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.Quality Evaluation of Zhuye Shigao Granules and Its Therapeutic Effect on Mice with Cold-dampness Pestilence Attacking Lung Syndrome
Haihong LI ; Jiaqi SHEN ; Liwen LIANG ; Ziqi YANG ; Yuting YANG ; Shuyun LIANG ; Zhiliang SUN ; Jiannan LI ; Guangzhi CAI ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):182-190
		                        		
		                        			
		                        			ObjectiveTo establish a quality evaluation method for Zhuye Shigao granules(Zhuye Shigaotang) based on fingerprint and determination of index components, and to investigate the therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome. MethodsThe fingerprint of Zhuye Shigao granules was established by high performance liquid chromatography(HPLC), and the methods for determination of total calcium, orientin, isoorientin, ginsenosides Rg1, Re and Rb1 and other 2 index components were established. Fifty ICR mice were randomly divided into the blank group, model group, Zhuye Shigao granules low, medium and high dose groups(9.3, 18.6, 37.2 g·kg-1·d-1), with 10 mice in each group. In addition to the blank group, the model mice with cold-dampness pestilence attacking lung syndrome was prepared by nasal drip of lipopolysaccharide combined with cold-dampness environment. Each administration group was given the corresponding liquid by gavage according to the dose, while the blank group and model group were given the same volume of normal saline by gavage. Then, the body temperature and organ index of mice in each group were measured, hematoxylin-eosin(HE) staining was used to investigate the lung tissue injury of mice in each group, and enzyme-linked immunosorbent assay(ELISA) was used to detect the changes of tumor necrosis factor-α(TNF-α), interleukin(IL)-lβ, IL-6, IL-10 levels in serum and lung tissue, as well as immunoglobulin(Ig)A and IgM levels in serum. ResultsThe fingerprint similarity of 10 batches of Zhuye Shigao granules was>0.950, and 20 common peaks were calibrated. Seven of them were identified, including peak 11(isoorientin), peak 12(orientin), peak 14(apioside liquiritin), peak 15(liquiritin), peak 17(apioside isoliquiritin), peak 19(isoliquiritin) and peak 20(liquiritigenin). The results of quantitative analysis showed that the content range of each index component in 10 batches of Zhuye Shigao granules was as follows:Total calcium of 9.978-11.294 mg·g-1, isoorientin of 0.033-0.041 mg·g-1, orientin of 0.046-0.055 mg·g-1, ginsenoside Rg1+ginsenoside Re of 0.748-0.762 mg·g-1, ginsenoside Rb1 of 0.151-0.197 mg·g-1, liquiritin of 1.106-1.366 mg·g-1, glycyrrhizic acid of 0.904-1.182 mg·g-1. Compared with the blank group, the body temperature of mice in the model group was significantly increased, the organ indexes of liver, lung and spleen were significantly decreased, the organ index of thymus was significantly increased, HE staining of lung tissue showed infiltration of inflammatory cells, a small amount of serous exudation was observed in the alveoli, and lung tissue was damaged. After the intervention of Zhuye Shigao granules, the pathological changes were improved compared with the model group. The expression levels of IL-1β, IL-6 and TNF-α were significantly increased, the expression level of IL-10 was significantly decreased in serum and lung tissue. The levels of IgA and IgM in serum were significantly decreased(P<0.01). Compared with the model group, the body temperature, the organ indexes and immune factor levels in serum and lung tissue of mice in the Zhuye Shigao granules medium and high dose groups were significantly reduced(P<0.05, P<0.01). ConclusionIn this study, the quality evaluation of Zhuye Shigao granules was carried out based on fingerprint combined with determination of index components, and the fingerprint of four herbs(Lophatheri Herba, Ophiopogonis Radix, Pinelliae Rhizoma and Glycyrrhizae Radix et Rhizoma) in this formula and the determination of 8 index components were established. The therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome may be related to inhibiting inflammatory response and mediating immune regulation. 
		                        		
