Dec. 25, 2018 source: China Medical News Author: Luo Nan
The picture shows linruichao, director of Beijing Key Laboratory for quality evaluation of traditional Chinese medicine, Beijing University of traditional Chinese medicine, showing calcium oxalate crystals and starch granules under different polarizations. Duranhao Photograph
The picture shows that experts' speeches were "warmly welcomed" by the audience at the seminar on the high quality development of Chinese traditional medicine. Duranhao Photograph
In recent years, the gross domestic product of traditional Chinese medicine industry has increased rapidly. According to the 2017 analysis on the economic operation of the pharmaceutical industry released by the national development and Reform Commission, the main business income of the traditional Chinese medicine slice processing and Chinese patent medicine production industries accounted for 26.5% of the main business income of Pharmaceutical Enterprises above designated size. However, traditional Chinese medicine is complex and diverse from the beginning. After industrialization, the quality of traditional Chinese medicine is reduced, and the standards of traditional Chinese medicine pieces are not unified, which restricts the development of traditional Chinese medicine industry to a higher level.
On December 20, at the seminar on the high quality development of Chinese traditional medicine held during the "2018 smart food and drug Expo and the first Sichuan (Leshan) traditional Chinese medicine Expo", industry experts gathered together to feel the way for the high quality development of Chinese traditional medicine from the perspective of the progress of the informatization work of the fourth national survey of Chinese traditional medicine resources, the quality evaluation of Chinese traditional medicine, quality control and the construction of the traceability system of Chinese traditional medicine. Experts present at the meeting jointly issued a voice: only good herbs can make good medicines.
Seek development for the purpose of sustainable utilization of resources
The day before the seminar, the Ministry of agriculture and rural areas, the State Drug Administration and the State Administration of traditional Chinese Medicine issued the national plan for the construction of genuine medicinal materials production base (2018-2025) (hereinafter referred to as the plan). "The plan can be formed, and the fourth national survey of traditional Chinese medicine resources has contributed a lot." Zhang Xiaobo, deputy director of the general survey office of traditional Chinese medicine resources of the traditional Chinese medicine resources center of the Chinese Academy of traditional Chinese medicine, could not restrain his excitement when he mentioned this at the seminar.
The sustainable development of traditional Chinese medicine industry depends on the protection and development of traditional Chinese medicine resources. In recent ten years, the Chinese traditional medicine industry has developed rapidly, and the sustainable utilization of Chinese traditional medicine resources is under pressure. In August, 2011, the pilot work of the fourth national census of traditional Chinese medicine resources was launched. Huangluqi, academician of the Chinese Academy of engineering and President of the Chinese Academy of traditional Chinese medicine, served as the leader of the technical guidance expert group for the census.
"The purpose of the census is to find out the resources of traditional Chinese medicine, find solutions to key problems restricting the development of the industry, and do a good job in related infrastructure construction, achievement undertaking and transformation." Zhang Xiaobo said that through the resource census, a large number of survey data of traditional Chinese Medicine resources have been put into the database, including 114504 samples, 11280 kinds of medicinal resources, 1995 kinds of reserves... Linking these data and the information "passwords" behind them can form a comprehensive picture of China's traditional Chinese medicine resources, and also provide a basis for the introduction of traditional Chinese medicine resource protection measures and the formulation of industrial policies.
This census is of great significance to relieve the pressure on traditional Chinese medicine resources. On the one hand, the census found many new species with medicinal potential. "At present, we have found 74 new species. According to statistical analysis of 63 of them, about 70% of them have potential medicinal value," Zhang said. On the other hand, to solve the problem of scarcity of traditional Chinese medicine resources, we should ultimately rely on artificial cultivation. Relying on the fourth national survey of traditional Chinese medicine resources, we have established a number of seed and seedling breeding bases for traditional Chinese medicine.
"This census used many modern scientific and technological means to assist in the discovery and monitoring of resources." Zhang Xiaobo said that in 2013, the census expert group applied remote sensing technology to the resource census, and set up a remote sensing monitoring center for traditional Chinese medicine resources, and set up an information service platform for the optimization and cultivation of genuine medicinal materials to monitor the water and fertilizer information of the growing environment of medicinal materials, the status of diseases and pests, and the growth of medicinal materials, so as to serve the fine planting and high-quality production of traditional Chinese medicine.
