1.Trends in incidence and mortality of acute myocardial infarction in Xiaoshan District, Hangzhou City from 2017 to 2023
Yuanyuan GAO ; Fenjuan WANG ; Dongfei WANG ; Yurong LI ; Yuanyuan JIANG ; Fangfang ZHAO ; Duanduan XIAO ; Junying LIN
Shanghai Journal of Preventive Medicine 2025;37(3):249-254
ObjectiveTo analyze the incidence rate and mortality of acute myocardial infarction (AMI) and their changing trends among the registered residents in Xiaoshan District, Hangzhou City from 2017 to 2023, so as to provide references for formulating policies related to AMI prevention. MethodsThe morbidity and mortality data of AMI among the registered residents in Xiaoshan District from 2017 to 2023 were collected through the Hangzhou Chronic Disease and Death Cause Monitoring System. Software such as Excel 2019, SPSS 25.0 and Joinpoint 4.9.1.0 were used to calculate the incidence rate, mortality, and average annual percentage change (AAPC) of AMI. ResultsFrom 2017 to 2023, the average annual crude incidence rate, age-standardized incidence rate using China standard population (ASIRC), and the age-standardized incidence rate using World standard population (ASIRW) of AMI in Xiaoshan District were 48.25/100 000, 29.14/100 000, and 21.64/100 000, respectively, and, from which the AAPCs were 5.495%, 6.010%, and 6.533%, respectively, all showing an upward trend. The average annual crude mortality rate, the age-standardized mortality rate using China standard population (ASMRC), and the age-standardized mortality rate using World standard population (ASMRW) were 11.76/100 000, 6.52/100 000, and 4.71/100 000, respectively, from which the AAPCs were -9.669%, -10.433% and -9.615%, respectively, all showing a downward trend. The average annual crude incidence rate of AMI was higher in males (65.87/100 000) than that in females (31.31/100 000). Moreover, the average annual crude mortality rate of AMI was higher in males (14.08/100 000) than that in females (9.52/100 000), and the difference was statistically significant (all P<0.001) .After age grouping, the crude incidence rate of AMI among the residents aged 35-, 45-, 55-, and 65- years in Xiaoshan District from 2017 to 2023 showed an upward trend over time, with AAPCs of 16.993%, 17.149%, 8.523%, and 5.002%, respectively. While the crude mortality rate in residents aged 35-, 75-, and 85-102 years showed an decreasing trend over time, with AAPCs of -23.977%, -15.467%, and -17.415%, respectively, but there was no statistically significant difference in the trends in incidence rate and mortality of other age groups (all P>0.05). ConclusionThe situation of AMI prevention and control among the registered residents in Xiaoshan District is not optimistic, and targeted measures should be strengthened for the male residents aged ≥35 years old.
2.Parents awareness and willingness regarding human papillomavirus and vaccination for male primary and secondary school students in Bao an District, Shenzhen
LU Fangfang, LIN Mingfeng, QIAN Miaofang, ZHANG Min, NI Xiuxian
Chinese Journal of School Health 2025;46(10):1432-1436
Objective:
To explore parents knowledge, vaccination attitude, and willingness influencing factors of human papillomavirus (HPV) and its vaccine for male primary and secondary school students, so as to provide a scientific basis for formulating targeted health education strategies and promoting the popularization of boys HPV vaccination.
Methods:
From March 3 to 14, 2025, a stratified cluster random sampling method was used to select 912 parents of boys in primary and secondary school in Bao an District, Shenzhen for a questionnaire survey. Data on their demographic characteristics, HPV related knowledge and its vaccine, vaccination attitude, and willingness were collected. Univariate analysis was performed by using the χ 2 test or t-test, and binary Logistic regression model was used to analyze related factors of HPV vaccine vaccination willingness.
