Current Situation of International Organization for Standardization/Technical Committee 249 International Standards of Traditional Chinese Medicine

Objective： To review the current situation and progress of traditional Chinese medicine（TCM） international standards, standard projects and proposals in International Organization for Standardization（ISO）/technical committee（TC） 249. Methods： ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group（WG）, current stage and classification. Results： In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fields, 7 groups and sub-groups based on International Classification Standards. Conclusion： A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Use of Non-Verbal Representations to Define Concept of Pulse Conditions in Traditional Chinese Medicine Standards

The standardization of terms and definitions is fundamental to all activities in the domain of traditional Chinese medicine(TCM).For decades,definitions of TCM terminology relied on conventional verbal representations to differentiate between related concepts.However,the ancient Chinese is obscure and comprises a massive volume of information,making it difficult to convey the definition accurately in other languages.This article proposes a potential solution that the definition for pulse terminology can be supplemented by modern means of non-verbal representation,i.e.,using pulse waveform graphs and parameters to complete the definition of each pulse.A discussion of the challenges of obtaining reliable data is also included.

International Communication of Traditional Chinese Medicine in the Context of COVID-19 Pandemic by Analogy of Directional Solidification

According to the phenomenon-taking of classified analog,directional solidification can be an excellent approach for international communication of traditional Chinese medicine(TCM)in the context of COVID‑19 pandemic.Attitudes toward TCM by Western Medicine(WM)can be represented by various morphologies of the solid/liquid interface.COVID‑19 has created an urgent need for the worldwide spread of TCM.To counter any doubts and objections against TCM,COVID‑19 pandemic provides a good opportunity,meanwhile a steady and firm pace forward should be kept.It is also necessary to resolve domestic controversies and to lower cultural shock.The philosophy of TCM can agree fairly well with dialectical materialism;the scientific connotation of pentacy in TCM can be explained through the symptoms of COVID‑19‑infected patients.A TCM understanding compatible with WM will accelerate its international acceptance,which could help to better elaborate the significance of humanity in TCM.Holistic medicine under the guidance of TCM principles is an important trend in medical development,whose framework is illustrated in a 4C+T diagram.

International Communication of Traditional Chinese Medicine in the Context of COVID-19 Pandemic by Analogy of Directional Solidification

According to the phenomenon-taking of classified analog,directional solidification can be an excellent approach for international communication of traditional Chinese medicine(TCM)in the context of COVTD-19 pandemic.Attitudes toward TCM by Western Medicine(WM)can be represented by various morphologies of the solid/liquid interface.COVID-19 has created an urgent need for the worldwide spread of TCM.To counter any doubts and objections against TCM,COVTD-19 pandemic provides a good opportunity,meanwhile a steady and firm pace forward should be kept.It is also necessary to resolve domestic controversies and to lower cultural shock.The philosophy of TCM can agree fairly well with dialectical materialism;the scientific connotation of pentacy in TCM can be explained through the symptoms of C OVID-19-infected patients.A TCM understanding compatible with WM will accelerate its international acceptance,which could help to better elaborate the significance of humanity in TCM.Holistic medicine under the guidance of TCM principles is an important trend in medical development,whose framework is illustrated in a 4C+T diagram.

Visualization analysis of the international standard ISO/TC 249 for traditional Chinese medicine

