1.Interpretation for the General Chapter 0237 the preparation and establishment of national biological reference standards in Chinese Pharmacopoeia 2025 Edition Volume Ⅲ
WANG Yiping ; MAO Qunying ; WANG Xiaojuan ; LIANG Zhenglun
Drug Standards of China 2025;26(1):099-104
The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.
2.Relationship between serum levels of miR-124,CD146 and Angptl2 and the stability of carotid atherosclerotic plaque in patients with acute cerebral infarction
Xia LI ; Jingmei WANG ; Junhua LI ; Yanyan HU ; Shanshan WANG ; Yajuan MAO ; Yiping WU
International Journal of Laboratory Medicine 2024;45(17):2121-2126,2131
Objective To explore the relationship between serum microRNA-124(miR-124),CD146,angio-poietin-like protein 2(Angptl2)and the stability of carotid atherosclerosis(CAS)plaque in patients with a-cute cerebral infarction(ACI),and to provide reference for early prevention and treatment of patients with ACI.Methods A total of 191 patients with ACI admitted in Handan Central Hospital from January 2020 to February 2023 were selected as ACI group,and another 61 healthy volunteers who were underwent physical examination during the same period were selected as control group.The patients with ACI were divided into unstable plaque group(56 cases),stable plaque group(71 cases),and non plaque group(64 cases)based on carotid color doppler ultrasound results.The serum miR-124 expression levels of all subjects were detected by real time fluorescence quantitative polymerase chain reaction(RT-qPCR),and the serum CD146 and Angptl2 levels were detected by enzyme-linked immunosorbent assay(ELISA).The influencing factors of the instabili-ty of CAS plaque in patients with ACI was analyzed by univariate and multivariate Logistic regression.The predictive value of serum miR-124,CD146 combined with Angptl2 for the instability of CAS plaque in patients with ACI was analyzed by the receiver operating characteristic(ROC)curve.Results The serum CD146 and Angptl2 levels in ACI group were higher than those in control group(P<0.05),and the miR-124 expression level was lower than that in control group(P<0.05).Univariate analysis showed that the stability of CAS plaques in ACI patients was correlated with age,hypertension,hyperlipidemia,fibrinogen(FIB),serum C-reac-tive protein(CRP),serum cystatin C(CyC),CD146,Angptl2 and miR-124(P<0.05).Multivariate Logistic regression analysis showed that the decrease of serum miR-124,the increase of CD146,the increase of Angptl2 and the combination of hyperlipidemia were risk factors for CAS plaque stability in ACI patients(P<0.05).The area under ROC curve(AUC)of serum miR-124,CD146,Angptl2 and the combination of the three indi-cators to predict CAS plaque instability in ACI patients were 0.741,0.719,0.781 and 0.834,respectively.Conclusion The serum miR-124 expression level,CD146 and Angptl2 levels are the influencing factors of CAS plaque instability in ACI patients,which may be involved in the formation and development of CAS plaque in ACI patients.The combined detection of the three factors has a good predictive effect on CAS plaque instability in ACI patients.
