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.

ObjectiveBased on the concept of quality by design（QbD）， the processing process of calcined Pyritum was optimized， and its X-ray diffraction（XRD） fingerprint was established. MethodsThe safety， effectiveness and quality controllability of calcined Pyritum were taken as the quality profile（QTPP）， the color， hardness， metallic luster， phase composition， the contents of heavy metals and hazardous elements were taken as the critical quality attributes（CQAs）， and the calcination temperature， calcination time， paving thickness and particle size were determined as the critical process parameters（CPPs）. Differential thermal analysis， X-ray diffraction（XRD） and inductively coupled plasma mass spectrometry（ICP-MS） were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then， based on the criteria importance through intercriteria correlation（CRITIC）-entropy weight method， the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process， and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures， and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS₂ to Fe₇S₈ during the process of temperature increase， the color gradually deepened from dark yellow， and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows：calcination temperature at 750 ℃， calcination time of 2.5 h， paving thickness of 3 cm， particle size of 0.8-1.2 cm， vinegar quenching 1 time［Pyritum-vinegar（10∶3）］. After calcination， the internal structure of Pyritum was honeycomb-shaped， which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96， and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing， the dissolution of the effective components in Pyritum increases， and the contents of heavy metals and harmful substances decrease， reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible， and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.

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.

ObjectiveBased on the concept of quality by design（QbD）， the processing process of calcined Pyritum was optimized， and its X-ray diffraction（XRD） fingerprint was established. MethodsThe safety， effectiveness and quality controllability of calcined Pyritum were taken as the quality profile（QTPP）， the color， hardness， metallic luster， phase composition， the contents of heavy metals and hazardous elements were taken as the critical quality attributes（CQAs）， and the calcination temperature， calcination time， paving thickness and particle size were determined as the critical process parameters（CPPs）. Differential thermal analysis， X-ray diffraction（XRD） and inductively coupled plasma mass spectrometry（ICP-MS） were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then， based on the criteria importance through intercriteria correlation（CRITIC）-entropy weight method， the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process， and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures， and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS₂ to Fe₇S₈ during the process of temperature increase， the color gradually deepened from dark yellow， and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows：calcination temperature at 750 ℃， calcination time of 2.5 h， paving thickness of 3 cm， particle size of 0.8-1.2 cm， vinegar quenching 1 time［Pyritum-vinegar（10∶3）］. After calcination， the internal structure of Pyritum was honeycomb-shaped， which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96， and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing， the dissolution of the effective components in Pyritum increases， and the contents of heavy metals and harmful substances decrease， reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible， and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.

