1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Detection rate and logistic regression analysis of pulmonary infection in patients with acute exacerbation of chronic obstructive pulmonary disease
Yongli XUE ; Juan DU ; Yinzhen SHU ; Lan LIN ; Jun LIU
Journal of Public Health and Preventive Medicine 2025;36(2):43-46
Objective To analyze the detection rate and risk factors of pulmonary infection in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods A total of 308 patients with AECOPD hospitalized at the Second Affiliated Hospital of Chengdu Medical College were selected from October 2020 to October 2023 as the research subjects. The incidence of pulmonary infections was analyzed, and univariate and logistic multivariate regression analyses were conducted to identify the risk factors of pulmonary infections. Results Among the 308 patients with AECOPD, 155 cases (50.32%) had pulmonary infection and were selected as the infected group, and 153 cases without pulmonary infection were included in the uninfected group. There were no obvious differences in gender, body mass index, education level, drinking history, hypertension, heart failure and malnutrition between the two groups (P>0.05). There were significant differences between the two groups in age, hospitalization time, mechanical ventilation history, smoking history, glucocorticoid use time, and diabetes mellitus (P<0.05). Logistic analysis showed that the ORs of pulmonary infection risk in AECOPD patients with age ≥ 60 years old, hospitalization time ≥ 14 days, mechanical ventilation history, glucocorticoid use time ≥ 7 days, diabetes mellitus, and smoking history were 2.740 (1.024-7.330), 4.586 (2.318-9.071), 3.971 (1.806-8.731), 3.264 (1.419-7.508), 2.680 (1.012-7.100), and 2.826 (1.156-6.909), respectively. Conclusion The risk of pulmonary infection is high in AECOPD patients, which is influenced by factors such as age, hospitalization time, mechanical ventilation history, smoking history, and glucocorticoid use time. Clinical screening should be focused on the above indicators and active prevention and treatment measures should be taken to reduce the occurrence of pulmonary infection.
3.Effect of warm acupuncture on PINK1/Parkin pathway in the skeletal muscle of rats with chronic fatigue syndrome
Huayuan LI ; Chun LI ; Junwei LIU ; Ting WANG ; Long LI ; Yongli WU
Chinese Journal of Tissue Engineering Research 2025;29(8):1618-1625
BACKGROUND:It has been found that mitochondrial function is abnormal in patients with chronic fatigue syndrome,and the administration of coenzymes can improve the symptoms.Warm acupuncture is one of the most important treatments for this disease,but its mechanism of action is unclear. OBJECTIVE:To investigate the effects of warm acupuncture on the phosphatase and tensin inducible kinase 1(PINK1)/Parkin pathway in the skeletal muscle of rats with chronic fatigue syndrome. METHODS:After 3 days of adaptive feeding,32 male Sprague-Dawley rats were randomly divided into normal control,model,warm acupuncture,and coenzyme Q groups with 8 rats in each group.The chronic fatigue syndrome model was established by multiple factors,including swimming exhaustion,chronic immobilization and fasting.After successful modeling,the normal group and the model group were treated with the same fixation and gavage procedures,and the warm acupuncture group was treated with acupuncture at Guanyuan,Zhongwan and Zusanli(bilateral)points,once a day.After the needling was inserted,the moxa pillar was put on the needle handle and ignited,three sessions once.The coenzyme Q group was given 1 mL/kg coenzyme by gavage,once a day for 14 days.The body mass,exhaustive swimming time and food utilization rate during the treatment were recorded.After the treatment,the bilateral gastrocnemius muscles of rats in each group were collected.The pathological morphology of the gastrocnemius muscle was observed by hematoxylin-eosin staining,the mitochondrial morphology and autophagosome of the gastrocnemius muscle were observed by transmission electron microscope.The expression level of microtubule-associated protein light chain 3(LC3)Ⅱ protein in the skeletal muscle was detected by immunohistochemistry.Western blot was used to detect the expression of PINK1,Parkin,LC3 Ⅰ,and LC3 Ⅱ in the skeletal muscle. RESULTS AND CONCLUSION:Compared with the normal group,the gastrocnemius muscle nuclei of the model group were pyknotic,condensed,the number of cells was increased,the cells were arranged disorderly,and the fibers in the gastrocnemius muscle were tightly arranged in the model group.Compared with the model group,the intercellular space became smaller,the nuclei were reduced,and the cell arrangement was orderly in the warm acupuncture group and coenzyme Q group.Compared with the normal group,the skeletal muscle mitochondria in the model group were swollen,fused,and vacuolated seriously,the membrane was partially broken,the matrix was more dissolved,the cristae was broken and disappeared,and autophagy appeared.Compared with the model group,the number of mitochondria increased,the arrangement was relatively neat,mitochondrial vacuolization and rupture of cristae in the gastrocnemius muscle were improved,the membrane structure was relatively intact,and autophagy occurred.Compared with the normal group,the expression of PINK1 protein in the skeletal muscle of the model group was significantly increased(P<0.05),while the expression of Parkin,LC3 Ⅱ and LC3 Ⅱ/Ⅰ protein was slightly upregulated(P>0.05).Compared with the model group,the protein expressions of PINK1,Parkin,LC3 Ⅱ and LC3 Ⅱ/Ⅰ were significantly upregulated in the warm acupuncture and coenzyme Q groups(P<0.05),and the up-regulation was more significant in the warm acupuncture group.To conclude,warm acupuncture can play a role in the treatment of chronic fatigue syndrome by activating the PINK1/Parkin pathway,upregulating LC3 Ⅱ expression,forming mitochondrial autophagosomes,promoting the degradation of damaged mitochondria,and improving mitochondrial quality.