Objective This study proposes to visually review the current situation and progress of standards sets by the International Organization for Standardization/Technical Committee on Traditional Chinese Medicine(ISO/TC 249). The review aims to explore the development strategies of the standards, which will exhibit the considerable impact on the economy, trade and exchanges, and cooperation in the area of traditional Chinese medicine(TCM).Methods ISO/TC 249 standards were searched on the ISO website, and their title, proposed time, current stage, scope, and classification were obtained for further summarization. Gephi was utilized to portray the co-occurrence network graph of the ISO/TC 249 standards subject.Results In ISO/TC 249, there were 116 standards, including 81 published standards and 35 developing standards by April 30, 2022. Two withdrawal standards were published after revision, which were not counted in the total standards. The number of published standards has been increasing since the first standard was published in 2014, whose title was “Sterile acupuncture needles for single use”. Among these standards, 17.24%(20/116) standards were in review, 56.03%(65/116) in publication, 3.45%(4/116) in approval, 5.17%(6/116) in enquiry,3.45%(4/116) in committee, and 14.66%(17/116) in preparation, respectively. With 116 standards, most of the research focused on the medicament, as its classification of the International Classification for Standards(ICS) showed the proportion reaching 49.54%. The network analysis data revealed that the top five most frequent words were “materials” “root” “requirements” “products” and “system”, after removing the noise data, such as prepositions,conjunctions, and pronouns. Additionally, the word “system” co-exists with the terms “computerized” “coding” “image” “tongue” and “analysis”;the word “requirement” co-exists with“manufacturing” “decoction” “process” and “materials”;whereas the word “devices” coexists with “pulse” “electric” “skin” and “measurement”.Conclusion With the increased diversification and complexity of problems, the development of standards is also oriented to multidisciplinary fields to cultivate the interdisciplinary talents, and especially the international standardization talents of compound TCM. Multi-angle analysis, formulation, and demonstration of standards, in line with industry needs in different disciplines, enhance the availability of standards and the ability to serve the industry.

Reflections on Traditional Chinese Medicine Culture Teaching in the Context of International Chinese Education

With the development of the times,both international Chinese education and traditional Chinese medicine have ushered in not only great potential development opportunities,but also various challenges.Traditional Chinese medicine culture has gradually gained international recognition,and many foreign students are now choosing to study traditional Chinese medicine.Therefore,the development of international Chinese education needs to embody traditional Chinese medicine culture teaching,which can promote the internationalization of traditional Chinese medicine.At the same time,encountering problems such as cultural differences ensue the need for improving the teaching system,which lacks teaching practice.On this basis,strategies such as exploring the teaching mode of traditional Chinese medicine culture,cultivating a team of high-quality international Chinese teachers,and creating experience courses with characteristics of traditional Chinese medicine culture have been put forward,so as to enhance the teaching of traditional Chinese medicine culture and promote the development of international Chinese education.

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

The Foundation of Traditional Chinese Medicine

In this paper, the authors examine and interpret the concept of Traditional Chinese Medicine (TCM) whom the Chinese believes and practices for so many centuries. The authors also explain the ancient Chinese con-cepts of Chi and Tao (Yin and Yang) which are the foundation of the TCM. This paper also seeks to discuss the ways of attaining a healthy body with the clarity of mind as well as to demonstrate the benefits of such healthy lifestyle.

Exploring the Application Effect of Flipped Classroom Combined with Problem-Based Learning Teaching Method in Clinical Skills Teaching of Standardized Training for Resident Doctors of Traditional Chinese Medicine

Objective: To explore the application effect of flipped classroom combined with problem-based learning teaching method in clinical skills teaching of standardized training for resident doctors of traditional Chinese Medicine. Methods: The study used the experimental control method. The study lasted from September to November 2022. The subjects of this study were 49 students of standardized training for resident doctors of traditional Chinese Medicine from grades 2020, 2021 and 2022 of Dazhou integrated TCM & Western Medicine Hospital. They were randomly divided into experiment group (25) and control group (24). The experiment group adopted flipped classroom combined with problem-based learning teaching method, and the control group adopted traditional teaching method. The teaching content was 4 basic clinical skill projects, including four diagnoses of traditional Chinese Medicine, cardiopulmonary resuscitation, dressing change procedure, acupuncture and massage. The evaluation method was carried out by comparing the students’ performance and a self-designed questionnaire was used to investigate the students’ evaluation of the teaching method. Results: The test scores of total scores in the experimental group (90.12 ± 5.89) were all higher than those in the control group (81.47 ± 7.96) (t = 4.53, P P Conclusions: The teaching process of the flipped classroom combined with problem-based learning teaching method is conducive to improving the efficiency of classroom teaching, cultivating students’ self-learning ability, and enhancing students’ willingness to learn.

