1.Intelligent blood logistics reinvention: HFMEA-applied transport pathway optimization for biopharmaceutical safety assurance
Qiming YING ; Fangfang JIN ; Fengmin XU ; Jiaji HU ; Danni SONG ; Bin WU ; Qinhong XU ; Dingfeng LYU
Chinese Journal of Blood Transfusion 2026;39(1):123-127
Objective: To explore the application effectiveness of healthcare failure mode and effect analysis (HFMEA) in optimizing intelligent blood logistics transport pathways for safety assurance. Methods: Data from 1 851 cases of intelligent blood logistics transport were collected between September 2023 and March 2025. Based on the implementation phases of HFMEA measures, the cases were divided into a control group (n=120), observation group 1 (n=219), and observation group 2 (n=1 512). Through systematic analysis of the transport processes, hazard scoring and decision tree analysis were conducted for each process, and phased optimization measures were implemented for high-risk failure modes. Results: The transport duration of intelligent blood logistics was 35.5 (20.8, 71.1) min in the control group, 25.1 (10.9, 40.7) min in observation group 1, and 9.9 (4.2, 44.5) min in observation group 2. Observation group 2 exhibited significantly shorter transport time compared to both observation group 1 and the control group, with statistically significant differences between groups (P<0.000 1). Conclusion: The implementation of HFMEA-driven measures significantly reduced intelligent blood logistics transport duration, thereby fostering the evolution of smart hospital ecosystems while enhancing healthcare service quality and operational efficiency.
2.Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
XU Xinyi ; WEI Shifeng ; ZHANG Qiming ; HE Langchong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):045-050
Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.
3.Establishment of Occupational Health Related Files in Laboratory Animal Institutions
Chao XU ; Qiufang SUN ; Qiming SHAO
Laboratory Animal and Comparative Medicine 2025;45(2):214-220
Establishing occupational health related files is a key component of building an occupational health and safety management system in laboratory animal institutions.These files not only serve as a critical means of protecting the legitimate rights and interests of laboratory animal personnel but also provide institutional safeguards.According to relevant laws and regulations,laboratory animal institutions are responsible for establishing and properly maintaining occupational health surveillance files(also known as occupational hygiene files)for both the institution and its personnel.In accordance with the Occupational Health Archives Management Standards,laboratory animal institutions are required to maintain at least seven categories of occupational health management archive folders:the"three simultaneous"occupational health archives for construction projects;occupational health management folders;occupational health publicity and training folders;folders for monitoring and evaluating occupational disease hazard factors;employer occupational health surveillance folders;individual occupational health surveillance folders for employees;and other relevant folders.Building upon this foundation,the Regulations on the Supervision and Administration of Occupational Health in the Workplaces further specify detailed requirements for occupational health files.These include:documents outlining the responsibility system for occupational disease prevention and control;occupational hygiene management systems and standard operating procedures,lists of types of occupational disease hazard factors in workplaces,their distribution by job distribution,and records of work exposure,basic information on occupational disease prevention and emergency rescue facilities,along with records of their allocation,usage,maintenance,inspection and replacement;records concerning the provision,distribution,maintenance and replacement of personal protective equipment(PPE);and reports on occupational disease hazard incidents;and corresponding emergency response records—amounting to twelve specific requirements in total.In short,occupational health management files are a comprehensive collection of data and documentation related to workers'occupational health.Based on the author's practical experience,this paper outlines the main types of occupational health management files,their basic contents,and key points in their development.It also offers a detailed analysis of how to establish such files,aiming to support laboratory animal institutions in successfully developing occupational health management archives and improving their occupational health and safety management systems.
4.Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
Xinyi XU ; Shifeng WEI ; Qiming ZHANG ; Langchong HE ; Jun ZHANG ; Shuangcheng MA
Drug Standards of China 2025;26(1):45-50
Objective:To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.Methods:Intro-duce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.Results:The general chapters of physi-cal and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guide-lines of the ICH Q series,and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety,efficacy,and quality controllability is further increased.Conclusion:The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China's drugs to go international,standardized testing technology support for achieving full process quality control,and better meet the needs of drug research and development,production,quality control,and supervision in China.
5.Analysis of Coordination Strategies with ICH Q3C for Residual Solvent Control in Pharmacopoeia of Various Countries
Min CHEN ; Weicong WU ; Xinyi XU ; Suming WANG ; Xiao LING ; Qiming ZHANG ; Ying CHEN ; Lei CHEN
Herald of Medicine 2025;44(2):227-235
Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.
6.Analysis of Coordination Strategies with ICH Q3C for Residual Solvent Control in Pharmacopoeia of Various Countries
Min CHEN ; Weicong WU ; Xinyi XU ; Suming WANG ; Xiao LING ; Qiming ZHANG ; Ying CHEN ; Lei CHEN
Herald of Medicine 2025;44(2):227-235
Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.
