阳长明.基于临床价值和传承创新的中药复方制剂设计[J].中草药,2019,50(17):3997-4002
基于临床价值和传承创新的中药复方制剂设计
Design of Chinese materia medica compound preparation based on clinical value and inheritance and innovation
投稿时间:2019-08-10  
DOI:10.7501/j.issn.0253-2670.2019.17.001
中文关键词:  中药复方制剂设计  临床价值  传承创新  中医药  质量源于设计
英文关键词:design of Chinese materia medica compound preparation  clinical value  inheritance and innovation  traditional Chinese medicine  quality by design
基金项目:
作者单位
阳长明 国家药品监督管理局 药品审评中心, 北京 100022 
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中文摘要:
      中药复方是中医药文化的精髓,是中医临床用药的主要形式,是中药新药研究和申报的主要类别和方向,中药复方制剂是中医药传承创新的重要载体,但由于中药复方制剂具有成分复杂、基础研究薄弱、有效成分不明确、多靶点作用等特点,再加上对中药复方制剂研究方法、评价的局限,如何科学开展中药复方制剂设计工作成了一个难以确切回答的问题。从药品基本属性和要求,结合中药复方新药研发路径、研发规律、研发策略的讨论,提出中药复方制剂设计应该基于临床价值和传承创新,以制剂安全有效为基础、尊重传统用药经验、质量源于设计、整体质量评价、质量均一稳定等作为中药复方制剂设计的基本原则,并对中药复方制剂设计中有关前处理、剂量、工艺、剂型、制剂处方设计以及设备选择与工业化生产等工作进行了讨论。
英文摘要:
      Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form in clinic of traditional Chinese medicine, the main categories and direction of research and registration of new CMM products, and an important carrier for traditional Chinese medicine inheritance and innovation. Due to the characteristics of complicated chemical constituents, weak research foundation, unclear effective components and multi-target effects, coupled with the limitations of research methods and evaluation of CMM compound preparation, how to scientifically carry out the design of CMM compound preparation has become a difficult question to answer. In this paper, from the basic attributes and requirements of drugs, combined with the discussion of research and development path, rule, strategy of new CMM compound preparation, it is proposed that the design of CMM compound preparation should be based on clinical value and inheritance and innovation, in the principle of the safety and effectivity of preparations, respecting traditional medicine experience, quality by design, whole quality evaluation, and quality uniformity and stability, etc. The pretreatment, dosage, process, dosage form, formulation design, equipment selection and industrial production in the CMM compound preparation design are also discussed.
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