Traditional Chinese Medicine and Standardization——Origin and development of TCM

Traditional Chinese Medicine (TCM) is the medical science based on theories and practicing experience of traditional Chinese medicine to study transferring principles of health and sickness,as well as prevention, diagnosis,treatment,rehabilitation and healthcare.TCM is marked with its long history of development,integrated theory system and abundant practicing experience.

Thoughts on the Construction of Evidence-based Nursing Standard Plan for Dominant Diseases in Traditional Chinese Medicine

The evidence-based Traditional Chinese Medicine(TCM) nursing in standard plan is to be constructed by a combination of evidence-based thinking and expert consensus.(1) The symptoms of diseases with better curative effect in TCM and the nursing techniques of TCM based on scientific evidence can be preliminarily presented through bibliometric analysis.(2) Expert consultation letters can be developed based on bibliometric results, and symptoms of dominant diseases in TCM and TCM nursing techniques can be selected through those letters.(3) Based on the selected symptoms and TCM nursing techniques, the PICO can be determined, and then evidence search, evidence extraction, evidence analysis can be conducted and synthesized, and recommendations would be chosen.(4) The recommendation grade of each recommendation can be determined by applying the Delphi method and referring to GRADE.(5) The plan will be determined through discussions of experts. The construction of TCM nursing plan would make sure that TCM nursing is scientific, and internationalize TCM nursing.

Promoting the Development of Traditional Chinese Medicine in the New Century

Reviewing the past, traditional Chinese medicine (TCM) in the 20th century experienced vicissitude. Since the founding the People's Republic of China, especially for the past twenty years, traditional Chinese medicine undertaking, full of vigor and vitality, has made an unprecedented development in China. The legal status and scientific status of traditional Chinese medicine and pharmacology have already been established. The medical system of traditional Chinese medicine, which is composed of traditional Chinese medicine hospitals, ethnic minority medicine hospitals, integration of traditional and western medicine hospitals and comprehensive hospitals, is playing an important role in preventing, treating diseases and enhancing people's health level. The system of production and circulation for traditional Chinese medicine has basically guaranteed the people's demand for Chinese medicine, with the principles of producing medicinal materials as basis, taking Chinese medicine industry as pillar and Chinese medicine as link. Remarkable achievements have been scored in the research of TCM development as well as research of TCM basic theory and clinical treatment. A number of scientific and technological results have been transformed into productive forces. TCM education has formed a rational pattern based on inheriting traditional way of transmission from master to disciple as well as taking the university and college education as the main part. Minority medical science has been further explored and sorted out; the level of medical treatment, teaching and scientific research for ethnic minority medicines has been improved. As the contingent of integrated traditional and western medicine is growing steadily, medical treatment system, scientific research system and teaching system for integrated traditional and western medicine takes shape progressively. International exchange and cooperation on traditional Chinese medicine has been greatly promoted. Various forms of cooperative relations on the TCM medical treatment, teaching and scientific research have been established between China and many other countries and regions in the world. With the increasing influence of TCM in the world, the accomplishment of traditional Chinese medicine in the 20th century has attracted world attention.

Research progress in the treatment of diabetic foot with traditional Chinese medicine

Diabetic foot is one of the chronic complications of diabetes,which is serious and expensive to treat.As an effective method for treating diabetic foot,Chinese medicine plays an important role in improving the clinical symptoms and reducing the suffering of diabetic foot patients.The methods of traditional Chinese medicine to treat diabetic foot include internal treatment method,external treatment method and comprehensive therapy.This article reviews the research results of traditional Chinese medicine treatment of diabetic foot in order to provide reference for the treatment of diabetic foot.

