| 张帆,吕明,佟飞,刘福利.化学药物中亚硝胺杂质的控制策略及审评考虑[J].中国药事,2023,(12):1431-1437 |
| 化学药物中亚硝胺杂质的控制策略及审评考虑 |
| Considerations and Requirements for Control of Nitrosamine Impurities inChemical Drugs |
| 投稿时间：2023-07-26 |
| DOI：doi:10.16153/j.1002-7777.2023.12.013 |
| 中文关键词: 亚硝胺杂质 沙坦类药物 质量控制 杂质限度 风险评估 |
| 英文关键词: nitrosamine impurities sartan drugs quality control impurity limit risk assessment |
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| 摘要点击次数: 554 |
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| 中文摘要: |
| 目的：为完善亚硝胺杂质的科学监管及制药企业建立亚硝胺杂质的控制策略提供参考。方法：通过梳理中国、美国和欧盟关于亚硝胺杂质的监管及控制要求，进一步探讨亚硝胺杂质的来源、质量控制及风险评估。结果与结论：自2018年在沙坦类等药物中检出不可接受水平的亚硝胺杂质以来，国内外监管机构相继开展了化学药物中亚硝胺杂质的调查并发布相关控制措施以降低风险。亚硝胺杂质属于ICHM7（R1）中提及的“关注队列”物质，可以通过多种途径引入到化学药物或药物自身降解产生，实现对亚硝胺杂质的有效控制，对于保证药品的安全及质量可控至关重要。 |
| 英文摘要: |
| Objective: To provide the control strategies of nitrosamine impurities for regulatory agencies andpharmaceutical companies. Methods: By sorting out the regulatory and control reguirements of China, the UnitedStates, and the European Union regarding nitroszmine impurites, futher explore the sources, quality control andrick assessment of nitrosamine impurities. Results and Conclusion: In 2018, unacceptable levels of nitrosamineimpurities were detected in sartan drugs. Domestic and foreign regulatory agencies have successively conductedinvestigation on nitrosamine impurities in chemical drugs and issued relevant control measures to reduce risks.Nitrosamine impurities were classifi ed as the “cohort of concern” by ICH M7 (R1), which could be produced froma variety of pathways or drug degradation. The eff ective control of nitrosamine impurities was essential to ensurethe safety and quality of drugs. |
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