BACKGROUND:Establishing a stable and reliable animal model of acute pancreatitis is of great significance for understanding its pathogenesis,pathophysiological characteristics,and clinical medication.Domestic and foreign studies have shown that cerulein,L-arginine,and sodium taurocholate can induce acute pancreatitis,but their pathophysiological characteristics and model characteristics are still unclear. OBJECTIVE:To establish an acute pancreatitis rat model using cerulein,L-arginine,and sodium taurocholate and to observe the changing patterns of model features at different time points. METHODS:Ninety-six healthy male Sprague-Dawley rats were randomly divided into normal group,cerulein group,L-arginine group,and sodium taurocholate group,with 24 rats in each group.Within each group,there were three subgroups(n=8 per group):12-,24-,and 48-hour subgroups.Cerulein was administered via intraperitoneal injection six times with a 1-hour interval.L-arginine was administered through two intraperitoneal injections with a 1-hour interval.Sodium taurocholate was injected for inducing acute pancreatitis models through retrograde injection into the bile-pancreatic duct.By examining the rat survival rate,gross morphology of the pancreas,calculating the pancreatic organ index,and measuring levels of amylase,lipase,alanine transaminase,aspartate transaminase,blood urea nitrogen,and creatinine,as well as observing pancreatic tissue pathological features through hematoxylin-eosin staining and conducting a pancreatic injury scoring,we evaluated the changing patterns of model features at different time points. RESULTS AND CONCLUSION:Compared with the normal group,the overall survival rate of rats was 100%in the cerulein group,88%in the L-arginine group,and 96%in the sodium taurocholate group.The pancreatic organ index was increased in all groups.Gross observation indicated that,In the cerulein group,pancreatic edema,blurred lobes,and looseness were visible.In the L-arginine group,the pancreatic glands were enlarged and thickened with patchy bleeding.In the sodium taurocholate group,pancreatic tissue showed varying degrees of congestion and edema accompanied by scattered flakes of hemorrhage and necrosis.The levels of serum alanine transaminase,aspartate transaminase,blood urea nitrogen,creatinine,amylase,and lipase in rats exhibited consistent changes.In the cerulein group,these parameters possibly peaked at 12 hours(P<0.05)and then showed a declining trend.In the L-arginine group,they reached the highest levels at 24 hours(P<0.05)and significantly decreased at 48 hours.In the sodium taurocholate group,serum amylase and lipase remained at higher levels at 12 hours with a slow decline trend(P<0.05).Compared with the normal group,microscopic examination revealed mild acinar edema and widened interlobular spaces in the cerulein group,with a higher presence of inflammatory cells.In the L-arginine group,there was widening of interlobular spaces,extensive infiltration of inflammatory cells,and patchy necrotic areas.In the sodium taurocholate group,significant pancreatic edema,structural disarray,extensive necrotic foci,and inflammatory cell infiltration were observed.Compared with the normal group,the pathological scores of induced acute pancreatitis in all three models were significantly different at each time point(P<0.05).Moreover,the pathological scores in each group increased over time,indicating a gradual worsening of pancreatic tissue damage.When comparing different models at the same time,there were differences in pathological scores,with the sodium taurocholate group having the highest scores,followed by the L-arginine group,and the cerulein group having the lowest scores.Analyzing the three models at the same time point,the most severe condition was in the sodium taurocholate group,which was characterized by pancreatic hemorrhage and necrosis,followed by the L-arginine group,which was characterized by necrosis,and the least severe condition was in the cerulein group,mainly characterized by edema.The serum biochemical index levels of the cerulein and L-arginine groups decreased at 48 hours,indicating that these two models may have a tendency to self-heal and belong to a self-limiting disease course.The serum biochemical index levels of the sodium taurocholate group decreased slowly after 12 hours.Therefore,pancreatic injury in the sodium taurocholate group might not be relieved after 48 hours or longer.

Purpose To explore the value of dual-layer spectral detector CT(DLSCT)in evaluating preoperative tumor staging in rectal adenocarcinoma(RA).Materials and Methods A total of 78 patients with pathologically confirmed RA in Guangdong Provincial Hospital of Chinese Medicine from May 2021 to March 2022 were involved in this retrospective study.All the patients underwent plain and dual-phase contrast-enhanced scans by DLSCT within one week before surgery.Taking pathological results as the golden standard,the accuracy rates of tumor staging were calculated and compared between the multiple-parameter maps derived from DLSCT and 120 kVp polyenergetic image.The effective atomic number(Z-eff)from plain scan,iodine concentration(IC)from arterial phase(AP)and venous phase(VP)were measured.The normalized iodine concentration(NIC)in AP and VP were calculated.The differences of Z-eff,NICAP and NICVP were compared among the pT1-2,pT3 and pT4 groups.The correlation between the pT stages and above values was assessed and the diagnostic efficiencies were analyzed.Results The overall accuracy rate(88.46%vs.67.95%;χ2=9.628,P=0.002),the pT1-2 staging accuracy rate(80.00%vs.40.00%;χ2=6.667,P=0.01),and the pT3 staging accuracy rate(88.10%vs.69.05%;χ2=4.525,P=0.033)of multiple-parameter maps derived from DLSCT were significantly higher than those of 120 kVp polyenergetic image,respectively.The Z-eff,NICAP and NICVP were significantly different among pT stage groups(F=6.456,11.029,12.698,all P<0.05)and exhibited a positive correlation with pT stages(r=0.371,0.367,0.363,all P<0.01).The areas under the curve of Z-eff,NICAP and NICVP to assess pT3-4 staging RA were 0.77,0.71 and 0.74,respectively.Conclusion The multiple-parameter maps derived from DLSCT can significantly improve the diagnostic accuracy of preoperative tumor staging of RA.Z-eff from plain scan and NIC from dual-phase helps differentiate pT1-2 from pT3-4 staging RA.