Results:
The total awareness rate of parents knowledge related to HPV and its vaccine was 35.75%, among which the awareness rates of boys vaccine types ( 6.36% ), optimal age (21.16%), and optimal vaccination period (31.25%) were the lowest. The scores of parents knowledge and attitude related to HPV and its vaccine were (4.31±2.66) and (3.82±0.63). About 64.25% of parents expressed willingness to have boys vaccinated against HPV. The scores of knowledge and attitude related to HPV and its vaccine of parents with vaccination willingness (4.86±2.55, 4.02±0.58) were higher than those of parents without vaccination willingness (3.34±2.57, 3.46±0.55), and the differences were statistically significant ( t =8.59,13.96, both P <0.01). Logistic analysis showed that parents without raising daughters had a lower willingness to vaccinate boys against HPV ( OR=0.49, 95%CI =0.35-0.70); for each 1 increase in parents knowledge score related to HPV and its vaccine, the vaccination willingness increased by 9.0% ( OR=1.09, 95%CI =1.01-1.17); parents who were worried about boys infection risk ( OR=1.50, 95%CI =1.08-2.08) and parents who had their children vaccinated against HPV even if their classmates were not vaccinated ( OR=3.68, 95%CI =2.73-4.94) had higher willingness to vaccinate boys against HPV(all P <0.05).
Conclusions
Parents of boys in primary and secondary schools of Bao an District, Shenzhen have low scores of knowledge related to HPV and its vaccine.While parents show strong willingness to vaccinate boys against HPV, limited knowledge may hinder both the sustained growth of vaccination intentions and the actual implementation of vaccination practices.
3.Distribution and resistance profiles of bacterial strains isolated from cerebrospinal fluid in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Juan MA ; Lixia ZHANG ; Yang YANG ; Fupin HU ; Demei ZHU ; Han SHEN ; Wanqing ZHOU ; Wenen LIU ; Yanming LI ; Yi XIE ; Mei KANG ; Dawen GUO ; Jinying ZHAO ; Zhidong HU ; Jin LI ; Shanmei WANG ; Yafei CHU ; Yunsong YU ; Jie LIN ; Yingchun XU ; Xiaojiang ZHANG ; Jihong LI ; Bin SHAN ; Yan DU ; Ping JI ; Fengbo ZHANG ; Chao ZHUO ; Danhong SU ; Lianhua WEI ; Fengmei ZOU ; Xiaobo MA ; Yanping ZHENG ; Yuanhong XU ; Ying HUANG ; Yunzhuo CHU ; Sufei TIAN ; Hua YU ; Xiangning HUANG ; Sufang GUO ; Xuesong XU ; Chao YAN ; Fangfang HU ; Yan JIN ; Chunhong SHAO ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Fang DONG ; Zhiyong LÜ ; Lei ZHU ; Jinhua MENG ; Shuping ZHOU ; Yan ZHOU ; Chuanqing WANG ; Pan FU ; Yunjian HU ; Xiaoman AI ; Ziyong SUN ; Zhongju CHEN ; Hong ZHANG ; Chun WANG ; Yuxing NI ; Jingyong SUN ; Kaizhen WEN ; Yirong ZHANG ; Ruyi GUO ; Yan ZHU ; Jinju DUAN ; Jianbang KANG ; Xuefei HU ; Shifu WANG ; Yunsheng CHEN ; Qing MENG ; Yong ZHAO ; Ping GONG ; Ruizhong WANG ; Hua FANG ; Jilu SHEN ; Jiangshan LIU ; Hongqin GU ; Jiao FENG ; Shunhong XUE ; Bixia YU ; Wen HE ; Lin JIANG ; Longfeng LIAO ; Chunlei YUE ; Wenhui HUANG
Chinese Journal of Infection and Chemotherapy 2025;25(3):279-289
Objective To investigate the distribution and antimicrobial resistance profiles of common pathogens isolated from cerebrospinal fluid(CSF)in CHINET program from 2015 to 2021.Methods The bacterial strains isolated from CSF were identified in accordance with clinical microbiology practice standards.Antimicrobial susceptibility test was conducted using Kirby-Bauer method and automated systems per the unified CHINET protocol.Results A total of 14 014 bacterial strains were isolated from CSF samples from 2015 to 2021,including the strains isolated from inpatients(95.3%)and from outpatient and emergency care patients(4.7%).Overall,19.6%of the isolates were from children and 80.4%were from adults.Gram-positive and Gram-negative bacteria accounted for 68.0%and 32.0%,respectively.Coagulase negative Staphylococcus accounted for 73.0%of the total Gram-positive bacterial isolates.The prevalence of MRSA was 38.2%in children and 45.6%in adults.The prevalence of MRCNS was 67.6%in adults and 69.5%in children.A small number of vancomycin-resistant Enterococcus