New Issue

  • Simulation of falling rate stage in drying of TCM pills: mechanisms, models, and applications

    XIE Yao-ting;WANG Xue-cheng;WANG Xiang;LI Yuan-hui;ZHU Wen-ting;WANG Ya-qi;YI Bing;WU Zhen-feng;Key Laboratory of Modern Chinese Medicine Preparations, Ministry of Education, Jiangxi University of Chinese Medicine;National Key Laboratory of Classic Formula Modern Chinese Medicine Creation;Traditional Chinese Medicine Pharmaceutical Technology Collaborative Innovation Institute;Jiangxi Hebai Kanghua Pharmaceutical Equipment Co., Ltd.;

    Drying, as a crucial stage in the preparation of pills, serves as a key step in ensuring pharmaceutical quality. During this process, the adoption of a scientifically drying method and the precise control of critical parameters such as temperature and humidity enable effective regulation of drying uniformity, thereby maximizing the retention of pharmacological activity while optimizing pill appearance, hardness, and disintegration time and ensuring the good quality of the drugs and their stable release. The drying process of pills is predominantly characterized by a falling rate drying stage. In this stage, if the rate of internal moisture diffusion fails to match the rate of surface moisture evaporation, quality defects such as surface hardening, cracking, and false drying may occur. These issues increase the resistance to water vapor mass transfer, further reducing the drying rate. At present, simulation technologies have been increasingly applied in the study of drying processes for TCM pills, achieving significant progress in process optimization, equipment improvement, and quality control and thereby providing theoretical and technical support for quality enhancement. However, existing models largely rely on empirical parameters and lack accurate databases of physical properties, leading to discrepancies between simulation results and practical outcomes. Consequently, future research should focus on integrating artificial intelligence-assisted techniques for model parameter identification and optimization, applying digital twin technology for real-time monitoring of drying processes, and advancing toward sustainable production characterized by green, low-carbon, and energy-efficient approaches. Such efforts will continuously overcome technical bottlenecks in pill drying and accelerate the upgrading of production equipment for TCM pills.

    2026 07 v.51 [Abstract][OnlineView][Download 265K]

  • Intelligent regulatory technological system for TCM production driven by digital intelligence and its practical applications

    MIAO Pei-qi;CEN Shi-xin;JU Ai-chun;MENG Zhao-ping;ZHANG Guo-feng;FAN Kai;HU Guo-xin;LI Zheng;College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine;State Key Laboratory of Chinese Medicine Modernization;Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine;Tianjin Tasly Pride Pharmaceutical Co., Ltd.;Tianjin Medical Products Administration;Tianjin Pharmaceutical and Cosmetic Evaluation a

    Regulation of TCM production is a key link in ensuring the quality and safety of TCM products and holds strategic significance for promoting the modernization of the TCM industry. In view of the core bottlenecks of conventional regulation models in terms of perception capability, response efficiency, and process controllability, this paper proposes an intelligent regulatory technology framework based on a dynamic "perception-cognition-decision-intervention" closed loop. Building on this, a key technological system supporting intelligent TCM regulation is summarized, focusing on core tasks such as data perception, model reasoning, and risk prediction. Finally, through typical scenario cases, the feasibility and practicality of the new intelligent regulatory paradigm are demonstrated, providing methodological paths and technical support for achieving high-quality, digital, and intelligent development of TCM production.

    2026 07 v.51 [Abstract][OnlineView][Download 273K]

  • Organoids and organ-on-a-chip: novel strategies for TCM against respiratory virus-induced cranial nerve injury

    SHEN Hai-shang;AN Chen;YANG Jian;State Key Laboratory of Chinese Medicine Modernization, Tianjin University of Traditional Chinese Medicine;Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine;Haihe Laboratory of Modern Chinese Medicine;

    Investigating TCM for preventing and treating respiratory virus-induced nerve injury urgently requires highly biomimetic models that can replicate the complex structure and physiological microenvironment of the body. Conventional two-dimensional cell models and animal experiments present significant limitations, hindering a comprehensive understanding of the complicated interactions between drug components and their targets. As cutting-edge technologies, organoids and organ-on-a-chip systems address these shortcomings by respectively modeling three-dimensional cellular architecture, inter-organ interactions, and dynamic microenvironments, thereby establishing novel technological platforms for pharmaceutical research. This review systematically summarized common respiratory viruses that induce cranial nerve injury. It analyzed the mechanism by which respiratory virus infections damage the lungs and, through direct injury and indirect invasion of the vascular system, lead to cranial nerve injury. By synthesizing literature from the past five years, the paper focused on the application and specific cases utilizing cutting-edge technologies like respiratory tract organoids, brain organoids, and related organ-on-a-chip in studying virus-induced nerve injury. The aim is to provide new perspectives and methodologies for future drug development against respiratory viruses and to formulate innovative research strategies for TCM-based interventions.

    2026 07 v.51 [Abstract][OnlineView][Download 326K]

  • Application of omics in quality evaluation and pharmacological mechanism of Pinellia ternata

    LIU Yuan;XU Yuan-yuan;QI Yu-juan;SUN Xun;QUAN Wen-yue;JIA Xi-wei;ZENG Cui-yun;WANG Hui-zhen;GAO Su-fang;GUO Da-quan;GUO Wei-cheng;ZHANG Xing-jun;CHEN Hong-gang;DU Tao;College of Pharmacy, Gansu University of Chinese Medicine;Gansu Pharmaceutical Industry Innovation Research Institute;School of Life Science and Technology, Ningxia Vocational and Technical College;Longnan Minle Seed Industry Technology Co., Ltd.;Gangu County Agricultural Industry Service Center;

    As an important component of systems biology, omics technologies, with their advantages of high-throughput and holistic analysis, are profoundly transforming the research model of TCM. Pinellia ternata, a commonly used TCM with the effects of drying dampness and resolving phlegm, directing rebellious Qi downward to stop vomiting, and relieving stuffiness and dissipating binds, presents major challenges in quality control and in the elucidation of its complex pharmacological mechanisms. This article systematically reviews the application progress of omics technologies such as genomics, transcriptomics, proteomics, and metabolomics in the study of P. ternata′s quality evaluation(covering factors such as cultivation environment, germplasm resources, and processing) and pharmacological mechanisms(including antiemetic effects, phlegm resolution and asthma relief, treatment of gastrointestinal diseases, and antitumor activities). By sorting through existing research findings, it summarizes the great potential of omics technologies in revealing the pharmacodynamic material basis, quality formation mechanisms, and multi-target action networks of P. ternata, and further looks ahead to future research directions such as multi-omics integration, data mining, and artificial intelligence, with a view to providing systematic theoretical and methodological references for the modernization and internationalization of P. ternata research.

    2026 07 v.51 [Abstract][OnlineView][Download 217K]

  • Research progress in mechanisms of Tripterygium wilfordii and its active ingredients in treatment of inflammatory bowel disease

    LI Huan;NIE Qing;NIU Xin;WANG Yi;SHI Meng-hua;WANG Jie;ZHANG Shuang-xi;ZHANG Xiang-an;Department of Anorectology, the First Affiliated Hospital of Henan University of Chinese Medicine;Henan University of Chinese Medicine;Anorectal Disease Diagnosis and Treatment Center, the First Affiliated Hospital of Henan University of Chinese Medicine;Shanghai University of Traditional Chinese Medicine;

    Inflammatory bowel disease(IBD), as a chronic and recurrent intestinal inflammatory disorder, has seen a continuous increase in global incidence, which urgently calls for the development of novel therapeutic strategies. Its pathogenesis is complex, involving multiple factors such as genetics, environment, abnormal immune responses, and dysbiosis of the intestinal microbiota. The current treatment strategies for IBD mainly focus on suppressing abnormal immune responses and controlling inflammation, but still face challenges such as high recurrence rates, numerous adverse drug reactions, and poor efficacy in some patients. TCM has a long history of treating IBD and offers unique advantages such as multi-target intervention, holistic regulation, and individualized treatment. Tripterygium wilfordii, a TCM, has the effects of dispelling wind and dampness, activating blood and removing stasis, clearing heat and detoxifying, and reducing swelling and relieving pain. Its active components(including T. wilfordii polycoride, triptolide, and celastrol) play significant roles in the treatment of IBD through multiple pathways such as anti-inflammation, immune regulation, protection of the intestinal barrier, and regulation of the intestinal microbiota. This article systematically reviews the therapeutic mechanisms and clinical research progress of T. wilfordii and its active ingredients in the treatment of IBD, with the aim of providing theoretical references for the clinical treatment and new drug development of IBD.

    2026 07 v.51 [Abstract][OnlineView][Download 362K]

  • Synchronous detection test strip of multiple exogenous mycotoxins in Chinese medicinal materials based on flower-like gold nanoparticles

    JIANG Xue;CHEN Ye-fei;OUYANG Zhen;ZHANG Xiao-bo;HUANG Lu-qi;YUAN Qing-song;School of Food and Biological Engineering, Jiangsu University;China Academy of Chinese Medical Sciences;Guizhou University of Traditional Chinese Medicine;School of Pharmacy, Jiangsu University;National Resources Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences;Guizhou Key Laboratory for Germplasm Innovation and Resource-Efficient Utilization of Dao-di Herbs;

    Mycotoxin contamination is one of the major causes of quality and safety risks in Chinese medicinal materials. To effectively ensure medication safety, this study established a multiplex and rapid detection method for exogenous fungal mycotoxins in Chinese medicinal materials. Flower-like gold nanoparticles(AuNPs) and gold-labeled probes were characterized using ultraviolet-visible spectroscopy and transmission electron microscopy. Key parameters, including the pH of the AuNP solution, antibody dosage, amount of gold-labeled probes, antigen-antibody jetting rate, nitrocellulose membrane selection, and the mixing ratios of multiple gold-labeled antibodies, were optimized. Gold-labeled probes capable of simultaneously detecting aflatoxin B1(AFB1), zearalenone(ZEN), ochratoxin A(OTA), deoxynivalenol(DON), and T-2 toxin(T2) were successfully prepared, with particle sizes of 90.16, 85.81, 83.12, 88.10, and 87.54 nm, respectively. The limit of detection(LOD) for AFB1, ZEN, OTA, DON, and T2 were 2.5, 5, 2.5, 5, and 2.5 ng·mL~(-1), respectively, meeting the mycotoxin limits required by the Chinese Pharmacopoeia for Chinese medicinal materials. The newly developed test strip was compared with LC-MS/MS for the detection of multiple mycotoxins in 85 commercially purchased medicinal materials. The two methods showed identical detection rates, indicating that the technique offers high accuracy, comprehensiveness, sensitivity, and anti-interference capability. Owing to its low cost and high efficiency, the test strip is suitable for large-scale rapid screening in primary-level laboratories, providing technical support for the rapid multi-mycotoxin screening of Chinese medicinal materials.