Remote sensing monitoring combined with field survey data can relatively accurately reflect the distribution area and planting quantity of medicinal materials, and the output of a medicinal material can be predicted by summarizing multi period information. "For perennial medicinal materials, the quantity that can be supplied can be inferred by summarizing the planting situation in several years." Zhang Xiaobo added that this information can guide enterprises to plant and produce.
It is also to solve the problem of sustainable utilization of traditional Chinese medicine resources. Duanjinlin, chairman of the traditional Chinese medicine resources recycling Professional Committee of the Chinese Medicine Association, pays attention to the value discovery and resource utilization of by-products in the production process of traditional Chinese medicine. According to him, in the production of Chinese medicinal materials, nearly 100 million tons of non medicinal parts are produced every year, and more than 100 million tons of solid / liquid wastes and by-products are produced every year in the deep processing processes such as traditional Chinese medicine pharmacy. These by-products still have resource value, but the utilization rate is not high.
Duanjinlin advocated the development of circular economy in traditional Chinese medicine industry. "The production of traditional Chinese medicine will certainly develop from the development mode of focusing on scale and quantity to the direction of focusing on quality and efficiency. The competition in the traditional Chinese medicine industry will be upgraded from the pure product quality competition to the quality control competition in the whole industry chain. The traditional Chinese medicine industry must change the extensive development mode and production mode, and cannot exhaust resources without limit." Duan Jinlin stressed.
Realizing modernization on the basis of solving practical problems
How to inject fresh vitality into traditional Chinese medicine, modernization is undoubtedly one of the development directions. Yangming, vice president of Jiangxi University of traditional Chinese medicine, believes that the modernization of traditional Chinese medicine should be based on solving practical problems. "Only by solving the practical problems encountered in the development of traditional Chinese medicine in a down-to-earth manner can the traditional Chinese medicine industry develop better." Yang Ming's view was recognized by many experts on the scene.
Yang Ming has long studied the quality process control of traditional Chinese medicine preparations. He said that in recent years, documents related to the development of traditional Chinese medicine have repeatedly emphasized process control, and the focus of process control is the digitalization and standardization of traditional Chinese medicine manufacturing.
"We now have a large amount of data, but the data has not formed a regular pattern and has not become a decision-making factor for quality control." Yang Ming explained that mass data such as production batch records and inspection reports are idle and have a low utilization rate; The production of many links still depends on experience judgment, but experience judgment has some defects, such as fuzziness, subjectivity and poor operability.
According to Yang Ming, experience digitalization, process refinement and operation standardization are the prerequisites for realizing intelligent manufacturing and continuous production. How to ensure the uniformity, stability and reliability of drugs in the production of traditional Chinese medicine? In this regard, Yang Ming summarized the 4W rules, that is, to clarify the key influencing factors (where), the degree of influence (why), how to control (how) and the scope of control (when).
"Ask at least 100 questions for each link of production from the perspective of 4W. If a product can answer 100 questions clearly and solve them all, it can be built into a high-quality product. ”Yang Ming called this practice "a hundred questions make perfect", and its essence is problem-oriented fine management and quality control. He said: "we have done a lot of work in this regard, focusing on the variety as the carrier, to carry out fine research on the extraction, alcohol precipitation and other technological processes, form data, combine it with the engineering principle research of pharmaceutical equipment, and seek solutions for the quality control of traditional Chinese Medicine in the R & D of pharmaceutical equipment."
"At present, traditional Chinese medicine is in a state of 'basically solving the authenticity, and there is no way to talk about its advantages and disadvantages'. The advantages and disadvantages of traditional Chinese medicine are reflected in its quality." linruichao, director of Beijing Key Laboratory for quality evaluation of traditional Chinese medicine at Beijing University of traditional Chinese medicine, introduced his concept and practice of quality evaluation of traditional Chinese medicine at the seminar.
The quality evaluation of traditional Chinese medicine is to study the connotation and characteristics (characteristics) of traditional Chinese medicine and describe it objectively, digitally and scientifically. Its core is the evaluation of truth, falsehood, excellence and inferiority, with the purpose of ensuring the safety, effectiveness, stability and controllability of drugs. Linruichao said that the quality evaluation model of traditional Chinese medicine has gone through a process from traditional character evaluation to physical and chemical detection through qualitative and quantitative analysis, instrumental determination of the content of active ingredients or index ingredients, and then to biological evaluation to evaluate the biological activity of drugs. In this process, the authenticity of traditional Chinese medicine has been basically solved. However, because the quality of traditional Chinese medicine is affected by its germplasm, origin, cultivation, collection, processing, storage, processing, preparation and other links, and its composition and action mechanism are complex, the evaluation criteria for the advantages and disadvantages of traditional Chinese medicine still need to be established. Linruichao proposed that a scientific, reasonable, practical, economic and environmental protection quality evaluation system of traditional Chinese medicine should be established from the multiple dimensions of biological evaluation, instrumental analysis and physical and chemical properties.
