1.Potential Toxicity of Traditional Chinese Medicine and Its Scientific Regulation
Ting WANG ; Can TU ; Lin ZHANG ; Zhaojuan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):1-9
In recent years, with the extensive application of traditional Chinese medicine (TCM) both domestically and internationally, safety concerns associated with TCM have been frequently reported. Notably, some TCM substances traditionally regarded as ''non-toxic'' have exhibited significant adverse reactions during clinical use, drawing substantial attention to TCM safety. This study first analyzed the risk factors contributing to the potential toxicity of TCM from perspectives such as drug properties, individual constitution, and clinical medication practices. Subsequently, it proposed research strategies and methodologies for investigating potential TCM toxicity: ① conduct studies under the guidance of TCM theory, adhering to the principle of diversity and unity. ② adopt an integrated research paradigm of ''originating from clinical practice-syndrome-based foundation-returning to clinical practice-serving supervision''. ③ implement a three-tier technical system of ''Mathematical modeling-high-throughput screening via liquid chromatography-mass spectrometry (LC-MS)-systems biology'' to systematically elucidate the causes, material basis, and mechanisms of toxicity. Finally, scientific regulatory recommendations for potential TCM toxicity are proposed: ① establish a multidimensional prevention and control system addressing drug properties, physical constitution factors, and clinical medication practices. ② address the impact of modern processing techniques on the safety of new TCM drugs. ③ strengthen the revision of standards for Chinese medicinal materials to ensure their safety. ④ account for disease-syndrome combination animal models and interspecies differences in safety assessment outcomes. This study aims to overcome critical challenges in TCM regulation by advancing evaluation through research and driving research through evaluation. By establishing a high-level scientific regulatory framework, it seeks to not only safeguard clinical medication safety but also propel the high-quality development of the TCM industry, thereby providing scientific support for the inheritance and innovative evolution of TCM.
2.Potential Toxicity of Traditional Chinese Medicine and Its Scientific Regulation
Ting WANG ; Can TU ; Lin ZHANG ; Zhaojuan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):1-9
In recent years, with the extensive application of traditional Chinese medicine (TCM) both domestically and internationally, safety concerns associated with TCM have been frequently reported. Notably, some TCM substances traditionally regarded as ''non-toxic'' have exhibited significant adverse reactions during clinical use, drawing substantial attention to TCM safety. This study first analyzed the risk factors contributing to the potential toxicity of TCM from perspectives such as drug properties, individual constitution, and clinical medication practices. Subsequently, it proposed research strategies and methodologies for investigating potential TCM toxicity: ① conduct studies under the guidance of TCM theory, adhering to the principle of diversity and unity. ② adopt an integrated research paradigm of ''originating from clinical practice-syndrome-based foundation-returning to clinical practice-serving supervision''. ③ implement a three-tier technical system of ''Mathematical modeling-high-throughput screening via liquid chromatography-mass spectrometry (LC-MS)-systems biology'' to systematically elucidate the causes, material basis, and mechanisms of toxicity. Finally, scientific regulatory recommendations for potential TCM toxicity are proposed: ① establish a multidimensional prevention and control system addressing drug properties, physical constitution factors, and clinical medication practices. ② address the impact of modern processing techniques on the safety of new TCM drugs. ③ strengthen the revision of standards for Chinese medicinal materials to ensure their safety. ④ account for disease-syndrome combination animal models and interspecies differences in safety assessment outcomes. This study aims to overcome critical challenges in TCM regulation by advancing evaluation through research and driving research through evaluation. By establishing a high-level scientific regulatory framework, it seeks to not only safeguard clinical medication safety but also propel the high-quality development of the TCM industry, thereby providing scientific support for the inheritance and innovative evolution of TCM.