4.Efficacy of intelligent temperature-pressure-controlled flexible ureteroscopy combined with negative-pressure suction sheath lithotripsy in the treatment of ≤2.5 cm upper urinary tract stones
Xiaofu WANG ; Yunxiang ZHANG ; Xinyu SHI ; Yongli ZHAO ; Changbao XU ; Changwei LIU ; Haiyang WEI ; Xinghua ZHAO
Journal of Modern Urology 2025;30(4):311-314
Objective: To investigate the efficacy and safety of intelligent temperature-pressure-controlled flexible ureteroscopy combined with negative-pressure suction sheath lithotripsy in the treatment of upper urinary tract stones ≤2.5 cm. Methods: The clinical data of 225 patients with ≤2.5 cm upper urinary tract stones treated with this surgical method in our department during Aug. 2023 and Jul. 2024 were retrospectively analyzed. The patients were divided into the dual-control group (n=36) and conventional group (n=189) according to whether or not the intelligent temperature and pressure control device was used during operation. In the dual-control group,the intraoperative temperature and pressure in the renal pelvis were monitored and controlled in real time by the temperature and pressure sensors distributed at the end of the ureteral soft lens. The perioperative parameters,stone-removal rate,complication rate and renal function were compared between the two groups. Results: All operations were successfully completed in both groups. The postoperative procalcitonin (PCT) level [(22.75±5.85) ng/L vs. (29.08±6.60) ng/L,P=0.001],difference in the white blood cell (WBC) level [(0.24±2.12)×10
cells/L vs. (1.19±2.17)×10
cells/L,P=0.016],incidence of fever (2.8% vs. 16.9%,P=0.028) and overall complication rate (5.6% vs. 19.6%,P=0.042) were significantly lower in the dual-control group than in the conventional group,while the stone-clearance rate was slightly higher (88.9% vs. 82.5%,P=0.346),with no significant difference. Conclusion: For upper urinary tract stones ≤2.5 cm,intelligent temperature-pressure-controlled ureteroscopy combined with negative-pressure suction sheath lithotripsy has a satisfactory stone-removal rate and a low rate of complications,which is worthy of clinical promotion.