faecium(2.2%)and linezolid-resistant Enterococcus faecalis(3.1%)were isolated from adult patients.The resistance rates of Escherichia coli and Klebsiella pneumoniae to ceftriaxone were 52.2%and 76.4%in children,70.5%and 63.5%in adults.The prevalence of carbapenem-resistant E.coli and K.pneumoniae(CRKP)was 1.3%and 47.7%in children,6.4%and 47.9%in adults.The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)and Pseudomonas aeruginosa(CRPA)was 74.0%and 37.1%in children,81.7%and 39.9%in adults.Conclusions The data derived from antimicrobial resistance surveillance are crucial for clinicians to make evidence-based decisions regarding antibiotic therapy.Attention should be paid to the Gram-negative bacteria,especially CRKP and CRAB in central nervous system(CNS)infections.Ongoing antimicrobial resistance surveillance is helpful for optimizing antibiotic use in CNS infections.
4.Changing antibiotic resistance profiles of the bacterial strains isolated from geriatric patients in hospitals across China:data from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Xiaoman AI ; Yunjian HU ; Chunyue GE ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(3):290-302
Objective To investigate the antimicrobial resistance of clinical isolates from elderly patients(≥65 years)in major medical institutions across China.Methods Bacterial strains were isolated from elderly patients in 52 hospitals participating in the CHINET Antimicrobial Resistance Surveillance Program during the period from 2015 to 2021.Antimicrobial susceptibility test was carried out by disk diffusion method and automated systems according to the same CHINET protocol.The data were interpreted in accordance with the breakpoints recommended by the Clinical and Laboratory Standards Institute(CLSI)in 2021.Results A total of 514 715 nonduplicate clinical isolates were collected from elderly patients in 52 hospitals from January 1,2015 to December 31,2021.The number of isolates accounted for 34.3%of the total number of clinical isolates from all patients.Overall,21.8%of the 514 715 strains were gram-positive bacteria,and 78.2%were gram-negative bacteria.Majority(90.9%)of the strains were isolated from inpatients.About 42.9%of the strains were isolated from respiratory specimens,and 22.9%were isolated from urine.More than half(60.7%)of the strains were isolated from male patients,and 39.3%isolated from females.About 51.1%of the strains were isolated from patients aged 65-<75 years.The prevalence of methicillin-resistant strains(MRSA)was 38.8%in 32 190 strains of Staphylococcus aureus.No vancomycin-or linezolid-resistant strains were found.The resistance rate of E.faecalis to most antibiotics was significantly lower than that of Enterococcus faecium,but a few vancomycin-resistant strains(0.2%,1.5%)and linezolid-resistant strains(3.4%,0.3%)were found in E.faecalis and E.faecium.The prevalence of penicillin-susceptible S.pneumoniae(PSSP),penicillin-intermediate S.pneumoniae(PISP),and penicillin-resistant S.pneumoniae(PRSP)was 94.3%,4.0%,and 1.7%in nonmeningitis S.pneumoniae isolates.The resistance rates of Klebsiella spp.(Klebsiella pneumoniae 93.2%)to imipenem and meropenem were 20.9%and 22.3%,respectively.Other Enterobacterales species were highly sensitive to carbapenem antibiotics.Only 1.7%-7.8%of other Enterobacterales strains were resistant to carbapenems.The resistance rates of Acinetobacter spp.(Acinetobacter baumannii 90.6%)to imipenem and meropenem were 68.4%and 70.6%respectively,while 28.5%and 24.3%of P.aeruginosa strains were resistant to imipenem and meropenem,respectively.Conclusions The number of clinical isolates from elderly patients is increasing year by year,especially in the 65-<75 age group.Respiratory tract isolates were more prevalent in male elderly patients,and urinary tract isolates were more prevalent in female elderly patients.Klebsiella isolates were increasingly resistant to multiple antimicrobial agents,especially carbapenems.Antimicrobial resistance surveillance is helpful for accurate empirical antimicrobial therapy in elderly patients.