3.Qingshen granules regulate mitophagy through miR-4516/SIAH3/PINK1 to attenuate renal fibrosis in rats
Kejun REN ; Hua JIN ; Dong WANG ; Yanping MAO ; Rong DAI ; Meng CHENG ; Yiping WANG ; Lei ZHANG
Chinese Journal of Pathophysiology 2024;40(8):1479-1487
AIM:To explore the mechanism by which Qingshen granules(QSG)intervene in the microRNA-4516(miR-4516)targeted regulation of the SIAH3/PINK1 axis,enhancing mitophagy and inhibiting renal fibrosis.METHODS:Male SD rats were randomly divided into three groups:control,model,and QSG groups.The QSG aqueous solution was administered via gavage once daily,4 mL each time,for 8 consecutive weeks.Blood creatinine levels were measured in each group.Hematoxylin-eosin(HE)and Masson staining were utilized to assess the degree of renal patholog-ical damage.Western blot analysis was performed to determine the expression levels of β-actin,PINK1,Parkin,SIAH3,VDAC1,Mfn1,Mfn2,OPA1,LC3B,and P62 proteins in renal tissue.RT-qPCR was used to detect the mRNA expres-sion level of SIAH3 in rat kidney tissue,and transmission electron microscopy was employed to observe mitochondrial dam-age in renal tissue.QSG-containing serum and transforming growth factor-β1(TGF-β1)were used to induce an HK-2 cell fibrosis model.The cells were divided into the following groups:normal cell(NC)group,model cell(MC)group,MC+miR-4516 mimics group,MC+miR-4516 NC+QSG group,MC+miR-4516 mimics+QSG group,and MC+QSG group.Cell activity in each group was detected using the CCK-8 method,and Western blot analysis was performed to determine E-cad-herin and α-SMA protein expression levels.The regulation of SIAH3 by miR-4516 was verified using a dual luciferase re-porter assay.RT-qPCR was used to detect the mRNA expression of miR-4516,SIAH3 mRNA,and PINK1.RESULTS:The results indicated that QSG intervention reduced fibrosis in rat renal tissue and HK-2 cells,decreased SIAH3 mRNA expression,increased PINK1 expression,and activated mitophagy in renal tissue.In vitro results confirmed that QSG can elevate miR-4516 expression,inhibit SIAH3 mRNA expression,promote PINK1 expression in HK-2 cells,and reduce the expression of the fibrosis marker protein α-SMA.CONCLUSION:In summary,this study preliminarily clarified the mechanism by which QSG intervention targets miR-4516 to regulate the SIAH3/PINK1 axis,thereby enhancing mitophagy and inhibiting renal fibrosis.
4.Isolation,identification and biological characteristics of lactic acid bacteria from rumen of Duolang sheep
Shiyu DUAN ; Zixuan WANG ; Yiping ZHU ; Mingwei MAO ; Keremu SIYITI ; Guoliang XIAO ; Shengyue WANG ; Jing LI ; Naisheng ZHANG
Chinese Journal of Veterinary Science 2024;44(8):1651-1658,1734
Under the background of high-intensity fattening,probiotics have gradually become wide-ly used feed additives.It can inhibit the proliferation of pathogenic bacteria,maintain the microeco-logical balance in the digestive tract,and improve the host immune function.In order to screen lac-tic acid bacteria strains with potential probiotic effects,23 acid-producing strains were isolated from rumen fluid of healthy Duolang sheep by CaCO3-MRS solid medium.Safe strains were re-screened through primary screening and hemolysis tests.Acid tolerance tests and bile salt tests were used to screen the strains that were relatively adapted to the rumen environment.The survival rate of the strain M2 was 93.80%under pH3.0 and 59.72%under bile salt concentration of 0.30%and the survival rate is higher than other strains under high temperature conditions.Subsequently,morphological observation,molecular biological identification,testing of pathogen antagonism,antibiotic tolerance analysis,growth characteristics detection and other methods were used to fur-ther explore the characteristics of the strain.The results showed that the strain to be tested was Gram-positive bacillus.After 16S rRNA gene sequence comparison,the strain was identified as Lactobac illus salivus,which could be used as a candidate strain to develop probiotics.The research results laid a foundation for its application in Duolang sheep breeding.