5.Relationship between default mode network functional connectivity and clinical symptoms in patients with first-episode major depressive disorder
Ziliang HAN ; Yongli LAI ; Dongsheng YU ; Wuhong LIN ; Ping YAO ; Min LIU ; Min CHEN ; Dongsheng LYU
Sichuan Mental Health 2025;38(5):398-404
BackgroundThe functional changes of the default mode network (DMN) are closely related to the onset of major depressive disorders. However, the relationship between the DMN subsystem (core subsystem, dorsomedial prefrontal cortex subsystem, medial temporal lobe subsystem) and symptoms of first-episode major depressive disorder remains unclear. ObjectiveTo investigate abnormal functional connectivity between DMN subsystems and the whole brain in first-episode major depressive disorder patients during the resting-state, and to analyse the correlations between these functional connectivity patterns and clinical symptoms, so as to reveal the potential neural mechanisms from the perspective of DMN subsystem. MethodsFrom September 2020 to September 2023, a total of 64 first-episode outpatients and inpatients meeting the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) were enrolled at the Inner Mongolia Autonomous Region Mental Health Center as the study group. During the same period, 54 healthy volunteers matched for age, gender, and years of education were recruited from the community as the control group. Both groups were assessed using the Hamilton Depression Scale-24 item (HAMD-24). Resting-state functional magnetic resonance images (rs-fMRI) of the two groups were acquired using a Siemens 3.0 T scanner, and differences in functional connectivity between DMN subsystems (core subsystem, dorsomedial prefrontal cortex subsystem, medial temporal lobe subsystem) and the whole brain were compared. The functional connectivity values of brain regions with statistically significant differences between the two groups were extracted. Spearman's rank correlation coefficient analysis was used to investigate the correlation between these functional connectivity values and HAMD-24 scores of the study group. ResultsUltimately, 46 patients and 43 controls completed the study. Compared with the control group, the study group exhibited significantly stronger functional connectivity in the following pathways: between the right superior parietal lobule (core subsystem) and right cerebellar lobule VIII (t=3.954, P<0.05, GRF-corrected), between the right lateral temporal cortex (dorsomedial prefrontal cortex subsystem) and right cerebellar lobule VIII, right and left hippocampi, right medial, and paracingulate gyrus (t=4.595, 4.208, 5.200, 4.038, P<0.05, GRF-corrected), and between the temporoparietal junction (dorsomedial prefrontal cortex subsystem) and left lingual gyrus and right cerebellar lobule VIII (t=3.557, 4.274, P<0.05, GRF-corrected). Conversely, weaker functional connectivity was observed between the right inferior frontal gyrus and left gyrus rectus (t=-3.824, P<0.05, GRF-corrected). Furthermore, within the study group, the functional connectivity values between the right lateral temporal cortex and right hippocampus, as well as between the temporoparietal junction and right cerebellar lobule VIII, were both negatively correlated with the HAMD-24 cognitive impairment factor score (r=-0.306, -0.318, P<0.05). ConclusionIncreased functional connectivity between the DMN (specifically its core and dorsomedial prefrontal cortex subsystems) and cerebellum, partial limbic system, and lingual gyrus may be associated with the neuropathology of first-episode major depressive disorder. Furthermore, alterations in functional connectivity between the dorsomedial prefrontal cortex subsystem and both the cerebellum and hippocampus in these patients may be related to cognitive function. [Funded by 2019 Annual Inner Mongolia Autonomous Region Natural Science Foundation Project (number, 2019MS03038); 2023 Annual Inner Mongolia Autonomous Region Natural Science Foundation Project (number, 2023MS08028)]
6.Readiness assessment and influencing factors analysis of evidence-based practice for prevention and management of urinary retention after cervical cancer radical operation
Yongli LYU ; Mengna WANG ; Qianru LIU ; Li GENG ; Can XIANG ; Yinglu WAN
Chongqing Medicine 2024;53(11):1656-1660
Objective To understand the readiness of gynecological wards in conducting the evidence-based practice for the prevention and management of urinary retention after cervical cancer radical resection,and to analyze the influencing factors.Methods The 190 nursing staffs in the gynecological oncology wards of this hospital in June 2020 were selected as the study subjects.The assessment of readiness for evidence-based nursing practice (CREBNA) and general information questionnaire were used to conduct the questionnaire survey,single factor and multiple factor stepwise regression to analyze the influencing factors.Results The score of CREBNA was (135.94±17.83) points,the evidence subscale was (52.41±7.88) points,the organi-zational environment subscale was (40.58±5.01) points and the promoting factors subscale was (42.67±6.24) points.The results of univariate analysis showed that the total score of CREBNA was related to the ed-ucational background,professional title,position,scientific research experience,understand degree on evidence-based and necessity of conducting evidence-based (P<0.05).The multiple stepwise regression analysis showed that the understanding degree on the evidenced-base and necessity of conducting evidence-based were the influencing factors of CREBNA scale (P<0.05).Conclusion The readiness of the evidence-based nursing practice in this study is good and has good feasibility.
