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.Research hotspots and future trends of drug resistance mechanism in treatment of renal cell carcinoma based on bibliometric analysis
Xinyi ZHENG ; Jiajun XU ; Xiaoyan QIU
Chinese Journal of Pharmacoepidemiology 2024;33(11):1276-1295
Objective To systematically analyze the research hotspots and development trends of drug resistance mechanisms in renal cell carcinoma(RCC),and to provide a reference for research in this field.Methods The literature related to drug resistance in treatment of RCC was obtained from Web of Science core collection.CiteSpace software was used for keyword clustering and trend analysis,and VOSviewer software was used for keyword co-occurrence network analysis.Results In total,1 392 literature were incorporated,including 736 regarding targeted therapy,158 in immunotherapy,and 369 in chemotherapy.The overall research trend in this field was on the rise,in which the research on targeted therapy resistance occupies a dominant position,and immunotherapy resistance was a new research direction.Key words in this field were focused on molecular mechanisms of drug resistance,potential signaling pathways,combination therapy,indicators,and novel therapy.The evolution of keywords and theme words suggests that the research tendency of RCC targeted therapy resistance in recent years focuses on the exploration of new mechanisms of drug resistance and the application of multi-target drugs.The research trend of immunotherapy resistance highlights combination therapy,tumor microenvironment,and metastasis correlation.The research trend of chemotherapy resistance focused on pharmacokinetic-related factors,multidrug resistance genes.Conclusion To provide references for researchers to accurately grasp the research status and development trend of drug resistance in RCC.
8.Practice of navigation bronchoscopy and artificial intelligence in the basic navigational bronchoscopy skills and technique training
Dingpei HAN ; Xinyi WANG ; Yanli XU ; Xijia FENG ; Yu ZHANG ; Lihua DENG ; Xiaoyang LI ; Hecheng LI
Chinese Journal of Medical Education Research 2024;23(10):1326-1330
Objective:To investigate the effects of navigation bronchoscopy and artificial intelligence in the standardized training of residents on basic bronchoscopy skills, with the goal of enhancing their practical abilities.Methods:We selected 26 trainees (14 on standardized training of residents and 12 on standardized training of specialists) who participated in the basic navigational bronchoscopy skills and technique training (NBSTAT) at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from September 2023 to January 2024. The training was structured around a modular curriculum with navigation as the core design concept, consisting of five modules: lesion identification, precise localization, route planning, navigation operation, and real-time error correction. Theoretical teaching and skill practice were combined. The skill proficiency of the trainees was assessed using the Ruijin Hospital bronchoscopy simulation training system and the electromagnetic navigation bronchoscopy system. SPSS 26.0 was used to perform the t-test and Wilcoxon rank-sum test for comparisons. Results:After the training, the trainees as a whole showed significant improvements in practicing the skills, with the simulated operation time was reduced from (125.08±48.16) seconds to (77.69±24.75) seconds, the number of errors decreased from 1 to 0, the total score increased from (60.77±15.01) to (75.19±17.63), and the navigation operation time was reduced from 3 (3, 4) minutes to 2 (2, 3) minutes (all P<0.05). There were no significant differences in these assessment items between resident trainees and specialist trainees. The satisfaction rate of the trainees with the training reached 100.00%. Conclusions:The curriculum is effective in basic bronchoscopy skill training, remarkably enhancing the bronchoscopy skills of resident and specialist physicians, which is a useful approach for physicians to cope with the continuous development of diagnostic and therapeutic techniques for pulmonary diseases.
9.Association of psychological stress with wives’ hypertension across over 10 million Chinese married female population aged 20-49 years
Zhenyan ZHAO ; Jiajing JIA ; Xinyi LYU ; Lihua ZHANG ; Yuanyuan WANG ; Yuan HE ; Zuoqi PENG ; Ya ZHANG ; Hongguang ZHANG ; Qiaomei WANG ; Haiping SHEN ; Yiping ZHANG ; Donghai YAN ; Xu MA ; Ying YANG
Chinese Medical Journal 2024;137(13):1583-1591
Background::Psychological stress has been reported to be a potential risk factor for hypertension among females, but it remains unclear whether spousal chronic stress levels alter the risk of hypertension among women. We examined the associations between stress within the family and hypertension among married women.Methods::Reproductive-aged women who were planning for pregnancy and their husbands were recruited from the National Free Pre-pregnancy Checkup Projects (NFPCP) across 31 provinces in China in 2016 and 2017. Perceived stress of wives or husbands was measured with a 5-point Likert-type scale, and assessed from three domains: work/life-related stress, economic stress, and overall stress. Multivariable-adjusted logistic regression models were used to assess the associations between stress status and the prevalence of hypertension.Results::Of 10,027,644 couples, 261,098 (2.60%) women had hypertension. The results showed that higher stress levels among themselves or their husbands were associated with a higher prevalence of hypertension in women ( Pfor trend <0.001). Compared with non-stressed participants, female participants with the highest stress themselves were at a greater risk of hypertension, with adjusted odds ratio (OR) of 1.31 (95% confidence interval [CI]: 1.25-1.37); and compared with participants whose husbands had no stress, those whose husbands had the highest stress level were at a higher risk of hypertension with adjusted OR of 1.24 (95% CI: 1.20-1.29). Moreover, compared with non-stressed status for both couples, only-wife-stressed, only-husband-stressed, and both-stressed couples were found to be significantly associated with increased risks of wives’ hypertension, with adjusted ORs of 1.28 (95% CI: 1.25-1.31), 1.19 (95% CI: 1.17-1.21), and 1.28 (95% CI: 1.26-1.31), respectively. Conclusion::Moderate to severe stress in both spouses might be associated with female hypertension prevalence, which highlights the importance of paying attention to the psychological stresses of couples within the family.
10.Comparison of system architecture between Chinese,United States,European and Japanese pharmacopoeias
Xinyi XU ; Zhen LIU ; Leran TAO ; Haoyun SONG ; Dan LI ; Wenli YU ; Guannan WANG ; Hao LI ; Zhaopeng YANG
Drug Standards of China 2024;25(3):209-219
The standard system refers to the scientific organic whole formed by the internal connections of stand-ards within a certain range.The completeness of the drug standard system plays a crucial role in ensuring drug safety.Pharmacopoeia is the core of the drug standard system.This article compared the architecture of the Chi-nese Pharmacopoeia,the United States Pharmacopoeia,the European Pharmacopoeia,and the Japanese Pharma-copoeia on the aspects of overall architecture,monographs architecture,general notice architecture,general tech-nical requirements architecture,and other standard architecture,as well as the implementation of various types of standards,aiming to provide reference for the optimization and improvement of the standard system of the Chinese Pharmacopoeia.

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