1.The effect of Chuju total flavonoids on the current and protein expression of BKCa channels in rat middle cerebral artery VSMC
Yuwen LI ; Xiao WANG ; Miao WU ; Shuo CHEN ; Zhiwu CHEN
Acta Universitatis Medicinalis Anhui 2026;61(3):387-394
ObjectiveTo investigate the relationship between the vasodilation and hydrogen sulfide (H2S) mechanism of total flavonoids of chrysanthemum (TFCC) and the large conductance Ca2+- activated K+ (BKCa) channels on vascular smooth muscle cells (VSMCs) of the middle cerebral artery in rats. In addition, this study will also investigate the effect of TFCC on the expression of BKCa channel alpha protein in rat middle cerebral artery VSMCs. MethodsThe primary method employed was acute digestion to isolate VSMCs from the middle cerebral artery of rats; whole-cell patch-clamp techniques were used to measure BKCa channel currents; primary tissue adherence culture was utilized to cultivate VSMCs from the middle cerebral artery of rats; Western blot were employed to determine protein expression levels. ResultsIn whole-cell patch-clamp experiments, both the H2S donor NaHS (100 μmol/L) and endogenous H2S enhanced BKCa channel currents. TFCC (30, 90, and 270 mg/L) also activatedBKCa channels and exhibited a certain concentration-dependent effect. Even after blocking endogenous H2S production, TFCC (270 mg/L) still activated BKCa channels in VSMCs of the middle cerebral artery in rats. In Western blot experiments, the α-subunit of BKCa channel proteins was expressed in all groups of cells, but TFCC (30, 90, and 270 mg/L) and inhibitor IBTX group did not affect the expression of channel protein content.Conclusion TFCC can promote the opening of BKCa channels by promoting the generation of endogenous H2S, or directly activate BKCa channels, thereby playing a role in relaxing cerebral blood vessels. However, TFCC had no significant effect on the expression of BKCa channel proteins.
2.Value of demographic factors in early identification of pediatric malignant vasovagal syncope in head-up tilt test
Shuo WANG ; Yuwen WANG ; Hong CAI ; Ping LIU ; Fang LI ; Chuan WEN ; Liqun LIU ; Runmei ZOU ; Cheng WANG
Clinical and Experimental Pediatrics 2026;69(4):353-361
Background:
Malignant vasovagal syncope (VVS) is characterized by cardiac arrest lasting more than 3 seconds during a syncope episode or head-up tilt test (HUTT). We aim to conduct a risk assessment for potential malignant VVS before the HUTT by using economic, simple and convenient demographic data, in order to prevent adverse outcomes for pediatric VVS.Purpose: To explore the correlation between demographic factors and pediatric malignant VVS, and verify the value of these factors in early risk assessment for malignant VVS before HUTT, so as to optimize test safety and reduce adverse events.
Methods:
We conducted a retrospective analysis of the clinical data of 3,734 children who were initially diagnosed with VVS due to unexplained syncope and presyncope. Finally, 122 children who met the diagnostic criteria for malignant VVS were included in the malignant VVS group, and 661 children who did not meet the criteria during the same period were matched as the control group. By analyzing demographic data and other factors, we attempted to clarify the association between these factors and malignant VVS.
Results:
Linear relationship: age and body mass index (BMI) have independent protective effects on malignant VVS. For every 1-year increase in age and every 1 kg/m2 increase in BMI, the risk of malignant VVS decreases by 12% and 9%, respectively. Nonlinear relationship: When the age is <12.9 years old, for every additional year of age, the risk of malignant VVS decreases by 20%. For ages 12.9 years and above, the efficacy is not significant. There is no significant nonlinear relationship between BMI and malignant VVS.
Conclusion
Age and BMI are independent protective factors for pediatric malignant VVS. Before the age of 12.9 years, the incidence of malignant VVS gradually decreases with the increase in age, and thereafter there is no significant impact.
