T/CATCM 032-2024中藥配方顆粒臨床使用指南

ICS11.120.10

CCSC10

團(tuán)體標(biāo)準(zhǔn)

T/CATCM032—2024

中藥配方顆粒臨床使用指南

GuidelinesfortheclinicaluseoftraditionalChinesemedicineformulagranules

2024?09?05發(fā)布2024?09?05實(shí)施

中國中藥協(xié)會發(fā)布

中國標(biāo)準(zhǔn)出版社出版

T/CATCM032—2024

目次

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

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

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

2規(guī)范性引用文件········································································································1

3術(shù)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(guī)范···········································································································4

4.6藥味數(shù)··············································································································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(diǎn)評······················································································6

5.2中藥配方顆粒的預(yù)警····························································································6

參考文獻(xiàn)·····················································································································7

Ⅰ

T/CATCM032—2024

前言

本文件按照GB/T1.1—2020《標(biāo)準(zhǔn)化工作導(dǎo)則第1部分：標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)

定起草。

請注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機(jī)構(gòu)不承擔(dān)識別專利的責(zé)任。

本文件由中國中藥協(xié)會提出并歸口。

本文件起草單位：北京中醫(yī)藥大學(xué)東直門醫(yī)院、北京中醫(yī)藥大學(xué)東方醫(yī)院、中國醫(yī)學(xué)科學(xué)院腫瘤醫(yī)

院、河南中醫(yī)藥大學(xué)第一附屬醫(yī)院、河南省中醫(yī)院、廣州中醫(yī)藥大學(xué)第一附屬醫(yī)院、北京中醫(yī)藥大學(xué)東

直門醫(yī)院洛陽醫(yī)院、天津中醫(yī)研究院附屬醫(yī)院、中國中藥協(xié)會中藥配方顆粒專業(yè)委員會、廣東一方制藥

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

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

集團(tuán)有限公司、江西百神藥業(yè)股份有限公司、仲景宛西制藥股份有限公司、北京春風(fēng)中藥股份有限公

司、吉林敖東延邊藥業(yè)股份有限公司、北京康仁堂藥業(yè)有限公司。

本文件主要起草人：曹俊嶺、李學(xué)林、何婷、李國輝、趙旭、薛春苗、唐洪梅、唐進(jìn)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(huán)、

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

軍、趙書勇、張?zhí)乩?、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(jīng)水提、分離、濃縮、干燥、制粒而成的顆粒，在中醫(yī)藥理論指導(dǎo)

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

量監(jiān)管納入中藥飲片管理范疇。

2021年2月，國家藥品監(jiān)督管理局、國家中醫(yī)藥管理局、國家衛(wèi)生健康委員會、國家醫(yī)療保障局四

部門聯(lián)合發(fā)布《關(guān)于結(jié)束中藥配方顆粒試點(diǎn)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(jiān)督管理局公布了首批160個中藥配方顆粒國家標(biāo)準(zhǔn)，標(biāo)志

著中藥配方顆粒行業(yè)邁進(jìn)了中藥配方顆粒國標(biāo)新時代。中藥配方顆粒國標(biāo)是嚴(yán)格按照《中藥配方顆粒

質(zhì)量控制與標(biāo)準(zhǔn)制定技術(shù)要求》（以下簡稱《技術(shù)要求》）制定的，《技術(shù)要求》充分體現(xiàn)了國家藥品監(jiān)督

管理局以最嚴(yán)謹(jǐn)?shù)臉?biāo)準(zhǔn)來推動中藥配方顆粒產(chǎn)業(yè)健康有序發(fā)展的頂層設(shè)計，首次提出了中藥飲片標(biāo)準(zhǔn)

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

藥飲片標(biāo)準(zhǔn)湯劑的質(zhì)量一致性原則。因此中藥配方顆粒國標(biāo)具有三大創(chuàng)新點(diǎn)：其一，規(guī)定了出膏率范

圍，對生產(chǎn)過程作出了明確規(guī)定，體現(xiàn)了產(chǎn)品質(zhì)量是生產(chǎn)出來的原則；其二，每個品種均規(guī)定了有效（或

指標(biāo)）成分的含量及含量轉(zhuǎn)移率，開創(chuàng)了我國中藥標(biāo)準(zhǔn)含量測定指標(biāo)規(guī)定上下限的先河，使產(chǎn)品批間質(zhì)

量更加穩(wěn)定均一；其三，每個品種均規(guī)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(xiàn)了中藥是多成分共同作用的結(jié)果，避免中藥摻偽，為我國中藥走出國門

奠定了堅實(shí)的基礎(chǔ)，使中藥配方顆粒國標(biāo)成為我國乃至世界中藥標(biāo)準(zhǔn)的標(biāo)桿。

為進(jìn)一步規(guī)范中藥配方顆粒的臨床使用，本文件起草組在堅持中醫(yī)藥特點(diǎn)的基礎(chǔ)上，總結(jié)中藥配

方顆粒近二十年來臨床使用經(jīng)驗，旨在制定規(guī)范的臨床使用指南，持續(xù)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(jié)合中藥配方顆粒臨床使用研究進(jìn)展以及行業(yè)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(yī)療機(jī)構(gòu)。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過文中的規(guī)范性引用而構(gòu)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(yīng)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(shù)語和定義

下列術(shù)語和定義適用于本文件。

3.1

中藥Chinesemedicines；CM

在中醫(yī)藥理論指導(dǎo)下，用于疾病預(yù)防、診斷、治療和康復(fù)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(jīng)過加工炮制后直接用于中醫(yī)臨床或制劑生產(chǎn)使用的藥品。

注：其臨床應(yīng)用形式有傳統(tǒng)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(jīng)水提、分離、濃縮、干燥、制粒而成的顆粒，在中醫(yī)藥理論指導(dǎo)下，按照中醫(yī)臨床

處方調(diào)配后，供患者沖服使用。

3.4

處方prescription

由注冊的執(zhí)業(yè)醫(yī)師和執(zhí)業(yè)助理醫(yī)師（以下簡稱醫(yī)師）在診療活動中為患者開具的、由取得藥學(xué)專業(yè)

技術(shù)職務(wù)任職資格的藥學(xué)專業(yè)技術(shù)人員（以下簡稱藥師）審核、調(diào)配、核對，并作為患者用藥憑證的醫(yī)療

文書。

注：處方包括醫(yī)療機(jī)構(gòu)病區(qū)用藥醫(yī)囑單。

3.5

中藥配方