1.Risk Analysis and Countermeasures of Laboratory Management of National Drug Sampling and Testing Institutions
Jialiang ZHU ; Hao XI ; Lei FENG ; Miao XU ; Songqing GU ; Rui LI ; Ting SUN ; Lei CHEN
Herald of Medicine 2025;44(1):68-72
Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.
2.Quality Evaluation of Propranolol Hydrochloride Tablets Based on National Drug Sampling and Testing
Li LU ; Fangxian SHAO ; Hui XU ; Chaoyu HUANG ; Jialiang ZHU ; Fei YAN ; Rui LI
Herald of Medicine 2025;44(9):1390-1400
Objective To evaluate the quality of propranolol hydrochloride tablets based on national drug sampling,to analyze existing quality issues and improve their quality standards,to provide references and suggestions for the production,quality control,and supervision of this product.Methods A comprehensive evaluation of 178 batches of sampled products was conducted using legal standards combined with exploratory research,including key quality indicators such as related substances,dissolution,content uniformity,content determination,in vitro dissolution profiles,and genotoxic impurity N-nitrosoproranolol.The quality of domestic propranolol hydrochloride tablets and the controllability of the current quality standards for product quality were assessed.Results According to the legal standard methods,the qualification rate of 178 batches of sampled products was 100%.Exploratory research revealed that the impurity levels of samples from six manufacturing enterprises were far below the limit requirements;however,differences existed in genotoxic impurity N-nitrosoproranolol and other aspects.Conclusions The overall quality of propranolol hydrochloride tablets is good,but the current standards need further improvement.It is recommended to add/revise the detection methods for related substances,content,and content uniformity,strictly control N-nitrosoproranolol,and urge enterprises to pay attention to the quality of excipients and the control of the preparation production process.
3.Quality Evaluation of Propranolol Hydrochloride Tablets Based on National Drug Sampling and Testing
Li LU ; Fangxian SHAO ; Hui XU ; Chaoyu HUANG ; Jialiang ZHU ; Fei YAN ; Rui LI
Herald of Medicine 2025;44(9):1390-1400
Objective To evaluate the quality of propranolol hydrochloride tablets based on national drug sampling,to analyze existing quality issues and improve their quality standards,to provide references and suggestions for the production,quality control,and supervision of this product.Methods A comprehensive evaluation of 178 batches of sampled products was conducted using legal standards combined with exploratory research,including key quality indicators such as related substances,dissolution,content uniformity,content determination,in vitro dissolution profiles,and genotoxic impurity N-nitrosoproranolol.The quality of domestic propranolol hydrochloride tablets and the controllability of the current quality standards for product quality were assessed.Results According to the legal standard methods,the qualification rate of 178 batches of sampled products was 100%.Exploratory research revealed that the impurity levels of samples from six manufacturing enterprises were far below the limit requirements;however,differences existed in genotoxic impurity N-nitrosoproranolol and other aspects.Conclusions The overall quality of propranolol hydrochloride tablets is good,but the current standards need further improvement.It is recommended to add/revise the detection methods for related substances,content,and content uniformity,strictly control N-nitrosoproranolol,and urge enterprises to pay attention to the quality of excipients and the control of the preparation production process.
4.Risk Analysis and Countermeasures of Laboratory Management of National Drug Sampling and Testing Institutions
Jialiang ZHU ; Hao XI ; Lei FENG ; Miao XU ; Songqing GU ; Rui LI ; Ting SUN ; Lei CHEN
Herald of Medicine 2025;44(1):68-72
Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.