3.Mechanisms of Xiaozhi Qinggan Decoction in Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease by Regulating Ferroptosis
Haihang DONG ; Yuying TU ; Xingrong LI ; Yujie CAI ; Yi REN ; Huiqin ZHANG ; Yinqiang ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):109-119
ObjectiveTo investigate the mechanism of Xiaozhi Qinggan decoction (XQD) in preventing and treating metabolic dysfunction-associated steatotic liver disease (MASLD) by regulating ferroptosis, network pharmacology, in vitro and in vivo experiments. MethodsIn the in vivo experiment, mouse MASLD models were established by high-fat diet (HFD) induction. The model mice were randomly assigned to a positive control group (silybin, 50 mg·kg-1), low-, medium- and high-dose XQD groups (4.725, 9.45, 18.9 g·kg-1), with a normal control group. After 4 weeks of modeling, mice except the normal group were administered intragastrically for 8 consecutive weeks. Liver function, serum lipid levels, hepatic histopathology, as well as the levels of malondialdehyde (MDA), superoxide dismutase (SOD), reduced glutathione (GSH) and oxidized glutathione (GSSG) and Fe2+ were detected. The mRNA and protein expression of p53, SLC7A11 and GPX4 were determined by quantitative Real-time quantitative polymerase chain reaction(Real-time PCR) and Western blot. In the network pharmacology analysis, active components and potential targets of XQD for MASLD were screened, followed by functional and pathway enrichment analyses, and molecular docking was performed to verify the target binding activity. In the in vitro experiment, the optimal concentration of XQD-containing serum was screened by cytotoxicity assay. HepG2 cells were transfected with ov-NC or ov-p53 plasmid, and a lipid accumulation model was induced by free fatty acid (FFA, 1.0 mmol·L-1). Cells were divided into a normal group, FFA model group, ov-NC+XQD (15%) group and ov-p53+XQD (15%) group. Intracellular Fe2+ level and lipid accumulation were evaluated, and the protein expression of p53, SLC7A11 and GPX4 was measured by Western blot. ResultsCompared with the normal group, the model group exhibited markedly elevated body weight, liver weight, liver index, fasting blood glucose, AUC of glucose tolerance test, serum liver function and blood lipid levels at week 12 (P<0.01). Hepatic steatosis and inflammatory infiltration were observed by pathological staining. Additionally, hepatic levels of MDA, SOD and Fe2+ were increased (P<0.01), while GSH, GSSG and the GSH/GSSG ratio were decreased (P<0.01). The mRNA and protein expression of hepatic p53 was upregulated (P<0.01), whereas the expression of SLC7A11 and GPX4 was downregulated (P<0.01). Compared with the model group, the low- and medium-dose XQD groups showed significantly decreased body weight at week 12 (P<0.05). The silybin group, together with the medium- and high-dose XQD groups, presented reduced liver weight and liver index (P<0.05). Fasting blood glucose and the AUC of glucose tolerance test were lowered in all four treatment groups (P<0.05, P<0.01). Pathological staining revealed alleviated hepatic steatosis and inflammation, accompanied by decreased serum liver function and blood lipid levels (P<0.05, P<0.01). Moreover, hepatic MDA and SOD levels were markedly reduced, while GSH, GSSG and the GSH/GSSG ratio were significantly elevated (P<0.05, P<0.01). Hepatic Fe2+ level was decreased (P<0.01). The mRNA and protein expression of hepatic p53 was downregulated, and the expression of SLC7A11 and GPX4 was upregulated (P<0.05, P<0.01). Network pharmacology analysis identified quercetin, kaempferol, luteolin, tanshinone IIA and isorhamnetin as the core active components of XQD, with p53 serving as the key target. Stable binding was verified between these active components and the p53 protein. The optimal concentration of XQD-containing serum in vitro was determined to be 15%. Compared with the normal group, the model group showed increased intracellular Fe2+ and lipid accumulation, significantly upregulated p53 protein expression (P<0.01), and markedly downregulated SLC7A11 and GPX4 protein expression (P<0.01). Compared with the model group, the ov-NC group exhibited reduced Fe2+ and lipid accumulation, downregulated p53 expression, and upregulated SLC7A11 and GPX4 expression. In the ov-p53 group, p53 expression was upregulated (P<0.01), while SLC7A11 and GPX4 expression was downregulated (P<0.01). ConclusionXQD inhibits ferroptosis by downregulating p53 and upregulating SLC7A11 and GPX4, thereby alleviating oxidative stress and lipid peroxidation in hepatocytes and improving MASLD.
4.Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome
Na LIN ; Yanqiong ZHANG ; Changhong XIAO ; Shenghao TU ; Jianning SUN ; Shijun XU ; Representation Preparation GROUP
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):47-54
Rheumatoid arthritis belongs to arthralgia syndrome in the theory of traditional Chinese medicine, and cold-dampness obstruction syndrome and dampness-heat obstruction syndrome are core syndromes and main syndrome differentiation types of this disease. Fine therapeutic effects have been obtained in the long-term clinical practice of many famous traditional Chinese medicine practitioners following the syndrome differentiation and treatment based on the guiding principles of cold and heat. To adapt to the clinical diagnosis practice of combining disease differentiation and syndrome differentiation, and to better carry out basic research on integrated Chinese and Western medicine and preclinical study on new traditional Chinese medicines, Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-Dampness Obstruction Syndrome and Dampness-Heat Obstruction Syndrome (hereinafter referred to as the Guidelines) were compiled by our research group, in cooperation with the renowned experts in research fields including traditional Chinese medicine, clinical medicine, zoology and evidence-based medicine, which provide a meaningful reference for scientific research, teaching and clinical applications. The compilation process of the Guidelines was guided by the theory of disease and syndrome integration and the principles of "evidence takes the main place, consensus plays an auxiliary role, and experience serves as the reference". Based on the comprehensive evaluation of pathogenesis homology, behavioral phenotypic consistency, and drug treatment predictability compared between animal models and human diseases, by the nominal group method, "recommendations" were formed for recommendations supported by evidence, and "consensus recommendations" were formed for recommendations not supported by evidence. Guidelines were formed involving content such as animal types, arthritis modeling methods, external stimulation conditions, and modeling assessment indicators during the establishment of the animal models of rheumatoid arthritis with cold-dampness obstruction syndrome and dampness-heat obstruction syndrome. The Guidelines are applicable for the disease and syndrome research on rheumatoid arthritis, investigation of therapeutic mechanisms, and development of new traditional Chinese medicine. The Guidelines also provide a reference for the establishment of guidelines on other types of diseases and syndromes combined with animal models to further promote the modernization of traditional Chinese medicine research and its integration with international academic development.
