1.Evaluation of the quality of Jingangteng capsules based on UPLC fingerprinting combined with multi-component content determination
Li SHEN ; Yue SHEN ; Yuying YANG ; Dandan ZHANG ; Yuxi WU ; Xuxiang ZHOU ; Jingyu YANG ; Peng HU ; Lei WANG ; Heming WU ; Dan LIU ; Xiaochuan YE
China Pharmacy 2026;37(10):1290-1294
OBJECTIVE To establish the UPLC fingerprint and the method for multi-component content determination in Jingangteng capsules, and to evaluate its quality by combining chemical pattern recognition analysis. METHODS An UPLC method was established. Separation was performed on a Zorbax SB-C 18 Rapid Resolution HD column, with acetonitrile-0.1% formic acid as the mobile phase for gradient elution.Using the Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicines (2012 edition), UPLC fi ngerprints were established for 10 batches of Jingangteng capsules, and similarity was evaluated. SPSS 22.0 and SIMCA 14.1 software were used to perform hierarchial-cluster analysis and orthogonal partial least squares discriminant analysis (OPLS-DA), respectively. The same UPLC method was employed to determine the contents of chlorogenic acid, 3,5-dihydroxy-2-methylbenzoic acid-3- O -glucoside (M1), caffeic acid, astilbin, oxyresveratrol, quercitrin and resveratrol in the 10 batches of samples. RESULTS A total of 17 common peaks were identified in UPLC fingerprints of the 10 batches of samples, of which 7 were identified as chlorogenic acid, M1, caffeic acid, astilbin, oxyresveratrol, quercitrin, and resveratrol. The similarities of 10 batches of samples ranged from 0.820 to 0.985. The results of hierarchial-cluster analysis showed that 10 batches of samples were grouped into four categories: S1-S4 formed one group, S5 and S6 formed another, S7, S8 and S10 formed a third, and S9 formed a fourth, consistent with the OPLS-DA results; the variable importance projection values for peaks 7, 10, 2, 16 (resveratrol), 13 (oxyresveratrol), 11, 6 (caffeic acid), 5 (M1) and 15 (quercitrin) were >1. Quantitative analysis results showed that the contents of chlorogenic acid, M1, caffeic acid, astilbin, oxyresveratrol, quercitrin, and resveratrol were 1.650 8-4.213 7, 0.636 2-2.161 7, 0.031 0-0.086 5, 0.239 1-1.069 3, 0.211 9-1.104 0, 0.488 8-2.399 2, and 0.164 0-0.699 8 mg/g, respectively. CONCLUSIONS UPLC fingerprint and content determination methods established in this study are simple to operate, accurate, reliable and reproducible; when combined with chemical pattern recognition analysis, they can be used to evaluate the quality of Jingangteng capsules. Nine components, such as resveratrol, oxyresveratrol, caffeic acid, M1 and quercitrin, may serve as markers of quality variation.
2.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.
3.Characterisation of whole-brain resting-state functional connectivity in children with Chinese developmental dys-lexia
Dandan LUO ; Min SHEN ; Sujuan WANG ; Wengxin QIU ; Yuxuan ZHANG ; Yun WU ; Shengxiao WANG
Chinese Journal of Rehabilitation Theory and Practice 2025;31(9):1023-1031
Objective To examine resting-state whole-brain network connectivity in children with Chinese developmental dyslexia(DD)and typically developing(TD)children using functional near-infrared spectroscopy(fNIRS).Methods From November to December,2024,19 DD children aged six to twelve years in Children's Hospital of Fudan University were enrolled,along with 18 TD children matching age and sex.Regions of interest included frontal cortex(FC),temporal lobe(TL),occipital lobe(OL)and parietal lobe(PL).Resting-state data were acquired by fNIRS for five minutes in both groups.Functional connectivity strength was calculated at rest,and between-group differences in connectivity strength and brain networks were compared,based on the time series of oxyhe-moglobin concentration.Results The whole-brain functional connectivity strength was higher in DD group than in TD group(t=2.100,P<0.05).Connectivity between the right OL-right FC(t=2.426,P<0.05),right OL-left FC(t=2.483,P<0.05),right TL-right FC(t=2.568,P<0.05)and right TL-left FC(t=2.304,P<0.05)were stonger in DD group than in TD group.The major regions exhibiting differences of whole-brain connectivity between two groups were the right dorsolateral prefrontal cortex,right visual association cortex,right frontal cortex,left orbitofrontal cortex,left visual association cortex,left primary visual cortex and right primary motor cortex.Conclusion Children with DD exhibited significantly stronger connectivity in the right occipital and temporal lobes,as well as between these regions and the prefrontal cortex,suggesting possible right-hemispheric compensation for insufficiency in the left-hemisphere reading network.