5.Clinical value of peripheral immune function status in the assessment of'Deficiency of Vital Qi'in lung cancer metastasis
Fan XU ; Jianhui TIAN ; Youjun LIU ; Zhenyang CHENG ; Zujun QUE ; Bin LUO ; Yun YANG ; Jialiang YAO ; Wang YAO ; Xinyi LU ; Yao LIU ; Yiyang ZHOU ; Jianchun WU ; Yingbin LUO ; Minghua LI ; Wenfei SHI ; Yajing CUI ; Wenji SHANGGUAN ; Yan LI
Chinese Journal of Cancer Biotherapy 2025;32(10):1065-1070
Objective:To investigate the association between peripheral immune function status and lung cancer metastasis,and to identify peripheral blood immune biomarkers for'Deficiency of Vital Qi'assessment in lung cancer metastasis.Methods:A retrospective analysis was conducted on peripheral blood immune markers collected before treatment from lung cancer patients admitted into Shanghai Municipal Hospital of Traditional Chinese Medicine,affiliated to Shanghai University of Traditional Chinese Medicine,between March 2023 and April 2025.Patients were categorized into the non-metastatic and the metastatic groups based on the presence of distant metastasis,and the differences in the expressions of immune cells and cytokines between groups were compared.Peripheral blood immune markers with P<0.05 in univariate analysis were incorporated into a multivariate binary logistic regression model to identify independent predictors of lung cancer metastasis.Results:A total of 193 lung cancer patients were included(101 in the non-metastatic group and 92 in the metastatic group).There were no statistically significant differences between the two groups in terms of gender,age,smoking history,drinking history,or pathological type(all P>0.05).Univariate analysis revealed significant differences in multiple immune markers between the non-metastatic and metastatic groups(all P<0.05),including:lymphocyte count,CD3+,CD4+,and CD8+T,CD19+B cells,absolute counts of CD3-CD16+CD56+NK cells,percentages of Treg cells,CD8+CD28+Treg cells,G-MDSC,and CD3-CD16+CD56+dim NK cells,and levels of cytokine IL-1β,IL-6,and IL-10.Binary logistic regression analysis of differential indicators suggested that the percentage of Treg cells and CD8+CD28+Treg cells in peripheral blood were independent predictors of distant metastasis in lung cancer(OR=1.193,95%CI[1.047,1.36],P<0.01;OR=0.978,95%CI[0.957,0.999],P<0.05).Conclusion:Peripheral blood immune dysfunction is the biological basis for'qi deficiency'in lung cancer metastasis.This study quantitatively demonstrates the correlation between peripheral immune function status and lung cancer metastasis,providing empirical evidence for the theories of'qi deficiency and hidden toxicity'and'metastatic state of tumors'.
6.bla NDM-1 Carried by a Transferable Plasmid in a Salmonella Strain Isolated from Healthy Individuals.
Wei ZENG ; Ming LUO ; Pengcheng DU ; Zhenpeng LI ; Yao PENG ; Mengyu WANG ; Wenxuan ZHAO ; Huayao ZHANG ; Yang LI ; Pengjie LUO ; Yannong WU ; Jialiang XU ; Xu LI ; Xin LU ; Biao KAN
Biomedical and Environmental Sciences 2024;37(11):1252-1261
OBJECTIVE:
Our study aimed to conduct genomic characterization of Salmonella strains carrying the bla NDM-1 gene in the intestinal tract of healthy individuals. The objectives were to underscore the importance of genomic surveillance for drug resistance in both commensal and pathogenic bacteria among healthy populations, and to establish protocols for regulating drug resistance plasmids based on the completion of a comprehensive map of drug resistance plasmid genomes.
METHODS:
We performed antimicrobial susceptibility testing and employed second- and third-generation sequencing techniques to analyze Salmonella strains harboring the bla NDM-1 gene, to surveil drug-resistant bacteria in the intestines of healthy subjects. Sequence comparison was conducted using both core- and pan-genome approaches. Concurrently, conjugation experiments were carried out to assess the efficiency of plasmid transfer.
RESULTS:
We isolated a carbapenem-resistant Salmonella enterica serovar Typhimurium strain from a healthy food worker in China. This strain harbored an IncHI2/IncHI2A plasmid carrying bla NDM-1 along with multiple antibiotic resistance genes (ARGs). Our findings highlight the potential for asymptomatic carriers to facilitate the transmission of ARGs. Pan-genomic analysis revealed that bla NDM-1-positive plasmids could traverse bacterial species barriers, facilitating cross-host transmission.