7.Characteristic spectrum and ginseng content determination of the famous classical formula Fuzi decoction
Xueyi WANG ; Junshuai WANG ; Zhenxia ZHAO ; Zhenyin LIU ; Xueying WANG ; Bing XU ; Jian SU ; Yongli LIU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(6):863-873
Objective We aimed to establish the benchmark characteristic map of Fuzi decoction and the determination method of multi-index components,and to clarify the key quality attributes of Fuzi decoction.Methods Fifteen batches of Fuzi decoction substance benchmarks samples were prepared;the high-performance liquid chromatography(HPLC)characteristic spectrum of Fuzi decoction was established;and characteristic peak attribution and similarity analysis were performed.Ginsenosides Rg1,Re,Rf,and Rb1 were used as the index components to establish a method to determine ginseng content in Fuzi decoction.The value range of each quality control index was set at a limit of 70%-130%of the average value,and the quantity transfer analysis was performed on the material basis of 15 Fuzi decoction batches.Results The characteristic spectra of the 15 Fuzi decoction batches had 12 common peaks,and seven characteristic peaks of gallic acid,catechin,paeoniflorin,ginsenosides Rg1,Re,and Rb1,and atractylenolide Ⅲ were identified,with a similarity of more than 0.98.Ginsenosides Rg1,Re,Rf,and Rb1 content ranges were 0.51-0.94,0.34-0.62,0.14-0.27,and 0.41-0.76 mg/g,respectively.The transfer rates of ginsenosides Rg1 and Re,Rf,and Rb1 were 12.05%-26.91%,11.15%-43.71%,and 10.53%-33.23%,respectively.Conclusion The characteristic HPLC of Fuzi decoction and the determination method of Fuzi decoction ginseng content established in this study are accurate,reproducible,and stable,laying the foundation for the quality evaluation of the key chemical properties of Fuzi decoction and its preparation.
8.Hypoglycemic activities of flowers of Xanthoceras sorbifolia and identification of anti-oxidant components by off-line UPLC-QTOF-MS/MS-free radical scavenging detection.
Xiajing XU ; Yongli GUO ; Menglin CHEN ; Ning LI ; Yi SUN ; Shumeng REN ; Jiao XIAO ; Dongmei WANG ; Xiaoqiu LIU ; Yingni PAN
Chinese Herbal Medicines 2024;16(1):151-161
OBJECTIVE:
To identify phytochemical constituents present in the extract of flowers of Xanthoceras sorbifolia and evaluate their anti-oxidant and anti-hyperglycemic capacities.
METHODS:
The AlCl3 colorimetric method and Prussian Blue assay were used to determine the contents of total flavonoids and total phenolic acids in extraction layers, and the bioactive layers was screened through anti - oxidative activity in vitro. The Waters ACQUITY UPLC system and a Waters ACQUITY UPLC BEH C18 column (2.0 mm × 150 mm, 5 μm) were used to identify the ingredients. And anti-oxidative ingredients were screened by off-line UPLC-QTOF-MS/MS-free radical scavenging. The ameliorative role of it was further evaluated in a high-fat, streptozotocin-induced type 2 diabetic rat model and the study was carried out on NADPH oxidase (PDB ID: 2CDU) by molecular docking.
RESULTS:
Combined with the results of activity screening in vitro, the anti - oxidative part was identified as the ethyl acetate layer. A total of 24 chemical constituents were identified by liquid chromatography-mass spectrometry in the ethyl acetate layer and 13 main anti-oxidative active constituents were preliminarily screened out through off-line UPLC-QTOF-MS/MS-free radical scavenging. In vivo experiments showed that flowers of X. sorbifolia could significantly reduce the blood glucose level of diabetic mice and alleviate liver cell damage. Based on the results of docking analysis related to the identified phytocompounds and oxidase which involved in type 2 diabetes, quercetin 3-O-rutinoside, kaempferol-3-O-rhamnoside, isorhamnetin-3-O-glucoside, and isoquercitrin showed a better inhibitory profile.
CONCLUSION
The ethyl acetate layer was rich in flavonoids and phenolic acids and had significant anti-oxidant activity, which could prevent hyperglycemia. This observed activity profile suggested X. sorbifolia flowers as a promising new source of tea to develop alternative natural anti-diabetic products with a high safety margin.
9.Analysis of Residue and Transfer Status and Risk Assessment of Plant Growth Regulator Paclobutrazol in Shenmai Granules
Xiaolei WANG ; Huizhu SUN ; Rong LEI ; Qi AN ; Yongli LIU
Herald of Medicine 2024;43(3):435-440
Objective To analyze the residual status,transfer behavior,and risk of paclobutrazole in the national mar-ket of Shenmai granules.Methods GC-MS/MS determined the residual amount of paclobutrazol in Shenmai granules,and ANOVA analyzed the distribution characteristics of sample residuals.The transfer rule of paclobutrazol from Ophiopogonis Radix to Shenmai granules was investigated by simulating the production process,and chronic exposure assessment was performed using the point evaluation model.Results The established method can accurately determine the residual amount of paclobutrazol in Shenmai granules.The residual amount of paclobutrazol in 85 batches of Shenmai granules ranged from 0.001 3 to 0.015 8 mg·kg-1,and there was a statistical difference in the residual amount among different enterprise samples.The transfer rate of paclobutrazol from decoction pieces to preparations was 29.8%.The chronic risk quotient(HQc)of paclobutrazol residues in Shenmai granules was 0.000 7%,far lower than 1.Conclusion There is a general presence of paclobutrazol residues in Shenmai granules.The risk assessment results show that the normal dosage of Shenmai granules does not pose an unacceptable risk to the general population.The residual distribution characteristics and process transfer rules can provide a reference for safety risk control in production enterprises.
