1.Research on the Coordinated Implementation Strategy Between the Chinese Pharmacopoeia Pharmaceutical Excipient Standards and ICH Q3C
Min CHEN ; Weicong WU ; Yu SONG ; Caimei WANG ; Yajuan GUO ; Ying CHEN ; Lei CHEN
Herald of Medicine 2025;44(2):208-212
Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.
2.Differences in cytokines expression between mild and severe infant cases infected with respiratory syncytial virus
Guangyu XUE ; Yuting HU ; Kexin ZONG ; Qin LUO ; Shengnan YANG ; Miao FENG ; Xiaoyu YI ; Zhiqiang XIA ; Chen GAO ; Haijun DU ; Ying LI ; Ying CHEN ; Feng HE ; Yajuan WANG ; Yingli QU ; Jin CAO ; Wenyan TIAN ; Qinqin SONG ; Hailan YAO ; Jun HAN
Chinese Journal of Experimental and Clinical Virology 2025;39(3):370-377
Objective:To analyze the clinical characteristics and cytokines expression characteristics in infants with mild and severe respiratory syncytial virus (RSV) infection.Methods:From May 2023 to December 2023, plasma samples and clinical information were collected from 16 infants with RSV infection and 14 control infants. Cytek Aurora flow cytometry (Cytek, America) and Enzyme linked immunosorbent assay (ELISA) were used to detect the expression levels of 25 cytokines after mild and severe RSV infection.Results:Cough and nasal obstruction were the main clinical manifestations in infants with mild RSV infection, accompanied by polypnea, wheezing and other symptoms. The main symptoms of severe RSV infection were cough and rales, accompanied by fever and polypnea. In comparison with the control group, the expression levels of IL-2, IL-4, IL-5, IL-6, IL-9, IL-13, IL-22, TNF-α, IFN-α, IFN-β, MIP-1β, I-TAC, ENA-78, GROα, Eotaxin, and MCP-1 in the RSV infection group all exhibited an upregulation trend. Both IP-10 and MIP-3α demonstrated a downward trend in the RSV infection group; however, there was no statistically significant difference ( P>0.05). The levels of IL-10, IFN-γ, MIP-1α, and IL-8 in the RSV infection group were significantly higher than those in the control group, whereas the levels of MIG, TARC, and RANTES in the RSV infection group were significantly lower than those in the control group ( P<0.05). The levels of IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-22, IFN-β, IFN-γ, TNF-α, IL-8, I-TAC, MIP-1β, Eotaxin, and MCP-1 in the mild RSV infection group were significantly higher than those in the severe RSV infection group ( P>0.05). Among these, the levels of MIG, RANTES, TARC, MIP-3α, and ENA-78 in the mild infection group were all lower than those in the severe infection group. The expressions of ENA-78 and MIP-1α in the severe infection group were significantly higher than those in the mild infection group and also higher than those in the control group. There was no significant difference in IP-10 and GROα between the mild and severe RSV infection groups ( P>0.05). Conclusions:The differences in clinical features and cytokines between infants with mild and severe RSV infection provide important data support for the prevention and treatment of RSV infection in infants.
3.Research on the Coordinated Implementation Strategy Between the Chinese Pharmacopoeia Pharmaceutical Excipient Standards and ICH Q3C
Min CHEN ; Weicong WU ; Yu SONG ; Caimei WANG ; Yajuan GUO ; Ying CHEN ; Lei CHEN
Herald of Medicine 2025;44(2):208-212
Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.
