1.Optimization suggestions for the review and approval system of clinically urgent overseas-marketed drugs in China
Tanlin SUN ; Yuchen WANG ; Yue XIAO ; Yong DENG
China Pharmacy 2026;37(12):1541-1546
OBJECTIVE To provide references for optimizing the review and approval system of clinically urgent overseas-marketed drugs in China. METHODS The characteristics of the review and approval system for clinically urgent overseas-marketed drugs were analyzed. A comparative research method was employed to examine differences between China and Australia, Switzerland, and Canada in three dimensions: qualification determination for clinical urgency (i.e., access qualification), review methods, and approval modalities. RESULTS & CONCLUSIONS In China’s current system, the legal nature of communication and consultation meetings is ambiguous, as the qualification determination function is embedded within technical consultation procedures without remedy channels. The pre-marketing clinical trial exemption for drugs is disconnected from the post-marketing confirmation obligation, and insufficient access to complete overseas review information weakens risk control effectiveness. A differentiated triage mechanism based on the timing of global approval has not been established, providing insufficient incentives for global simultaneous research and development. International typical regulatory models set access qualification, review methods, and approval modalities as independent modules, forming a quid pro quo relationship by relaxing pre-marketing access conditions and establishing post-marketing conditional approval mechanisms. It is recommended to formulate technical guidelines for the determination of clinically urgent drugs to clarify objective discretionary benchmarks, clarify the legal nature of communication and consultation meetings and allocate remedy channels, mandatorily include clinical trial-exempted varieties in the conditional approval procedure and establish a negative signal linkage mechanism, and implement differentiated triage based on approval timing, so as to improve China’s review and approval system.
2.Progress on the hazards and control of ship-borne vector organisms
Yun-chuan HE ; Hui-ling HAO ; Bin SUN ; Hong-yan LYU ; Deng-yong HOU ; Xiao-meng REN
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):144-151
In the context of burgeoning economic trade, there has been a remarkable increase in the number of ships travelling between domestic and international ports. Inbound and outbound cargo ships, cruise liners, ferries, and other types of vessels have emerged as critical vehicles for the dispersal of vector organisms and the spread of infectious disease agents. Public health concerns associated with these vessels represent a significant threat to human welfare. In this paper, we comprehensively review the hazards posed by vector organisms on ships, the latest advances in prevention and control strategies, and proposes appropriate countermeasures. The aim is to provide effective guidance for the prevention and control of public health security issues caused by ship-borne vector organisms.
3.Management loopholes and governance countermeasures in the “convenient medicine search”service of e‑commerce platforms
China Pharmacy 2026;37(14):1813-1818
OBJECTIVE To promote the management and regulation of the new service format of “convenient medicine search” pharmaceutical operations on internet e-commerce platforms, and to safeguard public medication safety and health. METHODS Through an administrative public interest litigation case involving the disguised sale of internet-prohibited drugs under the guise of false medical consultation in a “convenient medicine search” service, this paper examines the risk issues exposed in the implementation and supervision of the current “convenient medicine search” service model on e-commerce platforms, and accordingly proposes governance recommendations for management and regulation. RESULTS &CONCLUSIONS The current “convenient medicine search” service model on e-commerce platforms faces problems such as ambiguous characterization of the nature of the conduct, unclear regulatory subjects, a business model that requires improvement, relatively ambiguous provisions on platform obligations, and a need for clarification in the implementation of review obligations and safety guarantee obligations. It is recommended that the regulation and governance of the “convenient medicine search” service on e‑commerce platforms be advanced by clarifying the legal nature of relevant acts, strengthening regulatory duties, fulfilling platform obligations, and intensifying legal oversight, thereby facilitating effective supervision by administrative agencies and genuine oversight by procuratorial organs, and ultimately safeguarding the life and health of the public.