5.Effects of optimized catheter clipping training and automatic balloon retraction ureteral catheter removal on first urination of patients after neurosurgery
Jie ZHANG ; Yiping MAO ; Qi QI ; Tangjun GUO ; Lina HOU ; Chengwen CUI
Chinese Journal of Practical Nursing 2022;38(6):401-406
Objective:To investigate the effect of optimized catheter clipping training and automatic balloon retraction ureteral catheter removal on first urination of patients after neurosurgery, and provide guidance for postoperative micturition of these patients.Methods:From August 2020 to August 2021, 208 patients admitted to Department of Neurosurgery, the Affiliated Hospital of Xuzhou Medical University, undergoing craniocerebral surgery under general anesthesia and indurating catheter were selected as the study subjects by convenient sampling. They were divided into control group ( n=69), observation group A ( n=69) and observation group B( n=70) by random number table method. The control group received routine catheter clipping training and routine ureteral catheter removal, the observation group A received optimized catheter clipping training and routine ureteral catheter removal, and the observation group B received optimized catheter clipping training and automatic balloon retraction ureteral catheter removal. The first micturition time, first micturition volume, micturition circumstance, pain score and urethral irritation sign of the three groups were observed and compared. Results:The first urination time in observation group A and B were (11.58 ± 6.59) min and (10.06 ± 5.91) min, respectively, lower than (37.14 ± 13.74) min in control group, and the difference was statistically significant ( t=13.94, 15.07, both P<0.05); there was no significant difference between observation group B and observation group A ( P>0.05). The first urine volume were (303.66 ± 43.74) ml in control group, (299.06 ± 41.26) ml in observation group A and (299.28 ± 43.17) ml in observation group B, and the difference was not statistically significant ( P>0.05). The incidence of urination (spontaneous urination, induced urination and urinary retention) in observation group A was better than control group ( χ2=16.47), while observation group B was better than observation group A and control group ( χ2=8.59, 37.83), the differences were statistically significant (all P<0.05). There was no significant difference in pain score of ureteral catheter removal between observation group A (2.71 ± 0.67) and control group (2.87 ± 0.78) ( P>0.05). The score of observation group B (1.41 ± 0.65) was lower than that of control group and observation group A, the differences were statistically significant ( t=11.93, 11.62, both P<0.05). There was no significant difference of the incidence of urethral irritation (grade 0, 1, 2, and 3) between observation group A and control group ( P>0.05). Observation group B was lower than control group and observation group A, the differences were statistically significant ( t=38.81, 25.27, both P<0.05). Conclusions:Optimized catheter clipping training and automatic balloon retraction ureteral catheter removal can effectively shorten the first urination time of patients after neurosurgery, reduce the pain of ureteral catheter removal and urethral irritation during the first urination, improve the success rate of the first urination, and effectively prevent the occurrence of urinary retention.
6.Investigation on knowledge, attitude and behavior of volume management in maintenance hemodialysis patients
Quan SHI ; Yiping MAO ; Lingzhi SHI ; Lei SUN ; Siyuan TAN
Chinese Journal of Practical Nursing 2022;38(9):702-708
Objective:To understand the knowledge, attitude and behavior of volume management of maintenance hemodialysis patients, so as to provide a basis for standardizing volume management and carrying out refined individual care.Methods:By means of convenience sampling, 608 patients from 4 hospitals who received regular dialysis treatment in Xuzhou and Yancheng hemodialysis rooms in October 2021 were selected as subjects. Patients were surveyed by a self-designed knowledge questionnaires of volume management, Maintenance Hemodialysis Patients′ Capacity Management Behavior Scale and Self-Efficacy Scale. Questionnaires were collected through the questionnaire star.Results:A total of 608 valid questionnaires were collected. The knowledge dimension scored 8.21 ± 2.27 , atitude dimension scored 7.36 ± 2.06 and behavior dimension scored 15.07 ± 4.22. Multiplelinear regression analysis showed that age, dialysis age and self-care ability were predictors of volume management knowledge score ( t=-2.07, 2.35, -3.90, all P<0.05 ). Medical insurance type was a predictor of volume management attitude score ( t=-2.17, P<0.05). Education level was a predictor of volume management behavior score ( t=3.04, P<0.05). Conclusions:The capacity management knowledge and capacity management attitude of maintenance hemodialysis patients is in the medium level, but with poor volume management executive ability. It is suggested that medical staff carry out health education related to volume management according to different characteristics of patients, and effectively improve patients′ volume management ability.