    2026 07 v.51 [Abstract][OnlineView][Download 730K]

  • Spatiotemporal accumulation patterns of pharmacodynamic components in Taraxacum officinale and their response to drought stress

    WEI Ming-hui;FAN Xue-qing;YANG Li;ZHOU Gui-sheng;ZOU Li-si;SHI Wen-zheng;LI Chao;XIAO Sheng-wei;PU Chun-juan;YAN Hui;Jiangsu Collaborative Innovation Center of Chinese Medicinal Resources Industrialization/Key Laboratory of Chinese Medicinal Resources Recycling Utilization, National Administration of Traditional Chinese Medicine, Nanjing University of Chinese Medicine;Jichuan Pharmaceutical Group Co., Ltd.;

    This study systematically investigated the spatiotemporal accumulation characteristics of pharmacodynamic components in Taraxacum officinale and their response mechanisms to drought stress. The objectives were to elucidate the plant′s growth traits and quality formation patterns, so as to guide its standardized cultivation and ensure a stable supply of high-quality medicinal materials. The contents of seven pharmacodynamic components were determined in different organs(leaf, root, flower, and scape) of flowering plants to pinpoint their primary accumulation sites. A pot experiment was conducted with samples collected at various time points(40-110 days) to measure growth indicators and pharmacodynamic component contents, thereby determining the peak accumulation period for biomass and pharmacodynamic components. Drought stress treatments were applied by regulating soil moisture levels(90%, 80%, 70%, and 60%), during which plant growth indicators, physiological and biochemical indicators, as well as pharmacodynamic component contents were assessed. The results showed that leaves were the primary accumulation site for the pharmacodynamic components. Both biomass and the contents of multiple key pharmacodynamic components exhibited an initial increase followed by a decrease, peaking simultaneously at the 90th day. Drought stress significantly inhibited plant growth in T. officinale, induced the accumulation of proline and soluble sugars, and reduced the activities of peroxidase and catalase as well as the malondialdehyde content. Mild drought stress(80% soil moisture) increased the contents of certain phenolic acids and flavonoids, whereas severe drought stress(60% soil moisture) caused a significant decline in the content of most pharmacodynamic components. In conclusion, the pharmacodynamic components of T. officinale predominantly accumulate in the leaves and reach their peak levels concurrently with biomass(at the 90th day), highlighting the critical importance of timely harvesting for ensuring both yield and quality. Mild drought stress can enhance the content of pharmacodynamic components to varying degrees; however, severe drought stress leads to substantial reductions in both yield and quality.

    2026 07 v.51 [Abstract][OnlineView][Download 616K]

  • Construction of efficient yeast cell factory for kauniolide, a parthenolide derivative

    HAN Yang;TAN Hong-hu;SU Ping;HUANG Lu-qi;State Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences;

    Kauniolide, a parthenolide derivative, serves as a key biosynthetic intermediate for various guaianolide-type sesquiterpenoids, such as agrabin, lactucin, and lactupicrin. However, its chemical synthesis is often hampered by demanding reaction conditions and high reagent consumption, which severely limit further development and application. To address this, this study employed systematic metabolic engineering strategies to construct an efficient yeast cell factory for kauniolide production. First, the biosynthetic pathway genes for costunolide—the direct precursor of kauniolide(HaGAS, TpGAO, TpCOS, AaCPR)—were heterologously expressed in a lab-engineered yeast chassis strain with high farnesyl pyrophosphate(FPP) production. This initial strain produced costunolide at a titer of 6.1 mg·L~(-1). Subsequently, the co-expression of AaADH1, AaALDH1, and AaCYB5 was implemented to enhance the germacrene A acid synthesis and promote electron transfer, thereby boosting the catalytic efficiency of the key cytochrome P450 enzymes. This modification increased the costunolide titer to 71.5 mg·L~(-1). To optimize the conversion of costunolide to kauniolide, a promoter compatibility screen for the TpKLS gene was conducted. Among the tested promoters(P_(GAL1), P_(TDH3), P_(TEF1), P_(TPI1), P_(sptGAL2), and P_(skGAL2)), the strain harboring the P_(skGAL2)-driven TpKLS construct showed the highest performance, achieving a kauniolide titer of 28.2 mg·L~(-1). Furthermore, to further enhance the pathway flux, the catalytic efficiency of the TpKLS enzyme was improved through semi-rational design coupled with computer-aided design. The best-performing mutant, TpKLS~(V204R), exhibited a 2.7-fold higher catalytic activity compared to the wild-type enzyme. The final engineered strain, when cultivated in shake-flask fermentation, produced costunolide and kauniolide at titers of 35.0 and 71.1 mg·L~(-1), respectively. The kauniolide titer represents the highest level reported to date in a yeast system. In conclusion, this study successfully constructed an efficient yeast cell factory for kauniolide by reconstructing and optimizing its heterologous biosynthetic pathway. It provides a solid technical foundation and a valuable reference for the scalable biosynthesis of kauniolide and the exploration of its downstream derivatives.

    2026 07 v.51 [Abstract][OnlineView][Download 468K]

  • Study on mechanism of salt-stir fried Eucommiae Cortex to enhance therapeutic efficacy on renal fibrosis through epithelial-mesenchymal transition

    BAO Yi-ni;ZHU Qing-ru;ZHOU Li;YU Wen-kai;LI Hui-ting;ZHANG Wei-hao;CAO Gang;School of Pharmacy, Zhejiang Chinese Medical University;

    This study aims to systematically compare the differences in the effects of Eucommiae Cortex(EC) and salt-stir fried Eucommiae Cortex(SEC) on improving adenine-induced renal fibrosis in rats and explore the molecular mechanism by which SEC enhances the therapeutic effect on renal fibrosis based on epithelial-mesenchymal transition(EMT). Rats were randomly divided into a blank control group, model group, positive drug group, and groups with low, medium, and high-dose EC and SEC. Western blot and immunofluorescence techniques were utilized to detect the expression of fibrosis marker proteins such as α-smooth actin(α-SMA), collagen Ⅰ, fibronectin, and vimentin in renal tissue. Real-time fluorescent quantitative reverse transcription polymerase chain reaction(PCR) was used to detect the transcriptional expression levels of key EMT transcription factors snail family transcriptional repressor 1(Snai1), twist family BHLH transcription factor 1(Twist1), zinc finger E-box binding homeobox 1(ZEB1), inflammatory factors tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β), and interleukin-6(IL-6) in renal tissue. In in vitro experiments, a fibrosis model was established by using transforming growth factor-β(TGF-β) to stimulate renal tubular epithelial NRK-52E cells, thereby evaluating the inhibitory effects of EC and SEC on the protein expression of fibrosis markers and the EMT process. The underlying molecular mechanism was further explored by combining network pharmacology and western blot. Both EC and SEC significantly reduced the protein expression levels of fibrosis markers including fibronectin, collagen Ⅰ, vimentin, and α-SMA and obviously inhibited the transcriptional expression of key EMT transcription factors including Snai1, Twist1, and ZEB1 and inflammatory factors including TNF-α, IL-1β, and IL-6 in rats with adenine-induced renal fibrosis and in NRK-52E cells stimulated by TGF-β. The inhibitory effects of SEC were stronger than those of EC. Network pharmacology analysis revealed that the chemical components of SEC with significant change exerted the effect by focusing on the mitogen-activated protein kinase(MAPK) signaling pathway. Further experiments confirmed that both of EC and SEC significantly inhibited phosphorylation of p38 mitogen-activated protein kinase(p38) induced by adenine and TGF-β and elevated expression of its upstream apoptosis signal-regulating kinase 1(ASK1), with SEC exhibiting a more pronounced inhibitory effect. Furthermore, the ASK1 inhibitor Selonsertib significantly downregulated levels of EMT and p38 phosphorylation in NRK-52E cells stimulated by TGF-β. Therefore, SEC can enhance the therapeutic effect on renal fibrosis by inhibiting the EMT process, and its specific mechanism is related to the inhibition of the ASK1/p38 signaling pathway.

    2026 07 v.51 [Abstract][OnlineView][Download 517K]

  • Quality consistency evaluation method of Huangjing Zanyu Capsules based on multimodal information fusion

    JIA Meng-qi;FENG Hui-min;ZHU Jin-yuan;WANG Kai-yi;XIAO Ke-xin;LI Jia-xin;CHENG Yu-bin;LI Nan;SUN Qi-hui;WU Chun-yuan;WU Zhi-sheng;Shandong University of Traditional Chinese Medicine;School of Chinese Materia Medica, Beijing University of Chinese Medicine;Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education;Shanghai New Asia Pharmaceutical Hanjiang Co., Ltd.;

    The manufacturing quality consistency of TCM preparations is a crucial guarantee for their safety, efficacy, and quality controllability. In this study, 23 batches of Huangjing Zanyu Capsules were taken as the research object. In view of the shortcomings of existing quality consistency evaluation methods for this product, an integrated quality evaluation method combining spectral and chromatographic information was established. Firstly, high performance liquid chromatography(HPLC) was employed to construct data matrices for common peaks and non-common peaks in the fingerprints. Through correlation analysis and natural logarithm processing, the differences between batches and within batches were revealed. Secondly, near-infrared spectroscopy was introduced and combined with principal component analysis(PCA) to achieve rapid identification of samples. Finally, by integrating chromatographic information(common peaks and non-common peaks), near-infrared spectral information, and content data of 5 characteristic components, the multivariate statistical process control(MSPC) method was adopted to construct Hotelling′s T~2 and squared prediction error(SPE) control charts. Through this approach, 7 differential samples were successfully identified. This method provides methodological support for the manufacturing quality control and evaluation of Huangjing Zanyu Capsules and serves as an important reference for the manufacturing quality control and consistency evaluation of TCM preparations.