5.Two-Dimensional Speckle Tracking Echocardiography in Distinguishing Fabry Disease in Patients with Left Ventricular Hypertrophy
Chonghui WANG ; Han WANG ; Ying YANG ; Lin LIU ; Fangfang FAN ; Yawen ZHAO ; Wei ZHANG ; Yang YU ; Wei MA
Chinese Journal of Medical Imaging 2025;33(8):848-853,879
Purpose To explore the diagnostic value of two-dimensional speckle tracking echocardiography(2D-STE)in differentiating left ventricular hypertrophy(LVH)caused by Fabry disease from other etiologies.Materials and Methods A total of 23 patients clinically confirmed Fabry disease with LVH(Fabry disease group)in Peking University First Hospital from August 2014 to February 2023,retrospectively.23 patients with hypertensive LVH(hypertensive LVH group)and 23 with hypertrophic cardiomyopathy(HCM)(HCM group)were also included.Conventional echocardiographic parameters and 2D-STE-derived left atrial strain and left ventricular longitudinal strain were analyzed and compared among the three groups.LASSO regression was used to select variables and construct a diagnostic model to differentiate hypertensive LVH,HCM and Fabry disease group.Results The Fabry disease group showed significantly reduced left ventricular global longitudinal strain and segmental left ventricular longitudinal strain in the basal anterior wall,basal anterolateral wall and mid inferior wall compared to the hypertensive LVH group(P<0.05).There were no significant differences in left atrial strain,left ventricular global longitudinal strain and segmental left ventricular longitudinal strain between the Fabry disease and HCM groups(P>0.05).Compared to the conventional echocardiography-based model,the combined model did not significantly improve diagnostic accuracy for differentiating the three etiologies(Z=-1.314--0.594,all P>0.05).Conclusion Compared to patients with hypertensive LVH,HCM and Fabry disease group exhibit varying degrees of decrease in global and segmental longitudinal strain of the left atrium and left ventricle.Additional measurements of left ventricular longitudinal strain and left atrial strain do not provide significant incremental diagnostic value over conventional echocardiography in distinguishing among Fabry disease,hypertensive LVH and HCM.
6.Key Points Analysis of Physical Performance Evaluation Methods for Metallic MDI Inhalation Canister in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Fenglan ZHANG ; Fangfang ZHANG ; Rongjia WANG ; Lin YAO ; Lei CHEN
Herald of Medicine 2025;44(11):1751-1756
The 2025 Edition of the Pharmacopoeia of the People's Republic of China added the physical performance evaluation method of metallic metered dose inhalation(MDI)canister and related standards.The relevant physical performance evaluation methods are of great significance to the quality control of metallic inhalation canister,which is an important basis for the evaluation of drug protection ability,and also fills the blank of the physical performance evaluation method of metallic cans for drug packaging.It can scientifically and effectively guide the drug packaging material production enterprises to carry out standardized and unified quality control of metallic MDI inhalation canister,play a role in the quality control of metallic MDI inhalation canister,and ensure the safety,effectiveness,and accessibility of drugs in the whole life cycle.By comparing the domestic and international standards of metallic canister,this document mainly analyzed the detection principle,method points and its role in drug packaging quality control of pressure resistance performance、internal coating continuity,oxide film thickness,coating surface energy and coating contact angle,to help all parties more effectively and fully understand,master and apply the physical performance evaluation methods of the metallic MDI inhalation canister and relevant standards in the 2025 Edition of the Pharmacopoeia of the People's Republic of China,and provide theoretical guidance and technical support for the implementation of the standard.
