1.Expert Consensus on Clinical Application of Pingxuan Capsules
Yuer HU ; Yanming XIE ; Yaming LIN ; Yuanqi ZHAO ; Yihuai ZOU ; Mingquan LI ; Xiaoming SHEN ; Wei PENG ; Changkuan FU ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):201-210
		                        		
		                        			
		                        			As a patented characteristic medicine of Yi ethnic minority, Pingxuan capsules have the effects of nourishing the liver and kidney, pacifying the liver, and subduing Yang. With the main indications of dizziness, headache, palpitations, tinnitus, insomnia, dreaminess, waist and knee soreness caused by liver-kidney deficiency and liver Yang upward disturbance, Pingxuan capsules are widely used in the treatment of posterior circulation ischemic vertigo, vestibular migraine, benign paroxysmal positional vertigo. However, the current knowledge is limited regarding the efficacy, syndrome differentiation, and safety of this medicine. On the basis of summarizing the experience of clinicians and the existing evidence, this study invites clinical experts of traditional Chinese and Western medicine, pharmaceutical experts, and methodological experts from relevant fields across China to conduct evidence-based evaluation of Pingxuan capsules. The evaluation follows the Specifications for the Development of Clinical Expert Consensus on Chinese Patent Medicines issued by the Standardization Office of the China Association of Chinese Medicine, and reaches 5 recommendations and 16 consensus suggestions. The consensus clarifies the clinical applications, efficacy, dose, course of treatment, combination of medicines, precautions, and contraindications of Pingxuan capsules in the treatment of vertigo and explains the safety of clinical application. This consensus is applicable to clinicians (traditional Chinese medicine, Western medicine, and integrated traditional Chinese and Western medicine) and pharmacists in tertiary hospitals, secondary hospitals, and community-level medical and health institutions across China, providing a reference for the rational use of Pingxuan capsules in the treatment of vertigo. It is hoped that the promotion of this consensus can facilitate the rational use of drugs in clinical practice, reduce the risk of drug use, and give full play to the advantages of Pingxuan capsules in the treatment of vertigo diseases. This consensus has been reviewed and published by the China Association of Chinese Medicine, with the number GS/CACM330-2023. 
		                        		
		                        		
		                        		
		                        	
2.Improvement effects and mechanism of total secondary ginsenosides on hypertrophic changes in cardiomyocytes
Bin LI ; Jia LI ; Zhongjie YUAN ; Mingjun ZHU ; Shiyang XIE ; Yuan GAO ; Rui YU ; Xinlu WANG
China Pharmacy 2025;36(12):1430-1435
		                        		
		                        			
		                        			OBJECTIVE To investigate the ameliorative effects and potential mechanism of total secondary ginsenosides (TSG) on hypertrophic changes of primary cardiomyocytes stimulated by angiotensin Ⅱ (Ang Ⅱ). METHODS Primary cardiomyocytes were isolated from the hearts of neonatal SD rats and divided into the following groups: control group, AngⅡ group (2 µmol/L), TSG group (7.5 µg/mL), PFK-015 group [6-phosphofructo-2-kinase/fructose-2, 6-bisphosphatase 3 (PFKFB3) inhibitor, 10 nmol/L], and TSG+PFK-015 group (TSG 7.5 µg/mL+PFK-015 10 nmol/L). The surface area, protein synthesis, energy metabolism-related indicators [free fatty acid (FFA), coenzyme A (CoA), acetyl coenzyme A (acetyl-CoA)], and the expressions of glycolysis-related factors [hypoxia-inducible factor 1α (HIF-1α), glucose transporter protein 4 (GLUT-4), lactate dehydrogenase A (LDHA), pyruvate dehydrogenase kinase 1 (PDK1) and PFKFB3] in primary cardiomyocytes of each group were measured. RESULTS Compared with the control group, the surface area of primary cardiomyocytes and protein synthesis were significantly increased, the content of FFA, protein and mRNA expressions of HIF-1α, LDHA, PDK1 and PFKFB3 were significantly increased or up-regulated in the AngⅡ group, while the contents of CoA and acetyl-CoA, the protein and mRNA expressions of GLUT-4 were significantly decreased or down-regulated (P<0.05). Compared with the AngⅡ group, both TSG group and PFK-015 group showed significant improvements in these indexes, with the TSG+PFK-015 group generally demonstrating superior effects compared to either treatment alone (P<0.05). CONCLUSIONS TSG can reduce the surface area of AngⅡ-induced primary cardiomyocytes, decrease protein synthesis, and inhibit their hypertrophic changes. These effects may be related to improving energy metabolism and the inhibition of glycolysis activity.
		                        		
