The paper summarizes the authorized invention patents, device registration and the relevant published articles of acupuncture medical devices of TCM in recent 5 years, and analyzes the current status and challenges in this field. It is discovered that the optimization and substitution in diagnosis and treatment of acupuncture are involved in the development of acupuncture medical devices. The technology application of these devices are composed of traditional and emerging engineering technologies; and the theoretical guidance for their development requires the integration of traditional acupuncture principles with modern medical theories. The development of acupuncture medical devices highlights the characteristics of multidimensional integration, treatment for specific ailments, portability and wearability, painlessness and non-invasion, precision and personalization, as well as intelligent automation. Upon analysis, it is shown that in the development and product transformation of acupuncture medical devices in recent years, the theoretical principles of acupuncture of TCM have not been fully utilized yet, the transformation of patented product is low, the clinical evidence of product is insufficient, and the market competitiveness needs improvement. In the future, The theoretic guidance of acupuncture of TCM should be enhanced in the development of acupuncture medical devices, a production-education- research model with the combination of medicine and engineering be constructed, clinical verification of product be emphasized, and product development paradigms be advanced, so as to meet the demands of the medical market.
Acupuncture Therapy/trends* ; Humans ; Medicine, Chinese Traditional/instrumentation* ; Equipment and Supplies

As an innovative dosage form, traditional Chinese medicine(TCM) dry powder inhalers have emerged as a focal point in the research and development of new preparations due to its high efficiency, safety, and bioavailability. This paper systematically reviewed the relevant literature and patents associated with TCM dry powder inhalers to analyze the origins and the current research and development status. Furthermore, this paper probed into the research and development ideas of TCM dry powder inhalers regarding clinical positioning, prescription screening, and druggability. Additionally, the paper thoroughly analyzed the technical barriers in druggability studies and elaborated on corresponding research techniques and coping measures. Furthermore, it emphasized the need for improved regulations and policies governing TCM dry powder inhalers, advocated for strengthened oversight, and called for the establishment of a scientific quality evaluation system. Measures such as promoting production-education-research collaboration, enhancing personnel training, and fostering international exchanges were proposed to provide a scientific and systematic reference for the future research, development, and application of TCM dry powder inhalers, thereby facilitating the rapid modernization of TCM.
Humans ; Dry Powder Inhalers/trends* ; Drugs, Chinese Herbal/chemistry* ; Medicine, Chinese Traditional/instrumentation* ; Administration, Inhalation

This study systematically analyzed the global research landscape, technological composition, and core patents in the field of networks target and network pharmacology, and proposes further suggestions based on the IncoPat patent citation database and VOSviewer bibliometric network visualization tool. Using patent literature metrics and scientific knowledge mapping method, technological innovation pathways, research hotspots, and future directions in this field were further revealed. In particular, this field is moving towards data-driven, intelligent, and systematic approaches. Patent analysis indicated that most patent applications in this domain focused on traditional Chinese medicine(TCM), which have provided key engineering technical approaches to explore and solve complex problems of TCM. By integrating big data and artificial intelligence technologies, network targets and network pharmacology have conferred high-precision screening and quality control of key components and targets in herbal formulations and prescriptions, accelerating the clinical translation and industrialization of TCM-based new drugs and health products with medicine-food homology. Therefore, it is essential to optimize the patent protection system and establish integrated technology platforms in this field for ensuring the competitiveness of technological achievements in research and clinical application. These efforts will advance the widespread application and high-quality development of TCM modernization, precision medicine, and innovative drug discovery.
Bibliometrics ; Patents as Topic ; Humans ; Medicine, Chinese Traditional ; Network Pharmacology/trends* ; Drugs, Chinese Herbal/pharmacology*

Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

The guidelines for clinical research on new drugs provide unified standards for drug developers, researchers, and regulatory authorities, playing a crucial role in new drug development. This article systematically reviews the evolution of guidelines for clinical research on new traditional Chinese medicine(TCM) drugs in China, with a focus on analyzing the current status of these guidelines and the problems that exist. It also provides interpretations of three important guidelines. The article points out that with the continuous emergence of new clinical trial design methods, development concepts, and tools, and under the background of the "three combinations" evidence evaluation system for new TCM drugs, it is imperative to revise existing guidelines, formulate new ones, and develop new tools for clinical efficacy evaluation. It is hoped that relevant departments will adopt an open attitude and work together to build a technical system of clinical research guidelines for new TCM drugs that aligns with the characteristics of TCM.
Humans ; Biomedical Research/trends* ; China ; Clinical Trials as Topic ; Drugs, Chinese Herbal/therapeutic use* ; Guidelines as Topic ; Medicine, Chinese Traditional/standards*

