世界中医药
文章摘要
引用本文:王馨1,徐冰1,2,3,徐翔4,苑兆国4,吴志生1,2,3,史新元1,2,3,乔延江1,2,3.中药质量源于设计方法和应用:过程分析技术[J].世界中医药,2018,(03):.  
中药质量源于设计方法和应用:过程分析技术
Chinese Medicine Quality Derived From Design Methods and Applications for-(Ⅱ):Process Analytical Technology
投稿时间:2017-12-13  
DOI:10.3969/j.issn.1673-7202.2018.03.001
中文关键词:  质量源于设计  过程分析技术  中药  制药过程  在线质量控制
English Keywords:Quality by design  Process analytical technology  Chinese medicine  Pharmaceutical process  On-line quality control
基金项目:国家中药标准化项目(ZYBZH-C-QIN-45);国家自然科学基金项目(81403112);国家自然科学基金重点项目(81430094)
作者单位
王馨1,徐冰1,2,3,徐翔4,苑兆国4,吴志生1,2,3,史新元1,2,3,乔延江1,2,3 1 北京中医药大学中药信息学系北京102400 2 北京市科委中药生产过程控制与质量评价北京市重点实验室北京100029 3 教育部中药制药与新药开发关键技术工程研究中心北京100029 4 山东步长制药股份有限公司菏泽274000 
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中文摘要:
      过程分析技术(Process Analytical Technology,PAT)是实现药品质量源于设计(QbD)的关键工具之一。在线(On-line)和原位(In-line)等PAT技术的使用,为中药生产质量控制提供及时、准确的数据和决策支持,在稳定产品质量、优化工艺操作、提高生产效率和节能降耗等方面发挥了积极作用。本文从分析功能和属性角度,将PAT技术分为5个方面进行介绍:1)模拟视觉分析技术;2)模拟听觉分析技术;3)模拟味觉分析技术;4)模拟触觉分析技术和;5)多功能集成在线分析技术。同时综述了PAT在中药提取、浓缩、醇沉、柱层析、干燥、混合、制粒、包衣等制药过程中的应用。
English Summary:
      Process analytical technology (PAT) is one of the essential tools realizing the pharmaceutical quality by design (QbD). The use of on-line and in-line PAT tools, provides timely and accurate data and decision support for quality control of Chinese medicine production process. It plays a significant role in stabilizing product quality, optimizing process operation, improving production efficiency and saving energy. In this paper, PAT tools were divided into 5 aspects in terms of analysis functions and attributes:1)analogue visual analysis techniques, 2)analogue auditory analysis techniques, 3)analogue taste analogue analysis techniques, 4)analogue touch analysis techniques, and 5)multifunctional international on-line analysis techniques. Applications of PAT in the pharmaceutical processes of Chinese medicine, such as extraction, concentration, alcohol precipitation, column chromatography, drying, mixing, granulating and coating, were reviewed in this paper.
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