7.Exploration on the Effects of Yiqi Huoxue Huazhuo Jiedu Prescription on Cerebral Ischemia Reperfusion Injury in Rats Based on PERK/ATF4 Signaling Pathway
Tiantian XU ; Ye TIAN ; Shiduo WANG ; Jiayun ZHANG ; Qiming LIU ; Zhe ZHANG ; Xi LI ; Junbiao TIAN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):81-87
Objective To investigate the mechanism of Yiqi Huoxue Huazhuo Jiedu Prescription in regulating the endoplasmic reticulum stress PERK/ATF4 signaling pathway to improve cerebral ischemia reperfusion injury in rats.Methods A total of 48 male SD rats were randomly divided into sham-operation group,model group,TCM group and edaravone group,with 12 rats in each group.Cerebral ischemia reperfusion injury rat model was prepared using middle cerebral artery occlusion method,and administration 24 hours after modeling.The edaravone group was given intraperitoneal injection of 1.4 mg/mL edaravone injection,TCM group was given 55 g/(kg·d)of Yiqi Huoxue Huazhuo Jiedu Prescription for gavage,while the sham-operation group and model group were given equal volumes of normal saline for gavage,twice a day for 3 consecutive days.The neurological deficit scores of the rats in each group were observed,TTC staining was used to detect the volume of cerebral infarction,HE staining was used to observe the morphology of brain tissue in the ischemia-reperfusion area,immunohistochemistry staining was used to detect the positive expressions of glucose regulated protein 78(GRP78),protein kinase R-like endoplasmic reticulum kinase(PERK)and transcription activator factor(ATF)4 in the ischemia-reperfusion area brain tissue,RT-PCR was used to detect the mRNA expressions of GRP78,PERK and ATF4 in the ischemia-reperfusion area brain tissue,Western blot was used to detect the protein expressions of GRP78,PERK and ATF4 in the ischemia-reperfusion area brain tissue.Results Compared with the sham-operation group,the neurological deficit score of the model group rats increased,the volume of cerebral infarction increased,the number of neurons in the ischemia-reperfusion area decreased,the arrangement was loose,and the nuclei were condensed,the mRNA and protein expressions of GRP78,PERK and ATF4 increased,with statistical significance(P<0.05).Compared with the model group,the neurological deficit score of TCM group and edaravone group decreased,the cerebral infarction volume decreased,the number and arrangement of neurons of the brain tissue in the ischemia reperfusion area increased,and nuclear condensation decreased in rats,the mRNA and protein expressions of GRP78,PERK and ATF4 were all reduced,with statistical significance(P<0.05).There was no statistical significance in various indicators between TCM group and the edaravone group(P>0.05).Conclusion Yiqi Huoxue Huazhuo Jiedu Prescription can improve cerebral ischemia reperfusion injury,and its mechanism may be related to down-regulating the expression of PERK/ATF4 signaling pathway and alleviating endoplasmic reticulum stress.
8.Establishment of Occupational Health Related Files in Laboratory Animal Institutions
Chao XU ; Qiufang SUN ; Qiming SHAO
Laboratory Animal and Comparative Medicine 2025;45(2):214-220
Establishing occupational health related files is a key component of building an occupational health and safety management system in laboratory animal institutions.These files not only serve as a critical means of protecting the legitimate rights and interests of laboratory animal personnel but also provide institutional safeguards.According to relevant laws and regulations,laboratory animal institutions are responsible for establishing and properly maintaining occupational health surveillance files(also known as occupational hygiene files)for both the institution and its personnel.In accordance with the Occupational Health Archives Management Standards,laboratory animal institutions are required to maintain at least seven categories of occupational health management archive folders:the"three simultaneous"occupational health archives for construction projects;occupational health management folders;occupational health publicity and training folders;folders for monitoring and evaluating occupational disease hazard factors;employer occupational health surveillance folders;individual occupational health surveillance folders for employees;and other relevant folders.Building upon this foundation,the Regulations on the Supervision and Administration of Occupational Health in the Workplaces further specify detailed requirements for occupational health files.These include:documents outlining the responsibility system for occupational disease prevention and control;occupational hygiene management systems and standard operating procedures,lists of types of occupational disease hazard factors in workplaces,their distribution by job distribution,and records of work exposure,basic information on occupational disease prevention and emergency rescue facilities,along with records of their allocation,usage,maintenance,inspection and replacement;records concerning the provision,distribution,maintenance and replacement of personal protective equipment(PPE);and reports on occupational disease hazard incidents;and corresponding emergency response records—amounting to twelve specific requirements in total.In short,occupational health management files are a comprehensive collection of data and documentation related to workers'occupational health.Based on the author's practical experience,this paper outlines the main types of occupational health management files,their basic contents,and key points in their development.It also offers a detailed analysis of how to establish such files,aiming to support laboratory animal institutions in successfully developing occupational health management archives and improving their occupational health and safety management systems.
