氨曲南及注射用氨曲南的质量分析

Quality assessment of aztreonam and aztreonam for injection

目的:从安全性、有效性和质量可控性等方面对已上市的氨曲南及注射用氨曲南进行全面质量分析和评价。方法:依据现行法定质量标准,对已上市的氨曲南及注射用氨曲南进行标准检验,分析其质量总体水平,比较不同生产企业产品的质量。根据专题调研、文献检索和标准检验结果及分析等情况,就有关物质、加速试验后溶液的澄清度、残留溶剂和重金属等4个方面开展探索性研究。结果:本次抽验中涉及的42批次样品标准检验合格率为100%。但在探索性研究中发现了单个未知杂质超过鉴定限度、倒置加速试验后药物溶液的澄清度变差等问题。结论:氨曲南及注射用氨曲南现行质量评价标准可行,质量状况良好,但仍有提升空间。建议改进氨曲南的合成及生产工艺,降低未知杂质含量,进一步研究和考察合成及生产工艺引入的残留溶剂;加强主药与胶塞的相容性研究,使用覆膜胶塞或不与主药发生相互作用的胶塞进行包装,减少不溶性杂质的引入,确保临床用药安全。

Objective:To comprehensively analyze and evaluate the safety,efficacy and quality of aztreonam and aztreonam injection.Methods:Depending on the current specified quality standards,the standards of aztreonam and for injection were evaluated,overall quality level was analyzed,and the quality of products from different manufacturers was compared.Based on special investigation,literature retrieval and analysis of the testing results,an exploratory study was carried out corresponding to the detection of related substances,clarity of solution after accelerated tests,residual solvents and heavy metals.Results:The qualified rate of 42 batches of samples tested according to current legal quality standards was as high as 100%.In the exploratory study,it was found that one single unknown impurity or foreign matter exceeded the identification limit,and the clarity of the drug solution became worse after inverted accelerated test.Conclusion:The current evaluation standards of aztreonam and aztreonam for injection were practical and the drug quality was fine,but there is still space for further improvement.It is recommended that the synthesis and production process of aztreonam be further improved,the level of the unknown impurity reduced,and further research and investigation of residual solvents in the synthesis and production process be further required.Compatibility research on the main drug and the rubber plug should be intensified,and for packaging the plastic plug or the rubber plug which will not interact with the main drug should be used,so that entry of insoluble impurities could be reduced and safety of clinical medication be ensured.