| Traditional Chinese medicine is the material basis for the inheritance and development of traditional Chinese medicine and a strategic resource for the national economy and people’s livelihood.The promulgation and implementation of important documents such as the "Several Opinions of the State Council on Supporting and Promoting the Development of Traditional Chinese Medicine" and the "Notice on the Protection and Development of Chinese Herbal Medicines(2015-2020)" have not only demonstrated the state’s concern and emphasis on the development of Chinese medicine.It also reflects the long-term requirements for the scientific development of Chinese medicine industry.The issuance of the "Notice of the State Council on Printing and Initiating a Reform Plan for Deepening Standardization Work" has proposed the adoption of a new type of standard system to enhance the overall requirements for industrial competitiveness,development and internationalization.How to organically integrate traditional technologies,scientific and technological innovations,and industrial standards,promote the scientific cultivation of Chinese medicinal materials,maintain the authenticity and quality of medicinal materials,ensure the safety and efficacy of people’s medications,improve health standards,and develop strategic emerging industries to increase farmers It is of great significance to harmonize income and realize the development of Chinese medicine industry and sustainable development of the environment.At present,there are still a lot of problems in the quality standardization system of traditional Chinese medicines that need to be solved and continuously improved in the course of industrial development.The problems are mainly reflected in the following four aspects:(1)The basic model of the quality control of traditional Chinese medicines is based on the quality control methods of foreign plant medicines,and is based on the model of quality control of chemical drugs.Chemical qualitative identification and index component detection are the main contents.Due to the limitations of traditional Chinese medicines such as complexity,scientific and technical conditions,research ideas and methods,the current quality control methods and methods of traditional Chinese medicine are not only difficult to effectively control and evaluate the quality of traditional Chinese medicine,but also difficult to reflect its safety and effectiveness.(2)The quality standards of TCM originate from two aspects:one is the complete and accurate TCM quality index system,and the other is the TCM production operating rules formulated to meet the TCM quality indicators,such as GAP and GMP.However,at present,the formulation of operating procedures for Chinese medicine production considers the lack of correlation between the two,and there is no sufficient and necessary relationship between operating procedures and quality indicators.Sometimes,some key quality influencing factors are ignored,and sometimes many unnecessary technologies are added.Requirements,resulting in an inability to effectively control quality,have added a lot of burden to production companies.(3)In all aspects of production of traditional Chinese medicine,specific operations are directly controlled by front-line personnel and are highly concealed.Due to the influence of local interests,some farmers and processors may not strictly follow technical standards or even deliberately violate standards.Due to lack of real-time monitoring methods and data collection,the quality of the final product cannot be reversed when it comes to the quality of the final product,resulting in a huge waste of the production process.(4)Because of the contradiction between the scarcity of traditional Chinese medicine resources and the rapid development of the health industry,it has caused resources to simply pursue the output and quality of traditional Chinese medicines,regardless of the sustainable development of the environment and soil and other resources that have grown.And the serious crisis of the environment.In order to solve the above problems,this topic innovatively puts forward the concept and method of "quality tree of Chinese medicine".It is under the guidance of the concept of"quality-by-design" to consider the factors that affect the quality of Chinese medicine from the whole production process of Chinese Herbal Medicine.Apply advanced information technology and process analysis technology to study the full-process modeling and simulation method suitable for the production of Chinese Herbal Decoction pieces,the optimization and control method for the whole process of Chinese Herbal Decoction pieces,and the risk control strategy to achieve the safe and stable operation of Chinese medicine production process and the optimization of process parameters,to ensure that the production process of Chinese medicine is moving in a definite direction,to stabilize the quality of the final product,and to achieve the unity of "process control-process optimization-risk control-quality safety",which lays a theoretical and methodological basis for the quality risk assessment of the entire process of Chinese herbal medicine production.The specific research content includes the following four parts:1.This study proposes the concept of the quality tree of traditional Chinese medicine,and builds the whole course of traditional Chinese medicine that uses the quality of traditional Chinese medicine as the treetop event and uses various indicators and process parameters in the production process of traditional Chinese medicine decoction pieces as the bottom event.Industrial chain quality tree theoretical model It also established a full range of quality control,including the natural environmental factors of the site,and maintained the traditional quality of Chinese herbal medicines associated with the authenticity of Chinese medicines,enabling the maintenance of the medicinal herbs base.2.Starting from the actual demand for quality control of traditional Chinese medicines throughout the entire country,explore the basic terms of quality control for traditional Chinese medicines,and establish a data quality model and data relationship model for the whole process of traditional Chinese medicine to ensure effective organization of data collection,storage,and traceability of traditional Chinese medicine production,and establish Chinese medicine production.The traceability system and data monitoring system of the whole process of the technology can implement the quality standards and the production process standards at every stage,truly become a full-process controllable high-quality industrial chain,and establish the entire quality control and management system for TCM decoction pieces.3.Taking Angelica Sinensis slice as an example,the whole quality tree model of Angelica Sinensis Pieces was drawn,and the method of expert knowledge acquisition was used to analyze the quality tree module of Angelica sinensis seed seedling.It was found that the main factor influencing Angelica sinensis seed seedling was liquid soaking and disinfection.The risk assessment of the quality risk of seed seedlings was carried out.The quality risk assessment and supervision and optimization analysis of Chinese Herbal Pieces can be achieved.4.Through the whole process of quality control and management system of traditional Chinese medicine decoction pieces,this study effectively combines the process analysis method of traditional Chinese medicine quality tree with quality risk management,which can help managers to make real-time decisions while achieving the full-scale quality process control of traditional Chinese medicine.The entire quality control and management workflow system of TCM decoction pieces provides a personalized Web interface.User-oriented information feedback can be implemented to facilitate users’ quality prediction,risk assessment and regulation of Chinese medicine.As a new quality management model,it can provide reference for improving the quality of Chinese medicine production and standardizing quality. |
PDF Full Text Request