1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Clinical and Mechanism of Modified Xiaoyaosan and Its Effective Components in Treatment of Thyroid Diseases: A Review
Shanshan LI ; Yu FU ; Dandan WEI ; Fei WANG ; Mengjiao XU ; Ting WANG ; Shuxun YAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):302-310
Thyroid diseases are common clinical endocrine disorders, and their pathogenesis is generally considered to be closely related to genetic predisposition factors, immune system disorders, hormone levels, etc. Xiaoyaosan is widely used in the treatment of various thyroid diseases with excellent effects. This study summarized the relevant literature on the treatment of thyroid diseases with modified Xiaoyaosan prescriptions and their active ingredients from aspects such as theoretical analysis, clinical research, and mechanism research. Theoretical analysis revealed that Xiaoyaosan could not only disperse stagnated liver qi but also replenish deficient spleen Qi, which was consistent with the etiology and pathogenesis of thyroid diseases. Clinical studies found that Xiaoyaosan and its modified prescriptions could be widely used in the treatment of multiple thyroid diseases, such as hyperthyroidism, Hashimoto's thyroiditis, and thyroid nodules. Both the use of modified Xiaoyaosan alone and in combination with medications such as methimazole, propylthiouracil, and euthyrox could effectively improve patients' clinical symptoms. In the mechanism research, this study discovered that the whole formula of Xiaoyaosan and its modified prescriptions could inhibit inflammatory reactions, regulate immune balance, and delay liver damage during the treatment of thyroid diseases. The research on Xiaoyaosan for treating thyroid diseases mainly focused on thyroid cancer, autoimmune thyroiditis, hyperthyroidism, and hypothyroidism. The mechanisms of action mainly involved promoting cell apoptosis, inhibiting cell proliferation and migration, arresting the cell cycle, and regulating thyroid hormone levels. In conclusion, this study systematically combs and summarizes the research status of Xiaoyaosan in treating thyroid diseases through literature retrieval, aiming to provide new perspectives and new ideas for the prevention and treatment of thyroid diseases with traditional Chinese medicine.
3.Academic connotation of the "three phases and three methods" theory in preventing and treating radiation-induced lung injury
Kangdi CAO ; Dandan WANG ; Shuaihang HU ; Jiawei WANG ; Wei HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):412-417
Radiation-induced lung injury is a prevalent side effect of radiotherapy for chest cancer. The "three phases and three methods "is an innovative theory based on the evolution of the core pathogenesis of radiation-induced lung injury. Its formation also considers the understanding of radiation-induced lung injury by ancient and modern medical practitioners, pathological characteristics, clinical manifestations, and the development patterns of radiation-induced lung injury. The "three phases and three methods" refers to the three phases of the course and the three treatment methods. The core pathogenesis of radiation-induced lung injury from the beginning, middle and late stages is heat toxicity, yin deficiency, and blood stasis. Therefore, the course of radiation-induced lung injury is divided into three phases: blazing heat toxin, yin deficiency and heat accumulation, and static blood obstruction. The method of clearing the lung and resolving toxins, enriching yin and venting heat, invigorating blood and dissolving stasis are used respectively. Traditional Chinese medicines commonly used in each phase include Flos Lonicerae, Atrina Glass, heartleaf houttuynia herb, Radix Ophiopogonis, American Ginseng, Forsythiae Fructus, Radix Salviae Miltiorrhizae, Rhizoma Ligustici chuanxiong, Scorpio, etc. This article presents the theoretical origins of the "three phases and three methods" concept by reviewing of ancient literature, inheriting experience, and summarizing disease pathogenesis, as well as elaborating on the academic connotations of the "three phases and three methods". The scientific validity of the "three phases and three methods" is verified by literature, clinical, and basic research. The "three phases and three methods" interprets the core characteristics of each stage of radiation-induced lung injury, improves the traditional Chinese medicine prevention and treatment system for radiation-induced lung injury, and provides theoretical basis for achieving complete process management.