4.Development and reliability and validity testing of a patient-reported symptom and function scale for patients with pectus excavatum after the Nuss procedure
Qibin CHEN ; Liang XIE ; Dongkun ZHANG ; Cheng DENG ; Yong TANG ; Yinghong WU ; Qiuling SHI ; Guibin QIAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(08):1234-1239
Objective To develop a symptom and function assessment scale for patients after Nuss procedure for pectus excavatum and to test its reliability and validity. Methods Following the principles and procedures of patient-reported outcome (PRO) scale development stipulated by the U.S. Food and Drug Administration, an initial draft was formed through literature analysis, qualitative interviews, and Delphi expert consultation. The preliminary draft was used to conduct a pre-survey on patients who underwent Nuss procedure for pectus excavatum at Guangdong Provincial People's Hospital, and the reliability and validity of the scale were tested. Results A preliminary PRO-based symptom and function scale was constructed, covering two domains: symptoms and impact on daily functions. The symptom dimension included six items: chest tightness, palpitations, pain, shortness of breath, foreign body sensation of the steel plate, and distress; while the impact on daily functions included four items: difficulty in getting out of bed or lying down, raising arms, bending over, and standing or sitting for a long time. A total of 73 patients who underwent Nuss procedure for pectus excavatum were included in the questionnaire survey, with 70 valid questionnaires collected, including 64 males and 6 females, with 56 patients aged 12-17 years and 14 patients ≥18 years. Through exploratory factor analysis, two common factors were extracted, with a cumulative variance contribution rate of 70%. The Cronbach’s α coefficient of the scale was 0.917. Conclusion The scale developed in this study has good reliability and validity, high reliability and stability, and can be used as an evaluation tool for the recovery status of patients after Nuss procedure for pectus excavatum.
5.Exploring Mechanism of Luoshi Neiyi Prescription in Treating Endometriosis Based on Ferroptosis and Serum Metabolomics
Haixia PAN ; Yingqiao ZHONG ; Ting MAO ; Ziyi DENG ; Meilin WU ; Lei HUANG ; Siyang CHEN ; Yong GUO ; Ying ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):201-212
ObjectiveThis study aimed to investigate the mechanism by which Luoshi Neiyi prescription treats endometriosis (EMs) through regulating ferroptosis, and to screen key metabolites and analyze their association with ferroptosis. MethodsClinical samples of normal endometrium from patients without EMs and eutopic and ectopic endometrium from EMs patients (10 cases each) were collected and divided into control group, eutopic group, and EMs group. Hematoxylin-eosin (HE) staining was performed to observe ectopic lesions of EMs. Immunohistochemistry was used to detect the expression of solute carrier family 7 member 11 (SLC7A11) and glutathione peroxidase 4 (GPX4). Enzyme-linked immunosorbent assay (ELISA) was adopted to determine the levels of malondialdehyde (MDA), ferrous ion (Fe2+), GPX4 and glutathione (GSH) in endometrial tissues, as well as serum levels of Fe2+, GPX4 and GSH. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of SLC7A11, GPX4, transferrin receptor (TFR) and ferritin heavy chain 1 (FTH1). In the in vitro experiment, primary stromal cells were isolated from ectopic lesions of EMs patients. Cell counting kit-8 (CCK-8) was used to determine the optimal concentration of drug-containing serum for intervention. The level of reactive oxygen species (ROS) was measured, and Real-time PCR was applied to detect ferroptosis-related indicators. In the animal experiments, an EM rat model was established, and the rats were randomly assigned to the sham operation group, EMs group, low-dose Luoshi Neiyi Formula group (7.87 g·kg-1), high-dose Luoshi Neiyi prescription group (15.74 g·kg-1), and danazol group (42 mg·kg-1). Untargeted metabolomics detection and pathway enrichment analysis were conducted on serum samples from patients and rats. Spearman correlation analysis was performed to assess the relationship between differential metabolites and ferroptosis indicators. The correlations between differential metabolites in patient endometrium and serum and key ferroptosis indicators (GPX4, Fe2+, MDA, GSH) as well