    2026 07 v.51 [Abstract][OnlineView][Download 581K]

  • A new terpenoid from Paeoniae Radix Rubra and its anticoagulant activity in vitro

    TANG Zhi-yi;WANG Yu-tong;XIONG Ting;YU Nian;WU Hai-ju;LI Yong-jun;LI Lin-zhen;State Key Laboratory of Discovery and Utilization of Functional Components in Traditional Chinese Medicine,Engineering Research Center for the Development and Application of Ethnic Medicine and TCM (Ministry of Education),School of Pharmaceutical Sciences, Guizhou Medical University;

    Twenty-one compounds were isolated and identified from the 80% ethanol extract of Paeoniae Radix Rubra by various chromatographic techniques such as D101 macroporous resin, C_(18) reversed-phase silica gel, and gel chromatography, combined with modern spectroscopic techniques including infrared spectroscopy(IR), ultraviolet(UV), mass spectrometry(MS), and nuclear magnetic resonance(NMR). These compounds were 3-formyl-5-hydroxy-6-methyl-1H-indole-1-butyric acid(1), 3-hydroxymethyl-5-methyl-2,3-dihydrobenzofuran(2), paeoniflorin(3), 5-hydroxy-6-methyl-1H-indole-3-carbaldehyde(4), 5-hydroxy-3S-hydroxymethyl-6-methyl-2,3-dihydrobenzofuran(5), paeoveitol C(6), galloylpaeoniflorin(7), benzoylpaeoniflorin(8), 4-O-galloylpaeoniflorin(9), 1-borneol 6-O-[β-D-apiofuranosyl-(1→6)]-β-D-glucopyranoside(10), paeonidanin(11), paeonidanin E(12), paeonidanin B(13), palbinone(14), 23-hydroxybetulinic acid(15), hederagenin(16), N-methylhydroxylamine(17),(5Z,9Z)-17-methylnonadeca-5,9-dienoate(18), 3,3′,4′-tri-O-methylellagic acid(19), β-sitosterylglucoside-6′-octadecanoate(20), and trilinolein(21). Among them, compound 1 was a new compound, and compounds 10 and 17-21 were isolated from the Paeoniae genus for the first time. All the compounds were tested for their anticoagulant activity through three coagulation function indicators: activated partial thromboplastin time(APTT), thrombin time(TT), and prothrombin time(PT). Compounds 1 and 7 showed excellent anticoagulant activity, which was comparable to that of the positive control sodium heparin. Compounds 2, 3, 5, 6, 8-13, 15, and 19 exhibited good anticoagulant activity, while compounds 4 and 21 demonstrated moderate anticoagulant activity.

    2026 07 v.51 [Abstract][OnlineView][Download 482K]

  • A new triterpenoid from Cardiospermum halicacabum

    HUANG Mei-fang;CHEN Wen-jiao;LIAO Tu-hua;XIONG Ya-lan;WEI Jian-hua;LIANG Chen-yan;FENG Xu;LU Cheng-sheng;College of Pharmacy, Guangxi University of Chinese Medicine;Teaching Center of Experiment and Practical Training, Guangxi University of Chinese Medicine;National Demonstration Center for Experimental Chinese Medicine Education, Guangxi University of Chinese Medicine;

    Seventeen compounds were isolated from the 80% ethanol extracts of Cardiospermum halicacabum using various chromatographic techniques, including silica gel, MCI, Sephadex LH-20 and semi-preparative high-performance liquid chromatography. The structures of the compounds were elucidated by spectroscopic analysis, such as ultraviolet-visible spectroscopy(UV), infrared spectroscopy(IR), high-resolution electrospray ionization mass spectrometry(HR-ESI-MS) and one-dimensional/two-dimensional nuclear magnetic resonance(1D/2D NMR). The compounds were identified as: cardiospermone(1), 3β,6β-dihydroxy-21αH-24-norhopa-4(23),22(29)-diene(2), 3β-hydroxyolean-12-en-11-one(3), 18α-olean-12-ene-3,11-dione(4), β-amyrin(5), campest-4-en-3-one(6),(24S)6β-hydroxycampest-4-en-3-one(7), campestane-3,6-dione(8), stigmastane-3,6-dione(9), stigmasta-22-en-3,6-dione(10), stigmasta-4,22-dien-3-one(11),(20R)-6β-hydroxystigmasta-4,22-dien-3-one(12), β-sitostenone(13), 6β-hydroxystigmast-4-en-3-one(14), 7β-hydroxystigmast-4-en-3-one(15), 7-oxo-β-sitosterol(16), 3β-hydroxy-stigmasta-5,22-dien-7-one(17). Among them, compound 1 was identified as a new triterpenoid, while all compounds were isolated from this species for the first time. The inhibitory activities of compound 1 against α-glucosidase were assessed using the 4-nitrophenyl-α-D-glucopyranoside(PNPG) method. The results indicated that compound 1 exhibited moderate inhibitory activity on α-glucosidase at a concentration of 50 μmol·L~(-1), with an inhibition rate of 73.52%.

    2026 07 v.51 [Abstract][OnlineView][Download 321K]

  • Discovery and preliminary verification of direct targets of active ingredients of Shuangshen Ningxin Capsules in preventing and treating myocardial ischemia-reperfusion injury

    CHEN Xiao-xiao;SUN Ming-qian;GAO Yun-xiao;LIN Li;PENG Qing;LIU Jian-xun;MIAO Lan;REN Jun-guo;Beijing Key Laboratory of Pharmacology of Traditional Chinese Medicine,Institute of Basic Medical Sciences,Xiyuan Hospital,China Academy of Chinese Medical Sciences;Natural History Museum of China;

    Based on the magnetic bead "fishing" technology, this study explored the direct targets of the active ingredients of Shuangshen Ningxin Capsules in preventing and treating myocardial ischemia-reperfusion injury. Three active ingredients of Shuangshen Ningxin Capsules, namely dehydrocorydaline, salvianolic acid B, and ginsenoside Rg_1, were selected based on previous work. Firstly, three complexes of magnetic bead-single active ingredient of Shuangshen Ningxin Capsules were synthesized. Then, they were incubated with the protein solutions of SD rat heart tissue, mouse myocardial microvascular endothelial cells, and rat H9c2 cardiomyocytes separately to form magnetic bead-active ingredient-target protein complexes. The target proteins were separated by sodium dodecyl sulfate-polyacrylamide gel electrophoresis(SDS-PAGE), and then in-gel digestion was performed. The proteins were identified by high-resolution mass spectrometry. Potential target proteins were screened by bioinformatics analysis and molecular docking. A rat model of myocardial ischemia-reperfusion injury was established, and the biological function was verified preliminarily through Western blot experiments. The results showed that three complexes of magnetic bead-TCM monomer were successfully prepared, and the potential direct targets of the three active ingredients of Shuangshen Ningxin Capsules were obtained through the "fishing" method. Through mass spectrometry identification and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analysis, it was found that most of the target proteins were involved in metabolic pathways related to glucose, fatty acids, amino acids, and energy. After Venn analysis and molecular docking, proteins such as electron transfer flavoprotein subunit alpha(ETFA), pyruvate kinase M1/M2(PKM), acyl-CoA dehydrogenase medium chain(ACADM), ATP synthase F1 subunit alpha(ATP5F1A), isocitrate dehydrogenase(NADP~+) 2(IDH2), and aspartyl-tRNA synthetase(DARS) were finally screened out. Through the rat myocardial ischemia-reperfusion injury model, it was found that Shuangshen Ningxin Capsules significantly up-regulated the expression of ATP energy production-related proteins such as ATP5F1A, ETFA, 3-oxoacid CoA-transferase 1(OXCT1), and succinate-CoA ligase GDP-forming subunit beta(SUCLG2). This suggested that restoring mitochondrial energy supply was an important aspect for Shuangshen Ningxin Capsules to exert myocardial protective effects. In conclusion, ATP5F1A, ETFA, OXCT1, SUCLG2, etc. may be the direct targets of the active ingredients of Shuangshen Ningxin Capsules in preventing and treating myocardial ischemia-reperfusion injury.