4.Differences in cytokines expression between mild and severe infant cases infected with respiratory syncytial virus
Guangyu XUE ; Yuting HU ; Kexin ZONG ; Qin LUO ; Shengnan YANG ; Miao FENG ; Xiaoyu YI ; Zhiqiang XIA ; Chen GAO ; Haijun DU ; Ying LI ; Ying CHEN ; Feng HE ; Yajuan WANG ; Yingli QU ; Jin CAO ; Wenyan TIAN ; Qinqin SONG ; Hailan YAO ; Jun HAN
Chinese Journal of Experimental and Clinical Virology 2025;39(3):370-377
Objective:To analyze the clinical characteristics and cytokines expression characteristics in infants with mild and severe respiratory syncytial virus (RSV) infection.Methods:From May 2023 to December 2023, plasma samples and clinical information were collected from 16 infants with RSV infection and 14 control infants. Cytek Aurora flow cytometry (Cytek, America) and Enzyme linked immunosorbent assay (ELISA) were used to detect the expression levels of 25 cytokines after mild and severe RSV infection.Results:Cough and nasal obstruction were the main clinical manifestations in infants with mild RSV infection, accompanied by polypnea, wheezing and other symptoms. The main symptoms of severe RSV infection were cough and rales, accompanied by fever and polypnea. In comparison with the control group, the expression levels of IL-2, IL-4, IL-5, IL-6, IL-9, IL-13, IL-22, TNF-α, IFN-α, IFN-β, MIP-1β, I-TAC, ENA-78, GROα, Eotaxin, and MCP-1 in the RSV infection group all exhibited an upregulation trend. Both IP-10 and MIP-3α demonstrated a downward trend in the RSV infection group; however, there was no statistically significant difference ( P>0.05). The levels of IL-10, IFN-γ, MIP-1α, and IL-8 in the RSV infection group were significantly higher than those in the control group, whereas the levels of MIG, TARC, and RANTES in the RSV infection group were significantly lower than those in the control group ( P<0.05). The levels of IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-22, IFN-β, IFN-γ, TNF-α, IL-8, I-TAC, MIP-1β, Eotaxin, and MCP-1 in the mild RSV infection group were significantly higher than those in the severe RSV infection group ( P>0.05). Among these, the levels of MIG, RANTES, TARC, MIP-3α, and ENA-78 in the mild infection group were all lower than those in the severe infection group. The expressions of ENA-78 and MIP-1α in the severe infection group were significantly higher than those in the mild infection group and also higher than those in the control group. There was no significant difference in IP-10 and GROα between the mild and severe RSV infection groups ( P>0.05). Conclusions:The differences in clinical features and cytokines between infants with mild and severe RSV infection provide important data support for the prevention and treatment of RSV infection in infants.
5.Photobiomodulation Facilitates Rat Cutaneous Wound Healing by Promoting Epidermal Stem Cells and Hair Follicle Stem Cells Proliferation
Tong WANG ; Yajuan SONG ; Liu YANG ; Wei LIU ; Zhen’an HE ; Yi SHI ; Baoqiang SONG ; Zhou YU
Tissue Engineering and Regenerative Medicine 2024;21(1):65-79
BACKGROUND:
Cutaneous wound healing represents a common fundamental phenomenon requiring the participation of cells of distinct types and a major concern for the public. Evidence has confirmed that photobiomodulation (PBM) using near-infrared (NIR) can promote wound healing, but the cells involved and the precise molecular mechanisms remain elusive.
METHODS:
Full-thickness skin defects with a diameter of 1.0 cm were made on the back of rats and randomly divided into the control group, 10 J, 15 J, and 30 J groups. The wound healing rate at days 4, 8, and 12 postoperatively was measured. HE and Masson staining was conducted to reveal the histological characteristics. Immunofluorescence staining was performed to label the epidermal stem cells (ESCs) and hair follicle stem cells (HFSCs). Western blot was performed to detect the expressions of proteins associated with ESCs and HFSCs. Cutaneous wound tissues were collected for RNA sequencing. Gene ontology and the Kyoto Encyclopedia of Genes and Genomes analysis was performed, and the hub genes were identified using CytoHubba and validated by qRT-PCR.
RESULTS:
PBM can promote reepithelialization, extracellular matrix deposition, and wound healing, increase the number of KRT14+/PCNA+ ESCs and KRT15+/PCNA+ HFSCs, and upregulate the protein expression of P63, Krt14, and PCNA. Three hundred and sixty-six differentially expressed genes (DEGs) and 7 hub genes including Sox9, Krt5, Epcam, Cdh1, Cdh3, Dsp, and Pkp3 were identified. These DEGs are enriched in skin development, cell junction, and cadherin binding involved in cell–cell adhesion etc., while these hub genes are related to skin derived stem cells and cell adhesion.
CONCLUSION
PBM accelerates wound healing by enhancing reepithelialization through promoting ESCs and HFSCs proliferation and elevating the expression of genes associated with stem cells and cell adhesion. This may provide a valuable alternative strategy to promote wound healing and reepithelialization by modulating the proliferation of skin derived stem cells and regulating genes related to cell adhesion.