		                        		
		                        		
		                        	
3.Evaluation of Animal Models of Chronic Obstructive Pulmonary Disease Based on Clinical Characteristics in Traditional Chinese and Western Medicine
Beibei BAO ; Peng ZHANG ; Baichuan XU ; Yiyin ZHANG ; Suyun LI ; Yang XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):212-220
		                        		
		                        			
		                        			Chronic obstructive pulmonary disease (COPD) is a common clinical chronic airway disease with high morbidity, high mortality, a heavy disease burden, and complex mechanisms that have not been fully elucidated. Clinical problems promote the continuous progress of basic research. The establishment and evaluation of animal models is an important way to delve into the pathogenesis and treatment strategies of COPD. On the basis of the etiology, pathogenesis, diagnostic criteria, and syndrome differentiation of COPD in traditional Chinese medicine (TCM) and Western medicine, this paper summarizes the establishment methods and characteristics of existing animal models of COPD and analyzes the fitting degree of the models with the disease characteristics in Western medicine and syndrome characteristics in TCM. The results showed that the animal models of COPD in Western medicine were mainly induced by single factors and compound factors, and the model with the highest fitting degree was established by cigarette smoke combined with lipopolysaccharide and hormone. The model showed a fitting degree of 84% with the disease characteristics in Western medicine and 70% with the syndrome characteristics in TCM, being consistent with the clinical characteristics of COPD induced by multiple factors. Most of the animal models of COPD in TCM were established on the basis of disease models and combined with TCM etiology and pathogenesis characteristics, and prepared by syndrome differentiation. Among them, the model of accumulation of cold and water retention in lung had the highest fitting degree of 92% with the TCM diagnostic criteria. The models of phlegm-heat obstructing lung and phlegm-stasis obstructing lung had the fitting degree of 94% with clinical manifestations in Western medicine and the highest fitting degree with the diagnostic criteria in Western medicine. Different animal models of COPD have their own advantages and disadvantages, and most of them simply replicate the manifestations of COPD at a certain stage, failing to reflect the multiple causes and the dynamic changes of TCM etiology and pathogenesis. Moreover, the syndromes of these models fail to match the clinical syndromes in TCM. Therefore, establishing the animal models reflecting clinical characteristics of COPD in TCM and Western medicine and improving the model evaluation criteria are important contents to promote the overall development of integrated traditional Chinese and western medicine for COPD. 
		                        		
		                        		
		                        		
		                        	
4.Establishment and Implementation of Post-marketing Benefit-risk Assessment Strategy for Traditional Chinese Medicine
Meng QIAO ; Wenxi PENG ; Qiang ZHANG ; Chao LEI ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):253-260
		                        		
		                        			
		                        			The field of post-marketing benefit-risk assessment for traditional Chinese medicine(TCM) is still in its nascent stage, lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM, and explored the critical techniques and specific implementation steps involved in the assessment process. Initially, appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently, key technologies were outlined, including the establishment of a benefit-risk indicator system, the assignment of indicator weights, and the definition of criteria attributes. Furthermore, the implementation steps were elaborated, which involved defining decision-making issues, data collection, evaluation methodologies, variability factors, and sensitivity analysis. Finally, a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM. 
		                        		