ObjectiveTo investigate the impact of acute respiratory infections in children under 12 years old in Pudong New Area， Shanghai from 2019 to 2023. MethodsAcute respiratory infection samples of children under 12 years old from three sentinel hospitals in Pudong New Area， Shanghai from 2019 to 2023 were collected， and 42 respiratory infection pathogens， including influenza virus， adenovirus， parainfluenza virus， respiratory syncytial virus， human enterovirus/rhinovirus， human pulmonary virus， human bokavirus， coronavirus （229E， HKU1， NL63 and OC43）， and novel coronavirus， were detected with microfluidic chips. The situation of acute respiratory infections among outpatient and inpatient children in this area was analyzed for the before the implementation of non pharmacological intervention measures （2019.12‒2020.1）， during the period of non pharmacological intervention measures （2020.2‒2022.12）， and after non pharmacological intervention measures （2023.1‒2023.6）. ResultsFrom 2019 to 2023， a total of 1 770 samples were collected， and 445 pathogens were detected， with a detection rate of 25.14% （445/1 770）. The main pathogens detected during the study period were influenza virus： 8.70% （154/1 770）， respiratory syncytial virus： 4.41% （78/1 770）， human enterovirus/rhinovirus： 2.66% （47/1 770）， human adenovirus： 2.49% （44/1 770）， and parainfluenza virus： 2.20% （39/1 770）. Before the implementation of non pharmacological intervention measures， outpatients were primarily infected with influenza， parainfluenza virus， and respiratory syncytial virus， with detection rates of 8.09%， 4.49%， and 4.04%， respectively； inpatients were mainly infected with influenza， respiratory syncytial virus， and parainfluenza virus， with detection rates of 4.49%， 3.82%， and 3.15%， respectively. During the period of non pharmacological intervention measures， influenza， rhinovirus and respiratory syncytial virus were the main viruses detected in the samples of outpatient children， with detection rates of 4.04%， 3.60%， and 2.47%， respectively； inpatient samples mainly detected respiratory syncytial virus， rhinovirus， and influenza virus， with detection rates of 3.60%， 2.02%， and 1.80%， respectively. After non pharmacological intervention measures， influenza， rhinovirus and respiratory syncytial virus were the main pathogens detected in the outpatients， with detection rates of 9.89%， 2.92% and 2.02%， respectively； influenza， respiratory syncytial virus， and rhinovirus were the main pathogens detected in inpatient children， with detection rates of 6.29%， 1.57%， and 1.35%， respectively. ConclusionThe prevalence of pathogens related to acute respiratory infections in children is influenced by non pharmacological preventive measures.

Objective: To investigate sleep quality among patients with hypertension and diabetes, so as to provide the basis for improving the health of patients with chronic diseases. Methods: From May to August 2022, patients with hypertension and diabetes under the community management in 4 counties and cities (districts) of Shaoxing City, Zhejiang Province were recruited using a multi-stage stratified cluster random sampling method. Demographic information, disease history, smoking, alcohol consumption, physical activity and sleep quality were collected by questionnaire surveys, and blood pressure, fasting blood glucose and glycosylated hemoglobin were collected through physical examination and laboratory testing. The incidence of poor sleep quality symptoms (snoring/asphyxia/suffocation, difficulty falling asleep, night awakening, taking sleeping pills and early morning awakening) in patients with diabetes and hypertension was descriptively analyzed, and sleep quality was evaluated. Results: A total of 1 539 patients with hypertension and diabetes were surveyed, including 715 males (46.46%) and 824 females (53.54%). The patients had a mean age of (68.68±7.62) years. The proportions of night awakening, early morning awakening, snoring/asphyxia/suffocation, difficulty falling asleep and taking sleeping pills were 29.82%, 28.53%, 20.73%, 15.79% and 4.29%, respectively. The proportion of poor sleep quality was 66.54%. Employment status, smoking status, moderate/high intensity physical activity and blood pressure control were related to poor sleep quality (all P<0.05). Conclusion Poor sleep quality is common in patients with hypertension and diabetes, with the main symptoms being night awakening, early morning awakening, difficulty falling asleep and snoring/asphyxia/suffocation.

