Quality Analysis of Raw Material and Products of Goat Bezoar (Houzao), a Mysterious Traditional Medicine

Half of the 2015 Nobel Prize in Physiology or Medicine was awarded to Chinese scientist Youyou Tu in recognition of her pioneering work on the antimalarial artemisinin, extracted from Artemisia annua, a traditional Chinese herbal remedy used to treat fever. This is clearly a great encouragement for scientists who engage traditional medicine research. As Youyou Tu stated in her Nobel Prize awarding lecture, artemisinin is a gift from traditional Chinese medicine (TCM) to the world, this definitely will generate great interest in not only TCM but also other traditional medicine systems from other parts of the world, including Europe, Africa, India, Americas, etc. Though the Nobel Prize selection committee did not confess that the prize is to award traditional Chinese medicine, rather a new drug discovery inspired from TCM, this is indeed the exciting and encouraging event for Chinese TCM scientists. In my opinion, it is meaningless to dispute if artemisinin is still belonging to TCMor westernmedicine. Any contribution or new discovery derived from TCM to benefit for the human health should be recognized and respected. TCM needs to be developed and modernized. Any standpoint that developed or modernized TCM does not belong to TCM may drastically hinder the TCM modernization and integration with modern medicine process, or even deepen the gap between TCM and modern medicine. Evidence-based medicine is the future of TCM by means of modern biomedicine advances and novel approaches. In the past 20 years, TCM has undergone rapid development period evidenced by a number of achievements including the geometric growth of TCM research papers, booming TCM industry, TCM new drug research and development, etc. However, TCM is still facing grand challenges in the future development. Shortage of modern scientific evidence for safety, effectiveness, quality and mode of action should be emphasized and dealt with solutions. TCM experienced-based feature should be turned into evidence-based and science-based one. Following several aspects are suggested for the future modern TCM research: a) TCM-based new drug discovery. TCM is still a non-fully explored treasure house for new drug discovery and development. According to TCM resource survey, there are over 12000 TCM species, among which majority are herbs. Apart from artemisinin and its derivatives, a number of single chemical entity drugs have been developed and successfully marketed, such as arsenic trioxide, ginsenoside Rg3, bifendate, β-elemene, indirubin, etc. It is anticipated that more new drugs could be discovered from this vast TCM resource with modern drug discovery technology and methodology. b) Research on the holistic TCM quality control. The current quality control approach is more focused on a single marker or a few marker determinations, which follows the western drug quality control model and hence, could not really monitor the quality of TCM products. Systemic and comprehensive quality control method should be developed for the TCM crude drugs, prepared slices and finished products, especially for those multiple-ingredient herbal products. c) Research on TCM processing. All TCM crude drugs should be processed in different extent before they can be used either for decoction or for herbal production. TCM processing method is mainly based on the traditional knowledge or experience. Mechanism of processing either for the purpose of enhancing efficacy or eliminating toxicity should be thoroughly investigated and clarified. d) TCM efficacy and safety research. During the development of TCM, greater attention needs to be paid to the integrated evaluation of the effectiveness and safety based on TCM theory and modern scientific research. New evaluation methodology fit for TCM complex feature should be developed with international collaborations. Globally recognized evaluation criteria should be constructed. Other TCM research focuses include pharmacokinetics, geo-authenticity, active principles and giant data library. It is firmly believed that TCM will contribute more than ever to the human health along with the rapid advances of biomedicine science and eventually developed into an evidence-based medicine system.

BackgroundThe integration of artificial intelligence (AI) into traditional Chinese medicine (TCM) research and development offers promising solutions to longstanding challenges in the field. These challenges include the complexity of TCM formulations, variability in quality control, and hurdles in global market acceptance. The unique synergy between AI technologies and TCM principles creates opportunities to enhance research efficiency, standardization, and innovation.Aim of reviewThis review aims to explore the applications and impact of AI across three critical stages of TCM development: drug design, pharmaceutical manufacturing, and market access. By summarizing the advancements and limitations in these areas, the review identifies the transformative potential of AI and proposes future directions for integrating AI with emerging technologies to advance TCM research and development (R&D).Key scientific concepts of reviewAI has transformative potential in TCM development, addressing key challenges across various stages. In drug design, AI accelerates the identification of active compounds, optimizes formula composition, and models pharmacodynamic relationships to enhance innovation efficiency and precision. During pharmaceutical manufacturing, AI contributes to process optimization, quality control, and the standardization of TCM products, ensuring stable and scalable production. For market access, although no TCM developed by AI has entered the clinic, AI has played a role in comprehensive safety and efficacy assessments and simplified regulatory compliance in other drugs. By leveraging these advances and reviewing limitations, AI promotes the need to develop more integrated, more efficient, and more utilized methods in TCM R&D.

