1.National biological standards for antibiotics: an overview
Bufang MA ; Hui LIU ; Xuan JIN ; Yanchun FENG ; Jin LI
Journal of China Pharmaceutical University 2026;57(1):108-114
National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics. This article systematically reviews the classification, definition of potency units, and current research status of commercially available national antibiotic biological standards in China. At present, these standards can be categorized based on chemical structure, number of components, and development methods. The definition of potency units has evolved from an early “arbitrarily assigned unit” to “being represented by the mass of the antibiotic salt” and, more recently, to the current mainstream approach of “being represented by the mass of the active ingredient”. This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods. Current research focuses on optimizing potency determination methods, studying the unification of content and potency, and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics. For complex multi-component antibiotics, the microbiological assay based on biological activity remains irreplaceable in quality control. Future efforts should emphasize further method optimization, ensuring batch-to-batch consistency of standards, and advancing precision quality control as key research priorities for antibiotic biological standards.
2.Anti-inflammatory and hepatoprotective triterpenoids from the traditional Mongolian medicine Gentianopsis barbata.
Huizhen CHENG ; Huan LIU ; Xiaoyu QI ; Yuzhou FAN ; Zhongzhu YUAN ; Yuanliang XU ; Yanchun LIU ; Yan LIU ; Kai GUO ; Shenghong LI
Chinese Journal of Natural Medicines (English Ed.) 2025;23(9):1111-1121
Gentianopsis barbata (G. barbata) represents a significant plant species with considerable ornamental and medicinal value in China. This investigation sought to elucidate the primary constituents within the plant and investigate their pharmacological properties. Fifty triterpenoids (1-50), including nine previously undescribed compounds (1, 2, 7, 10, 20, 28, 29, 37, and 41) were isolated and characterized from the whole plants of G. barbata. Notably, compounds 1 and 2 exhibited the novel 3,4;9,10-diseco-24-homo-cycloartane triterpenoid skeleton. The isolated triterpenoids demonstrated substantial anti-inflammatory activity through inhibition of tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6) cytokine secretion in LPS-induced RAW264.7 macrophages, and hepatoprotective effects by preventing tert-butyl hydroperoxide (t-BHP)-induced oxidative injury in HepG2 cells. These results demonstrate both the presence of diverse triterpenoids in G. barbata and their therapeutic potential for inflammatory and hepatic conditions, providing scientific evidence supporting the clinical application of this traditional Mongolian medicinal plant.
Triterpenes/isolation & purification*
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Mice
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Anti-Inflammatory Agents/isolation & purification*
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Animals
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Humans
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RAW 264.7 Cells
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Hep G2 Cells
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Interleukin-6/genetics*
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Tumor Necrosis Factor-alpha/genetics*
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Medicine, Mongolian Traditional
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Macrophages/immunology*
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Protective Agents/isolation & purification*
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Liver/drug effects*
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Gentianaceae/chemistry*
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Plant Extracts/chemistry*
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Molecular Structure
3.Application effect of a non-contact sleep monitoring mattress based on body movement characteristics during sleep
Yanchun ZHANG ; Yan LIU ; Rui WANG ; Feilong WANG ; Yue ZHAO ; Fei LI ; Tunan CHEN ; Jishu XIAN
Journal of Army Medical University 2025;47(4):326-334
Objective To verify the accuracy of a Non-Contact Sleep Monitoring Mattress(NCSMM)based on body movement during sleep in assessing sleep quality of patients before neurosurgery in order to provide a more portable and efficient assessment tool for clinical staff.Methods A single-arm trial was conducted on 114 inpatients admitted in our department selected with convenience sampling.Sleep quality data of 1 night were collected through 5 sleep quality assessment tools,including NCSMM,polysomnography(PSG),Patient-Reported Outcome Measurement Information System(PROMIS)Sleep Disturbance scale,Richards-Campbell Sleep Scale(RCSQ),and a wearable device(smart watch for body movements and sleep quality monitoring).The sleep efficiency(≤85%)obtained by PSG was used as the diagnostic standard for sleep disorders.The area under the receiver operating characteristic curve(AUC),sensitivity,specificity,positive predictive value,negative predictive value,and Youden index were calculated for the other 4 tools to evaluate and compare their diagnostic effectiveness.Results The AUC value for NCSMM,PROMIS,RCSQ and smart watch was 0.788(95%CI:0.687~0.888,P<0.001),0.664(95%CI:0.543~0.784,P=0.02),0.723(95%CI:0.600~0.846,P=0.001)and 0.750(95%CI:0.654~0.846,P<0.001),respectively.The diagnostic accuracy rate was 0.774,0.559,0.742 and 0.602,with corresponding Youden index value of 0.488,0.321,0.456,and 0.459.NCSMM demonstrated the best AUC value,sensitivity and Youden index when compared with the other 3 tools.Conclusion NCSMM shows high accuracy in assessing sleep quality in pre-neurosurgery inpatients,and it is a viable portable and efficient assessment tool in clinical practice.