    2026 07 v.51 [Abstract][OnlineView][Download 388K]

  • Mechanism investigation of Wumei Wan in treatment of ulcerative colitis in mice based on transcriptomics and proteomics

    ZHANG Xi-lu;JIA Rui;SI Ming-ming;YANG Yan-yan;XIAO Gang;YAN Shu-guang;LI Jing-tao;WEI Hai-liang;LUO Hui;Affiliated Hospital of Shaanxi University of Chinese Medicine;Shaanxi University of Chinese Medicine;

    In this study, a dextran sulfate sodium(DSS)-induced chronic ulcerative colitis(UC) model was established in C57BL/6 mice, and the therapeutic effects of Wumei Wan were systematically investigated through histopathological evaluation, transcriptomics, proteomics, and molecular experiments. Mice were subjected to four cycles of 2.5% DSS for the modeling of chronic UC and then treated with mesalazine or different doses of Wumei Wan from the third cycle. Transcriptomics and proteomics analyses were conducted for the high-dose Wumei Wan group. The results showed that Wumei Wan markedly ameliorated the DSS-induced body weight loss, elevation of disease activity index(DAI), and colon shortening. Histological examination revealed attenuation of mucosal destruction, crypt injury, and inflammatory cell infiltration by Wumei Wan. Immunostaining showed that Wumei Wan decreased positive signals of F4/80 antigen(F4/80) and myeloperoxidase(MPO), indicating a clear anti-inflammatory effect. Transcriptomics analysis showed that Wumei Wan reversed widespread DSS-induced transcriptional abnormalities and inhibited multiple mucosal immune activation pathways, including inflammatory response pathways, chemokine signaling pathways, the interleukin-17(IL-17) signaling pathway, the tumor necrosis factor(TNF) signaling pathway, and the NOD-like receptor(NLR) signaling pathway. The proteomics analysis indicated that Wumei Wan mainly regulated immune responses, immune cell infiltration, and the intestinal immunoglobulin A(IgA) immune network, and significantly downregulated the number and expression intensity of ITGA4 and ITGB7 positive cells, thereby inhibiting the expression of integrin alpha-4 beta-7(α4β7). The results of qPCR, Western blot, and immunofluorescence assay consistently demonstrated reduced α4β7 expression, suggesting that Wumei Wan inhibited the α4β7-mucosal vascular addressin cell-adhesion molecule-1(MAdCAM-1) homing axis, thereby decreasing inflammatory cell infiltration, restoring mucosal immune homeostasis, and alleviating barrier injury. In conclusion, Wumei Wan effectively alleviates UC-associated inflammation and mucosal injury through multi-pathway and multi-target regulation. Its core mechanisms involve suppressing inflammatory cascades, modulating the IgA immune network, and downregulating integrin α4β7. The findings provide comprehensive modern pharmacological evidence for deciphering the therapeutic potential of Wumei Wan for UC.

    2026 07 v.51 [Abstract][OnlineView][Download 589K]

  • Buzhong Yiqi Decoction induces ferroptosis of A549/DDP cells to reverse cisplatin resistance in non-small cell lung cancer via AMPK/ACC1 signaling pathway

    LYU Jia-lu;WANG Jian-guang;ZHAO Qiu-yu;LIU Wen-jun;BAI Si-jia;LI He;WANG Chun;College of Basic Medicine, Liaoning University of Traditional Chinese Medicine;Teaching and Experimental Center, Liaoning University of Traditional Chinese Medicine;Northern Theater General Hospital;

    This study aimed to investigate the molecular mechanism by which Buzhong Yiqi Decoction(BZYQD), a representative TCM formula for invigorating the spleen and replenishing Qi, regulates fatty acid metabolism, induces ferroptosis in cisplatin-resistant lung adenocarcinoma A549/DDP cells, and reverses cisplatin resistance in non-small cell lung cancer(NSCLC) via the AMP-activated protein kinase(AMPK)/acetyl-CoA carboxylase 1(ACC1) signaling pathway. The sensitivity of parental A549 cells and cisplatin-resistant A549/DDP cells to different concentrations of cisplatin(0-128 μmol·L~(-1)) was compared, and the optimal cisplatin concentration for subsequent intervention was selected via the CCK-8 assay. The BZYQD-containing serum was prepared, and the effects of cisplatin, low-(L), medium-(M), and high-concentration(H) BZYQD, as well as the combinations of low-, medium-, and high-concentration BZYQD with cisplatin on the viability of A549/DDP cells were evaluated via the CCK-8 assay. RNA-seq was employed to analyze the effect of BZYQD-H+cisplatin treatment on the gene expression profile of A549/DDP cells. A549/DDP cells were randomly allocated into the control group, cisplatin group, and BZYQD-L+cisplatin, BZYQD-M+cisplatin, BZYQD-H+cisplatin groups. Western blot was performed to quantify the protein levels of AMPK, phosphorylated AMPK(p-AMPK), ACC1, fatty acid synthase(FASN), ATP-citrate lyase(ACLY), and carnitine palmitoyltransferase 1A(CPT1A). Immunofluorescence was used to observe lipid droplet synthesis in cells of each group under the intervention of BZYQD+cisplatin and AMPK inhibitor. The CCK-8 assay was adopted to examine the effect of the inhibitor on the viability of A549/DDP cells treated with BZYQD-H+cisplatin, and thus the underlying molecular mechanism was clarified. A ferrous ion assay kit was used to measure intracellular ferrous ion levels. The DCFH-DA fluorescent probe was employed to assess reactive oxygen species(ROS) levels. Western blot was conducted to determine the expression levels of ferroptosis-related proteins, including glutathione peroxidase 4(GPX4), acyl-CoA synthetase 4(ACSL4), and transferrin receptor 1(TFR1). The Liperfluo kit was used to assess intracellular lipid peroxidation levels, and the JC-1 probe was employed to quantify mitochondrial membrane potential. The results showed that cisplatin demonstrated the half-maximal inhibitory concentrations(IC_(50)) of 12.2 μmol·L~(-1) and 41.2 μmol·L~(-1) against A549 cells and A549/DDP cells, respectively, with a resistance index(RI) of 3.38. Compared with the cisplatin group, BZYQD-L+cisplatin, BZYQD-M+cisplatin, and BZYQD-H+cisplatin significantly inhibited the viability of A549/DDP cells. RNA-seq results revealed that the differentially expressed genes in the BZYQD-H+cisplatin group were associated with signaling pathways such as fatty acid synthesis and catabolism, AMPK, and ferroptosis. Compared with the cisplatin group, the BZYQD-L+cisplatin, BZYQD-M+cisplatin, and BZYQD-H+cisplatin groups showed a significant upregulation of p-AMPK, a significant downregulation of fatty acid synthesis-related proteins(FASN, ACC1, and ACLY), and a significant upregulation of CPT1A. Immunofluorescence results indicated that BZYQD+cisplatin treatment inhibited lipid droplet formation by activating the AMPK/ACC1 pathway. Meanwhile, CCK-8 results showed that the AMPK inhibitor significantly reversed the decrease in viability of cells treated by BZYQD-H+cisplatin. Compared with the cisplatin group, the BZYQD-M+cisplatin and BZYQD-H+cisplatin groups exhibited significant increases in intracellular ferrous ion levels, along with significant elevations in intracellular ROS levels and lipid peroxidation levels and a significant reduction in mitochondrial membrane potential. The expression of the ferroptosis-related protein GPX4 was significantly downregulated, suggesting an imbalance in the cellular antioxidant system, while the expression levels of ACSL4 and TFR1 were significantly upregulated. These findings indicate that BZYQD+cisplatin can induce ferroptosis in A549/DDP cells and reverse cisplatin resistance. In summary, the results indicate that BZYQD synergizes with cisplatin to inhibit fatty acid synthesis and induce ferroptosis in A549/DDP cells through the AMPK/ACC1 pathway, thereby reversing cisplatin resistance in NSCLC.

    2026 07 v.51 [Abstract][OnlineView][Download 357K]

  • Effect of modified Xiangsha Liujunzi Decoction on adipose tissue browning-Nrg4-liver fatty acid synthesis pathway in rat model of both spleen deficiency and hyperlipidemia

    QIAO Ai;ZHAO Na;ZHANG Qi;CHE Meng-zhu;SUI Guo-yuan;JIA Lian-qun;Liaoning University of Traditional Chinese Medicine;Key Laboratory of Visceral Phenomena Theory and Application, Traditional Chinese Medicine Innovation Engineering Technology Center, Ministry of Education, Liaoning University of Traditional Chinese Medicine;

    This study aims to investigate the effect of modified Xiangsha Liujunzi Decoction on adipose tissue browning-neuregulin 4(Nrg4)-liver fatty acid synthesis pathway in the rat model of both spleen deficiency and hyperlipidemia. Seventy SPF-grade male SD rats were randomly assigned into blank control(CON), high-fat diet(HFD), spleen deficiency and high-fat diet(SD-HFD), rosuvastatin(RSF), low-, medium-, and high-dose modified Xiangsha Liujunzi Decoction(XS-L, XS-M, and XS-H, respectively) groups, with 10 rats in each group. The rats in the SD-HFD, RSF, XS-L, XS-M, and XS-H groups were modeled for spleen deficiency by an improper diet combined with swimming exhaustion for a total of 15 days. The CON group was fed with a normal diet while the other groups with a high-fat diet for 10 weeks after successful modeling of spleen deficiency. The RSF, XS-L, XS-M, and XS-H groups were administrated with corresponding drugs by gavage for 8 weeks and the other groups were administrated with an equal volume of distilled water. The feeding method of each group was kept unchanged during the period of gavage. Four items of serum lipids were measured by an automatic biochemical analyzer. The pathological changes in the interscapular brown adipose tissue(BAT), abdominal white adipose tissue(WAT), and liver were observed by hematoxylin-eosin(HE) staining. The liver lipid deposition was observed by oil red O staining and the serum Nrg4 level was measured by enzyme-linked immunosorbent assay(ELISA). RT-qPCR was employed to determine the mRNA levels of peroxisome proliferator-activated receptor gamma(PPARγ), peroxisome proliferator-activated receptor gamma cofactor 1α(PGC1α), uncoupling protein 1(UCP1), and Nrg4 in the adipose tissue and liver X receptor alpha(LXRα), sterol regulatory element-binding protein-1c(SREBP-1c), acetyl-CoA carboxylase(ACC), and stearoyl-CoA desaturase 1(SCD1) in the liver tissue of rats in each group. Western blot was employed to quantify the protein levels of PPARγ, PGC1α, UCP1, and Nrg4 in the adipose tissue and Erb-B2 receptor tyrosine kinase 3(ErbB3), phosphorylated ErbB3(p-ErbB3), Erb-B2 receptor tyrosine kinase 4(ErbB4), phosphorylated ErbB4(p-ErbB4), signal transducer and activator of transcription 5(STAT5), phosphorylated STAT5(p-STAT5), LXRα, SREBP-1c, ACC, and SCD1 in the liver tissue. Compared with the CON group, the HFD and SD-HFD groups showed significantly elevated serum levels of triglycerides(TG), total cholesterol(TC), high-density lipoprotein-cholesterol(HDL-C), and low-density lipoprotein-cholesterol(LDL-C) and a significantly declined level of Nrg4. HE staining revealed enlarged BAT and WAT cells and increased lipid vacuoles in hepatocytes in the HFD and SD-HFD groups. The oil red O staining showed that the HFD and SD-HFD groups had more orange lipid droplets in hepatocytes than the CON group. Compared with the CON group, the SD-HFD group showed significantly down-regulated mRNA and protein levels of PPARγ, PGC1α, and Nrg4, significantly down-regulated protein levels of UCP1 in both BAT and WAT cells, and a significantly down-regulated mRNA level of UCP1 in BAT cells. In addition, the SD-HFD group showed significantly decreased p-ErbB3/ErbB3, p-ErbB4/ErbB4, and p-STAT5/STAT5 ratios and significantly up-regulated mRNA and protein levels of LXRα, SREBP-1c, ACC, and SCD1 in the liver tissue. Compared with the SD-HFD group, the RSF, XS-M, and XS-H groups showed significantly declined serum TG, TC, and LDL-C levels, and the XS-M and XS-H groups presented significantly elevated serum Nrg4 levels. In addition, these groups showed reductions in volumes of BAT and WAT cells, alleviated hepatocyte swelling, and decreased lipid droplets in hepatocytes. The mRNA and protein levels of related factors were improved in XS-M and XS-H groups compared with those in the SD-HFD group. This study indicates that modified Xiangsha Liujunzi Decoction could promote the browning of adipose tissue, increase the expression of Nrg4 in the adipose tissue, raise the level of circulating Nrg4, and reduce liver fatty acid synthesis in the rat model of both spleen deficiency and hyperlipidemia.

