1.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
2.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
3.Research on hepatitis E virus antigen screening among voluntary blood donors
Li ZHANG ; Xuelian DENG ; Lei ZHOU ; Dan LIU ; Liang ZANG
Chinese Journal of Blood Transfusion 2025;38(8):1083-1088
Objective: To investigate prevalence of hepatitis E virus (HEV) infection among voluntary blood donors in Dalian and provide evidence for enhancing blood screening strategies. Methods: A total of 3 277 blood donor samples collected between December 2023 and February 2024 at Dalian Blood Center underwent routine blood screening (ALT, HBsAg, anti-HCV, HIV Ag/Ab, anti-TP, and HBV/HCV/HIV NAT). Subsequently, HEV antigen (Ag) was detected using chemiluminescence immunoassay (CLIA). HEV-Ag reactive samples were further tested for HEV RNA, IgM and IgG antibodies. Blood donors with repeated reactive HEV Ag results were followed up to clarify the status of infection. Results: Among the 3 277 blood donor samples, 6 (0.18%) were repeatedly reactive for HEV Ag. However, supplemental testing for HEV RNA, anti-HEV IgM, and anti-HEV IgG on these samples yielded non-reactive results. One of these six blood donors was successfully followed up. On day 218 after the initial detection of HEV Ag reactivity, HEV Ag, HEV RNA, HEV IgM and IgG antibody were found to be non-reactive. Conclusion: The reaction rate for HEV antigen screening among voluntary blood donors in Dalian is low. CLIA method for detecting HEV antigen is easy to operate and cost-effective, but demonstrates some false reactivity. Improving the specificity of the assay and combining it with nucleic acid testing (NAT) would be valuable for implementing a selective HEV screening strategy for blood donors.
4.A study on the animal model preparation and early histological changes of trans-sutural distraction osteo-genesis
Zhihe ZHAO ; Yufan ZHANG ; Wenhui ZHANG ; Yicheng CHEN ; Xuelian JIA ; Shanluo ZHOU ; Fuding SHEN ; Yuxuan DU ; Yunpeng LI ; Liang KONG
Journal of Practical Stomatology 2024;40(2):173-179
Objective:To establish an animal model of trans-sutural distraction osteogenesis in SD rats.Methods:A self-designed V-shaped distraction device(distractor)was fabricated with the traction force(N)of 0,1.3,2.2,3.0,4.3 and 5.0 corresponding to the distraction length(mm)of 5,4,3,2,1 and 0 respectively,meeting the trans-sutural distraction osteogenesis requirements in skull of 5-week-old SD rats.The distractor was plased into the sagittal suture of 12 SD rats.Continuous sampling was conducted 1,3,5 and 7 days respectively(n=3)after operation.The tissue changes in the trans-sutural distraction area were observed by HE and Masson's trichrome staining.Inflammation levels were determined using Arg-1 immunofluorescence staining.The early angiogenesis was clarified through co-staining with CD31 and EMCN.Results:A stable trans-sutural distraction osteogenesis model was estab-lished,5 mm distraction osteogenesis width was observed completely within 7 days of distraction.Significant new bone formation was observed at 7 days after operation.Arg-1 expression increased and was concentrated at the bone margins,overlapping with the areas of new bone formation.EMCN expression gradually decreased,and by day 7 CD31 was predominant,indicating the basic maturation of blood vessels.Conclusion:This study successfully constructed a stable and effective trans-sutural distraction osteogenesis animal model,and provides an experimental basis for the investigation of its early continuous histological changes.
5.Phosphatidic acid-enabled MKL1 contributes to liver regeneration: Translational implication in liver failure.
Jiawen ZHOU ; Xinyue SUN ; Xuelian CHEN ; Huimin LIU ; Xiulian MIAO ; Yan GUO ; Zhiwen FAN ; Jie LI ; Yong XU ; Zilong LI
Acta Pharmaceutica Sinica B 2024;14(1):256-272
Liver regeneration following injury aids the restoration of liver mass and the recovery of liver function. In the present study we investigated the contribution of megakaryocytic leukemia 1 (MKL1), a transcriptional modulator, to liver regeneration. We report that both MKL1 expression and its nuclear translocation correlated with hepatocyte proliferation in cell and animal models of liver regeneration and in liver failure patients. Mice with MKL1 deletion exhibited defective regenerative response in the liver. Transcriptomic analysis revealed that MKL1 interacted with E2F1 to program pro-regenerative transcription. MAPKAPK2 mediated phosphorylation primed MKL1 for its interaction with E2F1. Of interest, phospholipase d2 promoted MKL1 nuclear accumulation and liver regeneration by catalyzing production of phosphatidic acid (PA). PA administration stimulated hepatocyte proliferation and enhanced survival in a MKL1-dependent manner in a pre-clinical model of liver failure. Finally, PA levels was detected to be positively correlated with expression of pro-regenerative genes and inversely correlated with liver injury in liver failure patients. In conclusion, our data reveal a novel mechanism whereby MKL1 contributes to liver regeneration. Screening for small-molecule compounds boosting MKL1 activity may be considered as a reasonable approach to treat acute liver failure.