4.Effect and mechanism of Jingangteng capsules in the treatment of non-alcoholic fatty liver disease based on gut microbiota and metabolomics
Shiyuan CHENG ; Yue XIONG ; Dandan ZHANG ; Jing LI ; Zhiying SUN ; Jiaying TIAN ; Li SHEN ; Yue SHEN ; Dan LIU ; Qiong WEI ; Xiaochuan YE
China Pharmacy 2025;36(11):1340-1347
OBJECTIVE To investigate the effect and mechanism of Jingangteng capsules in the treatment of non-alcoholic fatty liver disease (NAFLD). METHODS Thirty-two SD rats were randomly divided into normal group and modeling group. The modeling group was fed a high-fat diet to establish a NAFLD model. The successfully modeled rats were then randomly divided into model group, atorvastatin group[positive control, 2 mg/(kg·d)], and Jingangteng capsules low- and high-dose groups [0.63 and 2.52 mg/(kg·d)], with 6 rats in each group. The pathological changes of the liver were observed by hematoxylin-eosin staining and oil red O staining. Enzyme-linked immunosorbent assay was performed to determine the serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), alanine transaminase (ALT), aspartate transaminase (AST), tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-18. 16S rDNA amplicon sequencing and metabolomics techniques were applied to explore the effects of Jingangteng capsules on gut microbiota and metabolisms in NAFLD rats. Based on the E-mail:591146765@qq.com metabolomics results, Western blot analysis was performed to detect proteins related to the nuclear factor kappa-B (NF-κB)/NOD-like receptor family protein 3 (NLRP3) signaling pathway in the livers of NAFLD rats. RESULTS The experimental results showed that Jingangteng capsules could significantly reduce the serum levels of TG, TC, LDL-C, AST, ALT, TNF-α, IL-1β, IL-6, IL-18, while increased the level of HDL-C, and alleviated the hepatic cellular steatosis and inflammatory infiltration in NAFLD rats. They could regulate the gut microbiota disorders in NAFLD rats, significantly increased the relative abundance of Romboutsia and Oscillospira, and significantly decreased the relative abundance of Blautia (P<0.05). They also regulated metabolic disorders primarily by affecting secondary bile acid biosynthesis, fatty acid degradation, O-antigen nucleotide sugar biosynthesis, etc. Results of Western blot assay showed that they significantly reduced the phosphorylation levels of NF-κB p65 and NF-κB inhibitor α, and the protein expression levels of NLRP3, caspase-1 and ASC (P<0.05 or P<0.01). CONCLUSIONS Jingangteng capsules could improve inflammation, lipid accumulation and liver injury in NAFLD rats, regulate the disorders of gut microbiota and metabolisms, and inhibit NF-κB/NLRP3 signaling pathway. Their therapeutic effects against NAFLD are mediated through the inhibition of the NF-κB/NLRP3 signaling pathway.
5.Regulation of Renal Interstitial Fibrosis-related Pathways by Traditional Chinese Medicine: A Review
Dandan WEI ; Shanshan LI ; Yongjie WANG ; Hongling WANG ; Zongyao WU ; Qingbo WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):254-265
Renal interstitial fibrosis (RIF) is a common pathological change process from the development of various chronic nephropathies to the end stage, and it is an important histological manifestation of renal function decline. At present, no effective anti-fibrosis drugs have been found in clinical practice. In recent years, with the continuous development of traditional Chinese medicine (TCM) pharmacology, molecular biology, system biology, and network pharmacology, the research on regulating RIF with TCM monomer, single TCM, TCM compound, Chinese patent medicine, and TCM injection is deepening. Among them, Jianpi Yishen recipe, Shendi Bushen capsules, Jianzhong Bushen Xiaozheng decoction, Liuwei Dihuangtang, and Lycium barbarum polysaccharides can regulate transforming growth factor-β/small mother against decapentaplegic (TGF-β1/Smads), Wnt/β-catenin, and neurogenic locus notch homolog protein (Notch) signaling pathways. Wulingsan, Zhenwutang, pachymic acid ZA, pachymic acid ZC, and pachymic acid ZD, which mainly induce diuresis, can regulate the Wnt/β-catenin signaling pathway. Hirudin, curcumin, and Fuzheng Huayu recipe, which mainly promote blood circulation, can inhibit inflammation-related pathways such as p-nuclear transcription factor-κB (NF-κB), Toll-like receptor 4/p-nuclear transcription factor-κB (TLR4/NF-κB), and Janus kinase 2/signal transducer and activator of transcription 3 (JAK/STAT), so as to achieve anti-inflammatory and anti-oxidation effects and alleviate the progression of RIF. Shenshuai Xiezhuo decoction, Shenkang injection, and Shenshuai recipe, which are mainly used for invigorating Qi, removing blood stasis, and removing turbidity, can inhibit transdifferentiation of pericytes-myofibroblasts through vascular endothelial growth factor receptor (VEGFR) signaling pathway. At present, there are many studies on the regulation of the RIF signaling pathway by TCM, but there is a lack of a systematic summary. In this study, by combing the signaling pathway of TCM in the treatment of RIF, the effective target of TCM treatment is screened, and its possible mechanism is found, which provides new ideas for clinical treatment and new drug research and development.
