1.Mechanism of Zuoguiwan in Inhibiting Osteoclast Activation Induced by Breast Cancer via Regulating p38 MAPK/ERK Signaling Pathway
Jianjiang FU ; Yinlong MEI ; Junchao MA ; Xiaocui ZHU ; Wei WANG ; Hong LYU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):1-9
ObjectiveTo investigate the effects of Zuoguiwan on osteoclast activation induced by breast cancer and its mechanism. MethodsTo simulate breast cancer-induced osteoclastic bone metastasis, RAW264.7 cells were cultured in conditioned medium containing 50% supernatant of MDA-MB-231 breast cancer cells. The dosages of Zuoguiwan used in the experiment were sera containing 5% and 10% Zuoguiwan. Tartrate-resistant acid phosphatase (TRAP) staining was used to detect osteoclast activation. Enzyme-linked immunosorbent assay (ELISA) was used to measure Cathepsin K secretion from RAW264.7 cells. Real-time quantitative polymerase chain reaction (PCR) was used to detect the mRNA expression levels of osteocalcin (OCN) and bone sialoprotein (BSP). Immunoprecipitation was employed to detect the interaction between Runt-related transcription factor 2 (Runx2) and core binding factor β subunit (CBF-β). Western blot was used to assess the protein expression of Runx2, phosphorylated Runx2 (p-Runx2), extracellular signal-regulated kinases 1/2 (ERK1/2), p-ERK1/2, p38 mitogen-activated protein kinase (MAPK), p-p38 MAPK, and CBF-β. ResultsCompared with the blank group, the MDA-MB-231 cell supernatant group showed a significant increase in TRAP-positive cell counts and Cathepsin K secretion. Meanwhile, the expression levels of p-Runx2, Runx2-CBF-β interaction, BSP and OCN mRNA, p-p38 MAPK, and p-ERK1/2 proteins were significantly decreased (P<0.01). Compared with the MDA-MB-231 cell supernatant group, Zuoguiwan-containing sera significantly reduced TRAP-positive cell counts and Cathepsin K secretion (P<0.01), significantly increased p-Runx2, BSP and OCN mRNA expression, as well as p-p38 MAPK and p-ERK1/2 protein levels, and promoted the interaction between Runx2 and CBF-β (P<0.01). No significant change in Runx2 expression was observed. Compared to the blank group, the BVD-523 group showed significantly lower expression of p-p38 MAPK and p-ERK1/2 proteins (P<0.01). Compared with the BVD-523 group, both low and high concentration Zuoguiwan-containing sera groups showed significantly higher p-p38 MAPK expression (P<0.01), and the high concentration Zuoguiwan group also exhibited a significant increase in p-ERK1/2 expression (P<0.01), while no statistical difference was found in the low-dose group. ConclusionZuoguiwan inhibits osteoclast activation by inducing phosphorylation of the key transcriptional regulator Runx2 in intra-osteoclast bone formation, and this process is closely associated with the activation of the p38 MAPK/ERK signaling pathway.
2.Theoretical Exploration of Diabetic Retinopathy Guided by Luobing Theory
Liping CHANG ; Jing MA ; Kun MA ; Zhenhua JIA ; Cong WEI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):253-258
Diabetic retinopathy(DR), as one of the most common and serious microvascular complications of diabetes mellitus, seriously threatens human health, and belongs to "Xiaoke eye diseases" in traditional Chinese medicine(TCM), which has been richly experienced by medical practitioners through the ages, but is mostly recorded in a piecemeal manner and has not been systematically researched. This disease is featured by long course and repeated attack, and is refractory, which belongs to the research category of "persistent illness entering collaterals". Systematic establishment of TCM collateral disease theory for guiding prevention and treatment of DR has important clinical value. On the basis of close correlation between tertiary collaterals at the terminal of collaterals and capillaries and microcirculation, the concept of "tertiary collaterals-microvascular" is proposed. It is pointed out that DR falls within the scope of "tertiary collaterals-microvascular" diseases, and presents four types of micro-pathological characteristics, including stasis, insufficiency, growth and bleeding of tertiary collaterals. It is concluded that "deficiency of both Qi and Yin" is the basic pathogenesis of DR, and "blood stasis and collateral obstruction" is the important pathogenesis and key factor. Thus, the treatment method of "dispersing blood stasis, dredging collateral, tonifying Qi and Yin, stopping hemorrhage and improving eyesight" is determined, and the formula of Tongluo Mingmu capsules is developed. The article tightly focuses on the pathological changes such as stasis, growth, insufficiency and bleeding of collaterals, addresses both symptoms and root causes, and plays a synergistic role of both dispersing stasis and stopping bleeding. In this way, it can realize the purpose of tonifying Qi and Yin to replenish the essence, dispersing stasis and dredging collaterals to meet the requirement, as well as stopping hemorrhage and improving eyesight to deal with changes. Fundamental researches demonstrate that Tongluo Mingmu capsules has synergy effects of protecting both retinal capillaries and retinal cells. Phase-Ⅲ clinical trial of new drug has proven definite clinical efficacy and good safety, which provides a new drug choice for enhancing clinical effect of DR, and further supports the scientific value of Luobing theory in preventing and treating DR and other clinically significant diseases.
