中药制剂生产过程中的质量风险分析与对策  

Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations

作　　者：杨明[1,2] 杨园珍 王雅琪[1,2] 伍振锋[1] 王学成[1] 罗晶[1] 

机构地区：[1]江西中医药大学,江西南昌330004 [2]成都中医药大学,四川成都610075

出　　处：《中国中药杂志》2017年第6期1025-1030,共6页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81560649);江西省卫生计生委中医药科技项目(2015B041);江西省卫生计生委中医药科研课题(2014A016)

摘　　要：产品质量的优劣不仅依靠检验方法,更依靠设计开发、生产控制及物流管理等产品制造的所有环节,质量源于过程控制水平。因此,准确识别药品生产过程可能诱发质量风险的因素,及其合理的质量控制措施非常重要。该文系统分析中药制剂生产过程各环节质量风险来源,探讨中药制剂质量风险识别的途径和方法,并对如何控制中药制剂过程中的质量风险的产生提出相应的措施和建议,为完善中药制剂全过程质量管理提供参考。Product quality relies on not only testing methods, but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level. Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly. This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine prepara- tion. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation.

关 键 词：GMP 中药制剂 质量风险 生产过程 

分 类 号：TQ461[化学工程—制药化工]