    2026 07 v.51 [Abstract][OnlineView][Download 421K]

  • Lobetyolin inhibits T-BHP-induced ferroptosis in human nucleus pulposus cells by regulating PI3K/AKT pathway

    XU Shi-jia;JIANG Hao-bo;LI Shuo-fu;LI Zhao-yong;CHEN Long;OUYANG Wen-si;DUAN Jia-hao;YANG Shao-feng;the First Hospital of Hunan University of Chinese Medicine;

    This study aimed to investigate the effect of lobetyolin(LOB) on tert-butyl hydroperoxide(T-BHP)-induced ferroptosis in human nucleus pulposus cells(NPCs) based on the phosphoinositide 3-kinase(PI3K)/protein kinase B(AKT) pathway, thereby providing a theoretical basis for the treatment of intervertebral disc degeneration(IDD). Human NPCs were cultured in vitro. The cell counting kit-8(CCK-8) assay was used to screen the optimal concentration for T-BHP induction and the optimal intervention concentration of LOB. Cells in the logarithmic growth phase were randomly divided into a blank control group, a model group, a Ferrostatin-1(Fer-1) control group, a model + Fer-1 group, a LOB group, and a PI3K/AKT agonist 740Y-P group. Cell viability was assessed using the CCK-8 assay. Intracellular ferrous ion(Fe~(2+)), malondialdehyde(MDA), and glutathione(GSH) levels were measured using colorimetric assays. Mitochondrial ultrastructure was observed using transmission electron microscopy(TEM). The protein expression levels of solute carrier family 7 member 11(SLC7A11), glutathione peroxidase 4(GPX4), collagen type Ⅱ(collagen Ⅱ), matrix metallopeptidase-13(MMP-13), phosphorylated phosphatidylinositol 3-kinase(p-PI3K), and phosphorylated protein kinase B(p-AKT) were determined by Western blot. Additionally, the expression levels of p-PI3K and p-AKT were detected by immunofluorescence. Compared with that in the blank control group, the viability of human NPCs in the model group decreased significantly. Intracellular Fe~(2+) and lipid peroxidation product MDA levels increased significantly, while the antioxidant indicator GSH level decreased significantly in the model group. Protein analysis showed that the expression of SLC7A11, GPX4, and collagen Ⅱ was significantly downregulated, while MMP-13 expression was upregulated. The expression levels of p-PI3K and p-AKT were inhibited. Typical morphological changes of ferroptosis, such as mitochondrial shrinkage and reduction of cristae, were observed under a transmission electron microscope. Compared with the model group, the LOB group, model + Fer-1 group, and 740Y-P group showed significantly reduced levels of Fe~(2+) and MDA, increased GSH levels, upregulated protein expression of SLC7A11, GPX4, and collagen Ⅱ, and downregulated MMP-13 expression. Furthermore, LOB intervention significantly upregulated the expression levels of p-PI3K and p-AKT in human NPCs, and the improvement trend of related indicators was consistent with that of the 740Y-P group. LOB effectively alleviates T-BHP-induced ferroptosis in human NPCs and reduces extracellular matrix degradation. Its protective mechanism may be achieved by regulating the PI3K/AKT signaling pathway.

    2026 07 v.51 [Abstract][OnlineView][Download 359K]

  • Mechanism of Dangua Humai Oral Liquid in ameliorating vascular endothelial injury in type 2 diabetes mellitus via HIF-1α

    JIN Lin-xi;HAN Zhuang;CHEN Qi-wei;HENG Xian-pei;YANG Liu-qing;LI Liang;HE Wei-dong;YAO Shu-hong;RUAN Yi;HONG Xin-miao;WANG Zhi-ta;People′s Hospital Affiliated to Fujian University of Traditional Chinese Medicine;

    This study investigated whether Dangua Humai Oral Liquid regulates glycolipid metabolism and vascular endothelial ultrastructure in the rat model of type 2 diabetes mellitus(T2DM) by regulating the expression of hypoxia-inducible factor-1α(HIF-1α), aiming to explore the potential mechanism of the oral liquid in ameliorating vascular endothelial injury. Network pharmacology was employed to identify the active components of Dangua Humai Oral Liquid, their potential targets, and targets related to diabetic angiopathy. Protein-protein interaction(PPI) network construction, along with GO and KEGG enrichment analyses, were performed. An animal experiment was carried out for validation, with 36 SPF-grade female SD rats randomized into six groups: normal, model, treatment(Dangua Humai Oral Liquid, 20.5 g·kg~(-1)), inhibitor(PX-478, 2.5 mg·kg~(-1)), combination(Dangua Humai Oral Liquid + PX-478), and metformin(0.142 g·kg~(-1)). A rat model of T2DM was established via a high-fat and high-sucrose diet combined with intraperitoneal injection of streptozotocin(STZ). After 14 weeks of intervention, the body weight and liver weight were measured, and the liver index was calculated. Glucose metabolism parameters including fasting blood glucose(FBG), 2-hour postprandial blood glucose(2hBG), and glycated hemoglobin(HbA1c) were evaluated. Lipid metabolism parameters including total cholesterol(TC), triglycerides(TG), and free fatty acids(FFA) were measured. Liver lipid deposition was observed via oil red O staining. The serum HIF-1α level was measured by ELISA, and aortic HIF-1α protein expression by immunohistochemistry. The aortic histopathology was observed via hematoxylin-eosin staining, and endothelial cell ultrastructure was examined via transmission electron microscopy. Network pharmacology identified 144 active ingredients and 90 overlapping targets of Dangua Humai Oral Liquid, with HIF-1α being a core target. KEGG enrichment analysis indicated significant activation of the HIF-1 signaling pathway. Animal experiments showed that compared with the normal group, the model group and the inhibitor group exhibited significant dysregulation of glucose and lipid metabolism, while the treatment, combination, and metformin groups showed significant improvements in glucose and lipid metabolism indicators. Compared with the normal control group, both the model and inhibitor groups showed reduced aortic HIF-1α protein expression. After intervention, the treatment, combination, and metformin groups showed upregulation of HIF-1α expression. Histomorphological analysis revealed severe aortic endothelial damage in the model and inhibitor groups, while all intervention groups showed improved endothelial ultrastructure compared with the model group. Dangua Humai Oral Liquid may protect the vascular endothelium in T2DM by upregulating HIF-1α expression, improving glycolipid metabolism, and reversing vascular endothelial ultrastructural damage.

    2026 07 v.51 [Abstract][OnlineView][Download 543K]

  • Bidirectional regulation of ischemic myocardium and atherosclerotic plaque by Qixue Bingzhi Formula: role of angiogenesis in coronary heart disease and related mechanism

    ZHAO Han;HU Lan-tian;YUAN Rong;MIAO Yu;XIE Xue-na;MA Hua-gen;XIN Qi-qi;CONG Wei-hong;Tianjin University of Traditional Chinese Medicine;Cardiovascular Laboratory, Xiyuan Hospital of China Academy of Chinese Medical Sciences;

    This study investigated the therapeutic effects of the Qixue Bingzhi Formula(QXBZ) on coronary heart disease, focusing on its bidirectional regulation of angiogenesis in myocardial ischemia and atherosclerosis, using in vivo and in vitro models. Male ApoE~(-/-)mice were fed a high-fat diet for 9 weeks and then randomized into the following groups, with high-fat feeding continuing until 12 weeks: a control group, a model group, QXBZ groups(at high, medium, and low doses of 11.7, 5.85, and 2.92 g·kg~(-1)·d~(-1), respectively), and a positive group(receiving 26 mg·kg~(-1)·d~(-1) metoprolol plus 5.2 mg·kg~(-1)·d~(-1) simvastatin), with 12 mice per group. A myocardial infarction and atherosclerosis(MI-AS) composite model was established by ligating the left anterior descending coronary artery at week 11, and drug administration continued for 2 weeks post-surgery. C57BL/6J mice served as a blank control, receiving standard diet and intragastric administration of normal saline throughout the study and being subjected to threading but not ligating the coronary artery. After the final administration, cardiac function and carotid artery intima-media thickness were assessed by ultrasound. Histopathological examinations of the heart and plaques were performed using hematoxylin and eosin(HE), Masson, and Movat staining, along with immunofluorescence. Blood lipid levels were measured using biochemical assays, and the expression level of vascular endothelial growth factor A(VEGFA) was determined by RT-qPCR and Western blot. In vitro, endothelial cells were used to establish a hypoxic-induced(1% O_2) MI model and an oxidized low-density lipoprotein(ox-LDL)-induced AS model and divided into control, model, QXBZ(2.5%, 5%, 10%, and 15%), and positive groups. Cell proliferation was assessed using the cell counting kit-8(CCK-8) assay, cell migration was evaluated by the scratch assay, and tube formation ability was examined by the tube formation assay. The expression level of VEGFA was detected by RT-qPCR and Western blot. Results showed that QXBZ significantly reduced triglyceride and low-density lipoprotein cholesterol levels, increased left ventricular ejection fraction and left ventricular fractional shortening, and attenuated both myocardial fibrosis area and atherosclerotic plaque area in MI-AS composite model mice. It enhanced the fluorescence intensities of cluster of differentiation 31(CD31) and α-smooth muscle actin(α-SMA) in the ischemic myocardium but decreased them in plaques. QXBZ also promoted cell viability, migration, and tube formation in the MI model, while inhibiting these processes in the AS model. Furthermore, QXBZ upregulated VEGFA expression in the ischemic myocardium and the MI cell model, but downregulated it in the aortic tissue and the AS cell model, demonstrating a microenvironment-dependent bidirectional regulation. These findings suggested that QXBZ ameliorates coronary heart disease by promoting angiogenesis in the ischemic myocardium while inhibiting angiogenesis in plaques, potentially through bidirectional regulation of the VEGFA signaling pathway in different pathological microenvironments of ischemic myocardium and plaques.