<p indent="0mm">With the development of biomedicine, and significant success achieved by targeted therapy in the treatment of complex and refractory diseases such as cancers, clinical treatment and drug discovery based on molecular targets become the main direction of modern medical research. Guided by holistic concept, traditional Chinese medicine (TCM) has a unique advantage with regards to the prevention and treatment of complex diseases through its comprehensive effect. However, at present, TCM research is insufficient and problems such as inaccurate clinical findings, lack of dominant diseases, unclear evaluation of efficacy, and unclear mechanisms, cannot be solved easily. Therefore, the authors believe that the development of TCM should adopt an innovative approach that integrates the advantages of TCM and western medicine, and positively influences the development of TCM and even future medicine. This article proposes Target-combined Holistic Treatment (THT), a new concept based on the integration of TCM and western medicine. While being guided by the holistic and systematic perspective of TCM, THT also factors in the latest advances in both TCM and modern biomedical research, and uses macro-micro combination, target-syndrome combination, and internal and external co-division, as the primary strategies to establish a clinical diagnosis model that combines disease differentiation, syndrome differentiation, and target differentiation. It also uses drug ingredients/components to enable comprehensive interventions against multiple targets linked to a disease, and establishes target medication and research strategy of TCM, so as to improve its pertinence, efficacy, and safety, and ensure precise and effective medication. The theories and methods of THT fully integrate the advantages of TCM and western medicine, factoring in both macro-control and micro intervention, and also systematic confrontation, precision treatment, and embracing TCM theory and modern technology. This can guide the further development of TCM, western medicine, as well as the combination of TCM and western medicine. It will therefore help promote the integration and innovation of both TCM and western medicine, and the in-depth development of TCM. The theories and methods of THT can be used to guide not only the whole process of clinical diagnosis but also the development of innovative drugs. THT has been used to guide the formulation of TCM diagnosis and treatment for COVID-19 and has shown remarkable results. We have developed a Chinese herbal prescription “Keguan-1”, to prevent and treat COVID-19 based on the theory and method of THT, and use the doctrine of “resist foreign aggression and pacify the interior” of TCM against COVID-19. Using the findings of research in modern medicine, THT can innovate and develop TCM based treatments, and thus aid in the treatment of various diseases, and also help promote the integration and development of TCM and western medicine.

In the development of traditional Chinese medicine(TCM), the concept of &quot;preventive treatment of disease&quot; has a long history and plays a crucial role in bridging the past and the future. With the continuous growth of public health needs and the ongoing transformation of the registration management of TCM, its position in the research and development of new drugs has become increasingly significant. As one of the important sources of new drug innovation, the new TCM for &quot;preventive treatment of diseases&quot; represents a new thinking proposed based on the current routine registration and research and development. The research and development of TCM for &quot;preventive treatment of diseases&quot; mainly cover four stages: prevention(before the onset of disease), early intervention(when the disease is about to occur), interruption and reversal(when the disease has already occurred), and prevention of recurrence after recovery(after the disease). This study aims to comprehensively analyze the positioning, key points, and difficulties in the research and development of TCM for &quot;preventive treatment of diseases&quot; and explore effective paths to promote the innovative development of TCM through relevant cases. The research and development of new TCM for &quot;preventive treatment of disease&quot; require researchers to seize the opportunities for innovation before the start of the research and development, accurately grasp the key issues at different stages, and pay attention to the full lifecycle evaluation of the drugs. Meanwhile, in the design of the research plan, the optimal effectiveness evaluation indicators should be explored; key and difficult areas such as chronic diseases and rare diseases should be taken seriously, and the limitations of new drug development only based on the diagnosed diseases should be broken, so as to cater to more patients. In addition, through relevant representative cases in China and abroad, the unique advantages of TCM for &quot;preventive treatment of diseases&quot; should be fully leveraged. By learning from the past, all aspects of key points in the evaluation of new drug research and development should be strengthened. Finally, this study proposed that TCM for &quot;preventive treatment of diseases&quot; can employ novel methods and advanced technologies such as new biomarkers and innovative clinical design protocols, as well as new perspectives on disease research and health management. This can provide new paths for the innovation of TCM and public health management.

