中药复方新药是中药新药研究和申报的主要类别。以2005—2020年申请临床试验（investigational new drug，IND）未获批准的中药复方新药为研究对象，对其适应症、处方来源、剂型、生产工艺等进行回顾分析；对涉及药理毒理、临床、药学及综合方面的主要缺陷进行分类梳理。结果 显示：（1）据不完全统计，2005—2020年申请IND的中药复方新药总数为895个，不批准369个，不批准率为41.23%。（2）不同适应症、处方来源、剂型、生产工艺的中药复方新药，在IND不批准率方面有一定差异。（3）从研究的主要缺陷分析，IND未获批准中药复方新药品种中，75.88%涉及药理毒理专业，34.08%涉及临床专业，22.19%涉及药学专业，32.80%涉及综合方面缺陷。（4）涉及药理毒理缺陷的品种，以药效实验项目及模型、毒理实验质量控制、毒理实验项目选择等方面的问题较多；涉及临床缺陷的，以临床定位、方药与病症不对应等问题较多；涉及药学缺陷的，以提取纯化工艺等方面的问题较多。对IND未获批准新药的回顾分析可为今后中药复方新药研究提供有益借鉴。

New compound preparation of traditional Chinese medicine (TCM) is the main category of research and application of new TCM. The new compound preparations of TCM that have not been approved of investigational new drug (IND) from 2005 to 2020 are as research objects. The indications, prescription source, dosage form and production process are reviewed and main defects in pharmacology, toxicology, clinical trials, pharmacy and synthesis are classified. The results showed that:(1) According to incomplete statistics, the total number of IND applications for new compound preparations of TCM from 2005 to 2020 was 895, among which 369 were not approved, with a disapproval rate of 41.23%. (2) There were some differences in the IND disapproval rate of new compound preparations of TCM with different therapeutic areas, source of prescriptions, dosage form, or production process. (3) The analysis on reasons for disapproval of new compound preparations of TCM showed that 75.88% of disapproved cases were due to pharmacological and toxicological defects, 34.08% due to clinical defects, 22.19% due to pharmaceutical defects, and 32.80% due to comprehensive defects. (4) For disapproved new compound preparations of TCM due to pharmacological and toxicological issues, the reasons for IND disapproval and main research defects were mainly on aspects of pharmacodynamics test and models, toxicological test quality control, and the selection of toxicological test. For disapproved TCMs due to clinical issues, the disapproved reasons mainly were clinical positioning, prescription, and disease mismatch. For disapproved TCMs due to pharmaceutical issues, the disapproved reason focused on the extraction and purification technology. The retrospective analysis of unapproved new drugs in IND can provide useful reference for research of new compound preparations of TCM in the future.

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