4.Correlation Between Traditional Chinese Medicine Constitution and Clinical Characteristics of Allergic Rhinitis in Adults:A Survey of 215 Cases in Shenzhen Area
Tiantian LI ; Jiaxin LIU ; Tian FENG ; Yanchun XIAO ; Shiwen LIU ; Yunying LI ; Xiangjun CHEN
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(4):803-812
Objective To investigate the correlation between the clinical characteristics of allergic rhinitis(AR)in adults located in Shenzhen area and the traditional Chinese medicine(TCM)constitutions.Methods A cross-sectional survey of adult AR patients in Shenzhen was conducted.From June 2022 to December 2023,adult AR patients admitted to the Department of Otolaryngology outpatient clinic of Bao'an Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine(Shenzhen Bao'an District Hospital of Traditional Chinese Medicine)were selected as the study subjects.The clinical baseline data,Total Nasal Symptoms Score(TNSS),and Total Non-Nasal Symptoms Score(TNNSS)of the patients were collected for the analysis of clinical characteristics,and TCM constitutions were differentiated based on the information collected by TCM constitutions questionnaire.After that,the correlation between the biased TCM constitutions and clinical characteristics were explored by using analysis of variance,non-parametric test and Logistic regression analysis.Results(1)A total of 215 cases of adult AR patients from Shenzhen were included.Most of the patients were male(60.93%),and the patients were usually aged 18-29 years old(accounting for 48.84%).AR in adults often arose in the spring(33.49%)and fall(30.70%).(2)Lung qi deficiency-cold syndrome was the predominated TCM syndrome type of AR in adults,accounting for 40.93%,and then came kidney yang deficiency syndrome(26.98%),spleen qi deficiency syndrome(20.00%),and heat accumulation in lung meridian syndrome(12.09%).Lung qi deficiency-cold syndrome and heat accumulation in lung meridian syndrome were more common in young males,and kidney yang deficiency syndrome was frequently seen in middle-aged and elderly males.(3)The leading three TCM constitution types of AR in adults were qi deficiency constitution(30.23%),yang deficiency constitution(24.65%),and inherited special constitution(15.81%).In adult AR patients with lung qi deficiency-cold syndrome,the commonly-seen TCM constitution types were qi deficiency constitution,inherited special constitution,and balanced constitution.In adult AR patients with spleen qi deficiency syndrome,the commonly-seen TCM constitution types were inherited special constitution,phlegm-damp constitution,and yang deficiency constitution.In adult AR patients with kidney yang deficiency syndrome,the commonly-seen TCM constitution types were yang deficiency constitution,qi stagnation constitution,and inherited special constitution.In adult AR patients with heat accumulation in lung meridian syndrome,the commonly-seen TCM constitution types were damp-heat constitution,yin deficiency constitution,and blood-stasis constitution.The leading five TNSS scores were shown in adult AR patients with inherited special constitution,qi deficiency constitution,yang deficiency constitution,phlegm-damp constitution,and qi stagnation constitution,respectively.And the leading five TNNSS scores were shown in adult AR patients with yang deficiency constitution,inherited special constitution,qi stagnation constitution,yin deficiency constitution,and damp-heat constitution,respectively.(4)The results of statistical analysis showed that the differences in gender among the adult AR patients with various TCM constitution types were not statistically significant(P>0.05),but the differences in age groups,TCM syndrome types,TNSS scores and TNNSS scores were statistically significant(P<0.01 or P<0.001).(5)The results of Logistic regression analysis showed that the TNSS scores and TNNSS scores were all positively correlated with qi deficiency constitution,yang deficiency constitution,and inherited special constitution,and spleen qi deficiency syndrome was negatively correlated with damp-heat constitution,the differences being all statistically significant(P<0.01 or P<0.001).Conclusion The onset of AR in adults from Shenzhen area is closely related to age,gender,season,and TCM constitutions.The adult AR patients usually have the biased constitutions,in particular qi deficiency constitution,yang deficiency constitution,and inherited special constitution.In adult AR patients,higher TNSS scores are correlated with inherited special constitution,higher TNNSS scores are correlated with yang deficiency constitution,and the primary TCM syndrome type of lung qi deficiency-cold syndrome is correlated with qi deficiency constitution.
