中药配方颗粒汤剂与传统汤剂一致性评价存在的问题及建议  

Problems and Suggestions in the Consistency Evaluation of Granule Decoction and Traditional Decoction of Traditional Chinese Medicine

作　　者：麻利杰 姚静[2,3,4,5] 路露 侯富国 岳佑凇 谢梦迪 王艳丽 李学林[2,3,4,5] 刘瑞新 MA Lijie;YAO Jing;LU Lu;HOU Fuguo;YUE Yousong;XIE Mengdi;WANG Yanli;LI Xuelin;LIU Ruixin(School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China;Department of Pharmacy,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;Henan Province Engineering Research Center for Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine,Zhengzhou 450000,China;Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan&Education Ministry of China,Henan University of Chinese Medicine,Zhengzhou 450046,China;Henan Key Laboratory for Clinical Pharmacy of Traditional Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学药学院,郑州450046 [2]河南中医药大学第一附属医院药学部,郑州450000 [3]河南省中药临床应用、评价与转化工程研究中心,郑州450000 [4]河南中医药大学呼吸疾病中医药防治省部共建协同创新中心,郑州450046 [5]河南省中药临床药学中医药重点实验室,郑州450000

出　　处：《医药导报》2023年第7期1039-1048,共10页Herald of Medicine

基　　金：国家重点研发计划中医药现代化重点专项(2017YFC1703400);国家重点研发计划中医药现代化重点专项课题(2017YFC1703401,2017YFC1703402);国家自然科学基金资助项目(81773892,81001646);河南省中医药拔尖人才培养项目(重点项目)(2019ZYBJ07);河南省高层次人才特殊支持“中原千人计划”-“中原青年拔尖人才”项目(ZYQR201912158)。

摘　　要：开展中药配方颗粒汤剂与传统汤剂的一致性评价是解决二者是否等效问题的关键。近年来,已有许多学者从化学成分、入血成分等多方面对比了中药配方颗粒汤剂与传统汤剂的一致性。然而,由于缺乏完善的评价流程和明确的评价标准,二者的一致性评价出现了评价层次和指标的选取缺乏系统性、数据处理方法不合理等一系列问题。该文以中药配方颗粒汤剂与传统汤剂的一致性评价流程为脉络,梳理二者一致性评价过程中存在的问题,并从评价对象和方法的选择、评价标准的建立等方面提出建议,以期为中药配方颗粒汤剂或其他仿制类中药剂型一致性评价体系的建立提供参考,从而促进中药配方颗粒及其他相关中药剂型的合理应用。The consistency evaluation of traditional Chinese medicine dispensing granules(TCM dispensing granules)and traditional Chinese medicine decoction(TCM decoction)is the key to solving the problem of whether they are equivalent.In recent years,many researchers have compared the consistency of TCM dispensing granules and TCM decoction in terms of chemical components and ingredients absorbed into the blood.However,due to the lack of a suitable evaluation process and clear evaluation standards,their consistent evaluation has a series of problems,such as the lack of systematic index selection and evaluation level,unreasonable data processing methods,and so on.Therefore,taking the consistency evaluation process of TCM dispensing granules and TCM decoction as the context,this article makes a review of the problems that arise in the consistency evaluation process of them,and provides suggestions from the selection of evaluation objects and evaluating methods and the establishment of evaluation standards.It is expected to provide a reference for the establishment of consistency evaluation system of traditional Chinese medicine formula granule decoction or other imitation traditional Chinese medicine dosage forms,to promote the rational application of traditional Chinese medicine formula granules and other relevant traditional Chinese medicine dosage forms.

关 键 词：中药配方颗粒汤剂 传统汤剂 一致性评价 

分 类 号：R286[医药卫生—中药学] R95[医药卫生—中医学]