		                        		
		                        		
		                        	
5.Role of ceramide-regulated metabolic intermediates in retinal vein occlusion
International Eye Science 2025;25(9):1484-1490
		                        		
		                        			
		                        			 AIM: To investigate the causal effects of ceramides on retinal vein occlusion(RVO)and elucidate their potential mediating mechanisms using Mendelian randomization(MR)analysis.METHODS: Genome-wide association study(GWAS)data for four ceramide species were utilized as exposures, and RVO GWAS data from the FinnGen database as the outcome. Additionally, GWAS data for 1 400 intermediate metabolites were analyzed to identify potential mediators in the ceramide-RVO pathway.RESULTS: Two ceramide species exhibited significant causal associations with RVO: ceramide(d40:1)[IVW OR(95% CI): 0.750(0.604-0.930), P<0.05] and ceramide(d42:2)[IVW OR(95% CI): 0.771(0.632-0.941), P<0.05], suggesting protective effects. Mediation analysis revealed that ceramide(d40:1)influenced RVO risk through metabolites including 3-methylxanthine, branched/straight-chain/cyclopropyl 10:1 fatty acids, glutamine, and hydroxypalmitoyl sphingomyelin. Similarly, ceramide(d42:2)acted via N-methylhydroxyproline, the same fatty acid group, N1-methyladenosine, and the leucine-to-N-palmitoyl-sarcosinate ratio.CONCLUSION: Ceramides(d40:1)and(d42:2)confer protection against RVO, partially mediated by specific metabolic pathways. 
		                        		
		                        		
		                        		
		                        	
6.Association between 24 hour movement behavior composition and obesity indicators in children and adolescents
XIE Jichun, ZHAO Yang, XU Ruilin
Chinese Journal of School Health 2025;46(8):10963-1097
		                        		
		                        			Objective:
		                        			To identify optimal recommendations for 24 hour movement behaviors in relation to obesity indicators among children and adolescents, so as to provide scientific evidences for targeted obesity prevention strategies. 
		                        		
		                        			Methods:
		                        			From April to June 2024, 242 participants (96 children aged 6-11, 146 adolescents aged 12-18) were recruited from two schools(one combined junior and senior high school, one consistent school for 12 years) in Tianjin for performing physical examination. Obesity indicators including body mass index  Z scores (BMI  Z ), waist-to-hip ratio (WHR), body fat percentage (FAT), and fat mass index (FMI) were measured. Measurement of 24 hour movement behaviors using an accelerometer, comprised moderate-to-vigorous physical activity (MVPA), light physical activity (LPA), sedentary behavior (SB), and sleep (SLP). The optimal movement duration and interval for children and adolescents were determined through optimal time zone analysis. 
		                        		
		                        			Results:
		                        			Significant associations were found between 24 hour movement behaviors and BMI  Z ( F =2.35) and WHR ( F =3.55) in children, as well as BMI  Z ( F = 3.57 ), FAT ( F =2.44), and WHR ( F = 3.61 ) in adolescents (all  P <0.05). The results of optimal time zone analysis showed that optimal daily durations were MVPA 63( 40- 70) min, LPA 257(220-270) min, SB 467(390-600) min, SLP 653(590-680) min for children, and MVPA 65(40-70) min, LPA 262(220-270) min, SB 484(440-600) min, SLP 629(510-670) min for adolescents. 
		                        		
		                        			Conclusion
		                        			The recommended amount of 24 hour movement for children and adolescents based on obesity indicators could provide reference for informing the development of Chinesespecific guidelines,and promote healthy lifestyles among children and adolescents.
		                        		
		                        		
		                        		
		                        	
7.Improvement mechanism of Pangshi antai zhixue decoction on spontaneous abortion with heat syndrome by regulating NLRP3 inflammasome
Liya MA ; Xingfei WU ; Liujun WU ; Yanduo SHEN ; Bingheng XIE ; Jiale ZHANG ; Jinhao HAO ; Meng YU ; Yumiko NAKAYAMA ; Minghao ZHANG ; Dawei ZHANG
China Pharmacy 2025;36(1):37-43
		                        		
