再议新形势下中药创新药物的发现与研发思路

Research Approaches on Discovery R&D of Innovative Drug of Chinese Materia Medica under New Situations

本文根据近年来中国药监管理和审评部门对中药创新药物的认识和审批要求的变化,结合生命科学的快速发展,归纳并提出中药创新药物发现的5种途径:中药有效成分及其创新药物的发现、中药有效部位新药及其复方制剂的发现、基于经典名方的创新药物的发现、基于临床有效方剂的创新药物的发现和基于名优中成药的创新药物发现,并对以上途径的研究思路进行详细阐述;对中药创新药物的药学研究,包括生产工艺、化学成分、质量研究、质量标准、稳定性等研究内容提出一些新的思路,以供业内人士参考和批评指正。

In recent years, with the rapid development of life sciences, changes on the understanding and requirements for innovative drugs of Chinese materia medica （CMM） from the drug approval authorities have been made. In this paper, the discovery, research and development （R ＆ D） approaches for innovative drugs of CMM under new situations were summarized and introduced in details from five aspects as follows. The discovery of innovative drugs from active components of CMMs, active fractions of CMMs and their compound preparations, famous classic prescription, clinically effective prescriptions as well as the famous Chinese patent drugs. This paper puts forward some new ideas for the pharmaceutical researches of innovative drugs of CMM, including the production process, chemical components, quality study, quality standard and stability. This paper provided references for the discovery, R ＆ D of CMM.