中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方...中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。展开更多
Medicinal solid fermentation technology of fungal was unique within the traditional Chinese medicine （TCM） and one of the oldest bio-pharmaceutical technology in the history, for example, the production of medicated...Medicinal solid fermentation technology of fungal was unique within the traditional Chinese medicine （TCM） and one of the oldest bio-pharmaceutical technology in the history, for example, the production of medicated leaven named ＂Shenqu＂, the history of which had continued for more than 1,500 years. These kinds of productions were widly used and had a close relationship with TCM. The development of this technology had through stages of ＂yeast production＂, ＂solid culture＂, ＂solid fermentation＂, and nowadays toward a series engineering of solid fermentation with promising prospects. The author described the development of its history briefly, and the representative products and the characteristics of production process of every stage, respectively. This research focused on taking ＂Trametes robinioplila fermented substance＂, ＂T. robinioplila ＆ A. membranaceus fermented substance＂ and ＂T. wilfordii Hook.f. ＆ G. lucidum fermented substance＂ as examples to introduce R ＆ D ideas and important findings of＂common fermentation＂ and ＂bi-directional fermentation＂ which were recommended as studying hotspots. There were many unique and important functions in the fields of TCM about all kinds of＂fermentation substances＂. It is infered that there may exist some other innovate technologies such as ＂Multi-fungal fermentation＂, ＂Special elements fermentation＂, etc. which are remained to be researched and developed continuely. All kinds of＂fermentation substances＂ are looked forward to show unique and important roles in the fields of TCM.展开更多
文摘中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。
文摘Medicinal solid fermentation technology of fungal was unique within the traditional Chinese medicine （TCM） and one of the oldest bio-pharmaceutical technology in the history, for example, the production of medicated leaven named ＂Shenqu＂, the history of which had continued for more than 1,500 years. These kinds of productions were widly used and had a close relationship with TCM. The development of this technology had through stages of ＂yeast production＂, ＂solid culture＂, ＂solid fermentation＂, and nowadays toward a series engineering of solid fermentation with promising prospects. The author described the development of its history briefly, and the representative products and the characteristics of production process of every stage, respectively. This research focused on taking ＂Trametes robinioplila fermented substance＂, ＂T. robinioplila ＆ A. membranaceus fermented substance＂ and ＂T. wilfordii Hook.f. ＆ G. lucidum fermented substance＂ as examples to introduce R ＆ D ideas and important findings of＂common fermentation＂ and ＂bi-directional fermentation＂ which were recommended as studying hotspots. There were many unique and important functions in the fields of TCM about all kinds of＂fermentation substances＂. It is infered that there may exist some other innovate technologies such as ＂Multi-fungal fermentation＂, ＂Special elements fermentation＂, etc. which are remained to be researched and developed continuely. All kinds of＂fermentation substances＂ are looked forward to show unique and important roles in the fields of TCM.
