利奈唑胺葡萄糖注射液的质量分析

摘要：目的 评价利奈唑胺葡萄糖注射液的质量现状和存在的问题。方法 采用法定标准结合探索性研究，从多方面对83批利奈唑胺葡萄糖注射液抽验样品的质量进行分析与评价。结果 法定检验结果显示83批注射用利奈唑胺葡萄糖注射液均符合规定。探索性研究中对利奈唑胺葡萄糖注射液的有关物质、对映异构体杂质和葡萄糖含量测定等方法进行了优化；建立了能同时分离15个已知杂质的HPLC方法，并发现各企业样品的杂质谱基本一致；采用LC-MS分析发现样品中均存在潜在基因毒性杂质3-氟-4-(4-吗啉基)苯胺，且在加速稳定性试验中，3-氟-4-(4-吗啉基)苯胺的含量略有增加。结论 国内利奈唑胺葡萄糖注射液的产品质量较为理想；但各生产企业应对产品中的潜在基因毒性杂质3-氟-4-(4-吗啉基)苯胺予以关注。现行质量标准亟待统一和提高。

Quality analysis of linezolid and glucose injection

Abstract Objective To evaluate the suitability of the statutory standards and the current quality of linezolidand glucose injection of different manufacturers. Methods The statutory standard methods combined withexploratory researches were used to evaluate the quality of the 83 samples. Results The statutory test showed 83batches of samples all qualified. In exploratory researches, new analysis methods of related substances, enantiomers,and glucose content were established. The new HPLC method, which could simultaneously detect fifteen knownimpurities, showed that impurity profiles of the products from different manufacturers were similar. The exploratoryresearches also showed that the potential genotoxic impurity 3-fluoro-4-morpholin-4-yl-phenylamine was detectedin the products of different manufacturers by LC-MS method. In addition, the contents of 3-fluoro-4-morpholin-4-yl-phenylamine increased slightly in the accelerated stability test. Conclusion The quality of linezolid and glucose injection was generally under good control. However, manufacturers should pay attention to the potential genotoxic impurity 3-fluoro-4-morpholin-4-yl-phenylamine in the products. The current statutory standards should be unifiedand further