3.Network analysis comparison of depression-anxiety symptoms between medical staff and community residents in Dongguan
Yuwen HUANG ; Jingya YU ; Lunchi HUANG ; Zhizhong WANG ; Yongsheng LI
Sichuan Mental Health 2026;39(3):274-281
BackgroundThe mental health issues of medical staff have received increasing attention. Previous studies have mainly focused on the epidemiological characteristics and influencing factors, but there is a lack of sufficient understanding of the heterogeneity characteristics of the depression-anxiety symptoms network among medical staff. ObjectiveTo compare the differences in the depression-anxiety symptoms network between medical staff and community residents, so as to provide references for the promotion of the mental health of medical staff. MethodsFrom June 1, 2022 to December 31, 2024, a stratified random sampling method was used to recruit 1 959 medical staff from public hospitals and community health centers in 9 townships (industrial parks) of Dongguan City, Guangdong Province, as well as 2 412 community residents in this area, were selected as the research subjects. The general situation questionnaire, Patients' Health Questionnaire Depression Scale-9 item (PHQ-9), and the Generalized Anxiety Disorder Scale-7 item (GAD-7) were used for investigation. The network visualization was conducted using the qgraph package of R 4.0.0. The centrality indicators of the network were calculated using the networktools package. The reliability of the network structure was evaluated using the bootnet package. The differences in the depression-anxiety symptoms network between medical staff and community residents were compared using the NetworkComparisionTest package. ResultsA total of 1 792 medical staff and 2 110 community residents completed the survey. The numbers of medical staff with mild, moderate and severe depressive symptoms were 381 (21.26%), 217 (12.11%) and 169 (9.43%), respectively, while the numbers of community residents were 322 (15.26%), 98 (4.64%) and 66 (3.13%), respectively. The numbers of medical staff with mild, moderate and severe anxiety symptoms were 411 (22.94%), 126 (7.03%) and 93 (5.19%), respectively, while the numbers of community residents were 320 (15.17%), 73 (3.46%) and 18 (0.85%), respectively. The comparison of the detection rates of depressive symptoms and anxiety symptoms between the two groups showed statistically significant differences (χ2=152.012, 205.953, P<0.01). The network analysis results showed that the core symptom clusters of medical staff were "uncontrollable worry" "psychomotor retardation" "inability to relax", and "depression", while those of community residents were "uncontrollable worry" "inability to relax" "inferiority complex", and "depression". There was a statistically significant difference in the network structure between the two groups (M=0.275, P<0.05), and the overall connection strength of medical staff was lower than that of community residents (7.523 vs. 7.950, S=0.426, P<0.05). ConclusionThe detection rates of depression and anxiety symptoms among medical staff were higher than those among community residents. The depression-anxiety symptoms network of medical staff was more concentrated, and the core symptoms were more prominent.[Funded by Social Development and Technology Project of Dongguan City (number, 20221800902552)]
4.Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma Regulates Ferroptosis via Nrf2/SLC7A11/GPX4 Signaling Pathway to Alleviate Myocardial Remodeling in Rat Model of Myocardial Infarction
Xuesong CHEN ; Rongnan QIU ; Shenghao WANG ; Yan FENG ; Jutong XIE ; Yuwen YAN ; Tianlin YANG ; Changxu XIE ; Lei GAO ; Jianping SHEN ; Yuehong SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):54-62
ObjectiveTo investigate the effect of Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma on ferroptosis in the rat model of myocardial infarction and further elucidate its role in myocardial remodeling. MethodsThe rat model of myocardial infarction was established by ligation of the left anterior descending coronary artery. The 50 successfully modeled rats were randomly divided into model group, ferroptosis inhibitor group (2 mg·kg-1), enalapril group (2.1 mg·kg-1), and low- and high-dose (4 g·kg-1 and 8 g·kg-1, respectively) Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma, with 10 rats in each group. The rat model of myocardial infarction was established by ligation of the left anterior descending coronary artery. After 4 weeks of treatment, echocardiography was used to assess the cardiac structure and function. Hematoxylin-eosin (HE) staining and Masson staining were employed to observe pathological morphology and fibrosis of the myocardial tissue. Serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), transforming growth factor-β (TGF-β), and myosin heavy chain-β (MHC-β) were measured by enzyme-linked immunosorbent assay (ELISA). Prussian blue staining was performed to detect myocardial iron deposition. The myocardial mitochondrial structure was observed by transmission electron microscopy. Levels of malondialdehyde (MDA) and glutathione (GSH) in the myocardial tissue were determined by lipid peroxidation assay kits. Immunofluorescence assay was conducted to observe the fluorescence intensity of nuclear factor E2-related factor 2 (Nrf2) in the myocardial tissue. Western blot analysis was performed to evaluate the expression levels of proteins in the Nrf2/solute carrier family 7 member 11 (SLC7A11)/glutathione peroxidase 4 (GPX4) pathway. ResultsCompared with the sham group, the model group showed increased left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and serum levels of NT-proBNP, TGF-β, and MHC-β (P<0.01), decreased left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) (P<0.01), disarrangement of myocardial cells, inflammatory cell infiltration, severe myocardial fibrosis, increased myocardial iron deposition, and irregular mitochondrial morphology with vacuolation. Furthermore, the modeling led to increased MDA (P<0.01), decreased GSH (P<0.01), diminished Nrf2 fluorescence intensity in the myocardial tissue, and downregulated expression levels of Nrf2, SLC7A11, and GPX4 (P<0.01). Compared with the model group, Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma reduced the LVEDD, LVESD, and serum levels of NT-proBNP, TGF-β, and MHC-β (P<0.05, P<0.01), increased the LVEF and LVFS (P<0.05, P<0.01), alleviated pathological changes such as myocardial cell disarrangement, inflammatory cell infiltration, myocardial fibrosis, and iron deposition, lowered the level of MDA (P<0.05, P<0.01), raised the level of GSH (P<0.05, P<0.01), improved the mitochondrial morphology and reduced vacuolation in the myocardial tissue, enhanced Nrf2 fluorescence intensity, and upregulated the expression levels of Nrf2, SLC7A11, and GPX4 (P<0.05, P<0.01) in the rat model of myocardial infarction. ConclusionGardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma alleviates pathological damage and myocardial remodeling in the rat model of myocardial infarction by inhibiting ferroptosis, the mechanism of which is related to the activation of Nrf2/SLC7A11/GPX4 signaling pathway.
5.Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma Regulates Ferroptosis via Nrf2/SLC7A11/GPX4 Signaling Pathway to Alleviate Myocardial Remodeling in Rat Model of Myocardial Infarction
Xuesong CHEN ; Rongnan QIU ; Shenghao WANG ; Yan FENG ; Jutong XIE ; Yuwen YAN ; Tianlin YANG ; Changxu XIE ; Lei GAO ; Jianping SHEN ; Yuehong SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):54-62
ObjectiveTo investigate the effect of Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma on ferroptosis in the rat model of myocardial infarction and further elucidate its role in myocardial remodeling. MethodsThe rat model of myocardial infarction was established by ligation of the left anterior descending coronary artery. The 50 successfully modeled rats were randomly divided into model group, ferroptosis inhibitor group (2 mg·kg-1), enalapril group (2.1 mg·kg-1), and low- and high-dose (4 g·kg-1 and 8 g·kg-1, respectively) Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma, with 10 rats in each group. The rat model of myocardial infarction was established by ligation of the left anterior descending coronary artery. After 4 weeks of treatment, echocardiography was used to assess the cardiac structure and function. Hematoxylin-eosin (HE) staining and Masson staining were employed to observe pathological morphology and fibrosis of the myocardial tissue. Serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), transforming growth factor-β (TGF-β), and myosin heavy chain-β (MHC-β) were measured by enzyme-linked immunosorbent assay (ELISA). Prussian blue staining was performed to detect myocardial iron deposition. The myocardial mitochondrial structure was observed by transmission electron microscopy. Levels of malondialdehyde (MDA) and glutathione (GSH) in the myocardial tissue were determined by lipid peroxidation assay kits. Immunofluorescence assay was conducted to observe the fluorescence intensity of nuclear factor E2-related factor 2 (Nrf2) in the myocardial tissue. Western blot analysis was performed to evaluate the expression levels of proteins in the Nrf2/solute carrier family 7 member 11 (SLC7A11)/glutathione peroxidase 4 (GPX4) pathway. ResultsCompared with the sham group, the model group showed increased left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and serum levels of NT-proBNP, TGF-β, and MHC-β (P<0.01), decreased left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) (P<0.01), disarrangement of myocardial cells, inflammatory cell infiltration, severe myocardial fibrosis, increased myocardial iron deposition, and irregular mitochondrial morphology with vacuolation. Furthermore, the modeling led to increased MDA (P<0.01), decreased GSH (P<0.01), diminished Nrf2 fluorescence intensity in the myocardial tissue, and downregulated expression levels of Nrf2, SLC7A11, and GPX4 (P<0.01). Compared with the model group, Gardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma reduced the LVEDD, LVESD, and serum levels of NT-proBNP, TGF-β, and MHC-β (P<0.05, P<0.01), increased the LVEF and LVFS (P<0.05, P<0.01), alleviated pathological changes such as myocardial cell disarrangement, inflammatory cell infiltration, myocardial fibrosis, and iron deposition, lowered the level of MDA (P<0.05, P<0.01), raised the level of GSH (P<0.05, P<0.01), improved the mitochondrial morphology and reduced vacuolation in the myocardial tissue, enhanced Nrf2 fluorescence intensity, and upregulated the expression levels of Nrf2, SLC7A11, and GPX4 (P<0.05, P<0.01) in the rat model of myocardial infarction. ConclusionGardeniae Fructus-Salviae Miltiorrhizae Radix et Rhizoma alleviates pathological damage and myocardial remodeling in the rat model of myocardial infarction by inhibiting ferroptosis, the mechanism of which is related to the activation of Nrf2/SLC7A11/GPX4 signaling pathway.