Covid-19 pandemic has caused hundreds of thousands deaths and millions of infections and continued spreading violently. Although researchers are racing to find or develop effective drugs or vaccines, no drugs from modern medical system have been proven effective and the high mutant rates of the virus may lead it resistant to whatever drugs or vaccines developed following modern drug development procedure. Current evidence has demonstrated impressive healing effects of several Chinese medicines (CMs) for Covid-19, which urges us to reflect on the role of CM in the era of modern medicine. Undoubtedly, CM could be promising resources for developing drug candidates for the treatment of Covid-19 in a way similar to the development of artemisinin. But the theory that builds CM, like the emphasis of driving away exogenous pathogen (virus, etc.) by restoring self-healing capacity rather than killing the pathogen directly from the inside and the 'black-box' mode of diagnosing and treating patients, is as important, yet often ignored, an treasure as CM herbs and should be incorporated into modern medicine for future advancement and innovation of medical science.
Antiviral Agents/therapeutic use* ; COVID-19/therapy* ; Disease Outbreaks ; Drug Development/standards* ; Drug Resistance, Viral/genetics* ; Drug Therapy, Combination ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional/trends* ; Mutation Rate ; Pandemics ; Phytotherapy/methods* ; SARS-CoV-2/physiology*

The development of Chinese medicine and Western medicine andrology is based on different social background and academic systems, either Chinese medicine or Western medicine andrology has their limitations, therefore, integration of Chinese and Western medicine (ICWM) andrology is in a great need. After more than 30 years of development, andrology has made great achievements in the construction of specialized academic association, holding academic conferences and publication of academic monographs, and the research progress on this field is mainly in the combination of disease and syndrome, microdifferentiation of symptoms and signs and basic research development. However, the comprehensive theoretic system of ICWM andrology has not yet established, and the related studies are still on the primary stage. In the future studies, great efforts still need to be made to expand the methods for the investigation of ICWM, and make innovations in the field of andrology.
Andrology ; trends ; Humans ; Male ; Medicine, Chinese Traditional ; trends ; Periodicals as Topic ; Research Design

In order to find the trends in Panax notoginseng industries of China, a combination of data analysis and empirical analysis was applied to analyze the application of global P. notoginseng patents, the innovation field, the distribution of patent assets, the patent citation network, the distribution of enterprises, the talent team, the competition and cooperation situation based on the financial big data platform of intellectual property industry. From the perspective of industrial technology hotspots, the clinical application of P. notoginseng is becoming more and more widespread, and its clinical treatment field is further expanding. From the perspective of industrial fields, the P. notoginseng industry has gradually expanded from the traditional Chinese medicine field to food, cosmetics, beverages, tea and other daily consumer goods. From the perspective of patent quality, the average maintenance life of P. notoginseng patents of China is lower than the global level, and the value and quality of patents need to be further improved. And the quality of P. notoginseng of China related patent applications has gradually improved in recent years. We analyzed the technology, capital, and talent issues of P. notoginseng industry of China, and summarized and forecasted the status and trends of P. notoginseng industry development of China. It is considered that scientific and technological innovation has become the core engine for the development of the P. notoginseng industry and intellectual property, especially patent protection, escorted the sustainable development of the P. notoginseng industry. Based on the above analysis, several suggestions were put forward to promote the high-quality development of the P. notoginseng industry. It should strengthen scientific and technological support, especially the need for a large number of high-quality scientific and technological output, expand multi-party cooperation, build a high-level technological innovation platform for the P. notoginseng industry, guide long-term capital to continuously and stably invest, and help the P. notoginseng industry to revitalize.
China ; Drug Industry/trends* ; Drugs, Chinese Herbal ; Medicine, Chinese Traditional ; Panax notoginseng/chemistry* ; Patents as Topic

Coronavirus disease-2019 (COVID-19) is a new highly infectious disease caused by a novel coronavirus. Recently, the number of new cases infected pneumonia in the world continues to increase, which has aroused great concern from the international community. At present, there are no small-molecule specific anti-viral drugs for the treatment. The high mortality rate seriously threatens human health. Traditional Chinese medicine (TCM) is a unique health resource in China. The combination of TCM and Western medicine has played a positive and important role in combating COVID-19 in China. In this review, through literature mining and analysis, it was found that TCM has the potential to prevent and treat the COVID-19. Then, the network pharmacological studies demonstrated that TCM played roles of anti-virus, anti-inflammation and immunoregulation in the management of COVID-19 via multiple components acting on multiple targets and multiple pathways. Finally, clinical researches also confirmed the beneficial effects of TCM on the treatment of patients. This review may provide meaningful and useful information on further drug development of COVID-19 and other viral infectious diseases.
Antiviral Agents/pharmacology* ; COVID-19/drug therapy* ; Drugs, Chinese Herbal/pharmacology* ; Humans ; Medicine, Chinese Traditional/trends* ; SARS-CoV-2/drug effects*

As a large micro-ecosystem in the human body,the intestinal microbiota is closely associated with the occurrence of many diseases.The clinical investigations and animal experiments have showed that traditional Chinese medicine(TCM) could maintain the balance of the intestinal micro-ecological system.This review summarized the research methods and literatures on the regulation effects of TCM,including different effective ingredients,extracts and Chinese herbal formulae,on intestinal microflora in recent five years,in order to provide a reference for the further research and development of TCM.
Animals ; Gastrointestinal Microbiome ; drug effects ; Humans ; Intestines ; microbiology ; Medicine, Chinese Traditional ; Research ; trends