		                        		
		                        		
		                        	
3.Professor TONG Xiaolin's Experience in Treating Prediabetes with Overweight and Obesity Using the Method of Relieving Depression and Reducing Turbidity
Sicheng WANG ; Yangyang LIU ; Yan YAN ; Zishan JIN ; Boxun ZHANG ; Qingwei LI ; Xiaoxuan XU ; Linhua ZHAO ;
Journal of Traditional Chinese Medicine 2025;66(14):1424-1427
		                        		
		                        			
		                        			To summarise the clinical experience of Professor TONG Xiaolin in treating prediabetes combined with overweight or obesity using the method of relieving depression and reducing turbidity. It is believed that prediabetes belongs to the category of "spleen-heat syndrome" in traditional Chinese medicine, and its core pathogenesis is center fullness with internal heat, while obesity is the initiating factor for exacerbating center fullness and internal heat, therefore, it is of great significance to reduce the risk of diabetes by interrupting the transformation between overweight, obesity and glucose metabolism abnormality. It is proposed that the main pathogenesis of prediabetes combined with overweight or obesity is qi depression and turbidity obstruction in middle jiao, with qi depression as the root and turbidity obstruction as the cause, forming a treatment idea with the method of relieving depression and reducing turbidity as the core. In clinic, Dahuang Huanglian Xiexin Decoction (大黄黄连泻心汤) is used as the basic prescription, with a primary focus on directing the turbid downward, supplemented by regulating qi, which embodies the concept of "promoting movement through descent, then figuring out the root of spleen-heat syndrome. Furthermore, the treatment is flexibly modified based on the patient's deficiency-excess syndrome to ensure individualized therapy. 
		                        		
		                        		
		                        		
		                        	
4.The Solomon Four-Group Design:Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
Wenqian ZHANG ; Yufei LI ; Tong LIN ; Xintong WEI ; Yingjie WANG ; Jianping LIU ; Ying ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1649-1655
		                        		
		                        			
		                        			The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine (TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, know-ledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research. 
		                        		
		                        		
		                        		
		                        	
5.Quality Evaluation of Black Panacis Quinquefolii Radix Based on Neuroprotective Spectrum-effect Relationship
Yuting YANG ; Shuyun LIANG ; Shanshan LI ; Yulong YANG ; Ziqi YANG ; Guangzhi CAI ; Liru ZHAO ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):149-156
		                        		
		                        			
		                        			ObjectiveTo clarify the neuroprotective effect of black Panacis Quinquefolii Radix(PQR) and explore its active ingredients, with the aim of establishing an activity-oriented quality evaluation method. MethodsTransgenic Tg(HuC∶EGFP) zebrafish was used to establish a neuronal injury model by aluminum chloride immersion. Different doses(10, 20 mg·L-1) of PQR and black PQR ethanol extracts were administered. The neuroprotective effects of PQR and black PQR were compared by analyzing the fluorescent area and intensity of zebrafish neurons. Based on ultra-performance liquid chromatography(UPLC), a fingerprint profile of black PQR was established, followed by principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA). Differential components were screened using the criteria of variable importance in the projection(VIP) value>1 and P<0.05. The neuroprotective activity of 14 batches of black PQR was assessed, and Spearman correlation analysis was used to identify saponins related to neuroprotective activity, which were then validated. Based on the above results, active marker components were determined, and an UPLC method was established for their quantitation with clear content limits. ResultsPharmacological efficacy results showed that both PQR and black PQR at different doses could significantly improved neuronal damage in zebrafish. At a dose of 20 mg·L-1, black PQR demonstrated superior efficacy(P<0.05). The fingerprint similarities of 14 batches of black PQR were>0.94, with 26 common peaks identified. Through comparison with the reference standards, 8 components were confirmed, including peak 1(ginsenoside Rg1), peak 2(ginsenoside Re), peak 5(ginsenoside Rb1), peak 9(ginsenoside Rd), peak 16[ginsenoside 20(S)-Rg3], peak 17[ginsenoside 20(R)-Rg3], peak 18(ginsenoside Rk1), and peak 19(ginsenoside Rg5). The results of PCA and OPLS-DA indicated that there were differences in saponins among black PQR samples from different origins, and 12 differential components were screened. All 14 batches of black PQR exhibited good protective effects on zebrafish neurons, with Shaanxi-produced black PQR showing superior protective effects compared to the other three production regions. Spearman correlation analysis revealed that a total of 11 components, including ginsenosides 20(S)-Rg3, 20(R)-Rg3, Rk1 and Rg5, showed a significant positive correlation with the neuroprotective effect in zebrafish(P<0.05). The activity validation results indicated that ginsenosides 20(S)-Rg3, 20(R)-Rg3, Rk1 and Rg5 were the primary components responsible for the neuroprotective effects of black PQR. Quantitative analysis showed that the content of ginsenoside 20(S)-Rg3 in 14 batches of black PQR ranged from 0.17% to 0.52%, and the repair rate of neuronal damage ranged from 42.77% to 97.83%. ConclusionBased on the fingerprint and neuronal protective activity, the spectrum-effect related quality control model of black PQR was established, with ginsenoside 20(S)-Rg3 as the quality control index, and the neuronal damage repair rate≥60% as the evaluation standard, the minimum limit of ginsenoside 20(S)-Rg3 in black PQR should be≥0.20%. 
		                        		
