1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
XU Xinyi ; WEI Shifeng ; ZHANG Qiming ; HE Langchong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):045-050
Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.
3.Spatial Distribution Patterns and Environmental Influencing Factors of Flavonoid Glycosides in Epimedium sagittatum
Mengxue LI ; Wenmin ZENG ; Yiting WEI ; Fengqin LI ; Shengfu HU ; Xinyi WANG ; Zhangjian SHAN ; Yanqin XU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):217-226
ObjectiveTo explore the spatial distribution patterns of flavonoid glycosides in Epimedium sagittatum and the influences of environmental factors on the accumulation of these components. MethodsThe spatial statistical analysis and GeoDetector model were used to analyze the distribution patterns of epimedin A,epimedin B,epimedin C,icariin,and total flavonoid glycosides in E. sagittatum samples from 92 different production areas in 36 cities of 13 provinces/municipalities/autonomous regions of China,as well as the effects of 28 environmental factors on the accumulation of each component. ResultsThe average content of flavonoid glycosides 64 (69.56%) producing areas and 30 (83.33%) cities met the quality standard of no less than 1.50% of total flavonoid glycosides in the 2020 edition of Chinese Pharmacopoeia.Epimedin A,epimedin B,epimedin C,icariin,and their sum showed significantly high accumulation.The hot spots regions of epimedin A and epimedin B were similar with each other,mainly located in western Hunan,eastern Hubei,eastern Guizhou,and northern Guangxi.The common hot spot areas of epimedin C and total flavonoid glycosides were in western and southwestern Hunan,southern Henan,northern Anhui,eastern Guizhou,and southern Chongqing.The hot spots areas of icariin were in southern Chongqing,western Hunan,and eastern and northeastern Guizhou.The interactions between environmental factors had stronger explanatory power for the accumulation of components than single factors.The strongest single factor and interactive factor affecting the accumulation of epimedin C were precipitation of wettest quarter (q=0.16) and its interaction with temperature seasonality (q=0.35),respectively.The strongest single factor influencing both the accumulation of icariin and total flavonoid glycosides was the precipitation of coldest quarter (q equals 0.15 and 0.22,respectively).The strongest interactions were observed between precipitation of coldest quarter and gravel content (q=0.34),as well as between precipitation of coldest quarter and aspect (q=0.35). ConclusionThirteen cities,including Zhumadian and Nanyang in Henan,Huaihua,Shaoyang,and Zhangjiajie in Hunan,and Zunyi,Qiandongnan,and Tongren in Guizhou,were hot spots of total flavonoid glycosides in E.sagittatum.Precipitation,gravel content,temperature seasonality,and aspect significantly influence the accumulation of flavonoid glycosides in E.sagittatum.This study provides reference for the utilization and production zoning of E.sagittatum.
4.Research advances in prognostic score models and biomarkers for acute-on-chronic liver failure
Xinyi XU ; Xia YU ; Huilan TU ; Xiaohan QIAN ; Yida YANG ; Yu SHI
Journal of Clinical Hepatology 2025;41(6):1030-1036
Acute-on-chronic liver failure (ACLF) is a complex clinical syndrome, and early identification and accurate prognostic evaluation are of great importance for patient treatment and management. In recent years, with in-depth research on the pathogenesis of ACLF, multiple prognostic biomarkers have been proposed and used in clinical practice. This article systematically reviews the research advances in prognostic biomarkers for ACLF from the aspects of clinical predictive models, immunological biomarkers, metabolic biomarkers, genetic and epigenetic biomarkers, microbiome-related biomarkers, and emerging technologies such as artificial intelligence and multi-omics, and it also discusses the value and application prospects of these biomarkers in the prognostic evaluation of ACLF and proposes future research directions, in order to provide a scientific and comprehensive reference for clinicians, guide individualized treatment and management of ACLF patients, and finally improve the clinical outcomes of patients.