3.Introduction of the main addition and revision of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅱ)
ZHOU Yi ; WANG Zhijun ; YUE Zhihua ; CHENG Qilei ; YUE Ruiqi ; YANG Xi ; GUO Wei ; MA Shuangcheng
Drug Standards of China 2025;26(1):023-027
The Pharmacopeia of the People’s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025 Edition, ChP 2025) will be promulgated and implemented. This article introduces the process of development of ChP 2025 Edition (Volume Ⅱ), including the selection, the revision of general notices,the addition and revision of drug monographs, etc., and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition (Volume Ⅱ).
4.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
5.Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
XU Xinyi ; WEI Shifeng ; ZHANG Qiming ; HE Langchong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):045-050
Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.
6.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.
7.Premature Aging Prevention and Treatment Guided by Essence-Qi-Spirit Theory of Qiluo Doctrine: A Review
Chuanyuan JI ; Hongrong LI ; Jiameng HAO ; Dandong WANG ; Yucong MA ; Kun MA ; Cong WEI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):279-285
The theoretical basis of premature aging originates from The Yellow Emperor's Inner Classic. The etiology of premature aging is complex, and the disease mechanism is based on deficiency. The treatment for premature aging is based on tonicity. The essence-Qi-spirit theory of Qiluo doctrine summarizes that "essence is the origin of life, Qi is the driving force of life, and spirit is the embodiment of life", which is the law of life. The theory puts forward the core disease mechanism of aging, which states that "deficiency of kidney essence is the root of aging, deficiency of primordial Qi is the key to aging, impairment of soma and spirit is the manifestation of aging". The theory also proposes the treatment of "tonifying kidney and supplementing essence, harmonizing Yin and Yang, warming and supporting primordial Qi, and nourishing soma and spirit" and the representative anti-aging drugs. The article unfolds from the perspective of the concepts of natural life span, premature senility before fifty, decline, and aging and also explains the origins and connotations of premature aging. The article explains the disease mechanism of premature aging under the guidance of the essence-Qi-spirit theory of Qiluo doctrine, which is "early deprivation of kidney essence, deficiency of primordial Qi, accumulation of deficiencies into impairment, and decline and impairment of soma and spirit", summarizes the progress of modern medical research on the treatment of premature aging and representative drugs, and finds that Bazi Bushen capsules have a precise therapeutic effect on the overall premature aging, systematic functional decline, and related diseases. The study provides theoretical basis and new ideas to solve the problems of premature aging and geriatric diseases.
8.Textual Research on Historic Evolution and Ancient and Modern Application of Classic Prescription Huangqintang
Yuxin LI ; Lyuyuan LIANG ; Jialei CAO ; Tongyi HUANG ; Hejia WAN ; Bingqi WEI ; Mengting ZHAO ; Xiaoyang TIAN ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):184-191
Huangqintang, with its accurate efficacy, is a classic formula specialized in treating dysentery recommended and promoted by medical experts from successive generations, and it was included in the Catalogue of Ancient Classic Prescriptions (the Second Batch, Han Chinese medicine prescriptions) published by the National Administration of Traditional Chinses Medicine (TCM) in 2023. The method of bibliometrics was applied in this study to conduct textual research on the classic formula Huangqintang and provide a literature reference for the development of modern preparations of Huangqintang. A total of 2 026 pieces of ancient literature were searched with "Huangqintang" as the key word, and 23 pieces of effective data were selected, involving 15 ancient TCM books. The historic evolution, composition, dosage, origin, processing methods, preparation and decocting methods, efficiency, and application of Huangqintang were carefully reviewed. The results showed that Huangqintang was first recorded in the Treatise on Febrile Diseases written by ZHANG Zhongjing. It has the effect of clearing heat, stopping dysentery, regulating the middle, and downbearing counterflow and has become one of the classic formulas widely used in clinical practice. Because of its accurate efficacy, medical experts from later generations have modified it from its original composition. Though many prescriptions have different names, it is the manifestation of physicians' inheritance and development of the thought of ZHANG Zhongjing. Ancient literature showed this prescription had wide indications yet centered on digestive system diseases such as dysentery and abdominal pain. Modern applications of Huangqintang involve digestive, respiratory, ophthalmology and otolaryngology, gynecological, skin, musculoskeletal system, and connective tissue, and this prescription has great potential in treating ulcerative colitis, diarrhea, acute enteritis, and damp-heat dysentery. Through a systematic textual excavation and review of the ancient literature about Huangqintang, the paper has confirmed its key information, so as to provide a scientific basis for the clinical application and new drug development of classic formulas.
