OBJECTIVE To evaluate the differences between the sampling methods of peristaltic pump+membrane filtration and rinsing for monitoring the cleaning and disinfection effectiveness of flexible endoscopes,and to pro-vide a reference for selecting an efficient sampling method for monitoring the cleaning and disinfection effectiveness of flexible endoscopes.METHODS A total of 305 cases of monitoring data on the cleaning and disinfection of flexi-ble endoscopes from People's Hospital of Rizhao in Shandong Province from Jan.2021 to Dec.2024 were selected.The results of 93 cases sampled by rinsing from Jan.2021 to Dec.2022 were compared with those of 212 cases sampled by peristaltic pump+membrane filtration from Jan.2023 to Dec.2024.The monitoring capabilities of different sampling methods for flexible endoscopes after cleaning and disinfection were evaluated,and the con-sumable costs of different sampling methods were also calculated.RESULTS The detection rate of pathogenic bac-teria after biological monitoring of the peristaltic pump+membrane filtration sampling method was 25.94％(55/212),which was higher than that of the rinsing sampling method(8.60％,8/93)(P＜0.05).There was no sta-tistically significant difference in the sampling qualification rate between the two methods(P=0.075).There was no statistically significant difference in the qualification rate between manual and mechanical cleaning and dis-infection methods under the same sampling method.However,there was a statistically significant difference in the detection rate of pathogenic bacteria between manual cleaning and disinfection(36.21％)and mechanical cleaning and disinfection(22.08％)under the peristaltic pump+membrane filtration sampling method(P=0.036).The detection rate of pathogenic bacteria of the peristaltic pump+membrane filtration sampling method was higher than that of the rinsing sampling method for both cleaning and disinfection methods(P＜0.05).The consumable cost per endoscope of the peristaltic pump+membrane filtration sampling method was(84.90±2.91)yuan,which was higher than that of the rinsing sampling method(32.24±4.73)yuan(P＜0.001).CONCLUSION Al-though the peristaltic pump+membrane filtration sampling method has higher consumable costs,it can effec-tively improve the detection rate of pathogenic bacteria and enhance the sensitivity of biological monitoring of cleaning and disinfection.

OBJECTIVE To evaluate the differences between the sampling methods of peristaltic pump+membrane filtration and rinsing for monitoring the cleaning and disinfection effectiveness of flexible endoscopes,and to pro-vide a reference for selecting an efficient sampling method for monitoring the cleaning and disinfection effectiveness of flexible endoscopes.METHODS A total of 305 cases of monitoring data on the cleaning and disinfection of flexi-ble endoscopes from People's Hospital of Rizhao in Shandong Province from Jan.2021 to Dec.2024 were selected.The results of 93 cases sampled by rinsing from Jan.2021 to Dec.2022 were compared with those of 212 cases sampled by peristaltic pump+membrane filtration from Jan.2023 to Dec.2024.The monitoring capabilities of different sampling methods for flexible endoscopes after cleaning and disinfection were evaluated,and the con-sumable costs of different sampling methods were also calculated.RESULTS The detection rate of pathogenic bac-teria after biological monitoring of the peristaltic pump+membrane filtration sampling method was 25.94％(55/212),which was higher than that of the rinsing sampling method(8.60％,8/93)(P＜0.05).There was no sta-tistically significant difference in the sampling qualification rate between the two methods(P=0.075).There was no statistically significant difference in the qualification rate between manual and mechanical cleaning and dis-infection methods under the same sampling method.However,there was a statistically significant difference in the detection rate of pathogenic bacteria between manual cleaning and disinfection(36.21％)and mechanical cleaning and disinfection(22.08％)under the peristaltic pump+membrane filtration sampling method(P=0.036).The detection rate of pathogenic bacteria of the peristaltic pump+membrane filtration sampling method was higher than that of the rinsing sampling method for both cleaning and disinfection methods(P＜0.05).The consumable cost per endoscope of the peristaltic pump+membrane filtration sampling method was(84.90±2.91)yuan,which was higher than that of the rinsing sampling method(32.24±4.73)yuan(P＜0.001).CONCLUSION Al-though the peristaltic pump+membrane filtration sampling method has higher consumable costs,it can effec-tively improve the detection rate of pathogenic bacteria and enhance the sensitivity of biological monitoring of cleaning and disinfection.

