我国复杂制剂开发难点及应对策略探讨  

Discussion on development difficulties and countermeasures of complex preparations in China

作　　者：宋波 郑啸 石娟 操锋[2] SONG Bo;ZHENG Xiao;SHI Juan;CAO Feng(Center for Food and Drug Inspection of NMPA,Beijing 100044,China;School of Pharmacy,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100044 [2]中国药科大学药学院,南京210009

出　　处：《中国药房》2022年第13期1537-1540,1547,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81373362)。

摘　　要：目的探讨我国复杂制剂开发难点并提出解决方法,以期为复杂制剂的开发和制备提供一定参考。方法基于医药产业复杂制剂领域的发展现状,分析复杂制剂发展面临的挑战,并提出复杂制剂开发的应对策略。结果与结论复杂制剂的开发对人员素质要求高,且受药用辅料、给药器械及制药设备的限制,制备工艺复杂,质量控制参数多且存在专利壁垒。复杂制剂开发企业需加强对人才、药用辅料、给药器械及制药设备的重视,明确关键工艺对制剂生产及质量特性的影响;此外,还需加强自主研发,破解原研企业专利布局难题,保护自己的创新成果。国内复杂制剂开发企业可将仿制与创新结合,研发具有自主品牌的复杂制剂产品,更好地满足患者需求。OBJECTIVE To discuss the difficulties in the development of complex preparations and puts forward solutions,in order to provide some reference for the development and preparation of complex preparations.METHODS Based on the development status of complex preparations,the challenges faced by the development of complex preparations were analyzed,and the countermeasures for the development of complex preparations were proposed.RESULTS&CONCLUSIONS The development of complex preparations required high quality of personnel,and was limited by pharmaceutical excipients,delivery devices and pharmaceutical equipment.The preparation process was complex,there were many quality control parameters and patent barriers.Complex preparation development enterprises need to pay more attention to talents,pharmaceutical excipients,delivery devices and pharmaceutical equipment,and clarify the impact of key technology on preparation production and quality characteristics;in addition,they need to strengthen independent research and development,crack the patent layout of original research enterprises and protect their own innovative achievements.Domestic complex preparation development enterprises can combine imitation and innovation to develop complex preparation products with independent brands to better meet the needs of patients.

关 键 词：复杂制剂 药用辅料 给药器械 制药设备 专利壁垒 仿制药 创新 

分 类 号：R944[医药卫生—药剂学]