6.Ginkgolide B inhibits cell proliferation and promotes cell apoptosis of MH7A human fibroblast-like synoviocytes through PI3K/AKT pathway
Linchen LIU ; Xiaoyan XU ; Chunmeng WEI ; Jirong YU ; Qing SHI ; Junjun SUN ; Dandan PANG ; Feiran WEI ; Xing LIU
Journal of China Pharmaceutical University 2025;56(2):216-224
To explore the inhibitory effect of ginkgolide B (GB) on MH7A human fibroblast-like synoviocytes (FLS) and its potential mechanism. Firstly, 20 μg/L tumor necrosis factor-α (TNF-α) was pretreated with MH7A to establish a cell model of arthritis. After incubation of MH7A cells with various concentrations of GB, CCK-8 assay, Transwell assay, and flow cytometry (FCM) were separately used to detect cell viability, cell invasion, and cell apoptosis rate and cell cycle; Real-time quantitative PCR and Western blot assay were performed to detect the apoptosis- and cycle-related gene transcriptions and protein expressions, respectively. The results showed that compared with the control group, GB dose- and time-dependently suppressed cell viability to a greater extent; GB significantly reduced cell invasive ability and increased cell apoptosis rate and proportion of G0/G1 phase in MH7A cells, along with increased transcription levels of Bcl-2-associated X protein (Bax) and p21 mRNA and decreased transcription levels of Bcl-2, myeloid cell leukemia 1(Mcl-1), protein kinase B (PKB; AKT), IP3K, Cyclin D1 and cyclin-dependent kinase 4 (CDK4) mRNA; GB remarkably increased expression levels of Bax, p21, and cleaved-Caspase 3 protein and decreased expression levels of Bcl-2, Mcl-1, p-AKT, p-PI3K, Cyclin D1, and CDK4 protein, with decreased ratios of p-PI3K/PI3K, p-AKT/AKT, and Bcl-2/Bax. In conclusion, GB blocks the G1-to-S cell cycle transition, suppresses cell viability and cell invasion and induces cell apoptosis of MH7A human RA-FLS via suppressing the PI3K/AKT signaling pathway.