    2026 07 v.51 [Abstract][OnlineView][Download 1239K]

  • Mechanistic study on regulation of MAPK/NF-κB pathway axis by Jiangzhi Huaban Decoction based on "Qi meridian-blood collateral" theory in improving polarization state of macrophages in atherosclerotic plaques

    ZHU Wen-yi;CHEN Xu-shen;CAO Zhi-wei;WANG Jin;XIE Bo;REN Xue-feng;WANG Hong-yang;School of Public Health, Zhejiang Chinese Medical University;Suzhou Chongsheng Medicine Joint Laboratory, Zhejiang Chinese Medical University;

    This study aimed to investigate the therapeutic effects of Jiangzhi Huaban Decoction(JZHB) on atherosclerosis(AS) model mice and to explore its potential molecular mechanisms using proteomic analysis. C57BL/6J mice fed with a standard diet served as the control group. ApoE~(-/-) knockout mice were fed with a high-fat diet for 8 weeks to induce atherosclerosis, after which they were randomly divided into 5 groups(n=8 per group): the model group, low-, medium-, and high-dose JZHB groups(1.32, 2.64, and 5.28 g·kg~(-1)), and the atorvastatin calcium group(3.75 mg·kg~(-1)). All intervention groups lasted for 8 weeks. The body weight and general conditions of the mice were recorded weekly. Prior to sample collection, small animal color Doppler ultrasound was employed to assess carotid artery and aortic wall plague lesions. After sample collection, serum lipid and liver function levels were measured using an automated biochemical analyzer. Serum levels of interleukin(IL)-6, IL-1β, IL-4, and tumor necrosis factor-alpha(TNF-α) were quantified by enzyme-linked immunosorbent assay(ELISA). Hematoxylin-eosin(HE) staining. Masson and oil red O staining were used to comprehensively evaluate pathological changes in AS plaques. Proteomics sequencing technology was used to analyze core molecular mechanisms, and Western blot, qPCR, and immunofluorescence assays were used to verify the expression of core targets. The results showed that JZHB significantly improved serum lipid levels, liver function, and serum inflammatory microenvironment in AS mice(P<0.05, P<0.01). It can also comprehensively improved various pathological markers, including carotid artery and aortic root plaque area, collagen fiber content, lipid deposition, lumen stenosis, and hemorheological parameters(P<0.05, P<0.01). Proteomics analysis revealed that its core mechanism was associated with the mitogen-activated protein kinase(MAPK)/nuclear factor-κB(NF-κB) signaling pathway axis to improve macrophage polarization in AS plaques. Molecular biological assays indicated that JZHB could reduce the mRNA levels and the phosphorylation ratios of MAPK, c-Jun N-terminal kinase(JNK), NF-κB p65, and inhibitor of nuclear factor-κBα(IκBα) in the aortic tissue of mice. It also downregulated the mRNA and protein expressions of inducible nitric oxide synthase(iNOS) and IL-6(P<0.05, P<0.01). Additionally, JZHB improved the expression and localization of M1/M2 macrophage polarization markers, cluster of differentiation 86(CD86) and mannose receptor(CD206), within aortic plaques(P<0.05, P<0.01). In conclusion, JZHB can synergistically ameliorate the pathological changes in arterial plaques of AS mice through multiple pathways. Its core mechanism involves regulating the MAPK/NF-κB signaling pathway axis, ameliorating the macrophage polarization status and the internal inflammatory microenvironment within plaques, thereby exerting a comprehensive pharmacological effect on the prevention and treatment of atherosclerosis.

    2026 07 v.51 [Abstract][OnlineView][Download 689K]

  • Study on mechanism of serum transitional components of Yinxing Yangnao Formula against vascular dementia based on UPLC- Orbitrap-HRMS combined with network pharmacology

    XIONG Dan;TAO Ye-qin;JIANG Cui-ping;LI Xiang;LIN Tao;XIE Zong-ming;NIU Jiang-jin;GAO Ming-guo;the Second Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Hunan University of Chinese Medicine;

    This study adopted an integrated strategy combining serum transitional component screening, network pharmacology prediction, and animal experiment verification to systematically explore the core active components and mechanism of action of Yinxing Yangnao Formula(YYF) in the treatment of vascular dementia(VD), aiming to provide solid experimental evidence for the modernization of this classical TCM prescription. With the use of ultra-high performance liquid chromatography-Orbitrap high-resolution mass spectrometry(UPLC-Orbitrap-HRMS), a total of 97 chemical components were identified from the YYF extract by combining accurate mass-to-charge ratio, characteristic fragmentation ions of MS/MS, comparison with reference standards, and matching with literature databases. Furthermore, 27 serum transitional components were captured through the analysis of YYF-containing serum from rats, which were inferred as the key material basis for the in vivo pharmacodynamic effects of YYF. The potential targets of the serum transitional components were predicted using the SwissTargetPrediction database, and VD-related disease targets were screened from authoritative databases including GeneCard, OMIM, and GEO with the keyword dementia vascular. A total of 275 common targets were obtained with the Jvenn online tool. The "drug-component-target-disease" network was constructed using Cytoscape 3.9.1 software, and core active components such as isoscopoletin, jaceosidin, catalpol, senkyunolide F, and bilobalide were screened out. The protein-protein interaction(PPI) network was constructed via the STRING database, identifying key regulatory targets including the phosphatidylinositol 3-kinase family, sarcoma, protein tyrosine phosphatase, non-receptor type 11, Janus kinase 2, and protein tyrosine kinase 2. Gene Ontology(GO) functional enrichment and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway analysis revealed that the core targets were mainly enriched in biological processes such as oxidative stress, neurological function, and immune and inflammatory responses, involving phosphoinositide 3-kinase-protein kinase B(PI3K-Akt), mitogen-activated protein kinase(MAPK), and Janus kinase-signal transducer and activator of transcription 3(JAK-STAT3) signaling pathways. Molecular docking results showed that bilobalide had a good binding effect with core targets. Verification experiments on VD rat models demonstrated that YYF might exert the therapeutic effect by alleviating oxidative stress through modulating the serum levels of superoxide dismutase(SOD), glutathione peroxidase(GSH-Px), and malondialdehyde(MDA). This study preliminarily clarified the material basis, pharmacological effects, and underlying mechanism of YYF in the treatment of VD, providing a direction and basis for subsequent research on the complete regulatory chain of "drug-target-pathway-phenotype".

    2026 07 v.51 [Abstract][OnlineView][Download 375K]

  • Huangqi Chifeng Tang regulates Nrf2/NLRP3/Caspase-1/GSDMD pathway to attenuate neuronal injury and neuroinflammation after cerebral ischemia reperfusion injury

    ZHENG Yun-hui;YANG Yan-qi;ZHOU Xiao-li;ZHANG Jian;TANG Xia-lin;CHEN Xiao-min;College of Traditional Chinese Medicine, Hubei University of Chinese Medicine;Department of Neurology, Hubei Academy of Traditional Chinese Medicine, the Affiliated Hospital of Hubei University of Chinese Medicine, Hubei Provincial Hospital of Traditional Chinese Medicine;Hubei Key Laboratory of Theory and Application Research of Liver and Kidney in Traditional Chinese Medicine,the Affiliated Hospital of Hubei Universit

    This study aimed to investigate whether Huangqi Chifeng Tang(HQCFT) attenuates neuronal injury and inflammatory responses induced by cerebral ischemia reperfusion injury(CIRI) through regulating the nuclear factor erythroid 2-related factor 2(Nrf2)/NOD-like receptor protein 3(NLRP3)/cysteinyl aspartate-specific proteinase-1(Caspase-1)/gasdermin D(GSDMD) pathway. Oxygen-glucose deprivation/reoxygenation(OGD/R) was employed to establish an in vitro model with BV2 murine microglial cells, while the middle cerebral artery occlusion/reperfusion(MCAO/R) model was induced in mice through the suture method. The cell experiments were conducted with control, model, si-NC, si-Nrf2, HQCFT, and si-Nrf2+HQCFT groups. The animal experiments encompassed the sham, model, ML385, HQCFT, and ML385+HQCFT groups. Cell viability and injury were assessed via CCK-8 and lactate dehydrogenase(LDH) assays. Neurological function and tissue damage were evaluated by the modified neurological severity score(mNSS), TTC staining, HE staining, and Nissl staining. Western blot was employed to determine the expression levels of pyroptosis-related proteins, including Nrf2, NLRP3, Cleaved Caspase-1, GSDMD-Nterminal domain(GSDMD-N), and Cleaved Caspase-3. RT-qPCR was performed to quantify the mRNA levels of Nrf2 and NLRP3. The release of pro-inflammatory cytokines, including tumor necrosis factor(TNF)-α, interleukin(IL)-1β, and IL-18, was assessed by ELISA. The results of cell experiments showed that HQCFT increased the viability of BV2 murine microglial cells following OGD/R injury(P<0.05), reduced LDH release(P<0.001), and suppressed the expression of pyroptosis-related molecules and the secretion of inflammatory cytokines. The results of animal experiments showed that HQCFT improved the neurological function(P<0.05), reduced the infarct volume(P<0.01), alleviated neuronal structural damage, reversed the downregulation of Nrf2 and the upregulation of NLRP3, Cleaved Caspase-1, GSDMD-N, and Cleaved Caspase-3 in the brain tissue(P<0.05), and decreased the serum levels of pro-inflammatory cytokines(P<0.05) in MCAO/R mice. Genetic silencing or pharmacological inhibition of Nrf2 gene exacerbated the injury and significantly attenuated the protective effects of HQCFT, indicating that its beneficial effects were partially dependent on Nrf2 gene activation. In conclusion, HQCFT exerts neuroprotective effects against CIRI, in part by activating the Nrf2 signaling pathway and thereby inhibiting both the NLRP3/Caspase-1/GSDMD canonical pyroptosis pathway and the Caspase-3-mediated pyroptosis pathway, ultimately alleviating neuroinflammatory responses.