CONCLUSION
This study marks the first detection of bla NDM-1 in Salmonella strains isolated from healthy individuals. We underscore the risk associated with the transmission of conjugative hybrid plasmids carrying bla NDM-1, which have the potential to be harbored and transmitted among healthy individuals. Enhanced surveillance of drug-resistant pathogens and plasmids in the intestinal microbiota of healthy individuals could provide insights into the risk of ARG transmission and pathways for population-wide dissemination via ARG transfer factors.
beta-Lactamases/genetics*
;
Plasmids/genetics*
;
Humans
;
Anti-Bacterial Agents/pharmacology*
;
China
;
Microbial Sensitivity Tests
;
Salmonella typhimurium/isolation & purification*
;
Salmonella/isolation & purification*
;
Salmonella Infections/microbiology*
7.Neural substrates for regulating self-grooming behavior in rodents
LI GUANQING ; LU CHANYI ; YIN MIAOMIAO ; WANG PENG ; ZHANG PENGBO ; WU JIALIANG ; WANG WENQIANG ; WANG DING ; WANG MENGYUE ; LIU JIAHAN ; LIN XINGHAN ; ZHANG JIAN-XU ; WANG ZHENSHAN ; YU YIQUN ; ZHANG YUN-FENG
Journal of Zhejiang University. Science. B 2024;25(10):841-856
Grooming,as an evolutionarily conserved repetitive behavior,is common in various animals,including humans,and serves essential functions including,but not limited to,hygiene maintenance,thermoregulation,de-arousal,stress reduction,and social behaviors.In rodents,grooming involves a patterned and sequenced structure,known as the syntactic chain with four phases that comprise repeated stereotyped movements happening in a cephalocaudal progression style,beginning from the nose to the face,to the head,and finally ending with body licking.The context-dependent occurrence of grooming behavior indicates its adaptive significance.This review briefly summarizes the neural substrates responsible for rodent grooming behavior and explores its relevance in rodent models of neuropsychiatric disorders and neurodegenerative diseases with aberrant grooming phenotypes.We further emphasize the utility of rodent grooming as a reliable measure of repetitive behavior in neuropsychiatric models,holding promise for translational psychiatry.Herein,we mainly focus on rodent self-grooming.Allogrooming(grooming being applied on one animal by its conspecifics via licking or carefully nibbling)and heterogrooming(a form of grooming behavior directing towards another animal,which occurs in other contexts,such as maternal,sexual,aggressive,or social behaviors)are not covered due to space constraints.
8.blaNDM-1 Carried by a Transferable Plasmid in a Salmonella Strain Isolated from Healthy Individuals
Wei ZENG ; Ming LUO ; Pengcheng DU ; Zhenpeng LI ; Yao PENG ; Mengyu WANG ; Wenxuan ZHAO ; Huayao ZHANG ; Yang LI ; Pengjie LUO ; Yannong WU ; Jialiang XU ; Xu LI ; Xin LU ; Biao KAN
Biomedical and Environmental Sciences 2024;37(11):1252-1261
Objective Our study aimed to conduct genomic characterization of Salmonella strains carrying the b/aNDM-1 gene in the intestinal tract of healthy individuals.The objectives were to underscore the importance of genomic surveillance for drug resistance in both commensal and pathogenic bacteria among healthy populations,and to establish protocols for regulating drug resistance plasmids based on the completion of a comprehensive map of drug resistance plasmid genomes.Methods We performed antimicrobial susceptibility testing and employed second-and third-generation sequencing techniques to analyze Salmonella strains harboring the b/aNDM-1 gene,to surveil drug-resistant bacteria in the intestines of healthy subjects.Sequence comparison was conducted using both core-and pan-genome approaches.Concurrently,conjugation experiments were carried out to assess the efficiency of plasmid transfer.Results We isolated a carbapenem-resistant Salmonella enterica serovar Typhimurium strain from a healthy food worker in China.This strain harbored an lncHI2/lncHI2A plasmid carrying blaNDM-1 along with multiple antibiotic resistance genes(ARGs).Our findings highlight the potential for asymptomatic carriers to facilitate the transmission of ARGs.Pan-genomic analysis revealed that b/aNDM-1-positive plasmids could traverse bacterial species barriers,facilitating cross-host transmission.Conclusion This study marks the first detection of b/aNDM-1 in Salmonella strains isolated from healthy individuals.We underscore the risk associated with the transmission of conjugative hybrid plasmids carrying blaNDM-1,which have the potential to be harbored and transmitted among healthy individuals.Enhanced surveillance of drug-resistant pathogens and plasmids in the intestinal microbiota of healthy individuals could provide insights into the risk of ARG transmission and pathways for population-wide dissemination via ARG transfer factors.
