中药复方制剂工艺研究问题、模式与策略  

Problems, models, and strategies of preparation process of Chinese materia medica compound formulations

作　　者：杨明 伍振峰 林环玉 王雅琪 曾丽华 彭常春 张建锋 王勇平 钟志坚 宋民宪 YANG Ming;WU Zhen-fengl;LIN Huan-yu;WANG Ya-qi;ZENG Li-hua;PENG Chang-chun;ZHANG Jian-feng;WANG Yong-ping;ZHONG Zhi-jian;SONG Min-xian(Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China;Jimin Kexin Pharmaceutical Co., Ltd., Yichun 336000, China;Tongjitang （Guizhou） Pharmaceutical Co., Ltd., Guiyang 550000, China;Jiangxi Youmei Pharmaceutical Co., Ltd., Shangrao 334000, China;Jiangzhong Pharmaceutical Co., Ltd., Nanchang 330096, China)

机构地区：[1]江西中医药大学现代中药制剂教育部重点实验室,江西南昌330004 [2]江西济民可信药业有限公司,江西宜春336000 [3]国药集团同济堂(贵州)制药有限公司,贵州贵阳550000 [4]江西佑美制药有限公司,江西上饶334000 [5]江西江中药业股份有限公司,江西南昌330096

出　　处：《中草药》2018年第12期2735-2741,共7页Chinese Traditional and Herbal Drugs

基　　金：国家自然科学基金资助项目(81760716);江西省杰出青年人才基金资助项目(20162BCB23035)

摘　　要：中药复方是中医临床用药的主要形式和手段,在保障中药复方制剂安全、有效、稳定、可控的基础上,合理设计中药复方制剂的工艺路线、生产装备和质量控制方法,建立一套符合中药复方制剂特点的工艺研究模式尤为重要。基于中药复方制剂的政策、工艺、装备现状,运用整体观、动态观和辨证观分析中药复方制剂的工艺模式,突破中药复方制剂的研究难点,提出中药复方制剂工艺开发的研究策略,以期为中药复方制剂工艺研究提供参考。Chinese materia medica（CMM） compound is the main form and method of clinical drug in traditional Chinese medicine. On the basis of guaranteeing the safety, efficiency, stability, and controllability of CMM compound preparations, it is particularly important to rationally design process routes, production equipment, and quality control methods, and to establish a processing research model which conforms to the characteristics of CMM compound preparations. According to the status of policy, process, and equipment of CMM compound preparations, we analyze the technological mode of CMM compound preparations using holistic view, dynamic view, and dialectical view, break through the difficulties of this study, and propose research strategies for the development of CMM compound preparations, hoping to provide references for the preparation of CMM compound formulations.

关 键 词：中药复方 制剂工艺 经典名方 质量源于设计 研究策略 

分 类 号：R283.3[医药卫生—中药学]