6.Survey on oral health status of second-grade primary school students in Suzhou City
Yuwen ZHANG ; Bei LI ; Bing GE ; Ye ZHU ; Xiaozhen WANG ; Lu BAI ; Peng ZHU
STOMATOLOGY 2025;45(8):613-618,630
Objective To investigate the oral health status of second-grade primary school students in Suzhou,provide baseline data for evaluating Suzhou's"Bright Eyes and Healthy Teeth"public health project,and offer reference for formulating oral health policies for students in Suzhou.Methods A multi-stage,stratified,random sampling method was used to select 1 640 second-grade primary school students from 10 districts(county-level cities)across Suzhou.The oral health survey of primary school students in Suzhou was designedbased on WHO"Basic Methods for Oral Health Surveys"(5th edition).A survey on the students' oral health status was con-ducted.Results The caries prevalence,mean DMFT(Decayed,Missing,Filled Teeth),and caries filling rate for primary teeth among second-grade students in Suzhou were 80.73%,4.25,and 24.48%,respectively.For permanent teeth,the caries prevalence,mean DMFT(Decayed,Missing,Filled Teeth),and caries filling rate were 30.30%,0.62,and 16.96%,respectively.Specifically,the caries prevalence,mean DMFT,and filling rate for the first permanent molar were 29.88%,0.59,and 16.94%,respectively.The pit and fissure sealing rate for the first permanent molar was 13.74%.Additionally,the detection rate for gingival bleeding was 58.05%,and for dental calculus,49.15%.Conclusion The oral health status of second-grade primary school students in Suzhou is concerning.The caries prevalence rate for both primary and permanent teeth is high,while the filling rate is relatively low.Prior to the implementation of oral health programs,the pit and fissure sealing rate for the first permanent molars was low,with significant differ-ences observed between urban and rural areas,as well as among different districts(or county-level cities).
7.Finite element analysis of various root shield thicknesses in maxillary central incisor socket-shield technique
Guangneng CHEN ; Siyang LUO ; Mei WANG ; Bin YE ; Jiawen CHEN ; Yin LIU ; Yuwen ZUO ; Xianyu HE ; Jiajin SHEN ; Minxian MA
Chinese Journal of Tissue Engineering Research 2025;29(10):2052-2060
BACKGROUND:Socket-shield technique can effectively maintain labial soft and hard tissues,but the incidence of postoperative complications such as exposure and displacement of root shield is relatively high.It is speculated that the root shield may be exposed and displaced due to excessive load after long-term function of dental implants. OBJECTIVE:Through three-dimensional finite element analysis,we aim to study the influence of varying root shield thicknesses on the stress distribution,equivalent stress peaks,and displacement in the root shield,periodontal ligaments,implant,and surrounding alveolar bone under normal occlusal loading.We also attempt to analyze the correlation between the thickness of the root shield and occurrence of mechanical events such as root shield exposure,displacement,and fracture. METHODS:Cone-beam CT data of a patient who met the indication standard of socket-shield technique for maxillary central incisor were retrieved from database.Reverse engineering techniques were used to build models of the maxillary bone and root shield,while forward engineering was used to create models for the implant components based on their parameters.Models depicting various root shield thicknesses(0.5,1.0,1.5,and 2.0 mm)were created using Solidworks 2022 software.ANSYS Workbench 2021 software was then used to simulate and analyze the effects of varying root shield thicknesses on stress distribution,equivalent stress peaks,and displacement of the root shields,periodontal ligaments,implants,and surrounding alveolar bone under normal occlusion. RESULTS AND CONCLUSION:(1)In all root shield models,the stress was concentrated on the palatal cervical side,both sides of the edges and the lower edge of the labial side.As the thickness of the root shield increased,the equivalent stress peak and displacement showed a decreasing trend.The 0.5 mm thickness model produced a stress concentration of 176.20 MPa,which exceeded the yield strength(150 MPa)of tooth tissue.