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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。
A total of 176 newly approved Chinese medicines were retrieved from the database and approved by the State Food and Drug Administration (CFDA) for the approval of traditional Chinese medicines from 2011 to 2015. The types of Chinese medicine products registration, composition of traditional Chinese medicine, dosage forms and treatment areas were analyzed in four areas to explore the development trend of traditional Chinese medicine products for the domestic research and development of Chinese medicine to provide a reference. Among the 176 newly approved Chinese medicines, there are only 2 new drugs in 3 categories, 10 new drug categories in 5 categories and 42 new drug categories in 6 categories, with the rest being modified-type drugs and generic drugs; the multi-flavor Chinese herbal medicines have more preparations than traditional Chinese herbal medicines , Mainly composed of traditional Chinese medicine Bupleurum, Salvia and other commonly used herbs; formulations of a total of 9 species, mainly capsules and tablets; treatment mainly in the genitourinary system and circulatory system diseases. According to the results of the analysis, it is concluded that the development of traditional Chinese medicine products needs to be integrated with the traditional Chinese medicine theory, and the modern research and development production technology should be used for reference. The focus is on areas where the demand for urogenital system is gradually increasing. At the same time CFDA should also improve the efficiency of review in order to make China’s traditional Chinese medicine products be rapid and efficient development.