9.Kidney transplantation from donors with Marfan syndrome: report of 2 cases and literature review
Meng ZHANG ; Yibin WANG ; Yuchen WANG ; Rumin LIU ; Ziyan YAN ; Renfei XIA ; Wenli ZENG ; Jialiang HUI ; Minjie ZHOU ; Jian XU ; Yun MIAO
Organ Transplantation 2024;15(2):257-262
Objective To investigate the feasibility and clinical experience of kidney transplantation from donors with Marfan syndrome (MFS). Methods Clinical data of 2 recipients undergoing kidney transplantation from the same MFS patient were retrospectively analyzed and literature review of 2 cases was conducted. Characteristics and clinical diagnosis and treatment of kidney transplantation from MFS patients were summarized. Results The Remuzzi scores of the left and right donor kidneys of the MFS patient during time-zero biopsy were 1 and 2. No significant difference was observed in the renal arteriole wall compared with other donors of brain death and cardiac death. Two recipients who received kidney transplantation from the MFS patient suffered from postoperative delayed graft function. After short-term hemodialysis, the graft function of the recipients received the left and right kidney began to gradually recover at postoperative 10 d and 20 d. After discharge, serum creatinine level of the recipient received the left kidney was ranged from 80 to 90 μmol/L, whereas that of the recipient received the right kidney kept declining, and the lowest serum creatinine level was 232 μmol/L before the submission date (at postoperative 43 d). Through literature review, two cases successfully undergoing kidney transplantation from the same MFS donor were reported. Both two recipients experienced delayed graft function, and then renal function was restored to normal. Until the publication date, 1 recipient has survived for 6 years, and the other recipient died of de novo cerebrovascular disease at postoperative 2 years. Conclusions MFS patients may serve as an acceptable source of kidney donors. However, the willingness and general conditions of the recipients should be carefully evaluated before kidney transplantation. Intraoperatively, potential risk of tear of renal arterial media should be properly treated. Extensive attention should be paid to the incidence of postoperative complications.
10.Protease inhibitor DUBs-IN-1 suppresses proliferation of Marek's disease virus in chicken cells
Xin AI ; Jiacui XU ; Jialiang XIE ; Haoyuan MA ; Kai YU ; Mingcheng LIU ; Xinyue WANG ; Junyan LIN ; Xu GAO
Chinese Journal of Veterinary Science 2024;44(8):1622-1628
Vaccination is a main measure for protecting chickens against Marek's disease,while it is not able to suppress the infection,proliferation,transmission,and virulence enhancement on Marek's disease virus.Inhibiting the proliferation of Marek's disease virus in chicken is therefore an im-portant option for enhancing defense effectiveness.In this study,a compound,DUBs-IN-1,was found to inhibit the activity of MDV049,a protease encoded by Marek's disease virus,via screening a protease inhibitor library using MDV049 as target and ubiquitin probe.Molecular docking re-vealed that DUBs-IN-1 can interact with the residues which formed the catalytic pocket of MDV049,blocking the interaction between Ub substrate and the catalytic center of MDV049,then suppress the activity of MDV049 with competitive inhibition.Using the CPE model,it was found that DUBs-IN-1 at the concentration of 0.35 and 0.70 μmol/L significantly inhibited the CPE in-duced by Marek's disease virus in CEF cells.Quantitative analysis revealed that DUBs-IN-1 inhibi-ted the proliferation of Marek's disease virus in CEF cells(P<0.01).Furthermore,it was found that the administration of 80 and 150 pg/(kg·d)of DUBs-IN-1 in chicken infected by Marek's disease virus significantly inhibited the proliferation of MDV in T cells(P<0.01).In summary,this study demonstrated that the compound DUBs-IN-1 is able to inhibit the proliferation of Marek's disease virus in chicken cells,laying a theoretical and practical foundation for further de-velopment of the drugs against Marek's disease virus.

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