5.Editorial Explanation of Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome
Na LIN ; Yanqiong ZHANG ; Changhong XIAO ; Shenghao TU ; Jianning SUN ; Shijun XU ; Xia MAO ; Representation Preparation GROUP
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):55-59
The Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome (hereinafter referred to as the Guidelines) (No. T/CACM1567-2024) was published by Chinese Association of Chinese Medicine on January 11, 2024. To assist researchers and medical workers in understanding and applying the Guidelines more accurately, and also to provide reference and assistance for the establishment of guidelines on other types of diseases and syndromes combined with animal models, this paper made a declaration of the workflow, technological links, development references, promotion of its application and after-effect evaluation of the Guidelines that has been made according to the requirements of "Draft Group Standard of the Standardization Office of the Chinese Association of Traditional Chinese Medicine".
6.Experience in Staged Differentiation and Treatment of Cirrhotic Ascites Based on the Theory of Tonification and Purging
Haihang DONG ; Yujie CAI ; Huiqin ZHANG ; Yan CHEN ; Yuying TU ; Dongling WANG ; Yinqiang ZHANG
Journal of Traditional Chinese Medicine 2025;66(5):532-536
It is believed that patients with cirrhotic ascites exhibit a pathological mechanism characterized by the decline of healthy qi and the accumulation of pathogenic factors. Clinically, treatment should be based on the theory of tonification and purging, with a staged approach distinguishing between the active phase and the remission phase. The balance between tonification and purging should be adjusted according to the progression of pathogenic and healthy actors. In the acute phase, purging should take precedence over tonification, using purging as a means of tonification to facilitate the flow of water and qi through the triple energizer. The severity of water retention, dampness, blood stasis, and heat should be carefully assessed to ensure thorough elimination of pathogenic factors while avoiding harm to healthy qi. Medication adjustments should be made once the pathogenic factors are significantly weakened. In the remission phase, an integrated approach combining both tonification and purging should be adopted, incorporating purging within tonification to clear residual pathogens and prevent recurrence. Concurrently, proactive treatment of the underlying disease is essential to achieve complete recovery and prevent the recurrence of ascites.
7.Alternative Polyadenylation in Mammalian
Yu ZHANG ; Hong-Xia CHI ; Wu-Ri-Tu YANG ; Yong-Chun ZUO ; Yong-Qiang XING
Progress in Biochemistry and Biophysics 2025;52(1):32-49
With the rapid development of sequencing technologies, the detection of alternative polyadenylation (APA) in mammals has become more precise. APA precisely regulates gene expression by altering the length and position of the poly(A) tail, and is involved in various biological processes such as disease occurrence and embryonic development. The research on APA in mammals mainly focuses on the following aspects:(1) identifying APA based on transcriptome data and elucidating their characteristics; (2) investigating the relationship between APA and gene expression regulation to reveal its important role in life regulation;(3) exploring the intrinsic connections between APA and disease occurrence, embryonic development, differentiation, and other life processes to provide new perspectives and methods for disease diagnosis and treatment, as well as uncovering embryonic development regulatory mechanisms. In this review, the classification, mechanisms and functions of APA were elaborated in detail and the methods for APA identifying and APA data resources based on various transcriptome data were systematically summarized. Moreover, we epitomized and provided an outlook on research on APA, emphasizing the role of sequencing technologies in driving studies on APA in mammals. In the future, with the further development of sequencing technology, the regulatory mechanisms of APA in mammals will become clearer.
8.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
9.The technology of fecal microbiota transplantation and its application progress
Shuo YUAN ; Yi-fan ZHANG ; Peng GAO ; Jun LEI ; Ying-yuan LU ; Peng-fei TU ; Yong JIANG
Acta Pharmaceutica Sinica 2025;60(1):82-95
Fecal microbiota transplantation (FMT) technology originated in China during the Eastern Jin Dynasty and has rapidly developed over the past two decades, becoming a primary method for studying the causal relationship between gut microbiota and the occurrence and progression of diseases. At the same time, the therapeutic effects of FMT in the field of gastrointestinal diseases have gained widespread recognition and are gradually expanding into other disease areas. The FMT procedure is relatively complex, and there is currently no standardized method; its success is influenced by various factors, including the donor, recipient, processing of the fecal material, and the method of implantation. Given the increasingly recognized relationship between gut microbiota and various diseases, FMT has become a research hotspot in both scientific studies and clinical applications, achieving a series of significant advancements. To help researchers better understand this technology, this paper will outline the development history of FMT, summarize common operational methods in research and clinical settings, review its application progress, and look forward to future development directions.
10.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
Background:
s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer.
Methods:
We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R.
Results:
Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices.
Conclusions
SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation.

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