In recent years, the reform of the registration, evaluation, and approval system for traditional Chinese medicine(TCM) has been promoted at the national level, with establishment of an evaluation evidence system for TCM registration that combines TCM theory, human use experience, and clinical trials(known as the "three-combined" evaluation evidence system). This system, which aligns with the characteristics of TCM clinical practice and the laws of TCM research and development, recognizes the unique value of human use experience in medicine and returns to the essence of medicine as an applied science, thus receiving widespread recognition from both academia and industry. However, it meanwhile poses new and higher challenges. This article delves into the value and challenges faced by the "three-combined" evaluation evidence system from three perspectives: registration management, medical institutions, and the TCM industry. Furthermore, it discusses how the China Association of Chinese Medicine, leveraging its academic platform advantages and leading roles, has made exploratory and practical efforts to facilitate the research and development of new TCM drugs and the implementation of the "three-combined" evaluation evidence system.
Drugs, Chinese Herbal/standards* ; Humans ; Medicine, Chinese Traditional/standards* ; China ; Drug Development

The research and development of new traditional Chinese medicine (TCM) drugs have progressively established a novel system founded on the integration of TCM theory, human experience, and clinical trials (termed the "Three Combinations"). However, considering TCM's distinctive features of "syndrome differentiation and treatment" and "multicomponent formulations and complex mechanisms", current TCM drug development faces challenges such as insufficient understanding of the material basis and the overall mechanism of action and an incomplete evidence chain system. Moreover, significant obstacles persist in gathering human experience data, evaluating clinical efficacy, and controlling the quality of active ingredients, which impede the innovation process in TCM drug development. Network pharmacology, centered on the "network targets" theory, transcends the limitations of the conventional "single target" reductionist research model. It emphasizes the comprehensive effects of disease or syndrome biological networks as targets to elucidate the overall regulatory mechanism of TCM prescriptions. This approach aligns with the holistic perspective of TCM, offering a novel method consistent with TCM's holistic view for investigating the complex mechanisms of TCM and developing new TCM drugs. It is internationally recognized as a "next-generation drug research model". To advance the research of new tools, methods, and standards for TCM evaluation and to overcome fundamental, critical, and cutting-edge technical challenges in TCM regulation, this consensus aims to explore the characteristics, progress, challenges, applicable pathways, and specific applications of network pharmacology as a new theory, method, and tool in TCM drug development. The goal is to enhance the quality of TCM drug research and development and accelerate the efficiency of developing new TCM products.
Humans ; Consensus ; Drug Development/standards* ; Drugs, Chinese Herbal/chemistry* ; Medicine, Chinese Traditional ; Network Pharmacology/standards* ; Guidelines as Topic

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*

OBJECTIVEThe number of analyzed outcome variables is important in the statistical analysis and interpretation of research findings. This study investigated published papers in the field of environmental health studies. We aimed to examine whether differences in the number of reported outcome variables exist between papers with non-significant findings compared to those with significant findings. Articles on the maternal exposure to mercury and child development were used as examples.

METHODSArticles published between 1995 and 2013 focusing on the relationships between maternal exposure to mercury and child development were collected from Medline and Scopus.

RESULTSOf 87 extracted papers, 73 used statistical significance testing and 38 (43.7%) of these reported 'non-significant' (P>0.05) findings. The median number of child development outcome variables in papers reporting 'significant' (n=35) and 'non-significant' (n=38) results was 4 versus 7, respectively (Mann-Whitney test P-value=0.014). An elevated number of outcome variables was especially found in papers reporting non-significant associations between maternal mercury and outcomes when mercury was the only analyzed exposure variable.

CONCLUSIONAuthors often report analyzed health outcome variables based on their P-values rather than on stated primary research questions. Such a practice probably skews the research evidence.

Bias ; Child ; Child Development ; drug effects ; physiology ; Environmental Exposure ; statistics & numerical data ; Environmental Health ; statistics & numerical data ; Female ; Humans ; Maternal Exposure ; statistics & numerical data ; Mercury ; toxicity ; Outcome Assessment (Health Care) ; standards ; Periodicals as Topic ; standards ; statistics & numerical data

Small and medium-sized enterprises (SMEs) are important components in Chinese medicine industry. However, the lack of big brand is becoming an urgent problem which is critical to the survival of SMEs. This article discusses the concept and traits of Chinese medicine of big brand, from clinical, scientific and market value three aspects. Guided by market value, highlighting clinical value, aiming at the scientific value improvement of big brand cultivation, we put forward the key points in cultivation, aiming at obtaining branded Chinese medicine with widely recognized efficacy, good quality control system and mechanism well explained and meanwhile which can bring innovation improvement to theory of Chinese medicine. According to the characters of SMEs, we hold a view that to build multidisciplinary research union could be considered as basic path, and then, from top-level design, skill upgrading and application three stages to probe the implementation strategy.
China ; Drug Industry ; economics ; standards ; trends ; Drugs, Chinese Herbal ; economics ; standards ; Medicine, Chinese Traditional ; economics ; standards ; trends ; Plants, Medicinal ; growth & development ; Quality Control