Purpose To explore the value of iodine concentration(IC)and effective atomic number(Zeff)derived from dual-layer spectral detector CT in diagnosing the regional lymph nodes of gastric cancer.Materials and Methods From May 2021 to September 2022,108 patients pathologically confirmed with gastric cancer(92 non-metastatic lymph nodes and 116 metastatic lymph nodes),who underwent dual-phase enhanced dual-layer spectral detector CT scanning preoperatively in the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,were included in the study.The imaging and clinical data of all cases were collected,retrospectively.According to preoperative CT images,the short diameter,margin and enhancement homogeneity of the lymph nodes were evaluated.The IC and Zeff were obtained from the delineated region of interest of the solid portion of the maximum layer of the target lymph nodes,and the normalization IC(nIC)and normalization Zeff(nZeff)were calculated.The difference of parameters between two groups were compared.The efficiency of differential diagnosis and combined diagnosis of each parameter was analyzed.The area under the receiver characteristic curve(AUC)for each parameter were compared.Results There were statistical differences in short diameter,margin and enhancement homogeneity between the two groups(t/x2=-7.575,30.971,20.913,all P＜0.001).In the benign lymph nodes group,all spectral parameters in the arterial phase(AP)were lower than those in malignant lymph nodes,while the parameters in the venous phase(VP)were higher(t=-10.723-12.610,all P＜0.001).Among the three conventional features,the AUC of short diameter was the highest(0.749).Compared with the AUC values of ICAP and ZeffVP,the AUC values of short diameter and quantitative parameters had no statistical difference(P＞0.05),but were lower than those of other spectral parameters.Among the spectral parameters,the AUC value of nICVP was the highest(0.925).The sensitivity and specificity of the spectral parameters were higher than those of conventional features.The diagnostic efficacy of the multi-parameter combined model was superior to that of the univariate model.The AUC value of the combined model with conventional features was 0.815.Among the combined model based on CT spectral parameters,the diagnostic efficacy of model combined with the parameters of arteriovenous phase was the highest(AUC=0.993).Conclusion The quantitative parameters of dual-phase enhancement derived from dual-layer spectral detector CT can effectively evaluate the characteristics of gastric cancer regional lymph nodes,and the diagnostic efficiency is higher than the conventional characteristics of lymph nodes.The multi-parameter combined model can improve the diagnostic efficiency.

Objective To understand and assess the quality status of national drug sampling inspection in 2022 and the possible risks of drug quality.Methods With the aim of identifying issues and preventing risks,a sampling model of"dispersed sampling,centralized inspection,exploratory research,and comprehensive evaluation"was used to review the historical inspection data of national drug sampling.The overall quality and potential risks of national drug sampling in 2022 were analyzed,with a focus on identifying and examining the main quality problems and risks.Results The average pass rate of the sampling inspection in 2022 was 99.4% .The overall safety situation of China's post-marketing drug quality is stable and manageable,indicating that the drug quality is at a high level.Conclusions By carrying out exploratory studies related to drug safety,authenticity,and efficacy,national sampling plays an important role in comprehensively evaluating the quality status of drugs.It aids in improving the quality control level of drug varieties and industry standards,strengthening quality and safety supervision,combating illegal practices such as adulteration and falsification,and providing public warnings about drug safety.