9.Exploration on the Effects of Yiqi Huoxue Huazhuo Jiedu Prescription on Cerebral Ischemia Reperfusion Injury in Rats Based on PERK/ATF4 Signaling Pathway
Tiantian XU ; Ye TIAN ; Shiduo WANG ; Jiayun ZHANG ; Qiming LIU ; Zhe ZHANG ; Xi LI ; Junbiao TIAN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):81-87
Objective To investigate the mechanism of Yiqi Huoxue Huazhuo Jiedu Prescription in regulating the endoplasmic reticulum stress PERK/ATF4 signaling pathway to improve cerebral ischemia reperfusion injury in rats.Methods A total of 48 male SD rats were randomly divided into sham-operation group,model group,TCM group and edaravone group,with 12 rats in each group.Cerebral ischemia reperfusion injury rat model was prepared using middle cerebral artery occlusion method,and administration 24 hours after modeling.The edaravone group was given intraperitoneal injection of 1.4 mg/mL edaravone injection,TCM group was given 55 g/(kg·d)of Yiqi Huoxue Huazhuo Jiedu Prescription for gavage,while the sham-operation group and model group were given equal volumes of normal saline for gavage,twice a day for 3 consecutive days.The neurological deficit scores of the rats in each group were observed,TTC staining was used to detect the volume of cerebral infarction,HE staining was used to observe the morphology of brain tissue in the ischemia-reperfusion area,immunohistochemistry staining was used to detect the positive expressions of glucose regulated protein 78(GRP78),protein kinase R-like endoplasmic reticulum kinase(PERK)and transcription activator factor(ATF)4 in the ischemia-reperfusion area brain tissue,RT-PCR was used to detect the mRNA expressions of GRP78,PERK and ATF4 in the ischemia-reperfusion area brain tissue,Western blot was used to detect the protein expressions of GRP78,PERK and ATF4 in the ischemia-reperfusion area brain tissue.Results Compared with the sham-operation group,the neurological deficit score of the model group rats increased,the volume of cerebral infarction increased,the number of neurons in the ischemia-reperfusion area decreased,the arrangement was loose,and the nuclei were condensed,the mRNA and protein expressions of GRP78,PERK and ATF4 increased,with statistical significance(P<0.05).Compared with the model group,the neurological deficit score of TCM group and edaravone group decreased,the cerebral infarction volume decreased,the number and arrangement of neurons of the brain tissue in the ischemia reperfusion area increased,and nuclear condensation decreased in rats,the mRNA and protein expressions of GRP78,PERK and ATF4 were all reduced,with statistical significance(P<0.05).There was no statistical significance in various indicators between TCM group and the edaravone group(P>0.05).Conclusion Yiqi Huoxue Huazhuo Jiedu Prescription can improve cerebral ischemia reperfusion injury,and its mechanism may be related to down-regulating the expression of PERK/ATF4 signaling pathway and alleviating endoplasmic reticulum stress.
10.Research on the Current Situation of Synergistic Allocation of Production Factors in Medical Research Institutions under the Perspective of New Quality Productivity
Xianjing LI ; Rong PENG ; Lülü WEI ; Shanshan MENG ; Xianjing TAN ; Qiming FENG ; Tingting XU
Chinese Health Economics 2024;43(9):65-69
Objective:To explore the current situation of synergistic allocation of factors of production in China's medical research institutes,sort out the focuses and deficiencies of the existing policies,so as to provide references for the optimization of production factor and the new quality productivity formation in medical institutions.Methods:Based on the two-factor productivity theory,the index evaluation system is constructed,and the composite system synergy model is used to analyze the degree of order of production factors and the degree of synergy of the composite system,and explore the change of synergy degree of each sequential covariate;and the macro model of the health system is used in conjunction with the content analysis method to carry out the frequency counting of the policies to promote the enhancement of the capacity of each production factor of the main body of innovation of the medical scientific research institutes.Results:The synergistic degree of the production factors and the composite system of medical research institutions showed a non-synergistic development trend,with the worst synergistic level in 2021;number of personnel,number of institutions,building floor space,production factors and sequential coefficients were weakly synergized and in a state of non-synergistic development.Among the 43 policy texts,the internal submodular policy tools were used more,the external submodular policy tools were used less,and the use of internal and external policy tools is unbalanced.Conclusion:The number of personnel,institutions and building area of medical research institutions are constraints on the synergistic development of innovative entities.It is recommended to increase the training of innovative talents in medical research institutions,improve the construction of new institutions,coordinate the layout of large scientific devices and functional housing,introduce targeted systematic planning,improve the market of factors of production,and consolidate the technological foundation for future development.

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