Objective:To compare the differences in the evaluation of hemolysis performance of cellulose hemostatic materials using different detection methods and test media,and to explore a m ore reasonable testing plan for such products.Methods:Hemolysis tests were conducted on cellulose hemostatic materials using the absorbance measurement hemolysis method and hemoglobin concentration measurement hemolysis method in accordance with YY/T 1651.1-2019 standard.We compared the changes in hemolysis rate,pH value,and osmotic pressure under different experimental media.Results:Under the same experimental method,compared to SC,the hemolysis results using PBS as the extraction medium are smaller,and the changes in pH and osmotic pressure are closer to the normal range of human body changes.Conclusions:The changes in pH and osmotic pressure may be one of the reasons for the high hemolysis rate of cellulose hemostatic materials.Choosing PBS with buffering effect as the leaching medium may be more suitable for evaluating the hemolysis performance of cellulose hemostatic materials.

Objective:To compare the differences in the evaluation of hemolysis performance of cellulose hemostatic materials using different detection methods and test media,and to explore a m ore reasonable testing plan for such products.Methods:Hemolysis tests were conducted on cellulose hemostatic materials using the absorbance measurement hemolysis method and hemoglobin concentration measurement hemolysis method in accordance with YY/T 1651.1-2019 standard.We compared the changes in hemolysis rate,pH value,and osmotic pressure under different experimental media.Results:Under the same experimental method,compared to SC,the hemolysis results using PBS as the extraction medium are smaller,and the changes in pH and osmotic pressure are closer to the normal range of human body changes.Conclusions:The changes in pH and osmotic pressure may be one of the reasons for the high hemolysis rate of cellulose hemostatic materials.Choosing PBS with buffering effect as the leaching medium may be more suitable for evaluating the hemolysis performance of cellulose hemostatic materials.

Objective To analyze the cerebral angiographic characteristics of patients with central retinal artery occlusion(CRAO)and to study their prognosis.Methods A retrospective study was conducted,with 182 CRAO patients enrolled,who were treated at Xuanwu Hospital,Capital Medical University,the First Affiliated Hospital of Anhui Medical University,the Affiliated Suzhou Hospital of Anhui Medical University,and the People's Hospital of Shihezi City from January 1,2014,to June 1,2024.All patients underwent cerebral angiography within one month of onset.The baseline characteristics,treatment details,and follow-up data were collected.The Spearman rank correlation coefficient was used to evaluate the correlation between the characteristics of the ophthalmic artery and the ipsilateral carotid artery angiography,and Logistic regression analysis was performed to explore factors related to patient prognosis.Results Cerebral angiography results showed that 81.3％of patients had ocular blood supply from the ipsilateral internal carotid artery,12.1％from the ipsilateral external carotid artery,and 6.6％from the ipsilateral middle cerebral artery.Among the patients,80(44.0％)had varying degrees of stenosis or occlusion of the affected ophthalmic artery,with 69 patients(86.3％)showing stenosis at the origin of the ophthalmic artery.Additionally,135 patients(74.2％)had varying degrees of stenosis or occlusion of the ipsilateral carotid artery,with 110 patients(60.4％)showing stenosis at the carotid bulb,88 patients(48.3％)having unilateral carotid lesions,and 41 patients(22.5％)having multiple lesions.Correlation analysis indicated a significant correlation between the degree of stenosis in the ophthalmic artery and the carotid artery(r=0.76,P=0.006).Univariate and multivariate Logistic regression analyses revealed that the time from symptom onset to hospital admission(OR=0.93,95％CI:0.85-0.98,P=0.018),the grading of oxygenation-based hypoperfusion maculopathy(OHM)(OR=3.12,95％CI:1.09-6.34,P=0.005),intravenous thrombolysis(IVT)(OR=2.75,95％CI:1.08-5.35,P=0.031),and the absence of stenosis in the ophthalmic artery(OR=1.33,95％CI:1.02-3.41,P=0.026)were independent predictors of prognosis for CRAO patients.Conclusions The degree of stenosis in the ophthalmic artery is significantly correlated with the degree of stenosis in the carotid artery in CRAO patients.Time from symptom onset to hospital admission,OHM grading,IVT,and the absence of stenosis in the ophthalmic artery are independent factors influencing the prognosis of CRAO patients.

