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分析整理2010—2015年国内获得临床批准的中药品种具体情况,探讨国内中药品种申报审批的规律及其潜在原因。通过检索数据库获得2010—2015年国内获得临床批准的中药品种数量,逐个分析其具体信息,从获批品种的总体数量、注册分类、适应症分布、申报周期、剂型分布情况等多个方面进行分类整理,从各维度对批准趋势进行分析,以进一步阐述中药新药的临床前研发方向和临床批准情况。2010—2015年,中药总体临床批准数量呈下降趋势;中药复方新药(注册分类第6类)的批准数量最多,占比达83.75%;治疗领域方面,呼吸系统、消化系统、心脑血管系统、妇科、肌肉骨骼系统和结缔组织5个治疗领域批准品种数量较多,占总数量的70.03%;平均申报周期为27.36个月,其中内分泌、营养和代谢以及肿瘤领域的品均申报周期最长;剂型方面以片、胶囊、颗粒等口服固体制剂为主,且不同治疗领域对应的制剂剂型存在较大差异。总体而言,临床批准越来越注重新药的临床价值与定位合理性,注册审批情况的分析一定程度上反映了近年中药研发难度逐渐增加,获批形势更加严峻的实际情况,在一定程度上反映出现阶段中药新药研发所面临的主要问题。
Analyze and sort out the details of the varieties of traditional Chinese medicines approved for clinical approval in 2010-2015 in China and discuss the rules and potential causes of approvals and approval of domestic varieties of Chinese medicines. The number of Chinese medicine clinically approved in China from 2010 to 2015 was obtained through searching the database, and the specific information was analyzed one by one. The classification was classified according to the total number of approved varieties, the classification of registrations, the distribution of indications, the reporting period and the distribution of dosage forms Organize and analyze the approval trend from all dimensions to further elaborate the preclinical development directions and clinical approval of new Chinese medicine. In 2010-2015, the total number of approved clinical trials of Chinese medicines showed a downward trend. The number of approved new Chinese medicines (Category 6) was the largest, accounting for 83.75% of the total. In the field of treatment, respiratory, digestive, cardiovascular and cerebrovascular systems, Gynecology, musculoskeletal system and connective tissue 5 kinds of treatment approved a large number of species, accounting for 70.03% of the total number; the average reporting period of 27.36 months, of which endocrine, nutrition and metabolism, Dosage forms to tablets, capsules, granules and other oral solid preparations mainly, and different treatment areas corresponding formulations formulations are quite different. Overall, the clinical approval is paying more and more attention to the clinical value and positioning rationality of new drugs. The analysis of registration approval reflects, to some extent, the fact that the R & D difficulty of traditional Chinese medicine has been gradually increased in recent years and the actual situation of approving the approval is more severe, reflecting to some extent Emergence of Chinese medicine research and development phase of the main problems faced.