Promotion of Standardization and Internalization of Traditional Chinese Medicine:Interpretation of Chapters in the 13^(th) Five-Year Special Project for Scientific Innovation of Traditional Chinese Medicine

Traditional Chinese medicine(TCM) contains profound scientific connotation and has great potential in guiding the future development of bioscience,thus becoming the Chinese Treasure of Ancient Science and the Key to Open the Treasury of Chinese Civilization. 13^(th) Five-Year Special Project for Scientific Innovation of Traditional Chinese Medicine has proposed to promote the standardization and internalization of TCM,including implementation of TCM standardized action,establishment of TCM standard system to complete system and adapt development requirements,establishment of a standard system for TCM that can complete system and meets the requirement of development to capture the advantages in international standardization competition,so as to seize the leadership and discourse power in the establishment of TCM international standardization;to promote the implementing great scientific TCM plan to accelerate the international registration of brand-name and high-quality TCM,expedite TCM service and products entering into international main markets of medicines and heath care,propel the scientific cooperation and application of TCM in various countries along One Belt and One Road(B & R),and create Chinese standards and brands,so as to promote the TCM moving towards the whole world.

Retrospection and Reflection on the Role of Henry C.Lu as a Traditional Chinese Medicine Writer,Educator,and Translator

This paper respectfully commemorates the life of Dr.Henry C.Lu(1936-2022),who was the founding president of International College of Traditional Chinese Medicine of Vancouver.Dr.Lu was an active educator,a prolific writer and translator of traditional Chinese medicine(TCM)in the West and an influential figure during the initial stage of the international dissemination of TCM.By comprehensively searching,referencing,and cross-validating the literature,this article reviewed Dr.Lu’s major life events,bibliography,and,most importantly,his contribution to TCM education and translation.Dr.Lu should be given more credit for his achievements,and further studies are needed in future.

Research of Quality Standards for Stachydrine Hydrochloride in Chinese Medicine TJF Granule

A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile (50:50, v/v) by the Agilent Kromasi NH2 column (250 mm × 4.6 mm, 5 μm, S/N: 22N25110). Detection wavelength was 201 nm. The result revealed good linearity of stachydrine hydrochloride and was obtained within the range of 0.20 - 1.98 μg/mL (R = 0.9995). The average recovery was 97.01%;the relative standard deviation (RSD) was 0.19%. To the best of our knowledge, this is the first report dedicated to the determination of stachydrine hydrochloride by the evaporative light scattering detector-high-performance liquid chromatographic (ELSD-HPLC) method.

Professor Liu Guobin used traditional Chinese medicine to cure a case of primary erythema limb pain

Primary erythema limb pain is a very rare disease,and its pathogenesis is not clear.Usually,the pain symptoms of patients exist for a long time,which seriously affect the daily life of patients and increase the economic burden of patients.Professor Liu Guobin,who has been engaged in the diagnosis and treatment of peripheral vascular diseases for nearly 30 years,believes that heat-toxin and blood stasis collaterals are closely related to the disease,and emphasizes the principle of heat-toxin and evil qi causing the disease.It is emphasized that clearing heat and detoxification,promoting blood circulation and dispersing blood stasis are the main treatment principles.This paper selects a typical case to describe Professor Liu's clinical experience in the treatment of primary erythema limb pain by oral and external use of traditional Chinese medicine,so as to provide an effective method of traditional Chinese medicine for the treatment of primary erythema limb pain.

Impressions on the Book“On the Standard Nomenclature of Traditional Chinese Medicine”(by Professor XIE Zhu-fan,Foreign Languages Press Beijing, 2003)

Traditional Chinese medicine(TCM)is indubitably on the top of Chinese cultural treasures,deeplyimpressed in the mind of Chinese people.Unfortunately,TCM is facing difficulties in the route towardsinternationalization,up till now,TCM has not yet been granted a legal position for clinical practice in aconsiderable number of countries.So it is our responsibility tO make TCM internationalized and push TCMtobe accepted world—wide,even though we know that it is a long way to go.