6.Research on the integrity issues from clinical doctors to clinical researchers
Xuelian BAI ; Jie QIAO ; Mingjie ZI ; Zhihao ZHOU
Chinese Medical Ethics 2024;37(2):184-188
Scientific research is an important part of hospital work,the driving force of hospital construction and development,and the key to the hospital's comprehensive competitiveness and future development potential.Scientific research misconduct,which seriously deviates from the recognized norms of the scientific community,and will cause great harm to groups,society,and the public.It may also lead to the spread of false knowledge,resulting in misconceptions among peers and causing losses.By analyzing the scientific research integrity relationship between clinical doctors and clinical researchers,as well as looking at integrity standards from multiple dimensions,this paper found out the similarities and differences in the extension of integrity between them.Exploring measures to further promote the construction of scientific integrity and ethics,especially increasing the supervisory role of discipline inspection and supervision,which is conducive to the promotion of scientific research in the medical field in China.
7.Factors influencing medical narrative competence and its correlation with psychological resilience in pediatric staff
Xuelian ZHOU ; Ke HUANG ; Hu LIN ; Li ZHANG ; Zhaoyuan WU ; Yuanyuan MENG ; Wei WU ; Guanping DONG ; Junjun JIA ; Junfen FU
Chinese Journal of Medical Education Research 2024;23(3):321-326
Objective:To investigate the medical narrative competence of pediatric staff, and analyze its influencing factors and correlation with psychological resilience, and to discuss strategies to improve narrative competence.Methods:From January 11 to February 25, 2022, by convenience sampling, we sampled pediatric personnel and those on refresher training at Children's Hospital, Zhejiang University School of Medicine for a questionnaire survey involving general information, the narrative competence scale, and the 14-item resilience scale. With the use of SPSS 26.0, the narrative competence of different populations was compared, and factors affecting narrative competence were determined through Pearson correlation analysis and multiple regression analysis.Results:A total of 361 valid questionnaires were included in this study, and there was significant differences in the narrative competence score between different ages, professional titles, working years, income levels, and whether they wrote parallel charts ( P<0.05). The total score of narrative competence of pediatric staffs was (147.13±18.76), and positively correlated with the total resilience score and the score of each dimension ( P≤0.001). The regression analysis showed that writing parallel charts and resilience could explain 53.10% of the variation in narrative competence ( P<0.001). Conclusions:Pediatric staff's narrative competence is at low or intermediate levels. Parallel chart writing and resilience training can improve narrative competence and promote a harmonious doctor-patient relationship.
8.Efficacy of icodextrin dialysate in peritoneal dialysis for patients with diabetic nephropathy
Chinese Journal of Primary Medicine and Pharmacy 2024;31(10):1468-1472
Objective:To investigate the clinical efficacy of icodextrin dialysate in peritoneal dialysis for patients with diabetic nephropathy.Methods:A case-control study was conducted to retrospectively analyze 92 patients with diabetic nephropathy who underwent peritoneal dialysis at Yiwu Central Hospital from January 2021 to December 2023. The patients were divided into two groups based on the type of dialysis solution used: the control group ( n = 45) received glucose-based dialysate, while the observation group ( n = 47) received icodextrin dialysate. Both groups underwent dialysis for 2 months. Glycemic control indicators, lipid profiles, adverse reactions, and volume overload parameters (diastolic pressure, systolic pressure, and ultrafiltration volume) were assessed in both groups. Results:After treatment, fasting blood glucose, glycated hemoglobin, 2-hour postprandial blood glucose, triglycerides, and low-density lipoprotein cholesterol levels in the observation group were (7.56 ± 0.97) mmol/L, (7.64 ± 1.55)%, (8.49 ± 1.42) mmol/L, (2.02 ± 0.39) mmol/L, and (3.10 ± 0.47) mmol/L, respectively, all of which were significantly lower than those in the control group [(8.27 ± 1.25) mmol/L, (8.77 ± 1.89)%, (9.39 ± 1.64) mmol/L, (2.30 ± 0.44) mmol/L, (3.46 ± 0.55) mmol/L, t = 3.05, 3.14, 2.82, 3.23, 3.38, all P < 0.05]. The incidence of adverse reactions in the observation group was significantly lower than that in the control group [12.77% (6/47) vs. 31.11% (14/45), χ2 = 4.55, P < 0.05]. After treatment, the diastolic pressure and systolic pressure in the observation group were (83.75 ± 8.55) mmHg (1 mmHg = 0.133 kPa) and (142.35 ± 15.78) mmHg, respectively, both of which were significantly lower than those in the control group [(88.79 ± 8.90) mmHg, (156.20 ± 16.19) mmHg, t = 2.77, 4.16, both P < 0.05]. However, the ultrafiltration volume in the observation group was signifiantly higher than that in the control group [(638.77 ± 64.21) mL vs. (590.41 ± 60.34) mL, t = 3.72, P < 0.05]. Conclusion:Peritoneal dialysis using icodextrin dialysate in patients with diabetic nephropathy can improve glucose and lipid metabolism, reduce the incidence of adverse reactions, and effectively manage patients' volume overload.
