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我国复杂制剂开发难点及应对策略探讨
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| 篇名： | 我国复杂制剂开发难点及应对策略探讨 |
| TITLE： | CHINA PH ARMACY Volume 33，Number 13，July 15，2022 Semimonthly Table of Contents Discussion on development difficulties and countermeasures of complex preparations in China |
| 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。 |
| ABSTRACT： | OBJECTIVE To discuss the difficulties in t he 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. |
| 期刊： | 2022年第33卷第13期 |
| 作者： | 宋波，郑啸，石娟，操锋 |
| AUTHORS： | SONG Bo，ZHENG Xiao，SHI Juan，CAO Feng |
| 关键字： | 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 |
| KEYWORDS： | complex preparation ；pharmaceutical excipients ；delivery devices ；pharmaceutical equipment ；patent barrier ； |
| 阅读数： | 372 次 |
| 本月下载数： | 18 次 |
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