Construction of Chinese Herbal Medicine Traceability System Based on Influencing Factors of Chinese Herbal Medicine Quality / 中国实验方剂学杂志

As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the quality of Chinese herbal medicines is related to the development prospect of Chinese medicine industry in China. With the rapid development of new technologies such as traceability methods and monitoring instruments， it is imperative to integrate and innovate traditional Chinese herbal medicines with new-generation information technology in view of the quality problems existing in the current production and circulation of Chinese herbal medicines， and it is of great significance for the construction of traceability system to ensure the quality and safety of Chinese herbal medicines and to promote the industry of Chinese herbal medicines to move towards high-quality development. This paper reviews the development history of the traceability system of Chinese herbal medicines in China， takes the influencing factors of the quality of Chinese herbal medicines as the entry point， and proposes that the construction of the traceability system should satisfy the traceability requirements of the characteristics of Chinese herbal medicines and their traditional medication experience. By analyzing the influencing factors of the quality of Chinese herbal medicines， it is pointed out that focusing on the influencing factors to build a traceability system is of great significance for targeting the problematic links at a later stage and exploring the interrelationship between environmental factors and the quality of Chinese herbal medicines. Based on the previous explorations， the author summarizes the system framework， functional modules and practical applications of the traceability system of Chinese herbal medicines， and looks forward to the development of a traceability system with risk early warning function and expert decision-making function in its functional development. Finally， based on the factors affecting the quality of Chinese herbal medicines， the author puts forward several thoughts on construction of the traceability system， and makes an in-depth analysis and puts forward a solution for the current situation that a unified， standardized and universal traceability system has not yet been built， with a view to providing ideas and references for the construction of traceability system of Chinese herbal medicines.

Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability / 中国实验方剂学杂志

As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the traceability of Chinese medicinal materials is closely related to the high-quality development of Chinese medicine industry. This article intends to analyze the "new era of smarter food safety blueprint" and Proposed Rule for Food Traceability related to food traceability of the U.S. Food and Drug Administration （FDA）， including food traceability list， critical tracking events， and examples of exemptions. By studying the process and consideration of the construction of the FDA food traceability system， as well as the specific traceability requirements of fresh herbs， vegetables and fruits in the FDA food traceability system that are related to Chinese medicinal materials， on the one hand， it provides research materials for the communication and discussion of Chinese medicinal materials traceability， on the other hand， it also provides reference for the construction of food traceability system in China. To sort out the idea of constructing a traceability system for Chinese medicinal materials suitable for the current development status of traditional Chinese medicine， the contents to be considered are as follows：①To determine the traceability list of Chinese medicinal materials based on the risk control of Chinese medicinal materials. ②Determine the critical tracking links and information in the Chinese medicinal materials industry chain， and standardize the traceability information of Chinese medicinal materials. ③The quality information of Chinese medicinal materials should be reflected in the traceability of Chinese medicinal materials. ④Within the scope of the traceability list of Chinese medicinal materials， enterprises should be encouraged to make voluntary traceability by selecting Chinese medicinal materials with a good foundation of traceability work.

Application of traditional Chinese medicine(TCM) traceability system based on TCM quality characteristics and HACCP system / 中国中药杂志

It is crucial to establish a complete set of traditional Chinese medicine(TCM) quality traceability management process system, in order to stabilize the pricing order of TCM market and reconstruct the transmission path of TCM quality signals. In this study, we reviewed the mature experience of food and drug supervision at home and abroad, analyzed the quality characteristics of TCM, and put forward that the quality control of TCM products can learn from the hazard analysis and critical control point(HACCP) system in food safety quality control. This study points out that the HACCP system provides not only technical guidance for the traceability management of TCM, but also ideas for improving the quality of TCM products and the safety risk control of TCM. The application of the HACCP system in TCM quality control can help establish an international dialogue platform for TCM and help realize the modernization and internationalization of TCM industry.