4.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
Ying WANG ; Mingrui SHEN ; Yuanxi LIU ; Tiantian ZUO ; Dandan WANG ; Yi HE ; Xianlong CHENG ; Hongyu JIN ; Yongli LIU ; Feng WEI ; Shuangcheng MA
Drug Standards of China 2025;26(1):83-92
As people's attention to health continues to increase,the market demand for traditional Chinese medi-cine(TCM)is growing steadily.The quality and safety of Chinese medicinal materials have attracted unprecedent-ed 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 detec-tion 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.Moreo-ver,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.
5.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
6.Characterisation of whole-brain resting-state functional connectivity in children with Chinese developmental dys-lexia
Dandan LUO ; Min SHEN ; Sujuan WANG ; Wengxin QIU ; Yuxuan ZHANG ; Yun WU ; Shengxiao WANG
Chinese Journal of Rehabilitation Theory and Practice 2025;31(9):1023-1031
Objective To examine resting-state whole-brain network connectivity in children with Chinese developmental dyslexia(DD)and typically developing(TD)children using functional near-infrared spectroscopy(fNIRS).Methods From November to December,2024,19 DD children aged six to twelve years in Children's Hospital of Fudan University were enrolled,along with 18 TD children matching age and sex.Regions of interest included frontal cortex(FC),temporal lobe(TL),occipital lobe(OL)and parietal lobe(PL).Resting-state data were acquired by fNIRS for five minutes in both groups.Functional connectivity strength was calculated at rest,and between-group differences in connectivity strength and brain networks were compared,based on the time series of oxyhe-moglobin concentration.Results The whole-brain functional connectivity strength was higher in DD group than in TD group(t=2.100,P<0.05).Connectivity between the right OL-right FC(t=2.426,P<0.05),right OL-left FC(t=2.483,P<0.05),right TL-right FC(t=2.568,P<0.05)and right TL-left FC(t=2.304,P<0.05)were stonger in DD group than in TD group.The major regions exhibiting differences of whole-brain connectivity between two groups were the right dorsolateral prefrontal cortex,right visual association cortex,right frontal cortex,left orbitofrontal cortex,left visual association cortex,left primary visual cortex and right primary motor cortex.Conclusion Children with DD exhibited significantly stronger connectivity in the right occipital and temporal lobes,as well as between these regions and the prefrontal cortex,suggesting possible right-hemispheric compensation for insufficiency in the left-hemisphere reading network.
