缓释微球仿制药一致性评价过程中质量管理策略  

Quality Management Strategies on the Process of Consistency Evaluation of GenericDrugs of Sustained-release Microspheres:A Discussion

作　　者：魏颖 尹湉 张宇[1] 唐星[1] WEI Ying;YIN Tian;ZHANG Yu;TANG Xing(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;School of Functional Food and Wine,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]沈阳药科大学功能食品与葡萄酒学院,沈阳110016

出　　处：《医药导报》2022年第3期412-416,共5页Herald of Medicine

基　　金：国家药品监督管理局药品监管科学研究基地-沈阳药科大学药品监管科学研究院专项基金资助项目(2021jgkx007)。

摘　　要：目的研究缓释微球仿制药的质量管理策略,为缓释微球仿制药相关法律法规、审评监管工具及技术标准的制定与完善提供参考。方法梳理缓释微球制剂开发过程中关键质量属性,结合目前国内研发现状,提出将药物空间分布及存在形式应用于缓释微球质量管理。结果通过文献调研,了解到缓释微球复杂的生产工艺以及难以控制的释药行为对质量控制是巨大的挑战,且药物空间分布及其存在形式对药物释放行为的影响很大。结论建议将药物空间分布及存在形式也列为仿制缓释微球制剂质量控制的技术要求之一,从而提高质量管理的科学性。Objective The quality management strategy of generic drugs of sustained-release microspheres is studied in order to lay foundation for future formulation and refinement of relevant laws and regulations,regulatory tools and technical standards.Methods Combing the key quality attributes in the development process of sustained-release microspheres and the current domestic status of research and development,it is proposed to apply the spatial distribution and existing form of drugs to the quality management of sustained-release microspheres.Results Through literature research,we have learned that the complex production process of sustained-release microspheres and the hard-to-control drug release behavior are huge challenges for quality control,and the spatial distribution and existing form of drugs have a great influence on the drug release.Conclusion It is suggested that the spatial distribution and existing form of drugs should also be listed as one of the technical requirements for quality control of generic drugs of sustained-release microspheres in order to improve the scientific nature of quality management.

关 键 词：仿制药 一致性评价 质量管理 缓释微球 药物空间分布和存在形式 

分 类 号：R95[医药卫生—药学]