		                        			
		                        			OBJECTIVE To investigate the mechanism of Pangshi antai zhixue decoction in the improvement of spontaneous abortion with heat syndrome by regulating the NOD-like receptor protein 3 (NLRP3) inflammasome. METHODS The binding activities of 13 main components in Pangshi antai zhixue decoction with NLRP3, apoptosis-associated speck-like protein , containing a CARD (ASC), and caspase-1 precursor (pro- No.20-21ZY1053) caspase-1) were predicted by molecular docking. Sixty 1-day-old pregnant rats were randomly divided into normal group, model group, dexamethasone group (0.002 g/kg), and Pangshi antai zhixue decoction low-, medium-, and high-dose groups (11.025, 22.05, 44.10 g/kg), with 10 rats in each group. Each group was given distilled water/corresponding medicinal solution intragastrically, once a day, for 12 consecutive days. Except for normal group, other groups were given traditional Chinese medicine for warming yang and mifepristone to establish a model of spontaneous abortion with heat syndrome. 24 h after the last medication, serum levels of triiodothyronine (T3), thyroxine (T4), interleukin-2 (IL-2), IL-4, IL-6, IL-10, and interferon-γ (IFN-γ) were all detected; the abortion rate and uterine coefficient were calculated; the pathological morphology of the pregnant uterus was observed; protein expressions of NLRP3, ASC and caspase-1 were detected. RESULTS The molecular docking results showed that the binding energies of 13 main components of Pangshi antai zhixue decoction with NLRP3, ASC, and pro-caspase-1 were all less than -5 kJ/moL. The animal experiment results showed that compared with normal group, the uterine coefficient and serum levels of IL-4, IL-6 and IL-10 were decreased significantly in model group (P<0.05); the abortion rate and serum levels of T3, T4, IL-2 and IFN-γ as well as protein expressions of NLRP3, ASC and caspase-1 were increased significantly (P<0.05); there were abortion lesions in the pregnant endometrium. Compared with the model group, most of the quantitative indicators mentioned above were significantly reversed in Pangshi antai zhixue decoction groups (P<0.05), and the endometrial miscarriage lesions in pregnancy were improved to varying degrees. CONCLUSIONS Pangshi antai zhixue decoction influences the immune balance between mother and fetus by regulating the formation of NLRP3 inflammasome, down-regulating pro-inflammatory cytokines such as IFN-γ and IL-2, and up-regulating anti-inflammatory cytokines such as IL-4, IL-6 and IL-10, thereby improving spontaneous abortion with heat syndrome.
		                        		
		                        		
		                        		
		                        	
8.Quality analysis of Pinghuo tea standard decoction
Xinmei ZHAO ; Hongyang SANG ; Chunjing YANG ; Jingwei LEI ; Haiyan GONG ; Caixia XIE ; Chunya ZHANG ; Haohan DUAN ; Hao YU
China Pharmacy 2025;36(1):71-78
		                        		
		                        			
		                        			OBJECTIVE To establish the fingerprint of Pinghuo tea standard decoction and a method for determination of multi-component to clarify the transfer relationship of quantities and quality from pieces and standard decoction. METHODS Fifteen batches of Pinghuo tea standard decoction were prepared and the extract rate was determined; the fingerprint of the preparation was established by using high-performance liquid chromatography(HPLC); the similarity evaluation and the determination of common peaks were performed, and chemometric analysis was performed; the same method was used to determine the content of indicator components and the transfer rate was calculated. The chromatographic column was Venusil C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (gradient elution); the column temperature was 30 ℃, and the detection wavelengths were 238 nm (0-37 min, 85-102 min) and 330 nm (37-85 min) at a flow rate of 1.0 mL/min with an injection volume of 10 μL. RESULTS The similarity of HPLC fingerprints for 15 batches of Pinghuo tea standard decoction was not lower than 0.968. A total of 24 common peaks were calibrated and 9 peaks were recognized, which were as follows neochlorogenic acid (peak 3), chlorogenic acid (peak 6), geniposide (peak 9), glycyrrhizin (peak 10), galuteolin (peak 11), isochlorogenic acid A (peak 14), luteolin (peak 21), kaempferol (peak 23) and glycyrrhizic acid (peak 24). Cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis showed consistent results, all of which could classify the 15 batches of samples into three categories. The linear range of indicator components in 15 batches of Pinghuo tea standard decoction, such as geniposide, luteolin, isochlorogenic acid A, glycyrrhizin, and glycyrrhizic acid, were 0.020 580-0.411 600, 0.001 617-0.080 850, 0.006 076-0.607 600, 0.005 125-0.071 740, and 0.017 288-0.432 200 mg/mL, respectively; RSDs of precision, repeatability, stability and recovery rate tests were all not higher than 4% (n=6). The mass fractions ranged 3.227 9-10.002 2, 0.297 4-0.554 6, 3.350 1-6.159 6, 0.720 6-1.073 3, 2.003 1-3.030 1 mg/g; transfer rates from the pieces and standard decoction were 19.762 8%-35.840 5%, 12.123 3%-21.254 0%, 46.097 2%-82.869 4%, 58.708 8%-91.629 6%, 39.114 3%-63.710 6%. The transfer rates of the extract from 15 batches of Pinghuo tea standard decoction ranged from 61.15%-84.68%. CONCLUSIONS Established HPLC fingerprint and content determination methods in this study are simple and accurate, which can provide reference for the quantitative value transfer study, quality control, clinical application and the development of subsequent formulations of Pinghuo tea standard decoction.
		                        		