7.Investigation on the current situation and analysis of related influencing factors of xerosis in elderly inpatients
Fang DU ; Xuehong WANG ; Li ZHANG ; Bing WANG ; Yiping MAO ; Xinxin CAI ; Qiudi SONG
Chinese Journal of Practical Nursing 2022;38(34):2684-2690
Objective:To investigate the prevalence and influencing factors of xerosis in elderly inpatients, to provide basis for effective prevention and management of xerosis.Methods:Using the cross-sectional survey method and the self-designed survey table of the current situation of xerosis and prevention of the elderly, the incidence of xerosis in 1 028 patients hospitalized in Suqian Hospital Affiliated to Xuzhou Medical University, Suqian City Hospital of Traditional Chinese Medicine and Siyang County Hospital of Traditional Chinese Medicine was investigated, and the related factors were analyzed.Results:The incidence of xerofosis was 20.23%(208/1028); the incidence of xerosis was 20.23% (208/1 028), which was mainly found in the lower limbs, with the incidence of 53.37% (111/208), among which the incidence of mild xerosis was the most, with the incidence of 51.44% (107/208). The incidence rate of the elderly patients with xerosis between different age, qualifications, nutritional status, comorbidity, Braden score, drug use, main caregivers, departments, and daily skin care were statistically significant ( χ2 values were 6.91-35.71, all P<0.05). Binary logistic regression analysis showed that age, nutritional status, comorbidity status, Braden score and daily skin care were the independent influencing factors of skin dryness in elderly inpatients. Conclusions:There is a common skin symptom of xerosis in the elderly. It is necessary to establish a standardized management process and take targeted preventive and nursing measures.
8.Upper left lung cancer with congenital complete left pericardial defect: A case report
Chuanhui DUAN ; Dongliang YU ; Jianwen XIONG ; Wenxiong ZHANG ; Yu' ; ang MAO ; Qian SONG ; Yiping WEI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(02):272-274
A 54-year-old asymptomatic man underwent a video-assisted thoracoscopic left pneumonectomy for squamous-cell carcinoma. During the surgery, a complete left pericardial defect was unexpectedly discovered, but no special intervention was made. The preoperative chest CT was reciewed, which showed the heart extended unusually to the left, but the left pericardial defect was not evident. The operation time was 204 min and the patient was discharged from hospital upon recovery 9 days after the surgery. The pathological result indicated moderately differentiated squamous-cell carcinoma (T2N1M0, stage ⅡB), and metastasis was found in the parabronchial lymph nodes (3/5). The patient did not receive chemotherapy after the surgery, and there was no signs of recurrence 6 months after the surgery. Complete pericardial defects usually do not endanger the lives of patients, and if the patient is asymptomatic, pneumonectomy is feasible.
9.Effect of chicoric acid on oxidative stress during myocardial injury in sepsis rats and relationship with Nrf2 signaling pathway
Yiling LI ; Peng YAO ; Hao QI ; Yiping LU ; Yi MAO ; Jie MENG ; Hang XIAO
Chinese Journal of Anesthesiology 2021;41(4):491-495
Objective:To evaluate the effect of chicoric acid on oxidative stress during myocardial injury in sepsis rats and the relationship with nuclear factor E2-related factor 2 (Nrf2) signaling pathway.Methods:Forty healthy male Sprague-Dawley rats, aged 8-12 weeks, weighing 220-250 g, were divided into 5 groups ( n=8 each) using a random number table method: control group (group C), lipopolysaccharide (LPS) group (group LPS), LPS+ chicoric acid group (group LPS+ CA), LPS+ Nrf2 inhibitor ML385 group (group LPS+ ML) and LPS+ chicoric acid+ ML385 group (group LPS+ CA+ ML). LPS 15 mg/kg was intraperitoneally injected to induce sepsis.Immediately after intraperitoneal injection of LPS, chicoric acid 10 mg/kg or ML385 15 mg/kg (in dimethyl sulfoxide) was intraperitoneally injected in group LPS+ CA and group LPS+ ML, respectively, and ML385 15 mg/kg and chicoric acid 10 mg/kg were intraperitoneally injected in LPS+ CA+ ML group.The equal volume of dimethyl sulfoxide was given instead in group C. At 48 h after establishment of the model, blood samples were collected from the aorta for measurement of concentration of serum interleukin-6 (IL-6) and the activities of lactate dehydrogenase (LDH) and creatine kinase isoenzyme (CK-MB) (by enzyme-linked immunosorbent assay). The animals were then sacrificed, and myocardial tissues were obtained for microscopic examination of pathological changes (by HE staining), for