5.Effectiveness of fibrosis-4 versus aspartate aminotransferase-to-platelet ratio index in evaluating liver fibrosis degree in patients with chronic HBV infection
Xiaoting LI ; Bobin HU ; Hongyu LIU ; Chao JIN ; Cailian CAI ; Keshan WANG ; Yanchun WEI ; Jianning JIANG ; Minghua SU
Journal of Clinical Hepatology 2024;40(12):2424-2429
ObjectiveTo investigate the performance of fibrosis-4 (FIB-4) versus aspartate aminotransferase-to-platelet ratio index (APRI) in predicting advanced liver fibrosis and disease progression in patients with chronic HBV infection. MethodsA total of 497 patients with chronic HBV infection who underwent liver biopsy in The First Affiliated Hospital of Guangxi Medical University from February 2013 to December 2022 were enrolled, among whom 404 were enrolled in a retrospective study and 75 were enrolled in a prospective study. Related indicators were collected, including demographic features (sex and age), biochemical indices (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), and platelet count, and FIB-4 and APRI were calculated. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Kruskal-Wallis H test was used for comparison between multiple groups; the chi-square test was used for comparison of categorical data between groups. The area under the ROC curve (AUC) was used to assess the ability of APRI and FIB-4 in evaluating liver fibrosis degree and disease progression in patients with chronic HBV infection. ResultsIn the retrospective analysis, compared with the FIB-4<2.67 group, the FIB-4≥2.67 group had a significantly higher proportion of the patients who were diagnosed with liver cirrhosis or hepatocellular carcinoma (66.19% vs 47.54%, χ²=12.75, P<0.001). The medians of FIB-4 and APRI increased significantly with liver fibrosis degree from F0 to F4 (H=42.5 and 35.9, both P<0.001). As for the fibrosis stage of F0-F4, the median of FIB-4 was significantly higher than that of APRI in the patients with the same fibrosis stage (H=59.71, P<0.001). FIB-4 and APRI had a similar AUC for predicting stage F3 fibrosis (0.67 vs 0.65, Z=0.71, P=0.480), while FIB-4 had a higher AUC for predicting stage F4 fibrosis than APRI (0.72 vs 0.64, Z=10.50, P<0.001). In the prospective study cohort, FIB-4 and APRI showed an increasing trend over time in predicting disease progression (chronic hepatitis B to liver cirrhosis), with an AUC of 0.718 (95% confidence interval [CI]: 0.476 — 0.760) and 0.555 (95%CI: 0.408 — 0.703), respectively, and FIB-4 had a significantly higher accuracy than APRI in predicting disease progression (χ2=12.44, P<0.001). ConclusionFIB-4 and APRI can be used to evaluate advanced liver fibrosis (F3 and F4) and predict disease progression, and FIB-4 is superior to APRI in certain aspects.
