注射用氨苄西林钠氯唑西林钠质量评价

目的评价不同生产工艺的注射用氨苄西林钠氯唑西林钠的质量现状及存在问题。方法按照国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品研究,统计分析结果。结果法定标准检验47批次样品,合格率100%。探索性研究建立了有关物质检查方法,对各杂质的来源与结构进行了确证;杂质主要由原料引入,不同生产工艺样品中杂质的种类基本一致,但杂质含量及分布有较大差异。结论注射用氨苄西林钠氯唑西林钠质量总体较好,现行质量标准需进一步完善。原料药的质量影响制剂质量,采用不同生产工艺氨苄西林钠原料药生产的样品质量存在明显差异,冻干氨苄样品质量不及结晶氨苄样品,且更易受温度的影响。因此,应引导企业首选溶媒结晶工艺氨苄西林钠原料。

Quality assessment of ampicillin sodium and cloxacillin sodium for injection

Abstract Objective To evaluate the suitability of the statutory and the quality of ampicillin sodium and cloxacillin sodium for injection of different production processes. Methods According to the general requirements of national drug assessment programs, the statutory standard methods combined with exploratory researches were used to evaluate the quality of ampicillin sodium and cloxacillin sodium for injection. Results According to the statutory standards, 47 batches were examined and the qualified rate was 100%. The method of related substance test was optimized. This paper also researched the structures and sources of impurities. Exploratory research showed that all impurities were mainly from impurities in raw materials. The kinds of impurities from different batches of different production processes were roughly the same, but the distribution and the contents of them had greater differences. Conclusion The quality of ampicillin sodium and cloxacillin sodium was generally under good control. However, the quality control specification needs to be further improved. The quality of raw material affects the quality of ampicillin sodium and cloxacillin sodium. Studies have shown that the quality of freeze drying process sample is inferior to that of solvent crystallization process sample. Therefore, enterprises should be guided to choose the solvent crystallization process ampicillin sodium raw