IntroductionIn recent years, the increasing complexity and volume of data in traditional Chinese medicine (TCM) research have rendered the conventional experimental methods inadequate for modern TCM development. The analysis of intricate TCM data demands proficiency in multiple programming languages, artificial intelligence (AI) techniques, and bioinformatics, posing significant challenges for researchers lacking such expertise. Thus, there is an urgent need to develop user-friendly software tools that encompass various aspects of TCM data analysis.MethodsWe developed a comprehensive web-based computing platform, SZBC-AI4TCM, a comprehensive web-based computing platform for traditional Chinese medicine that embodies the “ShuZhiBenCao” (Digital Herbal) concept through artificial intelligence, designed to accelerate TCM research and reduce costs by integrating advanced AI algorithms and bioinformatics tools.ResultsLeveraging machine learning, deep learning, and big data analytics, the platform enables end-to-end analysis, from TCM formulation and mechanism elucidation to drug screening. Featuring an intuitive visual interface and hardware–software acceleration, SZBC-AI4TCM allows researchers without computational backgrounds to conduct comprehensive and accurate analyses efficiently. By using the TCM research in Alzheimer’s disease as an example, we showcase its functionalities, operational methods, and analytical capabilities.DiscussionSZBC-AI4TCM not only provides robust computational support for TCM research but also significantly enhances efficiency and reduces costs. It offers novel approaches for studying complex TCM systems, thereby advancing the modernization of TCM. As interdisciplinary collaboration and cloud computing continue to evolve, SZBC-AI4TCM is poised to play a strong role in TCM research and foster its growth in addition to contributing to global health. SZBC-AI4TCM is publicly for access at https://ai.tasly.com/ui/\\#/frontend/login.

Traditional Chinese medicine (TCM) is an integral part of mainstream medicine in China. Due to its worldwide use, potential impact on healthcare and opportunities for new drug development, TCM is also of great international interest. Recently, a new era for modernisation of TCM was launched with the successful completion of the Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM) project, the European Union’s Seventh Framework Programme (FP7) coordination action on TCM research. This 3.5-year project that involved inputs from over 200 scientists resulted in the production of 20 editorials and in-depth reviews on different aspects of TCM that were published in a special issue of Journal of Ethnopharmacology (2012; volume 140, issue 3). In this narrative review, we aim to summarise the findings of the FP7 GP-TCM project and highlight the relevance of TCM to modern medicine within a historical and international context. Advances in TCM research since the 1950s can be characterised into three phases: Phase I (1950s-1970s) was fundamental for developing TCM higher education, research and hospital networks in China; Phase II (1980s-2000s) was critical for developing legal, economic and scientific foundations and international networks for TCM; and Phase III (2011 onwards) is concentrating on consolidating the scientific basis and clinical practice of TCM through interdisciplinary, interregional and intersectoral collaborations. Taking into account the quality and safety requirements newly imposed by a globalised market, we especially highlight the scientific evidence behind TCM, update the most important milestones and pitfalls, and propose integrity, integration and innovation as key principles for further modernisation of TCM. These principles will serve as foundations for further research and development of TCM, and for its future integration into tomorrow’s medicine.

Benefiting from the complex system composed of various constituents, medicament portions, species, and places of origin, traditional Chinese medicine (TCM) possesses numerous customizable and adaptable efficacies in clinical practice guided by its theories. However, these unique features are also present challenges in areas such as quality control, screening active ingredients, studying cell and organ pharmacology, and characterizing the compatibility between different Chinese medicines. Drawing inspiration from the holistic concept, an integrated strategy and pattern more aligned with TCM research emerges, necessitating the integration of novel technology into TCM modernization. The microfluidic chip serves as a powerful platform for integrating technologies in chemistry, biology, and biophysics. Microfluidics has given rise to innovative patterns like lab-on-a-chip and organoids-on-a-chip, effectively challenging the conventional research paradigms of TCM. This review provides a systematic summary of the nature and advanced utilization of microfluidic chips in TCM, focusing on quality control, active ingredient screening/separation, pharmaceutical analysis, and pharmacological/toxicological assays. Drawing on these remarkable references, the challenges, opportunities, and future trends of microfluidic chips in TCM are also comprehensively discussed, providing valuable insights into the development of TCM.

