我国中药产品开发趋势:对2011—2015年CFDA批准中药的分析

Development trend of Chinese materia medica products in China: An analysis of CFDA-approved Chinese materia medica(2011—2015)

通过数据库检索并整理了2011—2015年国家食品药品监督管理总局(CFDA)批准中药的情况,共有176个新批准中药。对中药产品的药品注册类型、中药组成、剂型和治疗领域4个方面进行了分析,探索中药产品开发趋势,为国内中药研发提供参考。在176个新批准的中药中,3类新药仅有2个,5类新药10个,6类新药42个,其余为改剂型药和仿制药;多味中药材制剂比单味中药材制剂多,中药组成主要集中在柴胡、丹参等常用药材;剂型共有9种,以胶囊剂和片剂居多;治疗领域主要集中在泌尿生殖系统和循环系统等疾病。根据分析结果得出中药产品开发需要与传统中医药理论结合,借鉴现代化研发生产技术,重点关注泌尿生殖系统等需求量逐渐增大的领域。同时CFDA也应该提高审评效率,才能使我国中药产品得到快速、高效的发展。

To explore the innovation trend of Chinese materia medica（CMM） and provide reference for domestic research and development workers, we sorted out the drugs of CMM approved by China Food and Drug Administration（CFDA） during 2011—2015 through database retrieval, analyzed their drug categories, components, dosage forms, and therapeutic areas, and there were 176 approved CMM registration applications. Among all the 176 approved CMM registration applications, only two approved in class 3, and class 5 has 10, class 6 has 42, and others are three additional CMM categories of class 7—9. There are more compound preparations than on single preparations, and components focus on several key herbs such as Bupleurum and Salvia. Nine dosage forms are mostly focus on capsules and tablets. Therapeutic areas are focus on diseases of genitourinary system and circulatory system. It concludes that innovation of CMM needs to combine CMM theory, learn from modern research and development production technology, and focus on the urogenital system and other areas of increasing demand, and CFDA should also improve the efficiency of the review.