5.Phenomics of traditional Chinese medicine 2.0: the integration with digital medicine
Min Xu ; Xinyi Shao ; Donggeng Guo ; Xiaojing Yan ; Lei Wang ; Tao Yang ; Hao LIANG ; Qinghua PENG ; Lingyu Linda Ye ; Haibo Cheng ; Dayue Darrel Duan
Digital Chinese Medicine 2025;8(3):282-299
Abstract
Modern western medicine typically focuses on treating specific symptoms or diseases, and traditional Chinese medicine (TCM) emphasizes the interconnections of the body’s various systems under external environment and takes a holistic approach to preventing and treating diseases. Phenomics was initially introduced to the field of TCM in 2008 as a new discipline that studies the laws of integrated and dynamic changes of human clinical phenomes under the scope of the theories and practices of TCM based on phenomics. While TCM Phenomics 1.0 has initially established a clinical phenomic system centered on Zhenghou (a TCM definition of clinical phenome), bottlenecks remain in data standardization, mechanistic interpretation, and precision intervention. Here, we systematically elaborates on the theoretical foundations, technical pathways, and future challenges of integrating digital medicine with TCM phenomics under the framework of “TCM phenomics 2.0”, which is supported by digital medicine technologies such as artificial intelligence, wearable devices, medical digital twins, and multi-omics integration. This framework aims to construct a closed-loop system of “Zhenghou–Phenome–Mechanism–Intervention” and to enable the digitization, standardization, and precision of disease diagnosis and treatment. The integration of digital medicine and TCM phenomics not only promotes the modernization and scientific transformation of TCM theory and practice but also offers new paradigms for precision medicine. In practice, digital tools facilitate multi-source clinical data acquisition and standardization, while AI and big data algorithms help reveal the correlations between clinical Zhenghou phenomes and molecular mechanisms, thereby improving scientific rigor in diagnosis, efficacy evaluation, and personalized intervention. Nevertheless, challenges persist, including data quality and standardization issues, shortage of interdisciplinary talents, and insufficiency of ethical and legal regulations. Future development requires establishing national data-sharing platforms, strengthening international collaboration, fostering interdisciplinary professionals, and improving ethical and legal frameworks. Ultimately, this approach seeks to build a new disease identification and classification system centered on phenomes and to achieve the inheritance, innovation, and modernization of TCM diagnostic and therapeutic patterns.
6.Genetic Homology Analysis of Bloodstream Infection Secondary to Intestinal Colonization with Carbapenem-Resistant Klebsiella Pneumoniae
Xinyue LI ; Hongjuan ZHANG ; Xiaoyan ZHU ; Meijia HUANG ; Yunmin XU ; Xundie LI ; Xinyi ZHENG ; Shaoxuan LI ; Bin SHAN
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1138-1147
To investigate the genetic relatedness between carbapenem-resistant A retrospective analysis was conducted on clinical data from patients screened for carbapenem-resistant Among 12 878 patients screened for CRE, 60 (0.47%) were identified with intestinal CRKP colonization. Of these, 6 (10.0%) developed bloodstream infections, with an all-cause mortality rate of 66.7% (4/6) during hospitalization. The predominant strain type among paired isolates was ST11-KL64 producing KPC-2, accounting for 91.7%(11/12) of cases. Except for one patient(with a categorical agreement of 82.6%), colonizing and bloodstream isolates from the same patient showed complete agreement (100% categorical agreement) in antimicrobial susceptibility profiles for all antibiotics except tigecycline. Intraclass correlation coefficients for biofilm formation and siderophore production were both > 0.75 of all paired strains, indicating high phenotypic consistency. Except for one patient, core genome single nucleotide polymorphism (SNP) analysis and phylogenetic reconstruction revealed high genetic homology between colonizing and bloodstream isolates from the same patient (SNP difference < 10). Clonal relatedness was also observed among colonizing strains from different departments (SNP difference < 120). Although the intestinal colonization rate of CRKP is low, it poses a high mortality risk once bloodstream infection occurs. The high consistency in antimicrobial resistance profiles, biofilm formation, siderophore production, and genomic homology between colonizing and bloodstream isolates suggests that intestinal colonization is the direct source of subsequent invasive infection. Enhanced early screening, dynamic monitoring, risk-stratified prevention, and optimized intervention strategies are recommended to reduce the risk of CRKP infection and mortality.
7.The effect of ozone exposure on asthma and the potential mechanisms
Xinyi FANG ; Renjie CHEN ; Haidong KAN ; Yanyi XU
Shanghai Journal of Preventive Medicine 2024;36(3):303-310
Near-surface ozone is a profoundly reactive and highly oxidizing gas and one of the critical respiratory toxicants. Numerous epidemiological investigations have indicated that asthmatic individuals are the vulnerable group of ozone exposure, and there is a strong correlation between ozone exposure and asthma morbidity and mortality rates. The potential mechanisms include oxidative stress, inflammatory response, autonomic nerve impairment, and immune dysfunction. The present study summarized and discussed the effect of ozone exposure on asthma and its underlying biological mechanisms in order to galvanize public cognizance concerning the perils of ozone pollution and serve as a reference for future research on ozone exposure and asthma.