(2)The periodontal ligament stress in each group was concentrated in the neck margin and upper region.With the increase of root shield thickness,the equivalent stress peak and displacement of periodontal ligament showed a decreasing trend.(3)Implant stress in all models was concentrated in the neck of the implant and the joint of the implant-repair abutment,and the labial side was more concentrated than the palatal side.With the increase of root shield thickness,the equivalent stress peak of the implant in the model showed an increasing trend.(4)In each group of models,stress of cortical bone concentrated around the neck of the implant and the periphery of the root shield,and the labial side was more concentrated than the palatal side.With the increase of the thickness of the root shield,the equivalent stress peak around the root shield decreased;the peak value of the equivalent stress of the bone around the neck of the implant showed an increasing trend.In the model,the stress of cancellous bone was mainly concentrated around the neck of the lip of the implant,the top of the thread,the root tip and the lower margin of the root shield,and the labial side was more concentrated than the palatal side.With the increase of the thickness of the root shield,the peak value of the equivalent stress of the bone around the root shield in the model showed a decreasing trend.The minimum principal stress of cortical bone in each group of models was concentrated around the neck of the implant,exhibiting a fan-shaped distribution.As the thickness of the root shield increased,the minimum principal stress of cortical bone showed an increasing trend.(5)These results indicate that different thicknesses of the root shield have different biomechanical effects.The root shield with a thickness of 0.5 mm is easy to fracture.For patients with sufficient bone width,the root shield with a thickness of 2.0 mm is an option to reduce the risk of complications such as root shield exposure,fracture,and displacement.Meanwhile,it should be taken into account to protect the periodontal ligament in the preparation process,and rounding treatments ought to be carried out on both sides and the lower edge of the root shield.
8.Clinical and diffusion imaging study of brain damage in patients with neurosyphilis
Yuwen XIE ; Ruiyun ZHAO ; Pingping WANG
Journal of Practical Radiology 2025;41(7):1104-1108
Objective To investigate the clinical and diffusion imaging of brain damage in patients with neurosyphilis.Methods Eighty patients with neurosyphilis with brain damage were retrospectively selected as the study group,and were divided into mild group(n=38)and moderate to severe group(n=42)according to imaging results.Another 80 healthy subjects in the same period were selected as the control group.The values of apparent diffusion coefficient(ADC)and fractional anisotropy(FA)were compared among the three groups.Pearson test was used to analyze the correlation between ADC and FA values in various brain regions and cognitive function in patients with neurosyphilis brain damage.Results ADC values in parieto-occipital lobe,frontal lobe,basal gan-glia and hemioval center in moderate to severe group were significantly higher than those in mild group and control group,and FA values were significantly lower than those in mild group and control group(P<0.05).The results of Pearson analysis showed that the ADC and FA values of parieto-occipital lobe,frontal lobe and hemioval center were significantly correlated with Wechsler adult intel-ligence scale-revised of China(WAIS-RC)knowledge,WAIS-RC arithmetic,verbal fluency test(VFT),Montreal cognitive assess-ment(MoCA),forward digit span test(FDST),trail making test A(TMT-A)and trail making test B(TMT-B)scores(P<0.05).Conclusion The ADC and FA values of parieto-occipital lobe,frontal lobe,basal ganglia and hemioval center are closely related to the severity of brain damage,which is helpful for clinical diagnosis.