7.Clinical and Mechanistic Study of Modified Sinisan in Treating Precancerous Lesions of Digestive System Based on "Inflammation-to-Cancer Transformation"
Xuhang SUN ; Dandan WEI ; Xin PENG ; Shanshan LI ; Yihan ZHAO ; Fuke YAO ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):221-234
Tumorigenesis, invasion, and metastasis occur in the context of a persistent inflammatory microenvironment, and a variety of inflammatory factors can lead to the development of various tumors. Guided by the thought of "preventive treatment of disease" in TCM and the concept of tertiary prevention in modern medicine, it is of great significance to effectively intervene in the inflammatory stage of the disease, interrupt disease progression, prevent the occurrence of malignant tumors, and reverse the process of "inflammation-to-cancer transformation". Sinisan, a commonly used prescription in the Treatise on Febrile Diseases, has been widely applied in the treatment of precancerous lesions of the digestive system, demonstrating considerable advantages. This article reviewed literature from the past 20 years, summarizing the application of Sinisan in precancerous lesions of the digestive system from three aspects: the exploration of its prescription-syndrome relationship, clinical application, and mechanistic study. It is found that basic syndrome indications of Sinisan include harmonizing the Earth element to promote spleen-stomach transportation and transformation, soothing the liver and nourishing the Wood element to restore the smooth flow of Qi, and regulating Yin and Yang to relieve stagnation within the system. In clinical application, Sinisan has shown significant efficacy in atrophic gastritis and precancerous conditions such as intestinal metaplasia, gastric ulcer, ulcerative colitis, esophagitis, and pancreatitis. Mechanistic studies have revealed that Sinisan can inhibit inflammatory factors and improve the inflammatory microenvironment, inhibit cell proliferation and regulate apoptosis, exhibit anti-angiogenic and antitumorigenic effects, modulate immune function, and exert antioxidant effects. These mechanisms can be achieved by regulating pathways such as nuclear factor erythroid 2-related factor 2/heme oxygenase-1 (Nrf2/HO-1), farnesoid X receptor (FXR)/Nrf2, phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt), Takeda G protein-coupled receptor 5/cyclic adenosine monophosphate/protein kinase A (TGR5/cAMP/PKA), interleukin-4/signal transducer and activator of transcription 6 (IL-4/STAT6), Janus kinase/signal transducer and activator of transcription (JAK/STAT), RhoA/Rho-associated protein kinase (RhoA/ROCK), and transforming growth factor-β/Smad proteins (TGF-β/Smads), confirming Sinisan's role in reversing the inflammation-to-cancer transformation. The current research status of Sinisan in precancerous lesions of the digestive system was thoroughly examined through the above three aspects, along with the identification of limitations and areas for improvement in current research. The aim is to provide a basis and support for future in-depth research on Sinisan, promote the development of new integrated treatment models combining TCM and Western medicine for precancerous lesions, and aid in the research and development of drugs related to precancerous lesions.
8.Compatibility Effect and Mechanism of Astragali Radix-Curcumae Rhizoma on Antitumor: A Review
Hanyu KANG ; Shanshan LI ; Dandan WEI ; Yihan ZHAO ; Ruxin DU ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):276-286
Malignant tumor is a serious and difficult disease threatening human health, which has a high morbidity and mortality rate worldwide. Traditional Chinese medicine has unique advantages in improving the therapeutic effect of malignant tumors and alleviating adverse reactions. Traditional Chinese medicine believes that Qi deficiency and blood stasis are important pathogeneses in the development of malignant tumors, and the method of supplementing Qi and activating blood is an effective strategy for treating malignant tumors. Astragali Radix, sweet in taste and warm in nature, has effects of tonifying Qi and rising Yang, strengthening the exterior and reducing sweat, promoting fluid and nourishing blood. Curcumae Rhizoma, acrid and bitter in taste and warm in nature, has the effects of promoting Qi and breaking blood stasis, eliminating mass, and relieving pain. Astragali Radix-Curcumae Rhizoma, as the classic herb pair of invigorating Qi and activating blood, has a clear effect on inhibiting tumor growth and metastasis. Studies have shown that Astragali Radix-Curcumae Rhizoma contains astragalus polysaccharide, astragaloside, calycosin, formononetin, curcumin, β-elemene, curcumenol, curcumenone, curcumendione, gemacrone, and other anti-tumor active ingredients. It can significantly inhibit the occurrence and development of liver cancer, colorectal cancer, gastric cancer, lung cancer, ovarian cancer, cervical cancer, breast cancer, and other cancers and has the advantages of superposition effect, synergistic complementarity, and increased dissolution compared with single herb and monomer of Chinese traditional herbs and has been widely valued in the field of TCM anti-cancer. Its anti-tumor mechanism includes inhibition of tumor cell proliferation, promotion of tumor cell apoptosis and autophagy, anti-invasion and metastasis, regulation of immune function, and enhancement of anti-tumor drug sensitivity. By combining Chinese and foreign literature, the compatibility effect and anti-tumor mechanism of Astragali Radix-Curcumae Rhizoma were summarized, and then scientific compatibility of these two herbs was expounded, in order to provide a useful reference for clinical application and future research of Astragali Radix-Curcumae Rhizoma.