In order to increase the yield and quality of the medicinal plant and enhance the competitive power of industry of medicinal plant in our country, this paper analyzed the status, problem and countermeasure of the tissue culture of medicinal plant on large scale. Although the biotechnology is one of the most efficient and promising means in production of medicinal plant, it still has problems such as stability of the material, safety of the transgenic medicinal plant and optimization of cultured condition. Establishing perfect evaluation system according to the characteristic of the medicinal plant is the key measures to assure the sustainable development of the tissue culture of medicinal plant on large scale.
Drug Industry ; methods ; standards ; Medicine, Chinese Traditional ; methods ; standards ; Plants, Genetically Modified ; Plants, Medicinal ; genetics ; growth & development ; Quality Control ; Tissue Culture Techniques ; methods ; standards

Chinese herbal medicine are the main means to prevent and treat diseases in traditional Chinese medicine, thus the quality of traditional Chinese medicinal herbs decides the clinical efficacy. Though the producing areas of genuine medical herbs had been recorded in the Qing and Han Dynasties, genuine medical herbs had not been finally established and thrived until the Ming and Qing Dynasties. Their development in more than 1 000 years was affected by many factors. Thepractice examination and theoretical direction of TCM were the theoretical basis for the generation of genuine medical herbs, while the differences in the ecological environment and herbal germplasm indicated their essential causes. The social development in the Ming and Qing Dynasties was also an intangible impetus driving force that could not be neglected.
China ; Drug Industry ; economics ; trends ; Drugs, Chinese Herbal ; chemistry ; standards ; Ecosystem ; Geography ; Humans ; Medicine, Chinese Traditional ; economics ; standards ; trends ; Plants, Medicinal ; chemistry ; growth & development

Yiqi Fumai freeze-dried powder for injection was used as a model drug to establish an evaluation method mainly based on bio-thermodynamics profile detection. Fischer function was used to analyze the chemical and biological data In general, chemical chromatogram can distinguish the expired sample and thermal spectrum of biological activity can distinguish special samples exactly. Thus, we established the evaluation method regarding the quality volatility of Yiqi Fumai freeze-dried powder for injection. The method can be used as a useful supplement in quality control as, and it could provide some technical information for quality control of other varieties of traditional Chinese medicine for injection.
Biological Assay ; methods ; Chromatography, High Pressure Liquid ; methods ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; standards ; Escherichia coli ; chemistry ; drug effects ; growth & development ; Humans ; Kinetics ; Powders ; chemistry ; pharmacology ; standards ; Quality Control ; Thermodynamics

OBJECTIVETo investigate the effect of patulin producing strains on the different Chinese medicinal materials and the toxin biosynthesis mechanism.

METHODMicrobiology and HPLC analytical methods were adopted in this paper.

RESULTIt was showed that the materials rich in starch and other polysaccharides were easily polluted by the patulin producing strain. This strain grew well and produced more toxins under 25 degrees C, 95% moisture content and bulk package. And the effect of low illumination intensity on the strain growth and toxin biosynthesis was not notable. Sample stability, precision, repeatability and rate of recovery were studied. HPLC analytic method was established and it revealed that the test method was suitable.

CONCLUSIONThe pollution of Chinese medicinal materials by toxin producing microbes will be effectively controlled through establishing the suitable storage methods. So the study on the growing characteristics and toxin biosynthesis mechanism of toxin producing strains will be an important practical significance for controlling the toxin pollution of herbal medicines and contribute to establish the evaluation system of Chinese medicine safety.

Drug Compounding ; standards ; Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; adverse effects ; standards ; Fungi ; growth & development ; metabolism ; Patulin ; biosynthesis ; Quality Control ; Safety

OBJECTIVETo probe into the feasibility of screening anti-HIV compounds by using HIV-1 p24 detection kit made by Hebei Medical University.

METHODSThe sensitivity, reproducibility and efficacy of the Hebei p24 kit were evaluated compared with the commercially available Vironostika HIV-1 Antigen Microelisa System (Biomerieux).

RESULTSHebei p24 kit had high sensitivity and good reproducibility. In vitro screening demonstrated that there was no statistically significant difference (P greater than 0.05) between these two kits in assessing anti-HIV compounds.

CONCLUSIONHebei p24 kit could be used as an easily affordable alternative method for detection of HIV-1 in screening anti-HIV compounds.

Anti-HIV Agents ; isolation & purification ; pharmacology ; Cell Line ; Drug Evaluation, Preclinical ; instrumentation ; methods ; Feasibility Studies ; HIV Core Protein p24 ; analysis ; HIV-1 ; drug effects ; growth & development ; immunology ; Humans ; Reagent Kits, Diagnostic ; standards ; Reproducibility of Results