7.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.
8.Changing antimicrobial resistance profiles of Burkholderia cepacia in hospitals across China:results from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Chunyue GE ; Yunjian HU ; Xiaoman AI ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(5):557-562
Objective To examine the changing prevalence and antimicrobial resistance profiles of Burkholderia cepacia in 52 hospitals across China from 2015 to 2021.Methods A total of 9 261 strains of B.cepacia were collected from 52 hospitals between January 1,2015 and December 31,2021.Antimicrobial susceptibility of the strains was tested using Kirby-Bauer method or automated antimicrobial susceptibility testing systems according to a unified protocol.The results were interpreted according to the breakpoints released in the Clinical & Laboratory Standards Institute(CLSI)guidelines(2023 edition).Results A total of 9 261 strains of B.cepacia were isolated from all age groups,especially elderly patients.The proportion was 11.1%(1 032 strains)in children,significantly lower than the proportion in adults.About half(46.5%,4 310/9 261)of the strains were isolated from patients at least 60 years old and 42.3%(3 919/9 261)of the strains were isolated from young adults.Most isolates(71.1%)were isolated from sputum and respiratory secretions,followed by urine(10.7%)and blood samples(8.1%).B.cepacia isolates were highly susceptible to the five antimicrobial agents recommended in the CLSI M100 document(33rd edition,2023).B.cepacia isolates showed relatively higher resistance rates to meropenem and levofloxacin.However,the resistance rates to ceftazidime,trimethoprim-sulfamethoxazole,and minocycline remained below 8.1%.The percentage of B.cepacia strains resistant to levofloxacin was the highest compared to other antibiotics in any of the three age groups(from 12.4%in the patients<18 years old to 20.6%in the patients aged 60 years or older).Conclusions B.cepacia is one of the clinically important non-fermenting gram-negative bacteria.Accurate and timely reporting of antimicrobial susceptibility test results and ongoing antimicrobial resistance surveillance are helpful for rational prescription of antimicrobial agents and proper prevention and control of nosocomial infections.
9.Key Points Analysis of Physical Performance Evaluation Methods for Metallic MDI Inhalation Canister in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Fenglan ZHANG ; Fangfang ZHANG ; Rongjia WANG ; Lin YAO ; Lei CHEN
Herald of Medicine 2025;44(11):1751-1756
The 2025 Edition of the Pharmacopoeia of the People's Republic of China added the physical performance evaluation method of metallic metered dose inhalation(MDI)canister and related standards.The relevant physical performance evaluation methods are of great significance to the quality control of metallic inhalation canister,which is an important basis for the evaluation of drug protection ability,and also fills the blank of the physical performance evaluation method of metallic cans for drug packaging.It can scientifically and effectively guide the drug packaging material production enterprises to carry out standardized and unified quality control of metallic MDI inhalation canister,play a role in the quality control of metallic MDI inhalation canister,and ensure the safety,effectiveness,and accessibility of drugs in the whole life cycle.By comparing the domestic and international standards of metallic canister,this document mainly analyzed the detection principle,method points and its role in drug packaging quality control of pressure resistance performance、internal coating continuity,oxide film thickness,coating surface energy and coating contact angle,to help all parties more effectively and fully understand,master and apply the physical performance evaluation methods of the metallic MDI inhalation canister and relevant standards in the 2025 Edition of the Pharmacopoeia of the People's Republic of China,and provide theoretical guidance and technical support for the implementation of the standard.
10.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.


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