		                        		
		                        		
		                        	
6.Growth and Development of Atractylodes chinensis and Microecological Response of Cultivated Soil Mediated by Two Microbial Fertilizers
Xuewei LIU ; Chunping XIAO ; Lili WENG ; Zhaoyang LI ; Xinxing HU ; Bo LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):157-165
		                        		
		                        			
		                        			ObjectiveThe effects of two microbial fertilizers (Bacillus subtilis fertilizer and Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer) on the growth and development, the accumulation of active ingredients, and the microbial community diversity of rhizosphere soil of Atractylodes chinensis were investigated. MethodsA field experiment was carried out with two-year-old Atractylodes chinensis as the test material. Plant samples were collected during the wilt stage (September 26, 2023) to determine the general agronomic traits of Atractylodes chinensis. High-performance liquid chromatography (HPLC) was utilized to evaluate the effects of microbial fertilizers on the synthesis and accumulation of four active ingredients (atractylodin, atractylon, β-eudesmol, and atractylenolide Ⅰ) in Atractylodes chinensi. PacBio Sequel sequencing technology was used to explore the differences in bacterial community structures and diversity in the rhizosphere soil of Atractylodes chinensis treated with different microbial fertilizers. ResultsThe two microbial fertilizers had significant growth-promoting effects on Atractylodes chinensis. Compared with those of the CK group, the stem diameter, stem and leaf dry and fresh weight, and rhizome dry and fresh weight of Atractylodes chinensis significantly increased by 0.47-1.07 times (P<0.05) after the application of the Bacillus subtilis fertilizer (16 kg/667 m2), and those significantly increased by 0.62-0.96 times (P<0.05) after the application of the Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer (1.5 kg/667 m2). The effect on plant height was not significant. The application of two microbial fertilizers was beneficial to the accumulation of atractylodin, atractylon, β-eudesmol, and atractylenolide Ⅰ (P<0.01), and the effect of the Bacillus subtilis fertilizer on the accumulation of active ingredients of Atractylodes chinensis was better than that of the Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer. The results of high-throughput sequencing showed that compared with the CK group, the Bacillus subtilis fertilizer (8 kg/667 m2) could significantly increase the diversity of rhizosphere bacterial species by regulating the Simpson index and Shannon index (P<0.05), and the Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer significantly reduced the bacterial diversity (P<0.05). The relative abundance of dominant bacteria was compared at the phylum and genus levels. The relative abundance of Proteobacteria (45.73%) and Burkholderia_Caballeronia_Paraburkholderia (9.98%) significantly increased after the application of the Bacillus subtilis fertilizer (P<0.01), and the relative abundance of Acidobacteriota (20.53%) and Sphingomonas (3.63%) increased significantly (P<0.01) after the application of the Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer. The relative abundance of beneficial bacteria in the Bacillus subtilis fertilizer was slightly higher than that in the Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer. Pearson correlation analysis showed that Burkholderia_Caballeronia_Paraburkholderia and Sphingomonas were positively correlated with the content of atractylodin, atractylon, β-eudesmol, and atractylenolide Ⅰ (P<0.05). ConclusionThe application of the Bacillus subtilis fertilizer and Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer can increase the yield of medicinal materials and promote the synthesis and accumulation of active ingredients by regulating the rhizosphere microecological diversity of Atractylodes chinensis, and the application effect of the Bacillus subtilis fertilizer is better than that of the Trichoderma harzianum-Purpureocillium lilacinum compound fertilizer. 
		                        		