as ferroptosis-related mRNAs (GPX4, SLC7A11, FTH1) were analyzed, and correlation heatmaps were generated accordingly. ResultsCompared with normal eutopic endometrium, ectopic lesions in EMs patients showed glandular disorganization and stromal fibrosis. In ectopic endometrium, the contents of MDA, ROS, and Fe2+ decreased, while GPX4 level increased, and the mRNA expression of SLC7A11 and GPX4 was upregulated (P<0.05, P<0.01). In serum, the levels of GPX4 and Fe2+ were elevated, whereas the GSH level declined, suggesting abnormalities in ferroptosis-related pathways in ectopic lesions (P<0.05, P<0.01). After intervention with Luoshi Neiyi prescription-containing serum, the intracellular ROS level in ectopic endometrial stromal cells was elevated, the mRNA expression of SLC7A11 and GPX4 was downregulated, and TFR mRNA expression was upregulated (P<0.05, P<0.01). Metabolomics analysis revealed 1104 and 198 differential metabolites in EMs patients and EMs rats, respectively, compared with their corresponding control groups, and both low-dose and high-dose Luoshi Neiyi prescription were found to regulate this metabolic disturbance, with the core regulatory pathways mainly involving arginine and proline metabolism. Correlation analysis showed that the glycerophospholipids including PI(16∶0/17∶0) and PI[18∶2(9Z,12Z)] were negatively correlated with GPX4 and positively correlated with MDA, while 17α-hydroxyprogesterone was positively correlated with GPX4, SLC7A11, and FTH1 q<0.05). ConclusionLuoshi Neiyi prescription may systematically ameliorate disease-associated metabolic dysregulation via modulation of the serum arginine and proline metabolism pathway, and may regulate ferroptosis in ectopic lesions through a mechanism potentially linked to the serum glycerophospholipid and steroid metabolism pathways. Collectively, these findings provide experimental evidence for the clinical application of Luoshi Neiyi prescription.
6.Exploring Mechanism of Luoshi Neiyi Prescription in Treating Endometriosis Based on Ferroptosis and Serum Metabolomics
Haixia PAN ; Yingqiao ZHONG ; Ting MAO ; Ziyi DENG ; Meilin WU ; Lei HUANG ; Siyang CHEN ; Yong GUO ; Ying ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):201-212
ObjectiveThis study aimed to investigate the mechanism by which Luoshi Neiyi prescription treats endometriosis (EMs) through regulating ferroptosis, and to screen key metabolites and analyze their association with ferroptosis. MethodsClinical samples of normal endometrium from patients without EMs and eutopic and ectopic endometrium from EMs patients (10 cases each) were collected and divided into control group, eutopic group, and EMs group. Hematoxylin-eosin (HE) staining was performed to observe ectopic lesions of EMs. Immunohistochemistry was used to detect the expression of solute carrier family 7 member 11 (SLC7A11) and glutathione peroxidase 4 (GPX4). Enzyme-linked immunosorbent assay (ELISA) was adopted to determine the levels of malondialdehyde (MDA), ferrous ion (Fe2+), GPX4 and glutathione (GSH) in endometrial tissues, as well as serum levels of Fe2+, GPX4 and GSH. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of SLC7A11, GPX4, transferrin receptor (TFR) and ferritin heavy chain 1 (FTH1). In the in vitro experiment, primary stromal cells were isolated from ectopic lesions of EMs patients. Cell counting kit-8 (CCK-8) was used to determine the optimal concentration of drug-containing serum for intervention. The level of reactive oxygen species (ROS) was measured, and Real-time PCR was applied to detect ferroptosis-related indicators. In the animal experiments, an EM rat model was established, and the rats were randomly assigned to the sham operation group, EMs group, low-dose Luoshi Neiyi Formula group (7.87 g·kg-1), high-dose Luoshi Neiyi prescription group (15.74 g·kg-1), and danazol group (42 mg·kg-1). Untargeted metabolomics detection and pathway enrichment analysis were conducted on serum samples from patients and rats. Spearman correlation analysis was performed to assess the relationship between differential metabolites and ferroptosis indicators. The correlations between differential metabolites in patient endometrium and serum and key ferroptosis indicators (GPX4, Fe2+, MDA, GSH) as well as ferroptosis-related mRNAs (GPX4, SLC7A11, FTH1) were analyzed, and correlation heatmaps were generated accordingly. ResultsCompared with normal eutopic