中成药安慰剂辅料、制备与评价的研究进展  

Research progress on excipient,preparation and evaluation of Chinese patent medicine placebo

作　　者：李啸鹏 姚静[2] 施钧瀚[2] 桂新景 王盼盼[1] 李涵 任延娜 董峰宇 杨霄[2] 刘瑞新[2,3,4,5,6] LI Xiaopeng;YAO Jing;SHI Junhan;GUI Xinjing;WANG Panpan;LI Han;REN Yanna;DONG Fengyu;YANG Xiao;LIU Ruixin(Henan University of Chinese Medicine,Zhengzhou 450046,China;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 P.R.China,Henan University of Traditional Chinese Medicine,Zhengzhou 450046,China;Henan Engineering Research Center for Modernization of Clinical Application of Chinese Herbal Pieces,Zhengzhou 450000,China;Engineering Research Center for TCM Pharmaceutical and New Drug Development Ministry of Education,Beijing 100029,China)

机构地区：[1]河南中医药大学,河南郑州450046 [2]河南中医药大学第一附属医院,河南郑州450000 [3]河南省中药临床应用、评价与转化工程研究中心,河南郑州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,河南郑州450046 [5]河南省中药临床药学中医药重点实验室,河南郑州450000 [6]中药制药与新药开发教育部工程研究中心,北京100029

出　　处：《药物评价研究》2024年第3期632-641,共10页Drug Evaluation Research

基　　金：国家自然科学基金资助项目(81774452,81001646);河南省卫生健康中青年学科带头人专项(HNSWJW-2020014);河南省中医科学研究基地专项(2021JDZY036);国家中医药管理局青年岐黄学者培养项目(国中医药人教函[2022]256号)。

摘　　要：安慰剂对照试验是新药研发最常用的临床随机对照试验方法之一,但目前中成药安慰剂的制备存在诸多困难,其难点在于中药复方成分复杂且中药“气味、味道、颜色”较化学药、药用辅料及食品更为突出独特,而用于模拟味道和气味的辅料种类较少,且尚无完善的“气味、味道、颜色”模拟辅料的统计与归纳,因此模拟难度较大。针对中成药安慰剂制备难点,整理归纳出可用于模拟“气味、味道、颜色”的食品添加剂、食品或药食两用物质及香料等辅料,并对现有的制备和评价方法进行总结,以期为中成药安慰剂的辅料、制备、评价方法等研究提供参考。Placebo-controlled trial is one of the most commonly used clinical randomized controlled trial methods in new drug development.However,there are many difficulties in the preparation of Chinese patent medicine placebo.The difficulty is that the composition of Chinese medicine compound is complex and the smell,taste and color of Chinese medicine are more prominent and unique than chemical medicine,pharmaceutical excipient and food.However,there are few types of excipient used to simulate taste and odor,and there is no perfect statistics and induction of odor,taste and color simulation excipient,so the simulation is difficult.In view of the difficulties in the preparation of Chinese patent medicine placebo,food additives,food or drug-food dual-use substance,spices and other excipient that can be used to simulate odor,taste and color were summarized,and the existing preparation and evaluation methods were summarized,in order to provide reference for the research on excipient,preparation and evaluation methods of Chinese patent medicine placebo.

关 键 词：中成药 安慰剂 药用辅料 新药研发 制剂 添加剂 

分 类 号：R965.3[医药卫生—药理学]