		                        		
		                        		
		                        	
7.Integration of nuclear and radiation emergency medical treatment in the national emergency medical rescue team
Qiang ZHANG ; Yang LI ; Yan XIA ; Yuwei QI
Chinese Journal of Radiological Health 2025;34(3):433-436
		                        		
		                        			
		                        			This study aims to address the specificity of nuclear and radiation medical treatment and explore the way to integrate such emergency medical treatment in national emergency medical rescue teams. By analyzing the characteristics of nuclear and radiation medical treatment, as well as the foundation, roles, and development of national emergency medical rescue teams, the study proposes a series of practical and feasible strategies, including professional knowledge training, manpower and material resource assurance, emergency response coordination mechanisms, and psychological health support. These strategies help to compensate for the professional deficiencies of national emergency medical rescue teams in responding to nuclear incidents and enhance their overall comprehensive capabilities, enabling them to better fulfill their responsibilities in health emergency rescue.
		                        		
		                        		
		                        		
		                        	
8.Consistency Evaluation of Processing of Black Panacis Quinquefolii Radix Decoction Pieces Based on "Chromaticity-chemistry-activity"
Yulong YANG ; Shanshan LI ; Yuting YANG ; Ziqi YANG ; Guangzhi CAI ; Liru ZHAO ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):195-203
		                        		
		                        			
		                        			ObjectiveTo assess the quality consistency of black Panacis Quinquefolii Radix(bPQR) decoction pieces prepared by atmospheric and pressurized steaming processes based on chromaticity-chemical composition-vasoactive inhibition. The ultimate goal was to screen the pressurized steaming process yielding quality equivalent to atmospheric steaming, and optimize the processing technology of bPQR. MethodsThe bPQR decoction pieces were prepared using both atmospheric and pressurized steaming processes, and the chromaticity values[lightness value(L*), red/green chromaticity value(a*), yellow/blue chromaticity value(b*), total chromaticity value(E*ab)] were measured. High performance liquid chromatography(HPLC) was employed to establish fingerprint profiles for the decoction pieces, and cluster analysis was conducted on chromaticity values and the common peak areas in fingerprint profiles to elucidate the quality relationships between the decoction pieces processed by different methods. The optimal atmospheric steaming of bPQR decoction pieces was determined through zebrafish angiogenesis inhibition experiments. The contents of ginsenosides Rg1, Re, Rb1, 20(S)-Rg3, Rk1 and Rg5 in the decoction pieces were quantified, and Spearman correlation analysis was employed to investigate the relationship between saponin content, chromaticity, and angiogenesis inhibition activity during the steaming process. By integrating the consistency of chromaticity, saponin components and angiogenesis inhibition activity, pressurized steaming conditions with quality equivalent to the atmospheric pressure method were selected. ResultsCompared with the atmospheric steaming method, pressurized steaming resulted in faster color darkening and higher conversion rates of ginsenosides in bPQR decoction pieces. Moreover, the neovascularization inhibitory activity of bPQR decoction pieces continued to increase with the deepening of processing. Based on the effectiveness and safety, the optimal process for preparing bPQR decoction pieces with neovascularization inhibitory activity was determined to be atmospheric steaming for 21 h. All six ginsenosides tested exhibited strong to extremely strong correlations with both the chromaticity values of the decoction pieces and their neovascularization inhibitory activities. Among them, ginsenosides Rg1, Re and Rb1 exhibited positive correlations with chromaticity values and negative correlations with zebrafish angiogenesis inhibition activity. Conversely, ginsenosides 20(S)-Rg3, Rk1 and Rg5 showed negative correlations with chromaticity values and positive correlations with zebrafish angiogenesis inhibition activity. By integrating chromaticity values, cluster analysis results, as well as the results of activity, it was determined that the quality of bPQR decoction pieces steamed under pressurized conditions of 110 ℃(0.045 MPa) for 5 h and 115 ℃(0.07 MPa) for 3 h was highly consistent with that obtained by atmospheric steaming for 21 h. ConclusionThe preparation of bPQR decoction pieces by pressurized steaming has the advantages of short preparation time, low energy consumption, and rapid saponin conversion rate, making it a viable alternative to atmospheric steaming for preparing bPQR decoction pieces. Meanwhile, the evaluation method based on chromaticity-chemical composition-activity can provide a more scientific and effective explanation of change rules in the quality during traditional Chinese medicine processing, and offer a new model for optimizing processing technology and enhancing quality control. 
		                        		