Objective:To explore the impacts of remimazolam(REM)on the proliferation,migration,and invasion of hepatocellular carcinoma cells by regulating sphingosine kinase 1/sphingosine 1-phosphate/sphingosine 1-phosphate receptor 3(SPHK1/S1P/S1PR3)signaling pathway.Methods:Human hepatocellular carcinoma cell line HepG2 was treated with REM at concentrations of 0,20,40,80,160,and 320 μmol/L respectively.Cell survival rate was measured,and drug concentrations were screened.Based on the results of cell survival rate,the logarithmic phase cells were di-vided into five groups:Control group,low,medium,and high concentrations of remifentanil groups(REM-L,REM-M,REM-H groups;20,40 and 80 μmol/L),and high concentrations of remifentanil+SPHK1 activator group(REM-H+K6PC-5 group).MTT assay was used to detect the survival rate of HepG2 cells.Plate cloning experiment was performed to de-tect cell proliferation ability.Scratch experiment was performed to detect cell migration ability.Transwell chamber method was performed to detect cell invasion ability.Flow cytometry was used to detect cell apoptosis.Western blot was used to detect the SPHK1,S1P,S1PR3,Bax,and Bcl-2 proteins in cells.Results:For the Control group,the REM-L,REM-M,and REM-H groups showed that the number of HepG2 cell clones,scratch healing rate,invasion rate,Bcl-2,SPHK1,S1P,S1PR3,and N-cadherin proteins gradually decreased with increasing REM concentration,while the apoptosis rate and Bax,E-cadherin proteins showed an opposite trend(P<0.05).For the REM-H group,the REM-H+K6PC-5 group showed a clear increase in the number of HepG2 cell clones,scratch healing rate,invasion rate,Bcl-2,SPHK1,S1P,S1PR3,and N-cadherin proteins,and a clear decrease in the apoptosis rate and Bax,E-cadherin proteins(P<0.05).Conclusion:REM may inhibit the proliferation,migration,and invasion of hepatocellular carcinoma cells and promote cell apoptosis by suppressing SPHK1/S1P/S1PR3 signaling pathway.