9.A Retrospective Cohort Study on the Improvement of Prognosis of Hospitalized COVID-19 Patients Using Traditional Chinese Medicine Preparations
Li DOU ; Wei WANG ; Manshu YU ; Sicheng YUAN ; Jingyi HU ; Yuwen ZHUANG ; Minghao QI ; Yuanyuan WANG ; Fei YANG ; Jiale MENG ; Tao GUO ; Xiaoxiao WANG
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(11):1585-1595
OBJECTIVE The emergence of evolving variants of Coronavirus disease 2019(COVID-19)has fostered the need for change of newer and adaptive treatments for these infections.During the COVID-19 pandemic and persists,traditional Chinese medicine(TCM)herbs exhibit significant bioactivity and therapeutic effect.This study is aimed to evaluate the efficacy of four TCM preparations on 28-day mortality risk of patients and changes of the laboratory indicators.METHODS The retrospective cohort study included patients with COVID-19 who were admitted to the Jiangsu Province Hospital of Chinese Medicine from December 15,2022 to January 15,2023,and those died within 48 hours of admission or cannot be tracked for outcomes were excluded.The pri-mary outcome was survival status in 28 days(death or survival)starting from the day of admission.The second outcomes were labora-tory indicators,including absolute lymphocyte count,lactate dehydrogenase,creatinine,and blood urea nitrogen.Binary logistic re-gressions were used to estimate the effect of TCM preparations on the primary and secondary outcomes in main analysis.Meanwhile,heterogeneity and robustness of results from main analysis were assessed by subgroup analyses and multiple sensitivity analyses.RESULTS 1 816 eligible patients were included in analysis dataset,including 573 patients received standard care(control group)and 1 243 patients received TCM preparations(hospital preparation group).The 28-day mortality rate of hospital preparation group was lower than that of control group(4.75%vs.14.83%),and the difference was statistically significant(χ2=54.666,P<0.001).The risk of 28-day mortality was 0.535 times lower in the hospital preparation group as compared with the control group(OR=0.46,95%CI:0.305-0.708,P<0.001)showed by multivariable binary logistic regressions.Subgroup analyses showed that taking TCM preparations reduced the 28-day mortality risk.Sensitivity analyses demonstrated that the results of the main analysis for primary outcomes were robust.For secondary outcomes,the risk of abnormal absolute lymphocyte counts at discharge in the hospital prepara-tion group decreased by 0.284 times(OR=0.703,95%CI:0.515-0.961,P=0.027).CONCLUSION Compared with standard of care,taking four hospital preparations including Kanggan Heji,Feining Heji,Qishen Gubiao Keli,and Qianghuo Qushi Qingwen Heji decreased risk of 28-day mortality among hospitalized COVID-19 patients.TCM therapy achieves adequate therapeutic effects in COVID-19.
10.Determination of Trace N-nitrosopropranolol in Propranolol Hydrochloride Sustained Release Tablets by UHPLC-Q-Orbitrap HRMS
Changchuan GUO ; Songsong WEN ; Dengyi LYU ; Weijian WANG ; Shujuan YANG ; Chong NIU ; Yuwen XU
Herald of Medicine 2025;44(4):628-633
Objective To establish a ultrahigh-performance liquid chromatography-orbitrap high-resolution mass spectrometry(UHPLC-Orbitrap HRMS)method for the determination of the genotoxic impurity N-nitroso propranolol(NPPN)in propranolol hydrochloride sustained-release tablets.Methods The test sample was ultrasonically extracted using methanol as the solvent,then centrifuged and filtered before injection analysis.Chromatographic separation was performed using a 2.7 μm particle size C18 UHPLC column with a mobile phase of 0.1%formic acid(A)in water and 0.1%formic acid(B)in acetonitrile,using gradient elution.Mass spectrometry was conducted with an HESI ion source in positive ion parallel reaction monitoring(PRM)scan mode,monitoring the NPPN fragment ion at m/z 72.080 8,and quantification was performed using the standard curve method.Results The calibration curve was in good linearity in the range of 0.51-20.30 ng·mL-1 with excellent correlation coefficient(r)of 0.9999.The recoveries of NPPN at three levels(low,medium,and high)were in the range of 95.4%~98.3%,while the RSDs were from 2.5%to 4.2%.The limit of detection(LOD)was 0.20 ng·mL-1 while the limit of quantitfication(LOQ)was 0.51 ng·mL-1.This analytical method was used to determine NPPN in six batches of propranolol hydrochloride sustained release tablet samples.NPPN was detected in all six samples,among which the detection amount of 3 batches have exceeded the acceptable limit.Conclusion This method is sensitive,accurate,and fast,making it useful for pharmaceutical companies in controlling production processes and providing robust technical support for regulatory authorities.

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