Establishing traceability system to ensure the quality of traditional Chinese medicine products
At the seminar, zhaojunning, President of Sichuan Academy of traditional Chinese medicine, stressed that the high-quality development of traditional Chinese medicine is one of the foundations for the development of the great health industry and an important guarantee for providing health services to the people. Only good herbs can make good medicines. As the source of preparations, the quality problems of traditional Chinese medicine and its decoction pieces will affect the quality control of preparations. Traditional Chinese medicine is an agricultural and sideline product. Its production involves a wide range of people and a long chain. There are challenges in quality control.
"Tracing the quality of Chinese medicinal materials is one of the important means to solve the development problems of traditional Chinese medicine." wangchunlu, executive vice president of the Chinese medicinal materials warehousing branch of the China Warehousing and Distribution Association, believes that tracing itself is only a means and form, and the traceability of sources, whereabouts and responsibilities is only the function of the tracing system. Its fundamental purpose is to control the quality of Chinese medicinal materials in the whole process.
According to wangchunlu, a good traceability should have a legal basis, a quality assurance system, generate endogenous power and follow the basic principles of traceability. "Traceability that can generate endogenous power is good traceability." wangchunlu specially emphasized that when traceability can distinguish the quality of traditional Chinese medicine and traditional Chinese medicine pieces, price differences must be given to the products with or without traceability. If "high quality and good price" are not available, or the sales of products without traceability are not restricted, it will attack the enthusiasm of enterprises to carry out traceability construction, and it is difficult to stimulate their endogenous power.
Wangchunlu proposed that the quality traceability of traditional Chinese medicine should follow the principles of the whole process, comprehensiveness, unity and Sustainability: the front-end should be connected with planting, and the back-end should be connected with processing of decoction pieces; It should include basic product information, quality inspection, business entity category, logistics quality, in warehouse maintenance, outbound transportation handover and other information; The coding rules, identification methods and information platform of traceability should be unified nationwide. The traceability platform and the logistics information platform should preferably be integrated so that all information can be managed uniformly, kept continuously and checked at any time; It is necessary to organically integrate the traceability function with logistics management, operation management, e-commerce, guarantee financing and other functions, drive enterprises to actively and continuously carry out traceability, and gradually establish a long-term traceability mechanism.
In recent years, many enterprises and associations have actively participated in the traceability construction of traditional Chinese medicine. In july2017, the China Association of traditional Chinese medicine established a professional committee for traceability of traditional Chinese medicine and started to build a quality traceability system for traditional Chinese medicine. Zhaorunhuai, chairman of the Chinese medicine traceability Professional Committee of the China Association of traditional Chinese medicine, introduced at the seminar that by the end of August this year, 117 enterprises had tried out the quality traceability system of traditional Chinese medicine, including 89 drug planting enterprises, 25 decoction piece manufacturers and 3 proprietary Chinese medicine manufacturers.
According to zhaorunhuai, an enterprise is the basic unit of traceability and the source of traceability information. The traceability information must be true, complete and accurate, and the traceability process must be standardized, standardized and networked. He pointed out that the focus of the enterprise's traceability work is to select the key varieties of the traceability pilot, establish and improve the quality management system, establish a traceability organization and clarify the job responsibilities, ensure the standards and specifications of the traceability work, and implement the work in combination with the actual situation.
"There are many regulations for Chinese medicinal materials and prepared pieces of Chinese medicine, and it is difficult to trace them back, so they must be implemented in batches. The selection principle of the first batch of varieties should consider both the urgency and feasibility of tracing." zhaorunhuai explained that in terms of urgency, bulk varieties, high priced varieties, drugs and foods, toxic varieties and problematic varieties can be selected; In terms of feasibility, it should be selected in combination with traditional Chinese medicine variety protection, quality risk control, enterprise brand maintenance, market development strategy, national standard project related work, etc.