endometrium, ectopic lesions in EMs patients showed glandular disorganization and stromal fibrosis. In ectopic endometrium, the contents of MDA, ROS, and Fe2+ decreased, while GPX4 level increased, and the mRNA expression of SLC7A11 and GPX4 was upregulated (P<0.05, P<0.01). In serum, the levels of GPX4 and Fe2+ were elevated, whereas the GSH level declined, suggesting abnormalities in ferroptosis-related pathways in ectopic lesions (P<0.05, P<0.01). After intervention with Luoshi Neiyi prescription-containing serum, the intracellular ROS level in ectopic endometrial stromal cells was elevated, the mRNA expression of SLC7A11 and GPX4 was downregulated, and TFR mRNA expression was upregulated (P<0.05, P<0.01). Metabolomics analysis revealed 1104 and 198 differential metabolites in EMs patients and EMs rats, respectively, compared with their corresponding control groups, and both low-dose and high-dose Luoshi Neiyi prescription were found to regulate this metabolic disturbance, with the core regulatory pathways mainly involving arginine and proline metabolism. Correlation analysis showed that the glycerophospholipids including PI(16∶0/17∶0) and PI[18∶2(9Z,12Z)] were negatively correlated with GPX4 and positively correlated with MDA, while 17α-hydroxyprogesterone was positively correlated with GPX4, SLC7A11, and FTH1 q<0.05). ConclusionLuoshi Neiyi prescription may systematically ameliorate disease-associated metabolic dysregulation via modulation of the serum arginine and proline metabolism pathway, and may regulate ferroptosis in ectopic lesions through a mechanism potentially linked to the serum glycerophospholipid and steroid metabolism pathways. Collectively, these findings provide experimental evidence for the clinical application of Luoshi Neiyi prescription.
7.Analysis of Mechanism of Xingpi Capsules in Treatment of Functional Dyspepsia Based on Transcriptomics
Rongxin ZHU ; Mingyue HUANG ; Keyan WANG ; Xiangning LIU ; Yinglan LYU ; Gang WANG ; Fangfang RUI ; Qiong DENG ; Jianteng DONG ; Yong WANG ; Chun LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):164-172
ObjectiveTo investigate the ameliorative effect of Xingpi capsules on functional dyspepsia(FD) and the potential mechanism. MethodsSixty SPF-grade male SD neonatal rats(7 days old) were randomly divided into the normal group(n=12) and the modeling group(n=48), and the FD model was prepared by iodoacetamide gavage in the modeling group. After the model was successfully prepared, the rats in the modeling group were randomly divided into the model group, the low-dose and high-dose groups of Xingpi capsules(0.135, 0.54 g·kg-1) and the domperidone group(3 mg·kg-1), with 12 rats in each group. Rats in the normal and model groups were gavaged with distilled water, and rats in the rest of the groups were gavaged with the corresponding medicinal solution, once a day for 7 d. The general survival condition of the rats was observed, and the water intake and food intake of the rats were measured, the gastric emptying rate and the small intestinal propulsion rate were measured at the end of the treatment, the pathological damage of the rat duodenum was examined by hematoxylin-eosin(HE) staining, and the expressions of colonic tight junction protein(Occludin) and zonula occludens protein-1(ZO-1) were detected by immunofluorescence. The differentially expressed genes in the duodenal tissues of the model group and the normal group, and the high-dose group of Xingpi capsules and the model group were detected by transcriptome sequencing after the final administration, and Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses were carried out. The transcriptomic results were validated by Western blot, immunofluorescence, and real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the active ingredients of Xingpi capsules were screened for molecular docking with the key targets. ResultsCompared with the normal group, the general survival condition of rats in the model group was poorer, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly reduced(P<0.05), inflammatory infiltration was seen in duodenal pathology, and the fluorescence intensities of Occludin and ZO-1 in the colon were significantly reduced(P<0.01). Compared with the model group, the general survival condition of rats in the high-dose group of Xingpi capsules improved significantly, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly