Building a quality assurance system for Chinese medicine tablets

recently, at the "Academic Seminar on Key Disciplines of Chinese Medicine Concocting" held by the Chinese Academy of Traditional Chinese Medicine, experts pointed out that the quality of Chinese medicine tablets is not optimistic, and whether it is Chinese medicine, Chinese medicine tablets or pharmaceutical preparations, the use of the same quality evaluation system , which not only affected the objectivity and scientific quality evaluation of Chinese medicine, but also seriously affected the safety and effectiveness of chinese medicine clinical drug use Therefore, we must start from the needs of industrial development, to build a to stabilize the clinical efficacy of the core of the quality assurance of Chinese medicine tablets system . starting from facing the present situation
the State Administration of Traditional Chinese Medicine, the leader of the key disciplines of Chinese medicine, the Chinese Academy of Traditional Chinese Medicine Institute of the production of key disciplines construction project leader Li Li Associate researcher said that Chinese medicine tablets is the basic form of clinical medicine, at the same time it is also the raw materials for the production of traditional Chinese medicine With the "cure the disease" and the enhancement of the public's awareness of health care, Chinese medicine tablets have become the key in the whole Chinese medicine industry. "At present, the management level of China's drinking film industry is low "This is reflected in the general small size of enterprises, the traditional concept is deeply rooted, "family-style", "loose" management, focus on product management, neglect knowledge management and capital management, lack of innovative profit model, insensitive to changes in the market environment, do not understand the national pharmaceutical policies and regulations, lack of innovation awareness and brand awareness, not to mention strategic planning and strategic implementation capacity. Huang Qinlan analysis, hinder ingresss with the scale of Chinese medicine tablets, the important reason smaller than the development of modern drinking tablets can be summed up with "five more and five less": drink tablet sliver manufacturers more, small scale; The technical status quo of drink tablet production is also very weak, the cultivation and processing of medicinal herbs is not standardized, the quality standard system is lacking, the craft is simple, non-standard, and the basic research is weak He believes that "the technical research and development of Chinese medicine tablets has a huge operating space." Li Li, , stressed in particular that traditional pharmaceutical technology that best reflects the characteristics of Traditional Chinese medicine "Drinking tablets into medicine, raw and different treatment" is a high generalization of the characteristics and advantages of Traditional Chinese medicine, but also the theory of Chinese medicine and the principle of clinical treatment of Chinese medicine is an important embodiment Prescriptions play different therapeutic roles through the matching of tablets (changes in taste and dosage), while drink tablets are adapted to meet the different needs of clinical treatment through different concocting methods Therefore, the efficacy of Chinese medicine not only needs to have clinicians' superior medicine, but also depends on the stability of the quality of Chinese medicine tablets. " the current quality of Chinese medicine tablets is worrying, medicinal plant and distribution areas can be seen everywhere family-style drink tablet processing small workshop, cut drink tablets casually dry on the roadside, as well as the extraction of drink tablets to sell again phenomenon Li Li worried that this is only a production film, the quality of the production is more difficult to ensure: some individual processors do not in accordance with the standard of the production methods of the production processing, or even the use of dyeing and other means to make the appearance of the production to the prescribed degree. Li Li also pointed out that whether it is Chinese herbal medicine, Chinese medicine tablets or pharmaceutical preparations, the use of quality evaluation system is the same, which not only affects the objectivity and scientific quality evaluation, but also seriously affects the safety and effectiveness of clinical medicine in Chinese medicine Therefore, we must start from the needs of industrial development, to build a with stable clinical efficacy as the core of the quality assurance system of Chinese medicine tablets. from the key links Li Li suggested that the establishment of chinese medicine drink tablet quality assurance system, should start from the source quality assurance (the source of key technology inheritance and innovation), production mode assurance (the traditional consoning process and modern production mode innovation), quality evaluation mode assurance (the traditional quality evaluation experience and modern evaluation technology innovation) several key links. from the source, should inherit and innovate the cultivation of raw materials, and vigorously promote the imitation of traditional chinese medicine cultivation Due to the increasing demand for