7.Effect of exercise on cancer patients with anxiety and depression during chemotherapy: a meta-analysis
Yicheng YANG ; Dandan WANG ; Qunce SHEN ; Lei ZHANG ; Xueping WU
Chinese Journal of Rehabilitation Theory and Practice 2025;31(2):184-193
ObjectiveTo explore the effect of exercise on anxiety and depression in cancer patients during chemotherapy, as well as the optimal exercise dosage. MethodsA PICO framework was constructed, and randomized controlled trials (RCTs) on the effect of exercise on anxiety and depression in cancer patients during chemotherapy were retrieved from databases of PubMed, Web of Science, Cochrane Library, Embase, Medline, CNKI, VIP and Wanfang data, from the establishment to November, 2023. The quality of the literature was evaluated with Cochrane Risk of Bias Tool and Physiotherapy Evidence Database (PEDro) scale. Data were synthesized and analyzed using RevMan 5.3, and the risk of bias was evaluated using Stata 18.0. ResultsA total of 13 RCTs involving 1 340 subjects were included. The scores of PEDro scale were five to eight. Exercise interventions significantly improved anxiety (SMD = -0.70, 95%CI -1.18 to -0.22, P = 0.004) and depression (SMD = -0.89, 95%CI -1.43 to -0.34, P = 0.002) compared to the control group. Subgroup analyses showed that, the exercise effect on anxiety was less than 45 minutes a time (SMD = -0.26, 95%CI -0.46 to -0.05, P = 0.01), more than three times a week (SMD = -0.26, 95%CI -0.46 to -0.05, P = 0.01), and less than twelve weeks (SMD = -0.21, 95%CI -0.36 to -0.07, P = 0.005). For depression, it was less than 45 minutes a time (SMD = -0.69, 95%CI -1.29 to -0.08, P = 0.03), more than three times a week (SMD = -0.69, 95%CI -1.29 to -0.08, P = 0.03), and less than twelve weeks (SMD = -0.52, 95%CI -0.92 to -0.13, P = 0.01). Moderate to high-intensity exercise interventions significantly outperformed the control group in improving anxiety (SMD = -0.21, 95%CI -0.37 to -0.06, P = 0.007) and depression (SMD = -0.21, 95%CI -0.41 to -0.01, P = 0.04). ConclusionExercise interventions can effectively improve anxiety and depression in cancer patients during chemotherapy, and it suggests for high-intensity exercise, less than 45 minutes a time, more than three times a week, and less than twelve weeks.
8.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
9.Mechanisms of Wuzi Yuye Decoction in the treatment of diabetic oligoasthenozoospermia:Based on network pharmacology
Dandan HE ; Junjie WU ; Jinying SHEN ; Binbin ZHAO ; Jingyu ZHU ; Yi YU
National Journal of Andrology 2025;31(10):921-931
Objective The aim of this study is to systematically analyze the therapeutic mechanisms of Wuzi Yuye Decoction in diabetic oligoasthenozoospermia based on network pharmacology and animal experiments.Methods Active components and therapeutic targets of Wuzi Yuye Decoction were screened by integrating multiple databases,and their inter-section with diabetic oligoasthenozoospermia-related targets was obtained.Common targets were identified using the Venny platform,and protein-protein interaction(PPI)networks were constructed via the STRING database.And key targets were screened through topological analysis with Cytoscape.Gene Ontology(GO)functional enrichment and Kyoto Encyclopedia of Genes and Genomes(KEGG)pathway analyses were performed using the DAVID platform.A mouse model of diabetic oligoasthenozoospermia was established by high-fat diet combined with streptozotocin induction,followed by intervention with Wuzi Yuye Decoction.Body weight,testicular index,and sperm quality were assessed,while histopathological changes were evaluated by HE staining and transmission electron microscopy(TEM).In addition,ELISA,oxidative stress assays and Western blot were used to verify the changes in key pathway-related proteins.Results A total of 36 common targets were identified,including key nodes such as TNF,IL6 and IL1B.Enrichment analysis indicated that these targets were sig-nificantly involved in inflammatory responses,oxidative stress,autophagy-apoptosis regulation and reproduction-related pathways.Animal experiments confirmed that Wuzi Yuye Decoction markedly improved testicular mass and sperm motility in diabetic mice,reduced the levels of AGE,TNF-α,IL-6 and IL-1β in testicular tissues,alleviated oxidative stress damage,and restored autophagic flux and blood-testis barrier function by inhibiting the RAGE/NF-κB/mTOR signaling axis.Conclusion Wuzi Yuye Decoction improves the pathological progression of diabetic oligoasthenozoospermia by synergistically modulating multiple targets,including inflammation inhibition,antioxidant effects,autophagy regulation,and related pathways.
10.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.

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