    2026 07 v.51 [Abstract][OnlineView][Download 466K]

  • Exploring inhibitory effect and mechanism of Jianpi Huayu Jiedu Decoction inhibits gastric cancer HGC-27 cells by regulating ROS/PARP1/GSDME-mediated pyroptosis

    LIU Si-da;CHEN Xiao-dong;LIU Chang-hua;CUI Yong-chao;XIE Zi-chun;LIU Nai-hua;FANG Chong-kai;PAN Hua-feng;Guangzhou University of Chinese Medicine;

    This study aims to investigate the mechanism by which Jianpi Huayu Jiedu Decoction(JHJD) inhibits gastric cancer HGC-27 cells via regulation of the reactive oxygen species(ROS)/poly(ADP-ribose) polymerase 1(PARP1)/gasdermin E(GSDME) pathway. HGC-27 cell xenografts were established in Balb/c-nu mice. After tumor formation, mice were allocated into a low-dose(7.5 g·kg~(-1) per day) JHJD group, a high-dose(15 g·kg~(-1) per day) JHJD group, and a model group. The mice in the JHJD groups were administrated with corresponding doses of JHJD and those in the model group with an equal volume of normal saline by gavage. The body mass, subcutaneous xenograft volume, and tissue mass of the mice were measured, and the tumor inhibition rate was calculated. The pathological changes of the xenograft tissue in each group were observed under a microscope after hematoxylin-eosin(HE) staining. The ROS level in the tissue was measured by a ROS kit, and the mRNA levels of PARP1 and GSDME in the xenograft were determined by RT-qPCR. HGC-27 cells were assigned into 5%, 10%, and 15% blank serum groups and 5%, 10%, and 15% JHJD-containing serum groups. Cell viability was detected by the CCK-8 assay, and intracellular ROS levels were quantified by the ROS kit. The morphological changes of cells were observed under a microscope. The protein levels of PARP1 and GSDME were determined by Western blot. The lactate dehydrogenase(LDH) release rate and adenosine triphosphate(ATP) levels in the cell supernatant were determined by LDH and ATP kits, and high mobility group box-1 protein(HMGB1) levels in the cell supernatant were determined by ELISA. In vivo experiments revealed that the low-and high-dose JHJD groups had lower volume and mass of subcutaneous xenografts than the model group(P<0.05), with the tumor inhibition rates of 20.43% and 30.75%, respectively. HE staining showed that cells in the model group exhibited pleomorphism, clustered arrangement, and nuclear division. Cells in the low-dose JHJD group showed reduced nuclear volume, deeply stained nuclei, lack of mitotic figures, and numerous vacuoles. Cells in the high-dose JHJD group showed nuclear pyknosis, nuclear fragmentation, and numerous cell debris. The mRNA levels of PARP1 and GSDME and the levels of ROS in the tissue in both the low-dose and high-dose JHJD groups raised compared with those in the model group(P<0.05). In vitro experiments showed that serum containing JHJD at all concentrations inhibited the proliferation of HGC-27 cells at the time points of 24, 48, and 72 h(P<0.05), and the inhibitory effect increased in a concentration-dependent manner. Morphological features of pyroptosis, including swelling, rupture, and release of vesicular contents at the cell edges, were induced by JHJD-containing serum to varying degrees, being the most pronounced in the 15% JHJD-containing serum group. The ROS levels and the protein levels of PARP1 and GSDME in all JHJD-containing serum groups were higher than those in the 5% blank serum group(P<0.05), and the differences between JHJD-containing serum groups were significant(P<0.05). Compared with the 5% blank serum group, JHJD-containing serum increased the LDH release rate and the ATP and HMGB1 levels in the supernatant(P<0.05) in a concentration-dependent manner, and the differences between groups were significant(P<0.05). In conclusion, JHJD may inhibit the proliferation of gastric cancer HGC-27 cells by inducing pyroptosis through upregulating the ROS/PARP1/GSDME pathway.

    2026 07 v.51 [Abstract][OnlineView][Download 494K]

  • Exploring active components and targets of Gentiana straminea in treating rheumatoid arthritis based on serum pharmacochemistry and network pharmacology

    ZHAI Ke-xin;LI Ya-nan;DING Jia-li;WANG Min;ZHUANG Yuan-wen;LIN Peng-cheng;XIA Gui-yang;LIN Sheng;College of Pharmacy, Qinghai Minzu University;Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine;School of Ecological and Environmental Engineering, Qinghai University;

    This study aims to meet the therapeutic needs of rheumatoid arthritis(RA) by focusing on the traditional anti-arthritic medicinal plant Gentiana straminea. An integrated strategy combining characterization of absorbed components, network pharmacology, molecular docking, and molecular interaction verification was employed to systematically investigate the pharmacodynamic material basis and mechanism of this herb against RA. Ultra-high performance liquid chromatography-quadrupole-time of flight-tandem mass spectrometry(UHPLC-Q-TOF-MS/MS) was performed, which identified gentiopicroside, swertiamarin, and loganic acid as the core components absorbed into blood. Network pharmacology prediction and target mapping revealed that these components were primarily involved in RA-related biological processes such as inflammatory response and immune cell activation. Molecular docking suggested that the core components exhibited favorable binding potential with key targets including STAT3, EGFR, and MMP9. Further quantitative validation with bio-layer interferometry demonstrated that gentiopicroside(KD=50.1 nmol·L~(-1)) and swertiamarin(KD=87.7 nmol·L~(-1)) specifically bound to STAT3 with high affinity. The results indicate that G. straminea exert anti-RA effects through its iridoids by targeting STAT3 and modulating related inflammatory pathways, providing a scientific basis for the clinical application of G. straminea and the development of natural anti-RA drugs.

    2026 07 v.51 [Abstract][OnlineView][Download 725K]

  • Pharmacokinetics of four characteristic components from ethanol extract of Rehmanniae Radix in normal and depression model rats

    FEI Qian;AN Hong-zhi;TIAN Ping;LIANG Rui-feng;SHANG Xu-yang;HAN De-en;LI Hong-wei;WEI Ying;JIA Yong-yan;School of Pharmacy, Henan University of Chinese Medicine;Henan Integrative Medicine Hospital/Henan Academy of Chinese Medicine;

    This study investigated the pharmacokinetic characteristics of four blood-entering components(catalpol, rehmannioside D, rehmapicroside, and verbascoside) from the ethanol extract of Rehmanniae Radix in normal and chronic unpredictable mild stress(CUMS) depression model rats. Ultra performance liquid chromatography-quadrupole/electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Orbitrap-HRMS) was employed to quantitatively analyze the four components in the plasma of normal and CUMS depression model rats administrated with the ethanol extract of Rehmanniae Radix by gavage. The pharmacokinetic parameters of the four components were calculated and compared to explore the effects of depressive disease status on the main components from the ethanol extract of Rehmanniae Radix. The methodological verification results of four blood-entering components(catalpol, rehmannioside D, rehmapicroside, and verbascoside) from the ethanol extract of Rehmanniae Radix showed that the established analytical method for simultaneous determination of the four components met the requirements for the determination of biological samples. The pharmacokinetic results showed that compared with the normal group, the model group demonstrated significantly increased AUC, C_(max), and MRT, prolonged t_(1/2), and decreased CL for catalpol, rehmannioside D, and verbascoside. For rehmapicroside, only C_(max), T_(max), and MRT_(0-t) increased, and no statistical difference was observed for t_(1/2), MRT_(0-∞), AUC, and CL. This study shows that CUMS depression can significantly affect the pharmacokinetic characteristics of catalpol, rehmannioside D, and verbascoside from the ethanol extract of Rehmanniae Radix but exerts limited effect on rehmapicroside, suggesting that the body may have adaptive changes in the absorption, distribution, metabolism, and excretion of drugs under disease conditions.