6.Correlation study between epicardial fat and coronary artery lumen stenosis in young adults
Yanchun ZHANG ; Lixiang XIE ; Hao WANG ; Yong LIANG ; Kun DONG ; Huan LIU
Journal of Practical Radiology 2024;40(3):373-376,393
Objective To explore the correlation between epicardial fat volume(EFV),epicardial fat volume indexed(EFVi)and coronary artery lumen stenosis in young adults.Methods The data of 80 young patients who underwent both coronary computed tomography angiography(CCTA)and coronary angiography(CAG)within 2 weeks were analyzed retrospectively.The correlation between EFV,EFVi and coronary artery lumen stenosis in young adults was evaluated.Results A total of 80 patients were enrolled,taking CAG exomination results as the gold standard,58 cases were enrolled into the lesion group and the other 22 cases were enrolled into the control group.The incidence of coronary artery lumen stenosis was higher in young males than that in young females(t=4.309,P=0.038).EFV and EFVi in the lesion group were higher than those in the control group(t=3.023,P=0.001;t=2.785,P=0.001).The EFV in males was higher than that in females(t=2.558,P=0.012).There was no significant difference in EFVi between male and female groups.The differences between EFV and EFVi of males in lesion group and control group were statistically significant(t=4.083,P<0.01;t=4.429,P<0.01).The differences between EFV and EFVi of females in lesion group and control group showed no sta-tistical significance.EFV and EFVi were moderately positively correlated with coronary artery lumen stenosis(rs=0.437,P<0.01;rs=0.463,P<0.01).Receiver operating characteristic(ROC)curve analysis of EFV and EFVi showed that the area under the curve(AUC)of EFV was 0.784,the cut-off value was 107.24 cm3,the sensitivity was 0.776,and the specificity was 0.682.The AUC,cut-off value,sensitivity and specificity of EFVi was 0.793,53.68 cm3/m2,0.81,0.682,respectively.Conclusion EFV and EFVi are moderately positively correlated with coronary artery lumen stenosis in young adults,which is helpful to the diagnosis of coronary heart disease.However,the differences between EFV and EFVi of young females in lesion group and control group show no statistical significance.
7.Assessment of dynamic cerebral autoregulation in pilots after acute positive acceleration exposure
Yanchun YOU ; Minghao YANG ; Xiao ZHANG ; Jinjin LIU ; Xiaozhou FAN ; Siguo SUN ; Xi LIU
Chinese Journal of Ultrasonography 2024;33(3):242-246
Objective:To explore the changes of dynamic cerebral autoregulation ability in pilots exposed to acute positive acceleration(+ Gz) by transcranial Doppler combined with beat-to-beat blood pressure.Methods:A total of 26 pilots enrolled in the + 8Gz manned centrifuge trial at the Air Force Medical Center, Air Force Medical University from June to October 2022 were prospectively included. Blood pressure and heart rate were monitored in the resting state before the trial and within 5 min after centrifugation. Transcranial Doppler combined with noninvasive continuous beat-to-beat blood pressure monitor were used to detect bilateral middle cerebral artery blood flow velocity and beat-to-beat pulse pressure respectively. The transfer function analysis was applied to derive the parameters of cerebral blood flow autoregulation in each frequency band from 0.02 to 0.50 Hz, and the phase, gain and coherence were calculated. The above parameters were compared between resting state and after acute + 8Gz positive acceleration exposure.Results:Compared with the resting state, in all of the 26 pilots after acute + 8Gz positive acceleration exposure, the systolic and diastolic blood pressure and heart rate increased significantly ( P<0.001), the phase significantly increased and the gain significantly decreased in the ultra-low frequency band (0.02-0.07 Hz) ( P<0.05); whereas there were no statistical differences of gain and phase in the low frequency band (0.07-0.20 Hz) and the high frequency band (0.20-0.50 Hz) (all P>0.05). Conclusions:Transcranial Doppler combined with beat-to-beat pulse pressure can be used for the assessment of changes in immediate dynamic cerebral autoregulation after acute + Gz exposure, and transfer function analysis of ultra-low frequency band parameters is suitable for this type of evaluation.
8.Correlation between individualized coronary volumetric perivascular characterization index and coronary heart disease
Yanchun ZHANG ; Li CHENG ; Yue DAI ; Lixiang XIE ; Hao WANG ; Huan LIU ; Guangyi CHEN
Journal of Practical Radiology 2024;40(9):1444-1448
Objective To explore the correlation between coronary fat attenuation index of perivascular adipose tissue(FAIPVAT),as well as volumetric perivascular characterization index(VPCI),and coronary heart disease(CHD).Methods A total of 112 patients who underwent coronary computed tomography angiography(CCTA)and coronary angiography(CAG)examinations within 2 weeks were selected.The patients were divided into CHD group and control group according to the degree of coronary artery stenosis,and were divided into calcified plaque group,non-calcified plaque group and mixed plaque group according to the nature of plaque.The correlation between FAIPVAT,VPCI and CHD were evaluated.Results Of the 112 patients,71 patients in the CHD group and 41 patients in the control group.There were significant differences in gender,age,FAIPVAT and VPCI between the two groups.FAIPVAT and VPCI were positively correlated with CHD(r=0.445,P<0.01;r=0.669,P<0.01).FAIPVAT and VPCI were analyzed by receiver operating characteristic(ROC)curve,the area under the curve(AUC)of FAIPVAT was 0.770,the cut-off value was-81.659 HU,the sensitiv-ity was 0.592,and the specificity was 0.878,while the AUC of VPCI was 0.892,the cut-off value was 8.056,the sensitivity was 0.887,and the specificity was 0.805.There were significant differences in FAIPVAT and VPCI between non-calcified plaque group and calci-fied plaque group.FAIPVAT and VPCI of mixed plaque group and calcified plaque group were significantly different.Conclusion FAIPVAT and VPCI have some certain correlation with CHD.FAIPVAT and VPCI can accurately evaluate the risk level of CHD and coronary artery inflammation,and the value of individualized VPCI is higher.
