摘要
目的分析国内中药新药品种申报批准现状,为中药新药开发提供参考。方法检索咸达数据库2016年1月1日-2022年12月31日的药品注册数据,对此阶段中药新药批准和申报信息进行系统整理,从申请品种数量、注册分类、治疗领域、处方来源、剂型分布、研发周期、临床研究及对照药等方面进行分析。结果2016-2022年申报品种265个,申报以1.1类(原6类)复方制剂最多,剂型以载药量大的颗粒剂、胶囊剂、片剂为主,治疗领域集中在呼吸、精神神经类、消化及心脑血管疾病等。2016-2022年批准的中药新药品种共29个,其中2021-2022年19个,注册分类以1.1类为主,治疗领域主要为呼吸系统、妇科和精神神经疾病等;处方药味数多为6~15味,用药以甘草、麻黄、黄芩、半夏、茯苓、石膏为主;剂型以颗粒剂、胶囊剂、片剂等常规口服剂型为主;临床试验主要开展Ⅱ期、Ⅲ期;研发周期约10~20年;处方来源以临床经验方、医院制剂为常见。结论我国已逐渐建成一个相对完整的中药新药开发生态系统,有助于开发出更多优质中药。
Objective To discuss and analyze the current situation of the application and approval of new Chinese medicine in China;To provide a reference for the research and development of new Chinese medicines in the future.Methods The drug registration data were retrieved from Xanda database from January 1,2016 to December 31,2022,and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties,registration categories,therapeutic areas,prescription sources,dosage form distribution,development cycle,clinical research and control drugs.Results From 2016 to 2022,the total number of application for new Chinese medicines was 265.The number of registration classification 1.1 of new compound drugs was the largest.The dosage forms of new drugs were mainly granules,capsules,and tablets.Indications mainly focused on respiratory,neuropsychiatric,digestion and cardio-cerebrovascular diseases,etc.From 2016 to 2022,the total number of approval for new Chinese medicines was 29,of these,19 from 2021 to 2022.The number of registration classification 1.1 of new Chinese medicines was the largest.The treatment fields are mainly respiratory system,gynecology and neuropsychiatric diseases,etc.The dosage forms of new drugs were mainly granules,capsules,and tablets.The number of drugs in prescriptions was 6-15.High-frequency drugs included Glycyrrhizae Radix et Rhizoma,Ephedrae Herba,Scutellariae Radix,Pinelliae Rhizoma,Poria and Gypsum Fibrosum.PhaseⅡand phaseⅢof the clinical trials had the largest number.The development period was approximately between 10-20 years.The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines,helping to develop more high-quality Chinese medicines.
作者
李学臻
陈丽诗
平夏婷
周祥
Li Xuezhen;Chen Lishi;Ping Xiating;Zhou Xiang(Drug Research and Development Center,Zhejiang Conba Pharmaceutical Co.,Ltd.,Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmaceutical Technology,Hangzhou 310052,China)
出处
《国际中医中药杂志》
2024年第4期519-525,共7页
International Journal of Traditional Chinese Medicine
关键词
中药新药开发
审评审批
批准上市
新药临床试验申请
新药上市许可申请
数据分析
New drug research and development(TCD)
Review and approval
Marketing authorization
Investigational new drug
New drug application
Data analysis