6.New Ideas for Lean Management System Construction in Public Hospitals under the Connotation Framework of New Quality Productive Forces
Xiong SONG ; Yajuan LIU ; Hongmei LIANG ; Shaochun YANG
Chinese Hospital Management 2024;44(10):55-57
New quality productive forces are advanced productive forces in line with the new development concept,with the characteristics of high technology,high efficiency and high quality.It has a guiding role in realizing the high-quality and sustainable development of public hospitals.Starting from the basic connotation of the new quality productivity,it studies the core elements and implementation paths of establishing a lean management system that meets the requirements of high-quality development of public hospitals from the perspective of the leap in the combination of labourers,labour materials,labour objects and their optimisation.Combined with the actual situation of Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine,the specific application path is discussed,in order to be able to achieve the transformation and upgrading of public hospitals to provide experience to learn from.
7.New Ideas for Lean Management System Construction in Public Hospitals under the Connotation Framework of New Quality Productive Forces
Xiong SONG ; Yajuan LIU ; Hongmei LIANG ; Shaochun YANG
Chinese Hospital Management 2024;44(10):55-57
New quality productive forces are advanced productive forces in line with the new development concept,with the characteristics of high technology,high efficiency and high quality.It has a guiding role in realizing the high-quality and sustainable development of public hospitals.Starting from the basic connotation of the new quality productivity,it studies the core elements and implementation paths of establishing a lean management system that meets the requirements of high-quality development of public hospitals from the perspective of the leap in the combination of labourers,labour materials,labour objects and their optimisation.Combined with the actual situation of Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine,the specific application path is discussed,in order to be able to achieve the transformation and upgrading of public hospitals to provide experience to learn from.
8.New Ideas for Lean Management System Construction in Public Hospitals under the Connotation Framework of New Quality Productive Forces
Xiong SONG ; Yajuan LIU ; Hongmei LIANG ; Shaochun YANG
Chinese Hospital Management 2024;44(10):55-57
New quality productive forces are advanced productive forces in line with the new development concept,with the characteristics of high technology,high efficiency and high quality.It has a guiding role in realizing the high-quality and sustainable development of public hospitals.Starting from the basic connotation of the new quality productivity,it studies the core elements and implementation paths of establishing a lean management system that meets the requirements of high-quality development of public hospitals from the perspective of the leap in the combination of labourers,labour materials,labour objects and their optimisation.Combined with the actual situation of Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine,the specific application path is discussed,in order to be able to achieve the transformation and upgrading of public hospitals to provide experience to learn from.
9.New Ideas for Lean Management System Construction in Public Hospitals under the Connotation Framework of New Quality Productive Forces
Xiong SONG ; Yajuan LIU ; Hongmei LIANG ; Shaochun YANG
Chinese Hospital Management 2024;44(10):55-57
New quality productive forces are advanced productive forces in line with the new development concept,with the characteristics of high technology,high efficiency and high quality.It has a guiding role in realizing the high-quality and sustainable development of public hospitals.Starting from the basic connotation of the new quality productivity,it studies the core elements and implementation paths of establishing a lean management system that meets the requirements of high-quality development of public hospitals from the perspective of the leap in the combination of labourers,labour materials,labour objects and their optimisation.Combined with the actual situation of Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine,the specific application path is discussed,in order to be able to achieve the transformation and upgrading of public hospitals to provide experience to learn from.
10.New Ideas for Lean Management System Construction in Public Hospitals under the Connotation Framework of New Quality Productive Forces
Xiong SONG ; Yajuan LIU ; Hongmei LIANG ; Shaochun YANG
Chinese Hospital Management 2024;44(10):55-57
New quality productive forces are advanced productive forces in line with the new development concept,with the characteristics of high technology,high efficiency and high quality.It has a guiding role in realizing the high-quality and sustainable development of public hospitals.Starting from the basic connotation of the new quality productivity,it studies the core elements and implementation paths of establishing a lean management system that meets the requirements of high-quality development of public hospitals from the perspective of the leap in the combination of labourers,labour materials,labour objects and their optimisation.Combined with the actual situation of Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine,the specific application path is discussed,in order to be able to achieve the transformation and upgrading of public hospitals to provide experience to learn from.

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