodium / sulbactam sodium in general, the quality standards to be unified and improved.