通过数据库检索并整理2010—2014年国家食品药品监督管理总局批准生产的中药新药情况, 对其适应症领域分布、申报周期和批准情况3方面进行梳理, 综合分析中药品种开发预期前景看好的领域, 为选择国内中药新药研发方向提供参考。近5年, 国家食品药品监督管理总局批准的中药新药治疗领域主要集中于心脑血管、呼吸系统以及泌尿生殖系统;从审评周期来看, 妇科、呼吸系统和泌尿生殖系统药物平均申报周期较短;从批准率来看, 泌尿生殖系统、儿科为批准率较高的2个领域。由此推断心脑血管系统是中药研发的经典领域;泌尿生殖系统、儿科和妇科为中药新药研发较有前景的领域。

To provide the reference for selecting the research and development trend and direction of new drug in Chinese materia medica (CMM). We sorted out the new drugs of CMM approved by the China Food and Drug Administration (CFDA) during 2010—2014 through database retrieval, analyzed their indications, declared period and approval rates, then discuss and suggest the predominance of CMM for research and development. In recent five years, among the new drugs of CMM approved by CFDA, their main indications are those for cardiovascular system, respiratory system, and urogenital system. The declared period from short to long is gynaecology system, respiratory system, and urogenital system. From the point of approval rates, urogential system and pediatric system are higher than others. Comprehensive the above three factors, we get that cardiovascular system is a classic indication for CMM; Urogenital system, pediatrics system and gynecologic system will be the potential fields for CMM research and development.