试论完善传统中医药组方合理性评价技术在中药新药审评中的重要性  

Improving Evaluation Technology for the Rationality of Chinese Medicine Prescription in the New Drug Reviews of Chinese Patent Medicine

作　　者：金锐 王宇光 张冰[3] JIN Rui;WANG Yuguang;ZHANG Bing(Beijing Shijitan Hospital of Capital Medical University,Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use,Beijing 100038,China;Beijing Jiaotong University Community Health Center,Beijing 100044,China;Research Center for Chinese Medicine Pharmacovigilance and Rational Drug Use,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京世纪坛医院,临床合理用药生物特征谱学评价北京重点实验室,北京100038 [2]北京交通大学社区卫生服务中心,北京100044 [3]北京中医药大学中药学院,中药药物警戒与合理用药研究中心,北京100029

出　　处：《中药新药与临床药理》2020年第9期1117-1122,共6页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：首都卫生发展科研专项(首发2020-2-2081);北京中医药科技发展资金项目(QN2016-04);中国非处方药协会自主创新课题(ZJW2019-01)。

摘　　要：2019年中共中央、国务院发布实施的《关于促进中医药传承创新发展的意见》提出"加快构建中医药理论、人用经验和临床试验相结合的中药注册审评证据体系",明确要求应加强中医药传统理论在中药新药申报审评中的指导作用。目前,中药新药处方合理性审评环节的处方方解和配伍禁忌分析等要求仍显简略,难以体现传统中医药精准选药组方的全面内容。作者尝试构建一个由药方分析、病证分析、药证相符度分析和用药安全性评估4部分组成的传统中医药组方合理性评价技术体系,并以一个治疗"功能性便秘"的中药新药为实例进行示范评价,为完善中药新药的注册审评体系提供参考。In the Opinion on Promoting the Inheritance,Innovation and Development of Traditional Chinese Medicine(TCM) in 2019,"speeding up the construction of evidence system for registration of Chinese medicine with the combination of TCM theory,human experience and clinical trials" was mentioned,which clearly suggests that we should strengthen the guiding role of TCM theory in the application and evaluation of new drugs.The existing prescription and incompatibility analysis in the evaluation of prescription rationality of new Chinese patent medicine are too simple to reflect the traditional knowledge about the precise medication in TCM.Based on this,this paper attempts to build a technical system for evaluating the rationality of traditional Chinese medicine prescriptions,which is composed of TCM prescription analysis,TCM syndrome analysis,drug-syndrome compliance analysis and safety assessment.A new Chinese patent medicine for functional constipation was used as an example for demonstration.From the above work,this paper tried to provide some valuable thoughts for improving the registration review of new Chinese patent medicines.

关 键 词：中药新药 注册审评 证据体系 处方合理性 中医药理论 药证相符度 

分 类 号：R288[医药卫生—中药学] R285.6[医药卫生—中医学]