T/CATCM 032-2024 中药配方颗粒临床使用指南

ICS11.120.10

CCSC10

团体标准

T/CATCM032—2024

中药配方颗粒临床使用指南

GuidelinesfortheclinicaluseoftraditionalChinesemedicineformulagranules

2024⁃09⁃05发布2024⁃09⁃05实施

中国中药协会发布

中国标准出版社出版

T/CATCM032—2024

目次

前言··························································································································Ⅲ

引言··························································································································Ⅳ

1范围·······················································································································1

2规范性引用文件········································································································1

3术语和定义··············································································································1

4临床使用方法···········································································································3

4.1使用原则···········································································································3

4.2处方书写···········································································································3

4.3处方审核···········································································································3

4.4名称管理···········································································································4

4.5剂量规范···········································································································4

4.6药味数··············································································································4

4.7使用注意与禁忌··································································································4

4.8用法·················································································································5

5临床使用评价···········································································································6

5.1处方合理性的审核与点评······················································································6

5.2中药配方颗粒的预警····························································································6

参考文献·····················································································································7

Ⅰ

T/CATCM032—2024

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由中国中药协会提出并归口。

本文件起草单位：北京中医药大学东直门医院、北京中医药大学东方医院、中国医学科学院肿瘤医

院、河南中医药大学第一附属医院、河南省中医院、广州中医药大学第一附属医院、北京中医药大学东

直门医院洛阳医院、天津中医研究院附属医院、中国中药协会中药配方颗粒专业委员会、广东一方制药

有限公司、华润三九现代中药制药有限公司、江阴天江药业有限公司、上海雷允上药业有限公司、浙江

景岳堂药业有限公司、辽宁上药好护士药业（集团）有限公司、石家庄以岭药业股份有限公司、神威药业

集团有限公司、江西百神药业股份有限公司、仲景宛西制药股份有限公司、北京春风中药股份有限公

司、吉林敖东延边药业股份有限公司、北京康仁堂药业有限公司。

本文件主要起草人：曹俊岭、李学林、何婷、李国辉、赵旭、薛春苗、唐洪梅、唐进法、华国栋、梁颖、

伊博文、顾媛媛、李佳怡、马丽娜、赵薇、杨文华、朴晶竹、陈小菲、孟菲、李旨君、张如源、冷怡林、吴瑞环、

姚魁武、李元文、郭媛媛、牛源菲、郑长辉、蔺虎琴、程学仁、魏梅、张军、钱伟、王龙虎、李琦、周建富、吴永

军、赵书勇、张特利、付诚、高松、秦友文、李安宁、陆小中、孙冬梅、周颖、李涛、陈世兵、陈盛君、刘斌、

蔡亮、何正江、康伟、李红玉、谷赫沛、谢亮、陈玉海、耿春雷、毛艺文、马鲁锋。

Ⅲ

T/CATCM032—2024

引言

中药配方颗粒是由单味中药饮片经水提、分离、浓缩、干燥、制粒而成的颗粒，在中医药理论指导

下，按照中医临床处方调配后，供患者冲服使用，具有服用、携带、储藏方便等特点。中药配方颗粒的质

量监管纳入中药饮片管理范畴。

2021年2月，国家药品监督管理局、国家中医药管理局、国家卫生健康委员会、国家医疗保障局四

部门联合发布《关于结束中药配方颗粒试点工作的公告》（2021年第22号（)以下简称《公告》），自2021年

11月1日起施行。2021年4月，国家药品监督管理局公布了首批160个中药配方颗粒国家标准，标志

着中药配方颗粒行业迈进了中药配方颗粒国标新时代。中药配方颗粒国标是严格按照《中药配方颗粒

质量控制与标准制定技术要求》（以下简称《技术要求》）制定的，《技术要求》充分体现了国家