		                        		
		                        		
		                        	
9.Dipsacus asper Treats Alzheimer's Disease in Caenorhabditis elegans by Regulating PPARα/TFEB Pathway
Mengmeng WANG ; Jianping ZHAO ; Limin WU ; Shuang CHU ; Yanli HUANG ; Zhenghao CUI ; Yiran SUN ; Pan WANG ; Hui WANG ; Zhenqiang ZHANG ; Zhishen XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):104-114
		                        		
		                        			
		                        			ObjectiveTo investigate the anti-Alzheimer's disease (AD) effect of Dipsacus asper(DA) in the Caenorhabditis elegans model, and decipher the underlying mechanism via the peroxisome proliferator-activated receptor α (PPARα)/transcription factor EB (TFEB) pathway. MethodsFirst, transgenic AD C. elegans individuals were assigned into the blank control, model, positive control (WY14643, 20 µmol·L-1), and low-, medium-, and high-dose (100, 200, and 400 mg·L-1, respectively) DA groups. The amyloid β-42 (Aβ42) formation in the muscle cells, the paralysis time, and the deposition of amyloid β-protein (Aβ) in the head were detected. The lysosomal autophagy in the BV2 cell model was examined by Rluc-LC3wt/G120A. The expression levels of lysosomal autophagy-related proteins LC3Ⅱ, LC3I, LAMP2, and TFEB were detected by Western blot. Real-time quantitative polymerase chain reaction (Real-time PCR) was employed to determine the mRNA levels of autophagy-related genes beclin1 and Atg5 and lysosome-related genes LAMP2 and CLN2 downstream of PPARα/TFEB. A reporter gene assay was used to detect the transcriptional activities of PPARα and TFEB. Immunofluorescence was used to detect the fluorescence intensity of PPARα, and the active components of the ethanol extract of DA were identified by UPLC-MS. RCSB PDB, Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP), and Autodock were used to analyze the binding between the active components and PPARα-ligand-binding domain (LBD). ResultsCompared with the model group, the positive control group and 200 and 400 mg·L-1 DA groups showed prolonged paralysis time (P<0.05), and all the treatment groups showed decreased Aβ deposition in the head (P<0.01). DA within the concentration range of 50-500 mg·L-1 did not affect the viability of BV2 cells. In addition, DA enhanced the autophagy flux (P<0.05), up-regulated the mRNA levels of beclin1, Atg5, LAMP2, and CLN2 (P<0.05, P<0.01), promoted the nuclear translocation of TFEB (P<0.05), increased LAMP2 expression and autophagy flux (P<0.05, P<0.01), and enhanced the transcriptional activities of PPARα and TFEB (P<0.01). The positive control group and 200 and 400 mg·L-1 DA groups showed enhanced fluorescence intensity of PPARα in the BV2 nucleus (P<0.01). UPLC-MS detected nine known compounds of DA, from which 8 active components of DA were screened out. The docking results suggested that a variety of components in DA could bind to PPARα-LBD and form stable hydrogen bonds. ConclusionDA may reduce the pathological changes in AD by regulating the PPARα-TFEB pathway. 
		                        		
		                        		
		                        		
		                        	
            

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