9.Establishment and analysis of chronic rejection model of mouse heart transplantation
Wei ZHANG ; Qingrong ZHANG ; Maolin MA ; Qianghua LENG ; Fei HAN
Organ Transplantation 2025;16(1):99-105
Objective To establish a chronic rejection (CR) model of mouse heart transplantation and analyze its characteristics. Methods Allogeneic BALB/c and C57BL/6 mice were used as donor and recipient for heart transplantation, and intraperitoneal injection of cytotoxic T lymphocyte-associated antigen 4-immunoglobulin (CTLA4-Ig) was given 1 and 2 days after surgery. Graft survival time, donor specific antibody (DSA) level, graft pathology and inflammatory cell infiltration were observed. Results In allogeneic transplantation model, graft survival time was prolonged after CTLA4-Ig treatment [(28.2±4.1) d vs. (7.0±0.7) d, P < 0.01]. The level of serum DSA-IgG increased at 2, 3 and 4 weeks after surgery, while the level of DSA-IgM remained unchanged. Myocardial cell injury, inflammatory cell infiltration, interstitial fibrosis and C4d deposition in capillaries were aggravated 3 weeks after operation and worsened 4 weeks after operation. The infiltrated immune cells were mainly macrophages, T cells and plasma cells. Conclusions Mouse allogeneic heart transplantation combined with CTLA4-Ig successfully establishes a CR model, which provides a basis for subsequent studies on the pathogenesis and intervention of CR.
10.Textual Research of Key Information of Classic Formula Xieqingwan Based on Ancient and Modern Literature
Yujie CHANG ; Lyuyuan LIANG ; Jialei CAO ; Xinghang LYU ; Wenxi WEI ; Xiaofang WANG ; Huizhen ZHANG ; Sai REN ; Mengqi WANG ; Bingqi WEI ; Bingxiang MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):226-234
ObjectiveThis paper aims to systematically collect and organize ancient and modern clauses and studies containing Xieqingwan, excavate and analyze the key information of Xieqingwan, and provide a reference for facilitating the development of the classic formula Xieqingwan. MethodsThe composition, dosage, decocting methods, usage, and other key information of Xieqingwan in ancient traditional Chinese medicine books were collected and analyzed by means of literature research and metrological methods. The modern clinical application of Xieqingwan was summarized. ResultsA total of 42 pieces of effective data involving 32 ancient traditional Chinese medicine books were collected. Xieqingwan was first recorded in Xiaoer Yaozheng Zhijue. The drug origin of this formula is basically clear in the ancient traditional Chinese medicine books. The modern drug usage and decocting method were as follows: Angelicae Sinensis Radix, Gentianae Radix et Rhizoma, Chuanxiong Rhizoma, Gardenia seeds, Radix et Rhizoma Rhei, Notopterygii Rhizoma et Radix, and Saposhnikoviae Radix were grounded to fine powder, decocted with honey, and finally formed into pills with the size of a chicken head (1.5 g). It was suggested that half a pill or one pill were taken for one dose with warm Lophatheri decoction and sugar. The indications and clinical application had developed from the recordings in Xiaoer Yaozheng Zhijue and evolved from pediatrics to ophthalmic otolaryngology, neurology, dermatology, digestion, and respiratory diseases. The main pathogenesis of these diseases is heat in the liver meridian and is treated. The effect of Xieqingwan is "clearing away heat and toxicity, removing fire and relaxing the bowels, and dispersing swelling and relieving pain". It is recommended to use the corresponding preparation methods in the 2020 Edition of Pharmacopoeia of the People's Republic of China. Modern clinical studies are centered around the clinical application of Xieqingwan, which is often modified and used in treating Tourette syndrome, herpes, febrile convulsion, sleepwalking, and insomnia. ConclusionThis paper conducts a thorough textual research of the key information of Xieqingwan, induces its historic evolution, and confirms its key information, so as to provide a reference for the future development of Xieqingwan.

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