Traditional Chinese medicine (TCM) has a good reputation for preventing or healing diseases in clinic due to its higher efficacy, minor toxicity and abundant resources. Screening bioactive components in TCMs is not only crucial for clarifying their action mechanisms, but also the basis of their safety and quality control. TCM is characterized by multiple components, multiple targets and multiple mechanisms, however the complex composition of TCM makes it difficult to study the therapeutic material basis which has become the bottleneck in the process of its modernization and internationalization. Recently, with the rapid development of modern technologies and the unceasing progress of various disciplines, multidisciplinary approach, such as analytical chemistry, chemistry of TCM, pharmacology, cell biology, systems biology and bioinformatics has been successfully applied to the study of TCM. Multidisciplinary approach realizes the communication and interaction of multi-discipline, and accelerates the research and development of TCM. This review summarizes the application of multidisciplinary approach which may have certain potential of bringing new thoughts to TCM research and provide references for screening and identification of therapeutic material basis of TCMs.

Research of Traditional Chinese Medicine in Terms of Herbalomics

Traditional Chinese medicine (TCM) has over 3000 years of history to treat diseases in China and has played an essential role in the Chinese healthy system. More and more western scientists are now interested in TCM research and hope to learn about the basics of TCM in China. Hence, the following aspects related to TCM will be briefly overviewed in the lecture, including TCM theory, TCM resources, related research institutions and education systems, Chinese Pharmacopoeia on TCM volume, TCM new drug registration regulations by SFDA, TCM-based drug discovery, government funding sectors, TCM hospitals, recent research progress made on TCM research, which may help the audience to understand the basic current situation of TCM in China. In addition, the current research on the quality standard construction of traditional Chinese medicines will also be introduced with some concrete examples. The future directions on TCM modernization will also be insighted as a personal viewpoint.

In the recent years, a wide range of metabonomic analytical techniques are widely used in the modern research of traditional Chinese medicine (TCM). At the same time, the international community has attached increasing importance to TCM toxicity problems. Thus, many studies have been implemented to investigate the toxicity mechanisms of TCM. Among these studies, many metabonomic-based methods have been implemented to facilitate TCM toxicity investigation. At present, the most prevailing methods for TCM toxicity research are mainly single analysis techniques using only one analytical means. These techniques include nuclear magnetic resonance (NMR), gas chromatography-mass spectrometry (GC-MS), and liquid chromatography-mass spectrometry (LC-MS), etc.; with these techniques, some favourable outcomes have been gained in the toxic reaction studies of TCM, such as the action target organs assay, the establishment of action pattern, the elucidation of action mechanism and the exploration of action material foundation. However, every analytical technique has its advantages and drawbacks, no existing analytical technique can be versatile. Multi-analysed techniques can partially overcome the shortcomings of single-analysed techniques. Combination of GC-MS and LC-MS metabolic profiling approaches has unravelled the pathological outcomes of aristolochic acid-induced nephrotoxicity, which can not be achieved by single-analysed techniques. It is believed that with the further development of metabonomic analytical techniques, especially multi-analysed techniques, metabonomics will greatly promote TCM toxicity research and be beneficial to the modernization of TCM in terms of extending the application of modern means in the TCM safety assessment, assisting the formulation of TCM safety norms and establishing the international standards indicators.

