[关键词]
[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。
[Key word]
[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.
[中图分类号]
R28
[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)