increased(P<0.05), the duodenal pathology showed a decrease in inflammatory infiltration, and the fluorescence intensities of colonic Occludin and ZO-1 were significantly increased(P<0.01). Transcriptomic results showed that Xingpi capsules might exert therapeutic effects by regulating the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) through the key genes such as Slc5a1, Abhd6. The validation results showed that compared with the normal group, the phosphorylation levels of PI3K and Akt proteins, the protein expression level of interleukin(IL)-1β, and the fluorescence intensities of IL-6 and IL-1β were significantly increased in the model group(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3, Slc5a9 and other key genes were significantly increased(P<0.01). Compared with the model group, the phosphorylation levels of PI3K and Akt, the protein expression level of IL-1β and the fluorescence intensities of IL-6 and IL-1β in the high-dose group of Xingpi capsules were significantly reduced(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3 and Slc5a9 were significantly reduced(P<0.05). Weighted gene co-expression network analysis and molecular docking results showed that E-nerolidol and Z-nerolidol in Xingpi capsules were well bound to ABDH6 protein, and linarionoside A, valerosidatum and senkirkine were well bound to Slc5a1 protein. ConclusionXingpi capsules can effectively improve the general survival and gastrointestinal motility of FD rats, its specific mechanism may be related to the inhibition of PI3K/Akt signaling pathway to alleviate the low-grade inflammation of duodenum, and E-nerolidol, Z-nerolidol, linarionoside A, valerosidatum and senkirkine may be its key active ingredients.
8.Analysis of Mechanism of Xingpi Capsules in Treatment of Functional Dyspepsia Based on Transcriptomics
Rongxin ZHU ; Mingyue HUANG ; Keyan WANG ; Xiangning LIU ; Yinglan LYU ; Gang WANG ; Fangfang RUI ; Qiong DENG ; Jianteng DONG ; Yong WANG ; Chun LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):164-172
ObjectiveTo investigate the ameliorative effect of Xingpi capsules on functional dyspepsia(FD) and the potential mechanism. MethodsSixty SPF-grade male SD neonatal rats(7 days old) were randomly divided into the normal group(n=12) and the modeling group(n=48), and the FD model was prepared by iodoacetamide gavage in the modeling group. After the model was successfully prepared, the rats in the modeling group were randomly divided into the model group, the low-dose and high-dose groups of Xingpi capsules(0.135, 0.54 g·kg-1) and the domperidone group(3 mg·kg-1), with 12 rats in each group. Rats in the normal and model groups were gavaged with distilled water, and rats in the rest of the groups were gavaged with the corresponding medicinal solution, once a day for 7 d. The general survival condition of the rats was observed, and the water intake and food intake of the rats were measured, the gastric emptying rate and the small intestinal propulsion rate were measured at the end of the treatment, the pathological damage of the rat duodenum was examined by hematoxylin-eosin(HE) staining, and the expressions of colonic tight junction protein(Occludin) and zonula occludens protein-1(ZO-1) were detected by immunofluorescence. The differentially expressed genes in the duodenal tissues of the model group and the normal group, and the high-dose group of Xingpi capsules and the model group were detected by transcriptome sequencing after the final administration, and Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses were carried out. The transcriptomic results were validated by Western blot, immunofluorescence, and real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the active ingredients of Xingpi capsules were screened for molecular docking with the key targets. ResultsCompared with the normal group, the general survival condition of rats in the model group was poorer, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly reduced(P<0.05), inflammatory infiltration was seen in duodenal pathology, and the fluorescence intensities of Occludin and ZO-1 in the colon were significantly reduced(P<0.01). Compared with the model group, the general survival condition of rats in the high-dose group of Xingpi capsules improved significantly, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly increased(P<0.05), the duodenal pathology showed a decrease in inflammatory