traditional Chinese medicine, the cultivation of traditional Chinese medicine is more tending to the way of planting agricultural products, too much artificial intervention, field management, and even a large number of plant growth regulators, ignoring the reasonable growth cycle of medicinal herbs Although this short, frequent and fast planting model meets the market demand for Chinese herbal medicine, it has caused serious damage to the whole Chinese medicine industry The imitation of wild planting not only can maintain the appearance characteristics of Chinese herbal medicine to the maximum extent, but also can effectively guarantee the intrinsic characteristics of Chinese herbal medicine. in the production mode, should innovate the chinese medicine drink tablets production of the integrated production mode Chinese medicine in its long-term application process has formed a net production, finishing, cutting, concocted drink ingress production mode But the reality is that the medicinal parts to be dried into medicinal materials in the place of origin to drink tablet production enterprises for drinking tablets, must be softened again before the cutting drying This secondary processing not only prolongs the production cycle of drink tablets, increases production costs, but also easily causes the loss of active ingredients. Li Li suggested that many Chinese medicine, especially the hard texture, irregular shape of the root and root Chinese medicine, can be dried to the appropriate degree of fresh medicinal parts, directly for the cutting of drink tablets processing This kind of medicine and drink tablet sidon processing production mode, not only makes the drink tablet information more accurate, but also can reduce the processing cost, reduce environmental pollution, but also for the Chinese medicine tablet quality and safety of sulfur fumigation has provided a scientific and effective solution. ", in order to reverse the situation of 'many, small and scattered' in the Chinese medicine drinking tablet industry, we should carry out the traditional production process and the innovation of modern production mode, that is, to implement regional specialized large-scale production, maximize the advantages of regional resources, integrate production resources, realize the adjustment of industrial structure, and provide more convenient conditions for the subsequent market circulation and quality supervision In addition, we should establish a drinking tablet quality evaluation model combining the experience of traditional quality evaluation with modern quality evaluation," Li said. first, based on the principle of concocting to carry out the quality evaluation model of innovation The study of the principle of Chinese medicine concocting is the fundamental study of Chinese medicine concocting, whether it is the standardization of the concocting process or the personalization of the quality evaluation method of drink ingests, it must be based on the principle of concocting Only on the basis of the basic clear principle of concocting can we establish the quality evaluation method of raw and drinking tablet exclusiveness, and embody the connotation attribute of drink ingress film in a true and objective way. second, we should adopt the quality evaluation model combining traditional experience with modern methods The traditional quality evaluation method is the most convenient and effective quality evaluation method that has been used so far, and it should not be abandoned because of the emergence and application of modern science and technology However, it must also face up to its existing problems: with the change of the cultivation mode of medicinal herbs, the original identification characteristics of Chinese herbal medicine has been gradually diluted, and the characteristics that can be used for the identification of drink tablets are few and far between, the quality of medicinal herbs and drink tablets is contrary to the traditional evaluation results Therefore, it is necessary to combine the traditional empirical identification method with the modern evaluation method, and give play to the complementarity of the two in the quality evaluation, so as to construct a more scientific, objective and practical evaluation system of drinking tablets.  Xiao Yongqing, the leading researcher of the Chinese Academy of Traditional Chinese Medicine and leader of the key disciplines of Chinese medicine concocted by the State Administration of Traditional Chinese Medicine, pointed out that the implementation of regional professional production of Chinese medicine drink tablets is the only way to develop the chinese medicine tablet industry He suggested the establishment of the production mode of Chinese medicine tablets, the establishment of a quality evaluation system with personality characteristics of drink tablets, the construction of standardized and professional drinking tablet production lines, the development of vehicle-mounted, removable Chinese medicine tablets processing equipment, the establishment of large-scale beverage tablet storage warehouse, the construction of a data-based control system for the production process of drink tablets (base supporting system), and the improvement of high-quality beverage tablet marketing network and logistics system.