9.Distribution of Nardosinone and Its Metabolites in Rats Analyzed by UPLC-Q-Exactive Orbitrap MS/MS
Lijuan SHI ; Xuelian ZHAO ; Yifan TIAN ; Limin LI ; Yuan LIU ; Xiaojiang ZHOU ; Yanfei HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):187-195
ObjectiveUltra-performance liquid chromatography-quadrupole/electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Exactive Orbitrap MS/MS) was used to investigate the metabolism and distribution of nardosinone in rats, then metabolic pathways were speculated. MethodRats were administered with 30 mg·kg-1 of nardosinone suspension by gavage for 3 consecutive days, and plasma, urine, feces, and tissues of heart, liver, spleen, lung, kidney, brain, stomach, and intestine were collected at predetermined time points. After treatment, the samples were processed for UPLC-Q-Exactive Orbitrap MS/MS, and the MS data were analyzed using Xcalibur 2.2 software. The metabolites were searched by comparing the base peak chromatogram and extracted ion chromatogram between the treated group and blank group, and based on the relative retention time(tR), quasi-molecular ion peak, precise molecular mass, and fragment ions of MS/MS, the elemental composition were searched using databases such as SciFinder and PubChem, as well as referring to relevant literature, the possible metabolites were identified and the metabolic pathways were inferred. ResultA total of 30 metabolites of nardosinone were identified, including 15, 19, 12, 7, 4, 11, 8, 13, 13, 8 and 12 metabolites in urine, feces, plasma, brain, heart, liver, spleen, lung, kidney, stomach and intestine, respectively. The main metabolic pathways of nardosinone in rats were hydroxylation, dehydroxylation, reduction, dehydrogenation, hydration, dehydration, carboxylation, glucuronidation, and dehydroxy-isopropyl. ConclusionNardosinone can be metabolized by phase Ⅰ and phase Ⅱ metabolism in rats, and the metabolites are widely distributed in the major organs. The results of this study can provide a basis for further research on the pharmacodynamic material basis, pharmacological mechanism and clinical application of nardosinone.
10.Drug resistance mutation analysis of HIV-1 among blood donors in Dalian:2011-2020
Xiaohan GUO ; Xuelian DENG ; Xiaochun LIU ; Yingying WANG ; Liang ZANG ; Jun ZHOU
Chinese Journal of Blood Transfusion 2024;37(8):902-907
Objective To study the distribution and trend of HIV-1 drug resistance mutation in Dalian blood donors be-tween 2011 and 2020.Methods The protease-reverse transcriptase(PR-RT)region was sequenced in Dalian blood donors tested HIV-1 positive between 2011 and 2020.Drug resistance mutation(DRM)rate and level of resistance to selected drugs were analyzed by the Stanford HIV Drug Resistance Database.Results DRM were detected in 17.2%(30/174)of samples,while transmitted drug resistance(TDR)was5.7%(10/174).Between2011 and2020,DRM and TDR rates in-creased significantly in 2019 and reached their highest levels in 2020(44.4%and 22.2%,respectively).DRM carriage was associated with people with college degree or above and with local residents(P<0.05).NNRTI DRMs were the most fre-quently detected(12.6%,22/174),followed by PIs(5.7%,10/174),with V179D/E/T and M46I being the main DRMs detected.Only one HIV-1strain(0.57%,1/174)carried a NRTI DRM(L74I).The overall rate of predicted high level re-sistance to antiretroviral drugs was 6.9%(12/174),with the highest proportion of NNRTI resistance(83.3%,10/12).Two samples were classified as highly resistant to EFV and NVP,accounting for 1.1%(2/174).CRF55_01B strains showed a significantly higher DRM rate than strains of other HIV-1 genotypes(P<0.05).Conclusion Between 2011 and 2020,the rate of HIV-1 DRMs in blood donors in Dalian showed a significant upward trend,particularly in 2019-2020,with NNRTI resistance being the most common.The combination of DRMs detection before and after implementation of ART un-der the latest national ART treatment plan would improve the effectiveness of HIV-1 prevention and control locally.

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