医院中药制剂生产与质量控制要点浅析  

Key Points of Production and Quality Control of Hospital TCM Preparations

作　　者：李得堂[1] 刘翠珍 宛鑫 王春霞[3] 唐洪梅[1] 丘振文[1] 杨忠奇[1] LI Detang;LIU Cuizhen;WAN Xin;WANG Chunxia;TANG Hongmei;QIU Zhenwen;YANG Zhongqi(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangdong Guangzhou 510405,China;The First Clinical Medical College of Guangzhou University of Chinese Medicine,Guangdong Guangzhou 510405,China;Nanfang Hospital,Southern Medical University,Guangdong Guangzhou 510405,China)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405 [2]广州中医药大学第一临床医学院,广东广州510405 [3]南方医科大学南方医院,广东广州510405

出　　处：《中国医药导刊》2022年第5期454-459,共6页Chinese Journal of Medicinal Guide

基　　金：广州市科技计划项目(项目编号:202102010013,项目名称:中药早期临床研究重点实验室)。

摘　　要：规范医院制剂生产,提高制剂质量控制水平,使医院制剂规范化和标准化,是促进医院制剂发展的重点。医院中药制剂是近年来医院制剂重点发展方向,也为开发中药创新药提供更多候选药物。医院中药制剂主要以传统剂型为主,新剂型开发较少,生产与质量控制技术薄弱。为生产临床安全有效的医院中药制剂产品,本研究结合医院制剂生产与质量控制现状及实践工作经验,从医院中药制剂生产环境、人员、物料、设备、文件与配制管理、质量检验等关键环节质量控制要点进行阐述,并分类介绍医院中药制剂前处理工序,口服固体制剂、口服液体制剂、外用液体制剂以及外用半固体(固体)制剂的生产过程关键质量控制要点,为医院中药制剂生产与质量控制提供思路借鉴。Standardizing the production of hospital preparations,improving the quality control level of hospital preparations,and standardizing the development of hospital preparations are the key points of promoting the development of hospital preparations.Traditional Chinese medicine(TCM)preparations in hospitals are the key development direction of hospital preparations in recent years,which also can provide more candidate drugs for the development of new TCM.Hospital TCM preparations are mostly traditional dosage forms,new dosage forms are less developed,and the production and quality control technology is weak.To produce clinically safe and effective hospital TCM preparations,based on the current situation and practical experience of production and quality control of hospital preparations,this study illustrates the key points of quality control of hospital TCM preparations from aspects of the production environment,personnel,materials,equipment,documents,preparation management,quality inspection,etc.And the key quality control points in the production process of oral solid dosage form,oral liquid preparations,external use liquid preparations,and external use semi-solid(solid)preparations are also classified and introduced,which provides a reference for the production and quality control of TCM preparations in hospitals.

关 键 词：医院制剂 中药制剂 制剂生产 质量控制要点 

分 类 号：R288[医药卫生—中药学]