infiltration, and the fluorescence intensities of colonic Occludin and ZO-1 were significantly increased(P<0.01). Transcriptomic results showed that Xingpi capsules might exert therapeutic effects by regulating the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) through the key genes such as Slc5a1, Abhd6. The validation results showed that compared with the normal group, the phosphorylation levels of PI3K and Akt proteins, the protein expression level of interleukin(IL)-1β, and the fluorescence intensities of IL-6 and IL-1β were significantly increased in the model group(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3, Slc5a9 and other key genes were significantly increased(P<0.01). Compared with the model group, the phosphorylation levels of PI3K and Akt, the protein expression level of IL-1β and the fluorescence intensities of IL-6 and IL-1β in the high-dose group of Xingpi capsules were significantly reduced(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3 and Slc5a9 were significantly reduced(P<0.05). Weighted gene co-expression network analysis and molecular docking results showed that E-nerolidol and Z-nerolidol in Xingpi capsules were well bound to ABDH6 protein, and linarionoside A, valerosidatum and senkirkine were well bound to Slc5a1 protein. ConclusionXingpi capsules can effectively improve the general survival and gastrointestinal motility of FD rats, its specific mechanism may be related to the inhibition of PI3K/Akt signaling pathway to alleviate the low-grade inflammation of duodenum, and E-nerolidol, Z-nerolidol, linarionoside A, valerosidatum and senkirkine may be its key active ingredients.
9.Clinical Efficacy of Tangning Tongluo Tablets for Nonproliferative Diabetic Retinopathy
Fuwen ZHANG ; Junguo DUAN ; Wen XIA ; Tiantian SUN ; Yuheng SHI ; Shicui MEI ; Xiangxia LUO ; Xing LI ; Yujie PAN ; Yong DENG ; Chuanlian RAN ; Hao CHEN ; Li PEI ; Shuyu YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):132-139
ObjectiveTo observe the clinical efficacy and safety of Tangning Tongluo tablets in the treatment of nonproliferative diabetic retinopathy (DR). MethodsFourteen research centers participated in this study, which spanned a time interval from September 2021 to May 2023. A total of 240 patients with nonproliferative DR were included and randomly assigned into an observation group (120 cases) and a control group (120 cases). The observation group was treated with Tangning Tongluo tablets, and the control group with calcium dobesilate capsules. Both groups were treated for 24 consecutive weeks. The vision, DR progression rate, retinal microhemangioma, hemorrhage area, exudation area, glycosylated hemoglobin (HbA1c) level, and TCM syndrome score were assessed before and after treatment, and the safety was observed. ResultsThe vision changed in both groups after treatment (P<0.05), and the observation group showed higher best corrected visual acuity (BCVA) than the control group (P<0.05). The DR progression was slow with similar rates in the two groups. The fundus hemorrhage area and exudation area did not change significantly after treatment in both groups, while the observation group outperformed the control group in reducing the fundus hemorrhage area and exudation area. There was no significant difference in the number of microhemangiomas between the two groups before treatment. After treatment, the number of microhemangiomas decreased in both the observation group (Z=-1.437, P<0.05) and the control group (Z=-2.238, P<0.05), and it showed no significant difference between the two groups. As the treatment time prolonged, the number of microhemangiomas gradually decreased in both groups. There was no significant difference in the HbA1c level between the two groups before treatment. After treatment, the decline in the HbA1c level showed no significant difference between the two groups. The TCM syndrome score did not have a statistically significant difference between the two groups before treatment. After treatment, neither the TCM syndrome score nor the response rate had significant difference between the two groups. With the extension of the treatment time, both groups showed amelioration of TCM syndrome compared with the baseline. ConclusionTangning Tongluo tablets are safe and effective in the treatment of nonproliferative DR, being capable of improving vision and reducing hemorrhage and exudation in the fundus.