    2026 07 v.51 [Abstract][OnlineView][Download 285K]

  • Efficacy and safety of Compound Ciwujia Granules in treating insomnia (heart-spleen deficiency syndrome): multicenter, randomized, double-blind, double-dummy, positive drug-controlled, parallel-group clinical trial

    ZHANG Wen-jing;JIN Xin-yao;SHEN Li;WANG Guo-yun;YIN Ping;CAO Lu-jia;ZHENG Wen-ke;Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine;First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;School of Public Health, Huazhong University of Science and Technology;Haihe Laboratory of Modern Traditional Chinese Medicine;

    To evaluate the safety and efficacy of Compound Ciwujia Granules in the treatment of insomnia(heart-spleen deficiency syndrome), a multicenter, randomized, double-blind, double-dummy, positive drug-controlled, parallel-group clinical trial was conducted. A total of 423 eligible patients were enrolled and randomly assigned in 1∶1 ratio to experimental group or control group using block randomization. The experimental group(n=212) received Compound Ciwujia Granules + placebo for Guipi Granules, while the control group(n=211) received Guipi Granules + placebo for Compound Ciwujia Granules. The treatment lasted for 4 weeks, with visits conducted at baseline and at weeks 2 and 4 of treatment. The primary efficacy outcomes were the change in PSQI scale scores after 4 weeks of treatment(reduction from baseline) and improvement rate of PSQI scale scores. The secondary efficacy outcomes were PSQI single factor scores, changes in sleep diary records, ISI scale scores, use of sedatives and hypnotics, and TCM syndrome scores. Regarding primary efficacy outcomes, after 4 weeks of treatment, the reduction in PSQI scale scores in the experimental group was greater than that in the control group(P<0.000 1), and the PSQI improvement rate was also superior to that of the control group(P<0.000 1). The least-squares mean difference in PSQI scale scores changes between the two groups(experimental group minus control group) and the corresponding 95%CI were-1.13[-1.63,-0.64] in FAS and-1.16[-1.65,-0.67] in PPS. As the upper limits of the confidence intervals were below 0, the efficacy of the experimental group was considered superior to that of the control group, and the superiority test was confirmed. Regarding secondary efficacy outcomes, after 4 weeks of treatment, PSQI single factor scores in the experimental group were significantly improved, and both the ISI scale scores and TCM syndrome scores were significantly reduced compared with those in the control group(P<0.05). No statistically significant differences were observed between the two groups in changes in sleep diary records the use of sedative-hypnotic drugs. In terms of safety, 61 patients(83 events, 28.77%) in the experimental group and 44 patients(82 events, 21.05%) in the control group experienced adverse events. Adverse drug reactions occurred in 7 patients(8 events) in the experimental group and in 8 patients(12 events) in the control group. No serious adverse reactions were reported, and laboratory examinations revealed no abnormalities requiring special attention. These results indicate that Compound Ciwujia Granules administered for 4 weeks are effective and safe for the treatment of insomnia(heart-spleen deficiency syndrome).

    2026 07 v.51 [Abstract][OnlineView][Download 271K]

  • Status analysis of clinical outcome for treatment of long COVID with traditional Chinese and western medicines

    YAN Xing;TANG Xiang;ZHANG Ya-zi;LIU Yao-yuan;LIU Yang;PANG Wen-tai;YANG Feng-wen;JIN Xin-yao;Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;

    This study sorted out the clinical outcome of traditional Chinese and western medicines in the treatment of long COVID to lay the foundation for the construction of a core indicator set. Search was made on some databases and platforms from their inception to December 2024, which included eight databases of CNKI, Wanfang, SinoMed, VIP, PubMed, Cochrane Library, EMbase, and Web of Science and three clinical research protocol registration platforms, namely the Chinese Clinical Trial Registry(ChiCTR), the International Traditional Medicine Clinical Trial Registry(ITMCTR), and the American Clinical Trial Registry(ClinicalTrials.gov). Two researchers independently extracted the basic information, outcomes, measurement time points, and measurement tools of literature in parallel according to the inclusion and exclusion standards. If there are any differences, a third researcher would make discussions and decisions. A total of 152 studies, including 50 literature studies and 102 protocol studies, were ultimately included. A total of 338 outcomes indicators were reported, with a reporting frequency of 1 633 times. Outcome indicators can be classified into 10 indicator domains based on attributes, including symptoms and signs(694 times, 42.50%), TCM diseases(61 times, 3.74%), security incidents(93 times, 5.70%), etiological detection(23 times, 1.41%), long-term prognosis(72 times, 4.41%), economic indicators(14 times, 0.86%), physical and chemical testing(472 times, 28.90%), quality of life(173 times, 10.59%), major events(16 times, 0.97%), and other indicators(15 times, 0.92%). There were problems in the outcomes indicators of treating long COVID with both traditional Chinese and western medicines, such as significant differences in symptom descriptions, lack of standardization in indicator selection, diverse choices of measurement tools, diverse selection of measurement time, lack of practicality in clinical practice, and non-prominent TCM indicators. These issues led to scattered evidence and the absence of a unified core indicator set to guide clinical research. Further efforts are needed to develop COS of integrated traditional Chinese and western medicine treatments for long COVID, and to enhance the quality of clinical research on long COVID.

    2026 07 v.51 [Abstract][OnlineView][Download 677K]

  • Evaluation of application of TCM Fu-Zheng treatment in acute exacerbation of chronic obstructive pulmonary disease based on SrTO

    ZHANG Zhen;GUO Meng-ru;JIE Chen-yuan;YI Ming-yang;ZHONG Jia-hui;SONG Dong-min;WANG Zhi-wan;National Regional TCM (Lung Disease) Diagnostic and Treatment Center, the First Affiliated Hospital of Henan University of Chinese Medicine;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province &Ministry of Education of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Disease,Henan University of Chinese Medicine;

    Using the systematic review of text and opinion(SrTO) methodology, this study conducted a quality appraisal and synthesis of literature related to the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD) with the TCM Fu-Zheng(supporting healthy Qi) method, with the aim of providing evidence-based basis for its rational clinical application. Non-research literature on the use of the TCM Fu-Zheng method for AECOPD was comprehensively retrieved. Published literature was sourced from traditional sources, including CNKI, Wanfang, VIP, SinoMed, and Duxiu Academic Search, while grey literature was sourced from the Chinese Academy of Sciences pre-publication platform for scientific papers, government websites, industry association websites, and WeChat official accounts. Two researchers independently screened the literature and extracted data, and the included content was appraised using the JBI textual quality appraisal tool. Conclusions were generated using the three-stage conclusion aggregation method of the NOTARI module. Chi-square tests were used to analyze the association between geographic regions and conclusion types, and Mann-Kendall tests together with the Theil-Sen method were employed to compare temporal differences in the number of conclusions. A total of 319 documents were included, from which 378 textual units involving 219 physicians were extracted, spanning the period from 1994 to 2025 and covering 28 provinces and municipalities. All seven policy-related texts were rated as "clear" in credibility, with nine cumulative repetitions, yielding two secondary conclusions and one tertiary conclusion. These conclusions provided clear directional guidance: the treatment of AECOPD should follow the principle of "treating the manifestations in acute conditions and the root in stable phases", focusing primarily on pathogen-eliminating measures such as clearing heat, resolving phlegm, activating blood, diffusing the lung and descending Qi, and opening the orifices, while simultaneously emphasizing "attending to both Qi and Yin" through Fu-Zheng approaches, including tonifying the lung and strengthening the spleen or tonifying both the lung and kidney, so as to prevent excessive pathogen elimination from damaging healthy Qi. Among the 371 experiential opinion and/or case-based textual units, 129 were rated as "clear", 199 as "credible", and 43 as "not supported", with 476 cumulative repetitions, forming 14 secondary conclusions and 4 tertiary conclusions. Fu-Zheng by tonifying Qi(conclusion A) comprised 264 textual units, with 48.67% rated as "clear", and its dominant secondary conclusion was spleen-strengthening and Qi-tonifying(A1, 110 units). Fu-Zheng by warming Yang(conclusion B) included 76 units, with 39.48% rated as "clear". Fu-Zheng by nourishing Yin(conclusion C) comprised 86 units, with 37.21% rated as "clear". Conclusion D addressed the overall necessity of the Fu-Zheng method without specifying particular therapeutic approaches and included 50 units, 38.00% of which were rated as "clear". No statistically significant differences were observed in the distribution of conclusions across geographic regions. In terms of growth trends, conclusion A showed a significantly greater increase than conclusions B, C, and D(P<0.05), with a markedly larger difference, whereas no differences were observed among conclusions B, C, and D, whose trends were relatively modest. These results indicate that the Fu-Zheng method plays a clearly established role in the treatment of AECOPD, although its application requires strict adherence to appropriate indications. Among the various Fu-Zheng approaches, Qi-tonifying predominates, as reflected by its highest utilization proportion, most pronounced temporal growth, and strongest evidence base, with spleen-strengthening and Qi-tonifying being particularly critical. Yang-warming and Yin-nourishing therapies, while indispensable in specific syndrome patterns, have relatively limited application scenarios.

    2026 07 v.51 [Abstract][OnlineView][Download 797K]

  • Design and implementation of externally controlled trials and their application in field of TCM

    ZHOU Tian-tian;ZUO Jia-xin;HAN Fang;WANG Hong;LIAO Xing;HU Jing;Beijing Hospital of Traditional Chinese Medicine, Capital Medical University;Beijing Institute of Traditional Chinese Medicine/Beijing Evidence-based Chinese Medicine Center;Center for Evidence-based Medicine, Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;

    Randomized controlled trial(RCT), recognized as the gold standard for evaluating the efficacy of interventions, is widely applied in various clinical research fields, including pharmaceuticals, medical devices, and TCM therapies. However, RCTs often encounters practical challenges in certain scenarios such as rare diseases, severe diseases without effective therapeutic options, and TCM. These challenges include difficulties in subject recruitment, ethical controversies, and limited external validity in the real world. Consequently, there is a pressing need to explore research designs that integrate clinical practicality with scientific rigor. Externally controlled trial(ECT), a study design that compares patients receiving the experimental treatment with those outside the trials, can efficiently expand the sample size of the control group and enhance the generalizability of research evidence by incorporating external data, thus offering a novel approach to addressing the abovementioned challenges. This paper focused on two design types of ECT: the supplemented single-arm trials and the augmented randomized controlled trials. It elaborated on the design principles and key implementation steps of these approaches, with an emphasis on core methodological aspects, including the Pocock criteria for assessing the exchangeability of external data, propensity score methods(PSMs) and Bayesian methods for external data integration, as well as quantitative bias analysis(QBA). Given that RCT of TCM is characterized by complex interventions, dynamic diagnosis and treatment processes, and challenges in establishing appropriate control groups, the ECT design offers methodological support for integrating real-world data and developing a research paradigm tailored to the unique features of TCM. Furthermore, practical examples were used to highlight the design′s utility in TCM. This paper aimed to provide methodological references for relevant research and promote their standardized, high-quality application.

    2026 07 v.51 [Abstract][OnlineView][Download 379K]
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