		                        		
		                        		
		                        	
9.Research on the standardization of “Indications”in package inserts for Chinese patent medicines
Meiwei ZHANG ; Keqian LI ; Keyu YAO ; Yan ZHU
China Pharmacy 2025;36(5):513-518
		                        		
		                        			
		                        			OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia (Volume Ⅰ) and various national and regional standards. Identification criteria were established for syndrome, pathogenesis, disease name, and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements, followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these, the majority (7 991) contained symptom terminology, followed by disease names (5 867) and pathogenesis descriptions (5 167). Within disease name terminology, Western medical disease names predominated (4 446), followed by traditional Chinese medicine disease names (2 018). The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably, the secondary classifications of “disease name”, as well as the tertiary classification of “disease name+symptoms” and “symptoms”, failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome:“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information, adhere to standardized formatting, and employ appropriate conjunctions and punctuation. For non-prescription patent medicines, package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.
		                        		
		                        		
		                        		
		                        	
10.Mechanism of in Vitro and in vivo Models of Osteoporosis Regulation by Active Ingredients of Traditional Chinese Medicine: A Review
Ming YANG ; Jinji WANG ; Xuefeng ZHUANG ; Xiaolei FANG ; Zhijie ZHU ; Huiwei BAO ; Lijing LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):281-289
		                        		
		                        			
		                        			Osteoporosis is a common bone disease, whose incidence is still on the rise, posing great challenges to patients and society. This review mainly studies the pathogenesis of osteoporosis from the aspects of oxidative stress, inflammatory response, and glucolipotoxicity-induced injury and clarifies the efficacy and mechanism of some active ingredients of traditional Chinese medicine against osteoporosis through the integration of in vitro and in vivo experiments. The experimental results suggest that some active ingredients can improve bone resorption markers and maintain bone homeostasis by modulating inflammation, oxidative stress, etc. These active ingredients regulate osteoporosis through the receptor activator of nuclear transcription factor-κB (NF-κB) ligand (RANKL) pathway, osteoprotegerin (OPG) pathway, Wnt/β-catenin pathway, NF-κB pathway, mitogen-activated protein kinase (MAPK) pathway, adenosine monophosphate (AMP)-activated protein kinase (AMPK)/mammalian target of rapamycin (mTOR) pathway, and oxidative stress pathway. This review provides ideas for the progress of the prevention and treatment of osteoporosis with the active ingredients of traditional Chinese medicine, aiming to provide new potential lead compounds and reference for the development of innovative drugs and clinical therapy for the treatment of osteoporosis. 
		                        		
		                        		
		                        		
		                        	
            
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