10.In Vitro and in vivo Component Analysis of Total Phenolic Acids from Gei Herba and Its Effect on Promoting Acute Wound Healing and Inhibiting Scar Formation
Xixian KONG ; Guanghuan TIAN ; Tong WU ; Shaowei HU ; Jie ZHAO ; Fuzhu PAN ; Jingtong LIU ; Yong DENG ; Yi OUYANG ; Hongwei WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):156-167
ObjectiveBased on ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Orbitrap-MS), to identify the in vivo and in vitro chemical components of total phenolic acids in Gei Herba(TPAGH), and to clarify the pharmacological effects and potential mechanisms of the effective part in promoting acute wound healing and inhibiting scar formation. MethodsUPLC-Q-Orbitrap-MS was used to identify the chemical components of TPAGH and ingredients absorbed in vivo after topical administration. A total of 120 ICR mice were randomly divided into the model group, recombinant human epidermal growth factor(rhEGF) group(4 mg·kg-1), and low, medium, and high dose groups of TPAGH(3.5, 7, 14 mg·kg-1), with 24 mice in each group. A full-thickness skin excision model was constructed, and each administration group was coated with the drug at the wound site, and the model group was treated with an equal volume of normal saline, the treatment was continued for 30 days, during which 8 mice from each group were sacrificed on days 6, 12, and 30. The healing of the wounds in the mice was observed, and histopathological changes in the skin tissues were dynamically observed by hematoxylin-eosin(HE), Masson, and Sirius red staining, and enzyme-linked immunosorbent assay(ELISA) was used to dynamically measure the contents of interleukin-6(IL-6), tumor necrosis factor-α(TNF-α), vascular endothelial growth factor A(VEGFA), matrix metalloproteinase(MMP)-3 and MMP-9 in skin tissues. Network pharmacology was used to predict the targets related to the promotion of acute wound healing and the inhibition of scar formation by TPAGH, and molecular docking of key components and targets was performed. Gene Ontology(GO) biological process analysis and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analysis were carried out for the related targets, so as to construct a network diagram of herbal material-compound-target-pathway-pharmacological effect-disease for further exploring its potential mechanisms. ResultsA total of 146 compounds were identified in TPAGH, including 28 phenylpropanoids, 31 tannins, 23 triterpenes, 49 flavonoids, and 15 others, and 16 prototype components were found in the serum of mice. Pharmacodynamic results showed that, compared with the model group, the TPAGH groups showed a significant increase in relative wound healing rate and relative scar inhibition rate(P<0.05), and the number of new capillaries, number of fibroblasts, number of new skin appendages, epidermal regeneration rate, collagen deposition ratio, and Ⅲ/Ⅰ collagen ratio in the tissue were significantly improved(P<0.05, 0.01), the levels of IL-6, TNF-α, MMP-3 and MMP-9 in the skin tissues were reduced to different degrees, while the level of VEGFA was increased. Network pharmacology analysis screened 10 core targets, including tumor protein 53(TP53), sarcoma receptor coactivator(SRC), protein kinase B(Akt)1, signal transducer and activator of transcription 3(STAT3), epidermal growth factor receptor(EGFR) and so on, participating in 75 signaling pathways such as advanced glycation end-products(AGE)-receptor for AGE(AGE/RAGE) signaling pathway, phosphatidylinositol 3-kinase(PI3K)/Akt signaling pathway, mitogen-activated protein kinase(MAPK) signaling pathway. Molecular docking confirmed that the key components genistein, geraniin, and casuariin had good binding ability to TP53, SRC, Akt1, STAT3 and EGFR. ConclusionThis study comprehensively reflects the chemical composition of TPAGH and the absorbed components after topical administration through UPLC-Q-Orbitrap-MS. TPAGH significantly regulates key indicators of skin healing and tissue reconstruction, thereby clarifying its role in promoting acute wound healing and inhibiting scar formation. By combining in vitro and in vivo component identification with network pharmacology, the study explores how key components may bind to targets such as TP53, Akt1 and EGFR, exerting therapeutic effects through related pathways such as immune inflammation and vascular regeneration.


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