determination of activities of glutathione peroxidase (GSH-Px) and superoxide dismutase (SOD) and contents of reactive oxygen species(ROS) and iron (by colorimetry), for calculation of the ratio of oxidized nicotinamide adenine 2 nucleotides to reduced nicotinamide adenine 2 nucleotides (NAD + /NADH), and for detection of the expression of Nrf2, NADPH quinone oxidoreductase 1 (NQO1), glutathione peroxidase 4 (GPX4) and nicotinamide adenine dinucleotide phosphate oxidase 1 (NOX1) (by Western blot). Results:Compared with C group, the activities of serum LDH and CK-MB and concentration of IL-6 were significantly increased, the contents of ROS and iron and the ratio of NAD + /NADH were increased, activities of GSH-Px and SOD were decreased, expression of Nrf2, NQO1 and GPX4 was down-regulated, and NOX1 expression was up-regulated in the other four groups ( P<0.05). Compared with group LPS, the activities of serum LDH and CK-MB and concentration of IL-6 were significantly decreased, the contents of ROS and iron and the ratio of NAD + /NADH were decreased, activities of GSH-Px and SOD were increased, expression of Nrf2, NQO1 and GPX4 was up-regulated, NOX1 expression was down-regulated ( P<0.05), and the pathological changes of cardiomyocytes were significantly reduced in group LPS+ CA, and the activities of serum LDH and CK-MB and concentration of IL-6 were significantly increased, the ratio of NAD + /NADH were increased, activities of GSH-Px and SOD were decreased, expression of Nrf2, NQO1 and GPX4 was down-regulated, NOX1 expression was up-regulated ( P<0.05), and the pathological changes of cardiomyocytes were accentuated in group LPS+ ML.Compared with group LPS+ CA, the activities of serum LDH and CK-MB and concentration of IL-6 were significantly increased, the contents of ROS and iron and the ratio of NAD + /NADH were increased, activities of GSH-Px and SOD were decreased, expression of Nrf2, NQO1 and GPX4 was down-regulated, NOX1 expression was up-regulated ( P<0.05), and the pathological changes of cardiomyocytes were accentuated in group LPS+ CA+ ML. Conclusion:The mechanism by which chicoric acid reduces myocardial injury in sepsis rats may be related to activating Nrf2 signaling pathway and inhibiting oxidative stress.
10.Effect of Qingshen Granules on inflammation/hepcidin axis and iron metabolism in patients with renal anemia: a single-center, randomized controlled trial.
Lei ZHANG ; Yiping WANG ; Hua JIN ; Dong WANG ; Ling WEI ; Kejun REN ; Yanping MAO
Journal of Southern Medical University 2019;39(10):1155-1159
OBJECTIVE:
To evaluate the therapeutic effect of Qingshen Granules on renal anemia in patients with damp-heat syndrome and explore the mechanisms in light of inflammation/hepcidin axis and iron metabolism.
METHODS:
Sixty patients with renal anemia and dampness-heat syndrome were randomized into control group (=30) and treatment group (=30). All the patients were given routine treatment, and the patients in the treatment group received additional treatment with Qingshen Granules (3 times a day). After 12 weeks of treatments, the patients were examined for changes in the integral value of TCM syndrome, serum creatinine (Scr), glomerular filtration rate (eGFR), hemoglobin (HGB), hematocrit (HCT), red blood cell (RBC) count, interleukin-6 (IL-6), hypersensitive C-reactive protein (hs-CRP), ferritin, growth differentiation factor-15 (GDF-15), serum iron (SI), total iron binding capacity (TIBC), transferrin saturation (TAST), soluble transferrin receptor (sTfR) and ferritin levels.
RESULTS:
After the treatment, the scores of TCM syndrome were significantly improved in the treatment group and were better than those in the control group (=0.000). Scr and eGFR were improved in both groups after the treatment. The levels of HGB, HCT and RBC were all improved in the two groups after treatment, and the improvements were more obvious in the treatment group (=0.002, 0.002, and 0.017, respectively). The levels of IL-6, hs-CRP, hepcidine and GDF-15 were all lowered in the two groups after the treatment, and they were all significantly lower in the treatment group than in the control group (all =0.000). The treatments increased the levels of SI and TAST in both of the groups, and compared with those in control group, the levels of TIBC, sTfR and ferritin were significantly lowered in the treatment group after the 12-week treatment (=0.000).
CONCLUSIONS
Qingshen granules can effectively improve renal anemia in patients with damp-heat syndrome possibly by improving iron metabolism through alleviation of inflammation and reduction of hepcidine level.

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