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中药连续化生产的必要性与可行性探讨
引用本文:关志宇,刘星宇,姜晟,刘婧,管咏梅,王勇平,王志敏,刘荣华,朱卫丰.中药连续化生产的必要性与可行性探讨[J].中草药,2022,53(12):3573-3580.
作者姓名:关志宇  刘星宇  姜晟  刘婧  管咏梅  王勇平  王志敏  刘荣华  朱卫丰
作者单位:江西中医药大学, 江西 南昌 330004;江西佑美制药有限公司, 江西 上饶 334000;华润三九(南昌)药业有限公司, 江西 南昌 330012
基金项目:国家重大新药创制科技重大专项(2018ZX09721002-008);国家重点研发计划中医药现代化研究重点专项(2017YFC1702904);江西省中医药管理局科技计划项目(2020B0366);江西省博士后研究人员科研项目(2020KY51)
摘    要:连续化生产技术具有高质量、高效率、低成本等优势,已在诸多行业广泛应用。中成药作为全生命周期产品,更是迫切需要在保证质量的前提下,适应行业进步与产业发展。近年来,国内外制药企业对药品连续化生产展开了大量的探索与实践,已经有9个化学药品采用连续化生产工艺成功上市,中药制药行业也有不少企业也尝试采用了连续化生产工艺。现从中药生产加工的现状出发,介绍中药实现连续化生产的优势,探讨中药连续化生产必要性,并对其可行性进行分析。

关 键 词:中药  连续化生产  中药制药  制药工艺  制药设备  质量控制
收稿时间:2022/3/10 0:00:00

Necessity and feasibility analysis of traditional Chinese medicines continuous manufacturing
GUAN Zhi-yu,LIU Xing-yu,JIANG Sheng,LIU Jing,GUAN Yong-mei,WANG Yong-ping,WANG Zhi-min,LIU Rong-hu,ZHU Wei-feng.Necessity and feasibility analysis of traditional Chinese medicines continuous manufacturing[J].Chinese Traditional and Herbal Drugs,2022,53(12):3573-3580.
Authors:GUAN Zhi-yu  LIU Xing-yu  JIANG Sheng  LIU Jing  GUAN Yong-mei  WANG Yong-ping  WANG Zhi-min  LIU Rong-hu  ZHU Wei-feng
Institution:Jiangxi University of Chinese Medicine, Nanchang 330004 China;Jiangxi Youmei Pharmaceutical Co., Ltd., Shangrao 334000, China;China Huarun Sanjiu (Nanchang) Pharmaceutical Co., Ltd., Nanchang 330012, China
Abstract:Continuous manufacturing has the advantages of high quality, high efficiency and low cost, and has been widely used in many industries. As a lifecycle product, Chinese patent medicine urgently needs to adapt to the progress and development of the industry on the premise of ensuring the quality. In recent years, domestic and foreign pharmaceutical enterprises have carried out a lot of exploration and practice on continuous manufacturing. Nine chemical medicines have been successfully listed by using the continuous manufacturing, and many enterprises in the traditional Chinese medicine pharmaceutical industry have also tried to adopt the continuous manufacturing. Starting from the current situation of traditional Chinese medicines production and processing, this paper introduces the advantages of traditional Chinese medicine continuous manufacturing, discusses the necessity of traditional Chinese medicine continuous manufacturing, and analyzes its feasibility.
Keywords:traditional Chinese medicine  continuous manufacturing  traditional Chinese medicine preparation  pharmaceutical process  pharmaceutical equipment  quality control
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