8.Electrospun nanofiber scaffolds for soft and hard tissue regeneration
Xinyi WANG ; Xianrui XIE ; Yujie CHEN ; Xiaoyu WANG ; Xiaoqing XU ; Yihong SHEN ; Xiumei MO
Chinese Journal of Tissue Engineering Research 2024;28(3):426-432
BACKGROUND:Currently,electrospun nanofibers,which are biomimetic materials of natural extracellular matrix and contain a three-dimensional network of interconnected pores,have been successfully used as scaffolds for various tissue regeneration,but are still faced with the challenge of extending the biomaterials into three-dimensional structures to reproduce the physiological,chemical as well as mechanical properties of the tissue microenvironment. OBJECTIVE:To summarize the process and principles of electrostatic spinning and to explore the applications of the resulting electrospun nanofibers in tissue regeneration of skin,blood vessels,nerves,bone,cartilage and tendons/ligaments. METHODS:With"electrospinning,electrospun nanofibers,electrospun nanofiber scaffolds,tissue regeneration"as the Chinese and English search terms,Google Academic Database,PubMed,and CNKI were searched,and finally 88 articles were included for review. RESULTS AND CONCLUSION:(1)The electrospun nanofibers are a natural fibrous extracellular matrix mimetic material and contain a three-dimensional network of interconnected pores that have been successfully used as scaffolds for a variety of tissue regeneration applications.(2)Several papers have described the great potential of electrospun nanofiber scaffolds applied to the regeneration of skin,blood vessels,nerves,bones,cartilage and tendons/ligaments,providing a solid theoretical basis for its final application in clinical disease treatment,or for its transformation into practical products to enter the market.(3)However,the current research results are mostly based on cell experimental research results in vitro,and whether it can be finally applied to human body still needs clinical verification.(4)At present,many kinds of electrospun products for various clinical needs have been commercialized in and outside China,indicating that the research field of electrospun nanofiber scaffolds for soft and hard tissue regeneration has great research value and application potential.
9."Four types in one" assignment design strategy and its significance in histology and embryology
Libin LIAO ; Xueping YAO ; Tian LI ; Xiaoyu XU ; Xinyi ZHANG ; Shengbin BAI
Chinese Journal of Medical Education Research 2024;23(3):382-386
As essential part of teachers' teaching practice, the design and arrangement of assignments is the main carrier of interaction between teachers and students, and is also an important learning way for students. According to the discipline characteristics and teaching modes of histology and embryology courses, we have developed a systematic assignment design model that covers theory, practice, and application with four types of assignments—pre-class assignments, exploratory assignments, practical assignments, and innovative assignments distributed before class, in class, after class, and throughout the teaching process. Behind this assignment design strategy is the concept of learner-centered teaching, which aims to help students learn professional knowledge and develop comprehensive literacy.
10.Effect and Mechanism of Cyclocarya paliurus(Batal.)lljinskaja Polysaccharides on Type 2 Diabetic Rats by Regulating GLUT4 Translocation in Islet and Liver
Haiyun LIU ; Miaoting SHI ; Xinyi LUO ; Minyan SUN ; Chenxi XU ; Kunhan CHEN ; Xiaomin WANG ; Rengeng SHU
Herald of Medicine 2024;43(1):13-19
Objective To investigate the effect of Cyclocarya paliurus(Batal.)lljinskaja polysaccharides on insulin resistance in type 2 diabetic rats by regulating glucose transporter 4(GLUT4)translocation in islet and liver.Methods High-fat diet combined with low-dose streptozotocin(35 mg·kg-1)to induce type 2 diabetes model,all the rats were randomly divided into model control group,Cyclocarya paliurus polysaccharides groups(5,10 g·kg-1)and metformin group(0.25 g·kg-1),and treated for eight weeks(n=9 in each group).Fasting glucose and lipid were determined.Histopathology of rat islet and liver were observed by hematoxylin and eosin staining.Protein expressions of phosphorylated phosphoinositide-3-kinase(p-PI3K),phosphorylated serine-threonine kinase 1(p-Akt1),and GLUT4 in islet were measured by immunohistochemistry staining.GLUT4 translocation in the islet and liver was detected by immunofluorescence.Results Compared with the model control group,the Cyclocarya paliurus polysaccharides group and metformin group had declined fasting glucose levels and increased high-density lipoprotein(P<0.05).The structure of the islets and liver was relatively complete.The content of p-PI3K,p-Akt1 and GLUT4 in the islet increased(P<0.05).GLUT4 translocation in the liver and islet enhanced(P<0.05).Conclusions Cyclocarya paliurus polysaccharides alleviate glucose and lipid metabolism disorders.The mechanism may lay in it activating protein expressions of p-PI3K,p-Akt1,and GLUT4 in islet cells.GLUT4 translocation to the islet and liver cell membrane are increased to regulate peripheral islet resistance.

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