Development of Traceability System for Planting Chinese Medicinal Plants / 世界科学技术-中医药现代化

The quality and safety of traditional Chinese medicines directly affect the development of the entire Chinese medicine industry. Establishing and improving traceability systems for Chinese medicine quality will play a decisive role in improving the quality of Chinese medicine. The traceability system of Chinese herbal medicines as an important part of the quality traceability system of traditional Chinese medicine overcomes the inability of existing technologies to achieve traceability, control, and queryability of information on the whole process of planting Chinese medicinal materials. The recording, inquiry and traceability of important information to track and supervise the whole process of cultivation of Chinese herbal medicines is an effective measure to realize the availability, retrievability and accountability of Chinese medicines, and to strengthen quality safety management and risk control throughout the entire process.

Construction of traceability system of Chinese materia medica product quality based on quality marker of Chinese materia medica / 中草药

In the development process of quality markers of Chinese materia medica (CMM) from the concept to the theory of the development process, quality markers of CMM have attracted the national CMM research and industry attention. Focusing on the factors that affect the quality of CMM, the author analyzed the markers which affect the quality to identify the quality markers, analyzed the comprehensive information, performed risk assessment, and identified and controlled all factors that affect the product quality. Especially the author presented the concept on whole process of quality control, standards and control research to build a full range of traceable control to build a new system, product quality traceability system, to ensure the quality of CMM products and industrial process control. The system will have a new impact on the healthy development of traditional Chinese medicine industry.

Necessity and exploration of constructing quality control system of Chinese herbal pieces in hospital / 中草药

The hospital is one of the main subjects for application of Chinese herbal pieces (CHP) which is the prescription drug for Chinese medicine clinical prevention and treatment of disease. The quality of CHP in hospital has a direct impact on clinical effect and is related to the health of the patients. But presently the market of CHP is chaotic with the prominent issue. The cultivation, the production and processing, the storage management and operation of CHP are not standardized. Simultaneously, the supply method of CHP is cut off from the right of the hospital to know the source and production process of CHP. The hospital is restricted to the supply enterprises of CHP. This situation makes a great obstacle to the quality control of CHP in hospital. The quality control system of CHP in hospital is composed of the source and the quality management of CHP. The quality control system of CHP includes the measures such as the purchasing management, acceptance of storage, storage and maintenance, and personnel capacity improvement. The prescription-based processing of Chinese materia medica should play an important role in this system. The whole process traceability system and the guarantee function of the market supervision system of Chinese medicinal materials should also be taken effect. In this way, the dominant position of hospital in the quality control system of CHP is strengthened.

Research on construction of traceability system of Chinese herbal medicines supply based on collectivization / 中草药

To those Group of companies whose businesses cover planting, primary processing, storage, and distribution of traditional Chinese herbal medicines, this article researches and analyzes the critical information, compares five kinds of traceability modes, such as chain, cross-type, central database type, analog, and mixed-type, proposes traceability mode, key technologies, overall framework, and traceability process. As well this article analyzes the main problems existing in traditional Chinese herbal medicines traceability system from laws and regulations, management, standards, range of applications, at last proposes the appropriate countermeasures adapted to Group of companies.

Preliminary studies on critical control point of traceability system in wolfberry / 中国中药杂志

As a traditional Chinese medicine, wolfberry (Lycium barbarum) has a long cultivation history and a good industrial development foundation. With the development of wolfberry production, the expansion of cultivation area and the increased attention of governments and consumers on food safety, the quality and safety requirement of wolfberry is higher demanded. The quality tracing and traceability system of production entire processes is the important technology tools to protect the wolfberry safety, and to maintain sustained and healthy development of the wolfberry industry. Thus, this article analyzed the wolfberry quality management from the actual situation, the safety hazard sources were discussed according to the HACCP (hazard analysis and critical control point) and GAP (good agricultural practice for Chinese crude drugs), and to provide a reference for the traceability system of wolfberry.

Development of standard defibrillation energy source / 医疗卫生装备

To develop a standard defibrillation energy source which can output monophasic and biphasic de-fibrillation impulses and can display standard energy values. The storage capacitor was charged by single-end flyback transformator and discharged through the H bridge composed of insulated gate bipolar transistor (IGBT). Impulse voltage and current were collected by divider while discharging, and the energy value was calculated by STM32. The en-ergy value and waveform were displayed through the control module. The energy source could output both monophsic and biphasic waveforms, and the accuracy of displayed value was higher than ±2% or ±1 J. The standard defibrillation energy source can be used as standard device for defibrillator analyzer, and the metrological trace-ability system of defibrillation energy may come to be completed.