9.The preliminary application of cinematic rendering reconstruction technology in acute aortic dissection
He ZHANG ; Zhongxiao LIU ; Meng YU ; Miao YU ; Ziyou WANG ; Wenbei XU ; Xiaonan SUN ; Shenman QIU ; Lixiang XIE ; Yanchun ZHANG ; Yankai MENG ; Cunjie SUN ; Kai XU
Journal of Practical Radiology 2024;40(10):1620-1624
Objective To analyze the clinical application value of cinematic rendering(CR)reconstruction technology in acute aortic dissection(AAD),and to compare the imaging quality between CR and volume rendering(VR)reconstruction.Methods Patients with suspected A AD who underwent aortic computed tomography angiography(CTA)were analyzed retrospectively.All images were uploaded to Siemens Syngo.via post-processing workstation for VR and CR three-dimensional reconstruction,respectively.The optimized view angle,staining and transparency were selected and segmented by a radiologist to display the lesion to the full extent.All subjective evaluations of post-processing images were randomly evaluated on Siemens Syngo.via post-processing workstation by two radiologists.The two radiologists reached a consensus after consultation,and the results without consensus were evaluated by another senior radiologist.The 3-point scale was used in the subjective evaluation of post-processing images.The scores of rupture,endometrium,and true and false cavity were recorded.The diagnostic confidence was also recorded.Results A total of 21 ADD patients were enrolled,11 patients(52.3%)were Debakey Ⅲ type.The scores of rupture in CR and VR reconstruction were 2.952 points and 2.619 points,respectively,which had significant difference(P=0.016).For the endometrium of AAD,the score of all 21 patients in the CR reconstruction was 3 points,while only 7 patients(33.3%)in the VR reconstruction had 3 points,which showed significant difference between the both(P<0.001).For the true and false cavity of AAD,only 1 patient(4.8%)in the VR reconstruction was 3 points,while all 21 patients in the CR reconstruction had 3 points(P<0.001).The scores of CR reconstruction on the diagnostic confidence were significantly higher than those of VR reconstruction(P<0.001).Conclusion CR reconstruction can provide photorealistic anatomical post-processing images,and can improve the display and evaluation of AAD.
10.Clinical effectiveness of dynamic joint mobilization combined with core stability training for nonspecific low back pain treatment
Lingling ZHU ; Yanchun CHEN ; Liang FANG ; Chengyan CAI ; Ting LIU
The Journal of Practical Medicine 2024;40(18):2602-2606
Objective To observe the clinical efficacy of dynamic joint mobilization combined with core stability training in the treatment of nonspecific low back pain.Methods 60 patients with nonspecific low back pain were randomly assigned into either the treatment group or control group.Each group had 30 patients.The treatment group received a therapeutic regimen combining dynamic joint mobilization and core stability training,while the control group only received core stability training.Both groups were evaluated for therapeutic effectiveness using the Visual Analogue Scale(VAS)for pain,the Oswestry Disability Index(ODI),and the range of motion(ROM)of the lumbar spine before treatment,and at the 1st,3rd,and 6th weeks after treatment.At the conclusion of the treatment,a thorough assessment of the overall therapeutic efficacy was performed.Results At the 1st,3rd,and 6th weeks post-treatment,both groups showed statistically significant differences in VAS scores,ODI scores,and ROM scores over time(P<0.05).The improvements in these indices were significantly greater in the treatment group compared to the control group(P<0.05).The treatment group had considerably higher therapeutic effective-ness compared to the control group(P<0.05).Conclusions Dynamic joint mobilization combined with core stabil-ity training is effective in treating nonspecific low back pain.It can help with pain relief,lumbar and back function restoration,and lumbar and back mobility improvement.This approach is worthy of clinical application and promotion.

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