中药饮片产地加工与炮制生产一体化研究现状与展望  

Research status and prospects of integration of habitat processing and processing of Chinese medicinal decoction pieces

作　　者：张伟[1,2,3] 张玖捌 何天雨 秦宇雯 杨俊杰 李林[1] 季德[1] 吴啟南[1] 王端恒[5] 陆兔林 ZHANG Wei;ZHANG Jiu-ba;HE Tian-yu;QIN Yu-wen;YANG Jun-jie;LI Lin;JI De;WU Qi-nan;WANG Duan-heng;LU Tu-lin(School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;College of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012,China;Anhui Province Key Laboratory of Traditional Chinese Medicine Decoction Pieces of New Manufacturing Technology,Hefei 230012,China;Xinyang Agriculture and Forestry University,Xinyang 464399,China;Jiangsu Deyuan Pharmaceutical Co.,Ltd.,Lianyungang 222047,China)

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]安徽中医药大学药学院,安徽合肥230012 [3]中药饮片制造新技术安徽省重点实验室,安徽合肥230012 [4]信阳农林学院,河南信阳464399 [5]江苏德源药业股份有限公司,江苏连云港222047

出　　处：《中国中药杂志》2022年第10期2565-2571,共7页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2018YFC1707000)。

摘　　要：中药饮片产地加工与炮制生产一体化(简称“一体化”)改变了传统的加工模式,能够从源头保障中药饮片的质量。该文从一体化的内涵与外延、相关政策法规、品种发展状况对一体化的背景进行介绍;从存在问题和当前研究进展对一体化的现状进行分析,并给出发展建议。认为一体化虽然符合行业发展趋势,具有提高饮片质量、规范饮片管理等优势,但仍然存在缺少品种遴选原则、缺乏生产技术规范、生产过程质量控制标准不完善、标准与监管融合不到位等问题,因此建议尽快建立一体化技术指导原则及品种范围、建立相关技术规范、完善生产过程质量控制标准,并加强政策引导与监管,从而推动一体化健康有序的发展。The integration of habitat processing and processing of Chinese medicinal decoction pieces(hereinafter referred to as"integration")has changed the traditional processing mode and can ensure the quality of Chinese medicinal decoction pieces from the source.This paper introduced the background of integration from the connotation and denotation of integration,relevant policies and regulations,and variety development.The present situation of integration was analyzed from the existing problems and current research progress,and the development suggestions were proposed.It is considered that although the integration is in line with the development trend of the industry with the advantages of improving the quality and standardizing the management of decoction pieces,there are still some problems,such as the lack of variety selection principles and production technical specifications,imperfect quality control stan-dards in the production process,and inadequate integration of standards and supervision.Therefore,it is suggested to determine the integrated variety selection principles and variety range as soon as possible,establish relevant technical specifications,improve quality control standards in the production process,and strengthen policy guidance and supervision to promote the healthy and orderly development of integration.

关 键 词：中药饮片 产地加工与炮制生产一体化 研究现状 展望 

分 类 号：R283[医药卫生—中药学]