10.Study on epidemiological prevalence and serological marker characteristics of hepatitis E infection
Chengrong BIAN ; Xin LIU ; Ruirui HAN ; Lili ZHAO ; Yeli HE ; Lihua YANG ; Weiwei LI ; Lijuan SONG ; Yingwei SONG ; Yongli LI ; Aixia LIU ; Jinli LOU ; Bo′an LI
Chinese Journal of Laboratory Medicine 2024;47(3):245-251
Objective:This study aims to explore the prevalence of hepatitis E virus (HEV) infection in patients and the screening value of serological indicators for HEV infection patients.Methods:Retrospective analysis was conducted on 97 440 cases of anti-HEV IgM and IgG simultaneously tested in two Beijing hospitals from January 1, 2018 to August 31, 2023. Among them, there were 61 005 males and 36 435 females, with an average age of 51.65±13.05 years old. According to the positivity of anti HEV specific antibodies, they were divided into anti-HEV IgM positive group (3 588 cases), anti-HEV IgG positive group (18 083 cases), and anti-HEV antibody negative group (78 892 cases). Results of HEV RNA, liver function, AFP, PIVKA-Ⅱ and PT were collected, and their basic clinical information were recorded. The prevalence of HEV infection in patients, as well as the relationship between the positivity of anti-HEV specific antibodies and the patient′s age group, HEV RNA, and clinical characteristics were analyzed.Results:Among 97 440 patients who tested anti-HEV IgM and IgG simultaneously, the positivity rate of anti-HEV IgM was 3.68% (3 588/97 440), and was 18.56% for anti-HEV IgG (18 083/97 440). The overall positivity rates of anti-HEV IgM in two Beijing hospitals from 2018 to 2023 were 2.51%, 2.53%, 3.02%, 4.59%, 5.72%, and 4.26% ( χ2=1 401.73, P<0.001), while the positivity rates of anti-HEV IgG were 12.56%, 12.32%, 12.85%, 22.65%, 27.42%, and 26.66% ( χ2=1 058.29, P<0.001). These rates showed a gradual increase until 2023 when a decline was observed. The positivity rates of anti-HEV IgM (2.28%, 3.60%, 4.47%) ( χ2=89.62, P<0.001) and IgG (4.71%, 17.86%, 25.94%) ( χ2=2 017.32, P<0.001) increased with age in patients who aged 1-30, >30-60, and over 60 years old. The age and ALB values of patients in the anti-HEV IgM positive group were lower than the IgG-positive group, while the proportion of males, TBIL, ALT, AFP and PT values were higher than the IgG-positive group, and the differences were statistically significance ( P<0.05). Furthermore, patients in both the anti-HEV IgM and IgG positive groups had higher age, male proportion, TBIL, ALT, AFP, PIVKA-Ⅱ, and PT values than the anti-HEV negative group. Additionally, both groups had lower ALB values than the anti-HEV negative group, all of which were statistically significant ( P<0.05). 2 162 HEV infected patients were grouped based on HEV RNA positivity. The proportion of anti-HEV IgM single positive, IgG single positive, IgM+IgG double positive, and antibody negative patients in the HEV RNA positive group were 5.42% (18/332), 3.62% (12/332), 90.36% (300/332), and 0.60% (2/332), respectively. Among them, the proportion of anti-HEV IgM+IgG double positive patients in the HEV RNA positive group was higher than that in the HEV RNA negative group ( χ2=302.87, P<0.001), while the proportion of anti-HEV IgG single positive ( χ2=174.36, P<0.001) and anti-HEV antibody negative patients ( χ2=59.28, P<0.001) were lower than that in the HEV RNA negative group, both of which were statistically significant ( P<0.001). In addition, the positive rates of HEV RNA in anti-HEV IgM positive, IgG positive, and antibody negative patients were 29.23% (318/1 088), 17.59% (312/1 774), and 0.65% (2/306), respectively. Conclusion:The HEV infection rate among patients declined in 2023. HEV infection is age-related, with older individuals being more susceptible. Abnormal liver function and jaundice were commonly observed during HEV infection. It is crucial to note that the absence of anti-HEV specific antibodies cannot rule out HEV infection; therefore, additional testing for HEV RNA and/or HEV Ag is necessary for accurate diagnosis.


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