The research on traditional Chinese medicine (TCM) has experienced the transition from qualitative research to quantitative study. The application of mathematical modeling for data processing and analysis offers a more efficient and precise approach compared to conventional methods, enabling the timely acquisition of key efficacy indicators for preliminary evaluation. Therefore, the concept of mathematical modeling has been proposed to form a systematic theoretical system of TCM and diseases. The article reviews the application of mathematical models in the research of traditional Chinese medicine in terms of compounding, extraction, optimization, quality evaluation, production, new drug development, pharmacokinetics, pharmacodynamics, and clinical symptom analysis. Relevant Chinese and English literature was obtained from PubMed, Cochrane Library, China Science and Technology Journal Database (VIP), Wanfang Data, CNKI and China Biomedical Literature Database (CBM). We have found that integrating the concept of mathematical modeling with TCM theory has shortened the cycle of extracting active ingredients in traditional Chinese medicine and the development of new drugs, while also accelerating the realization of maximum clinical efficacy. However, the comprehensiveness and precision of existing databases remain areas for improvement. In the future, further integration of multi-disciplinary technologies will be essential to advance the convergence of traditional medicine and modern science. This review explores the application of mathematical models in the study of traditional Chinese medicine. It is evident that mathematical modeling has played a pivotal role in promoting fundamental research and the modernization of TCM.

Safety Research in Traditional Chinese Medicine: Methods, Applications, and Outlook

Several clinical cases and experiments have demonstrated the effectiveness of traditional Chinese medicine (TCM) formulas in treating and preventing diseases. These formulas contain critical information about their ingredients, efficacy, and indications. Classifying TCM formulas based on this information can effectively standardize TCM formulas management, support clinical and research applications, and promote the modernization and scientific use of TCM. To further advance this task, TCM formulas can be classified using various approaches, including manual classification, machine learning, and deep learning. Additionally, large language models (LLMs) are gaining prominence in the biomedical field. Integrating LLMs into TCM research could significantly enhance and accelerate the discovery of TCM knowledge by leveraging their advanced linguistic understanding and contextual reasoning capabilities. The objective of this study is to evaluate the performance of different LLMs in the TCM formula classification task. Additionally, by employing ensemble learning with multiple fine-tuned LLMs, this study aims to enhance classification accuracy. The data for the TCM formula were manually refined and cleaned. We selected 10 LLMs that support Chinese for fine-tuning. We then employed an ensemble learning approach that combined the predictions of multiple models using both hard and weighted voting, with weights determined by the average accuracy of each model. Finally, we selected the top 5 most effective models from each series of LLMs for weighted voting (top 5) and the top 3 most accurate models of 10 for weighted voting (top 3). A total of 2441 TCM formulas were curated manually from multiple sources, including the Coding Rules for Chinese Medicinal Formulas and Their Codes, the Chinese National Medical Insurance Catalog for proprietary Chinese medicines, textbooks of TCM formulas, and TCM literature. The dataset was divided into a training set of 1999 TCM formulas and test set of 442 TCM formulas. The testing results showed that Qwen-14B achieved the highest accuracy of 75.32% among the single models. The accuracy rates for hard voting, weighted voting, weighted voting (top 5), and weighted voting (top 3) were 75.79%, 76.47%, 75.57%, and 77.15%, respectively. This study aims to explore the effectiveness of LLMs in the TCM formula classification task. To this end, we propose an ensemble learning method that integrates multiple fine-tuned LLMs through a voting mechanism. This method not only improves classification accuracy but also enhances the existing classification system for classifying the efficacy of TCM formula.

Traditional Chinese medicine (TCM) has been practiced for thousands of years in China. TCM formula, usually composed of several or even dozens of herbal medicines, is the main form of TCM practicing, which is extremely complex due to multiple components and therapeutic targets, especially the characteristics of formula compatibility. Thus, it is an enormous challenge for the modernization of TCM. Systems biology is a strategy for investigating the complex interactions between genes, mRNA, proteins, and metabolites by using integrated omics approaches. In recent years, systems biology has been increasingly adopted in TCM study. This review comprehensively summarized status of syndrome and application of TCM formulae in clinical and preclinical studies and discussed the advances of systems biology in TCM research. Then, a “Disease-Syndrome-Formulae-Effect” strategy was proposed for TCM research. Combination of systems biology and “Disease-Syndrome-Formulae-Effect” strategy provided a novel approach to understand the complex interactions among biological systems, drugs, and complex diseases from a network perspective, thus facilitating the modernization of TCM. The objective of this manuscript is to provide comprehensive and up-to-date review on the application of systems biology in TCM research, as well as the perspective of TCM modernization with systems biology.