ICS11.120.10

CCSC10

團體標準

T/CATCM032—2024

中藥配方顆粒臨床使用指南

GuidelinesfortheclinicaluseoftraditionalChinesemedicineformulagranules

2024?09?05發布2024?09?05實施

中國中藥協會發布

中國標準出版社出版

T/CATCM032—2024

目次

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

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

1范圍·······················································································································1

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

3術語和定義··············································································································1

4臨床使用方法···········································································································3

4.1使用原則···········································································································3

4.2處方書寫···········································································································3

4.3處方審核···········································································································3

4.4名稱管理···········································································································4

4.5劑量規范···········································································································4

4.6藥味數··············································································································4

4.7使用注意與禁忌··································································································4

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

5臨床使用評價···········································································································6

5.1處方合理性的審核與點評······················································································6

5.2中藥配方顆粒的預警····························································································6

參考文獻·····················································································································7

Ⅰ

T/CATCM032—2024

前言

本文件按照GB/T1.1—2020《標準化工作導則第1部分：標準化文件的結構和起草規則》的規

定起草。

請注意本文件的某些內容可能涉及專利。本文件的發布機構不承擔識別專利的責任。

本文件由中國中藥協會提出并歸口。

本文件起草單位：北京中醫藥大學東直門醫院、北京中醫藥大學東方醫院、中國醫學科學院腫瘤醫

院、河南中醫藥大學第一附屬醫院、河南省中醫院、廣州中醫藥大學第一附屬醫院、北京中醫藥大學東

直門醫院洛陽醫院、天津中醫研究院附屬醫院、中國中藥協會中藥配方顆粒專業委員會、廣東一方制藥

有限公司、華潤三九現代中藥制藥有限公司、江陰天江藥業有限公司、上海雷允上藥業有限公司、浙江

景岳堂藥業有限公司、遼寧上藥好護士藥業（集團）有限公司、石家莊以嶺藥業股份有限公司、神威藥業

集團有限公司、江西百神藥業股份有限公司、仲景宛西制藥股份有限公司、北京春風中藥股份有限公

司、吉林敖東延邊藥業股份有限公司、北京康仁堂藥業有限公司。

本文件主要起草人：曹俊嶺、李學林、何婷、李國輝、趙旭、薛春苗、唐洪梅、唐進法、華國棟、梁穎、

伊博文、顧媛媛、李佳怡、馬麗娜、趙薇、楊文華、樸晶竹、陳小菲、孟菲、李旨君、張如源、冷怡林、吳瑞環、

姚魁武、李元文、郭媛媛、牛源菲、鄭長輝、藺虎琴、程學仁、魏梅、張軍、錢偉、王龍虎、李琦、周建富、吳永

軍、趙書勇、張特利、付誠、高松、秦友文、李安寧、陸小中、孫冬梅、周穎、李濤、陳世兵、陳盛君、劉斌、

蔡亮、何正江、康偉、李紅玉、谷赫沛、謝亮、陳玉海、耿春雷、毛藝文、馬魯鋒。

Ⅲ

T/CATCM032—2024

引言

中藥配方顆粒是由單味中藥飲片經水提、分離、濃縮、干燥、制粒而成的顆粒，在中醫藥理論指導

下，按照中醫臨床處方調配后，供患者沖服使用，具有服用、攜帶、儲藏方便等特點。中藥配方顆粒的質

量監管納入中藥飲片管理范疇。

2021年2月，國家藥品監督管理局、國家中醫藥管理局、國家衛生健康委員會、國家醫療保障局四

部門聯合發布《關于結束中藥配方顆粒試點工作的公告》（2021年第22號（)以下簡稱《公告》），自2021年

11月1日起施行。2021年4月，國家藥品監督管理局公布了首批160個中藥配方顆粒國家標準，標志

著中藥配方顆粒行業邁進了中藥配方顆粒國標新時代。中藥配方顆粒國標是嚴格按照《中藥配方顆粒

質量控制與標準制定技術要求》（以下簡稱《技術要求》）制定的，《技術要求》充分體現了國家藥品監督

管理局以最嚴謹的標準來推動中藥配方顆粒產業健康有序發展的頂層設計，首次提出了中藥飲片標準

湯劑的概念，首次建立了全過程量值傳遞質量控制體系，首次明確了中藥配方顆粒的物質基礎要與中

藥飲片標準湯劑的質量一致性原則。因此中藥配方顆粒國標具有三大創新點：其一，規定了出膏率范

圍，對生產過程作出了明確規定，體現了產品質量是生產出來的原則；其二，每個品種均規定了有效（或

指標）成分的含量及含量轉移率，開創了我國中藥標準含量測定指標規定上下限的先河，使產品批間質

量更加穩定均一；其三，每個品種均規定了特征/指紋圖譜，首次對我國幾乎所有常用中藥材做了全面

特征/指紋圖譜研究，充分體現了中藥是多成分共同作用的結果，避免中藥摻偽，為我國中藥走出國門

奠定了堅實的基礎，使中藥配方顆粒國標成為我國乃至世界中藥標準的標桿。

為進一步規范中藥配方顆粒的臨床使用，本文件起草組在堅持中醫藥特點的基礎上，總結中藥配

方顆粒近二十年來臨床使用經驗，旨在制定規范的臨床使用指南，持續提升中藥配方顆粒臨床使用安

全性與有效性。本文件可以結合中藥配方顆粒臨床使用研究進展以及行業需求變化而不斷修訂和

完善。

Ⅳ

T/CATCM032—2024

中藥配方顆粒臨床使用指南

1范圍

本文件提供了中藥配方顆粒的臨床使用指南，包括了臨床使用方法和使用評價。

本文件適用于醫療機構。

2規范性引用文件

下列文件中的內容通過文中的規范性引用而構成本文件必不可少的條款。其中，注日期的引用文

件，僅該日期對應的版本適用于本文件；不注日期的引用文件，其最新版本（包括所有的修改單）適用于

本文件。

中華人民共和國藥典

3術語和定義

下列術語和定義適用于本文件。

3.1

中藥Chinesemedicines；CM

在中醫藥理論指導下，用于疾病預防、診斷、治療和康復的天然藥物及其提取物或制成品。

3.2

中藥飲片decoction?readymedicines

中藥材經過加工炮制后直接用于中醫臨床或制劑生產使用的藥品。

注：其臨床應用形式有傳統中藥飲片、小包裝中藥飲片等。

3.3

中藥配方顆粒medicinalgranulesofCM

由單味中藥飲片經水提、分離、濃縮、干燥、制粒而成的顆粒，在中醫藥理論指導下，按照中醫臨床

處方調配后，供患者沖服使用。

3.4

處方prescription

由注冊的執業醫師和執業助理醫師（以下簡稱醫師）在診療活動中為患者開具的、由取得藥學專業

技術職務任職資格的藥學專業技術人員（以下簡稱藥師）審核、調配、核對，并作為患者用藥憑證的醫療

文書。

注：處方包括醫療機構病區用藥醫囑單。

3.5

中藥配方