9.Chinese Medicine Regulates Signaling Pathways Related to Esophageal Cancer: A Review
Shanshan LI ; Dandan WEI ; Junwen PEI ; Hongling WANG ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(3):226-238
Esophageal cancer is a common malignant tumor of the digestive tract. At present, the pathogenesis of esophageal cancer has not been fully clarified. Although surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy have achieved good clinical results in the treatment of esophageal cancer, there are still many complications and severe adverse reactions. As an important part of traditional Chinese medicine (TCM), in recent years, many basic experiments and clinical studies have proved that Chinese medicine has a good effect in treating esophageal cancer. At the same time, the multi-component and multi-target characteristics of Chinese medicine and unclear pathogenesis of esophageal cancer determine that there are some problems such as unclear mechanisms of Chinese medicine in preventing and treating esophageal cancer. It is necessary to start with modern medicine and reveal the mechanism of Chinese medicine in preventing and treating diseases from the aspects of molecular biology and network pharmacology. It is believed in TCM that the occurrence of esophageal cancer is mostly attributed to stagnation of liver Qi, phlegm stasis and Qi stagnation, fluid consumption and heat accumulation, the decline of healthy Qi, and the cementation of cancer toxicity. According to the literature review, Chinese medicinal compounds mainly include tonic formulae (such as Liu Junzitang), drying and moistening formulas (such as Qigesan), and heat-clearing formulas (such as Fufang Kushen injection). Chinese medicinal monomers mainly include drugs potent in attacking poison and killing insects, clearing heat, activating blood and resolving stasis, and regulating Qi, which is consistent with the etiology and pathogenesis of esophageal cancer in TCM. It is also found that Chinese medicine can promote cell apoptosis and autophagy, block cell cycle, and reverse cell resistance by regulating phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt), neurogenic locus notch homolog protein (Notch), Wnt/β-catenin, mitogen-activated protein kinase (MAPK), nuclear factor-κB (NF-κB), Janus kinase 2/signal transducer and activator of transcription 3 (JAK2/STAT3), and other related signaling pathways, but there is no systematic summary. This study systematically summarized the relevant signaling pathways of Chinese medicine in regulating esophageal cancer, which is helpful to clarify the relevant mechanisms of Chinese medicine in the process of esophageal cancer occurrence, development, invasion, and metastasis, so as to provide new targets and new perspectives for the treatment of esophageal cancer and promote the modernization of TCM.
10.Traditional Chinese Medicine Regulates Gut Microbiota in Treatment of Thyroid Diseases via Gut-thyroid Axis: A Review
Shanshan LI ; Dandan WEI ; Yu FU ; Ping WANG ; Hui WANG ; Shuxun YAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(19):254-262
Thyroid diseases are common endocrine disorders with high incidence. The diseases are closely related to genetic factors, immune system disorders, and hormone levels. Although modern medical therapies have achieved certain therapeutic effects, the side effects have affected clinical treatment. In recent years, studies have proven that gut microbiota is a key factor affecting thyroid diseases, and increasing studies have referred to the bidirectional information interaction system between the gut and thyroid as the gut-thyroid axis. This study adopts the meridian-collateral theory and the visceral manifestation theory of traditional Chinese medicine (TCM) to explain the functions, physiological characteristics, and pathological mechanisms of the gut and thyroid. Furthermore, this paper clarifies the mechanism of gut microbiota in modulating thyroid homeostasis by inducing inflammation and altering thyroid hormone metabolism from the perspective of molecular biology, clarifying the rationality of the gut-thyroid axis from the perspectives of TCM and Western medicine. Meanwhile, under the guidance of the gut-thyroid axis, increasing studies have been carried out regarding the application of TCM in regulating gut microbiota in the treatment of thyroid diseases. Both the active component emodin and compound prescription Yiqi Huatan Huoxue prescription of Chinese medicine can treat thyroid diseases by regulating the abundance and diversity of gut microbiota and improving the intestinal mucosal barrier. However, the systematic review of the research on TCM treatment of thyroid diseases by regulating gut microbiota remains to be conducted. This study expounds the gut-thyroid axis from both TCM and Western medicine and reviews the research progress in the TCM treatment of thyroid diseases by regulating gut microbiota, aiming to give new insights into the prevention and treatment of thyroid diseases with TCM.


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