基于既定条件和设计空间的非诺贝特胶囊药学变更研究  

Pharmaceutical Changes of Fenofibrate Capsules Based on Established Conditions and Design Space

作　　者：白秀秀 陈歆宇 王丹 杜宏伟 BAI Xiuxiu;CHEN Xinyu;WANG Dan;DU Hongwei(Xi'an Hanfeng Pharmaceutical Co.,Ltd.,Xi'an,Shaanxi,China 710500;Shaanxi Provincial Drug and Vaccine Inspection Center,Xi'an,Shaanxi,China 710065)

机构地区：[1]西安汉丰药业有限责任公司,陕西西安710500 [2]陕西省药品和疫苗检查中心,陕西西安710065

出　　处：《中国药业》2023年第17期44-49,共6页China Pharmaceuticals

摘　　要：目的基于既定条件和设计空间探讨已上市药品药学变更管理的路径。方法根据人用药品注册技术要求国际协调会(ICH)Q系列技术指南Q8和Q12中既定条件和设计空间的定义和要求,评估变更事项和确定变更研究事项,并对西安汉丰药业有限责任公司生产的非诺贝特胶囊进行药学变更管理。结果以非诺贝特胶囊药学变更管理为例,增加原料药供应商、变更制粒设备、增加整粒工艺步骤。变更前后,原料药质量一致,产品质量稳定,符合非诺贝特胶囊质量标准要求,且产品溶出行为相似。结论应用既定条件和设计空间理念指导非诺贝特胶囊原料药供应商、生产工艺和生产设备变更研究,可为已上市药品的药学变更管理提供参考。Objective To investigate the path for pharmaceutical change management of marketed drugs based on established conditions and design space.Methods According to the definition and requirements of the established conditions and design space in the Q series Technical Guidelines Q8 and Q12 of the International Council for Harmonisation of Technical Requirements for pharmaceuticals for Human Use(ICH),the change matters were evaluated,the change research matters were determined,and the pharmaceutical change management of fenofibrate Capsules from the Xi'an Hanfeng Pharmaceutical Co.,Ltd.was carried out.Results Taking the pharmaceutical change management of Fenofibrate Capsules as an example,adding active pharmaceutical ingredients(API)suppliers,changing granulation equipment and increasing the whole granulation process steps.Before and after the change,the quality of API was consistent,the quality of the product was stable,which could meet the quality standard requirements of Fenofibrate Capsules,and the dissolution behavior of the product was similar.Conclusion Established conditions and design space concepts used for the guidance of the change of API suppliers,production process and production equipment of Fenofibrate Capsules can provide a reference for the pharmaceutical change management in marketed drugs.

关 键 词：非诺贝特胶囊 药学变更 既定条件 设计空间 溶出曲线 

分 类 号：R95[医药卫生—药学] R972.6[化学工程—制药化工] TQ460.6