国产注射用美洛西林钠质量评价

Quality Assessment of Mezlocillin Sodium for Injection

关键词:  注射用美洛西林钠  质量分析

Key words:  mezlocillin sodium for injection  quality assessment

摘要:

目的 通过对20个生产企业的204批注射用美洛西林钠的评价性抽验结果进行分析，评价国产注射用美洛西林钠的质量现状。方法 采用水活度、水分、有关物质等方法测定不同工艺的样品；通过加速试验、多因素相关分析，探索性地考察样品胶塞中部分挥发性物质与药物的相容性，综合评价产品质量。结果 冷冻干燥工艺生产的样品质量及稳定性均较无菌分装样品更好，水分及温度与产品质量密切相关，原料质量是影响制剂质量的关键。结论 国产注射用美洛西林钠总体质量较好，现行质量标准有待提高。

Abstract:

OBJECTIVE To evaluate the quality status of mezlocillin sodium for injection through 204 batches of samples from 20 producers. METHODS The samples and accelerated samples were analyzed by determining water activity, water, and related substances. The volatile substances of butyl rubber closures were studied on patibility between them and mezlocillin sodium for injection. The quality status of samples were evaluated by multi-factors correlation analysis of the determination results. RESULTS The quality and stability of the samples produced by freezing drying were better than those produced by sterilized shipment. The water and temperature were closely related to the quality of mezlocillin sodium for injection and the quality of raw material was the key to the quality of preparation. CONCLUSION The most products quality of mezlocillin sodium for injection meet current standards. The existing standard is in deficiencies’ and need to be improved.