Objective To evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets using hydroxyethyl starch(HES)130/0.4 sodium chloride injection as an extraction medium.Methods Firstly,40 Sprague Dawley(SD)rats including 20 male and 20 female ones were seleted and randomly enrolled into a sample group and a control group by sex,with 20 ones in each group.Secondly,instead of plasma HES 130/0.4 sodium chloride injection was used to leach disposable plasma virus-inactivated blood transfusion sets to prepare the test solution by simulating clinical application such as lighting,adsorption and filtration and storage.Finally,the test solution and HES 130/0.4 sodium chloride injection were injected into the tail vein of the SD rats at a dose of 20 mL/kg for 28 d in the sample group and in the control group respectively,and the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets and the feasibility of using HES 130/0.4 sodium chloride injection as the extraction medium to assess their subchronic systemic toxicity were evaluated with clinical observation,body mass monitoring,clinical pathology examination,gross necropsy and histopathology examination.Results The sample group and control group had no significant differences in mortality rates,clinical observation results,body mass,gross necropsy results,hematological and coagulation examination results and organ weight(all P>0.05);blood biochemical examinations showed the male rats in the sample group had the cholesterol(CHO)values higher while the creatinine(CR)values lower than those in the control group,with the differences being statistically significant(both P<0.05)and the two indexes within the range of the laboratory's historical reference data,and other blood biochemical indexes were not significantly different(all P>0.05);the sample group had the spleen weight-to-body mass ratios of the female rates lower significantly than those in the control group(P<0.05),and the ratios of other organ weight to body mass had significant differences(all P>0.05);histopathology examination showed slight pathological changes in liver,spleen and kidney of female rats and in spleen and kidney of male rats in the sample group,and the female and male rats in the control group had similar pathological changes found in the sample group,which might be caused by HES metabolites.Conclusion Disposable plasma virus-inactivated blood transfusion sets prove to have no significant subchronic systemic toxicity,and its feasible to use HES 130/0.4 sodium chloride injection as the extraction medium to evaluate the subchronic systemic toxicity of disposable plasma virus-inactivated blood transfusion sets.[Chinese Medical Equipment Journal,2025,46(10):29-35]

Objective To evaluate the pharmacokinetics(PK)and pharmacodynamics(PD)of propofol injectable emulsion,and to assess the bioequivalence of test and reference formulations in healthy Chinese adult volunteers.Methods Thirty-two healthy Chinese adult volunteers were recruited and randomly assigned to a fasting.single-dose,two-period and double-crossover study.Propofol was given to eligible subjects at a speed of 30 μg·kg-1·min-1 for 30 min.The concentration of propofol in plasma was determined by avalidated high performance liquid chromatography-tandem mass spectrometery(HPLC-MS/MS)method.The PK parameters of the two preparations were calculated.Bispectral index(BIS)was measured to calculate the PD parameters of two formulations.Adverse events during the trial were recorded.Results Thirty-one volunteers were included in the pharmacokinetic parameter set.The mean values of PK parameters of test andreference formulations were as follows:Cmax were(660.87±110.25)and(683.13±125.75)ng·mL-1;AUC0-t were(473.50±86.03)and(478.40±80.25)h·ng·mL-1;AUC0-∞ were(500.45±96.49)and(507.84±88.00)h·ng·mL-1;tmax were 0.47(0.25,0.53)and 0.50(0.40,0.54)h;t1/2 were(2.97±1.74)and(3.08±1.82)h.Thirty-one volunteers were included in the bioequivalence set.The 90％confidence intervals(CI)for the geometric mean ratios of Cmax,AUC0-t,AUC0-∞ were 92.64％-101.39％,96.43％-101.00％,95.67％-100.70％,respectively.The mean values of PD parameters of test and reference formulations were as follows:BISmin were(75.94±13.66)and(74.39±12.32);BISAUC0-60minwere 5 569.85±182.78 and 5 575.68±166.19;T-BISmin were 23.00 and 29.00 min,respectively.There were no serious adverse events.Conclusion Two formulations of propofol injectable emulsion were bioequivalent and both of them exhibited good safety.

To meet the domestic clinical demand timely,the national health commission has released three batches of encourage generic drug catalogues,which plays a good guiding role in improving the supply level and accessibility of generic drugs.Based on literature investigation,the typical cases of novel pharmaceutical preparations were analyzed,and the pharmaceutical considerations were put forward in terms formulation,manufacturing process and quality control,aimed to provide scientific reference for research and development of such drugs.

Objective:To explore the impacts of remimazolam(REM)on the proliferation,migration,and invasion of hepatocellular carcinoma cells by regulating sphingosine kinase 1/sphingosine 1-phosphate/sphingosine 1-phosphate receptor 3(SPHK1/S1P/S1PR3)signaling pathway.Methods:Human hepatocellular carcinoma cell line HepG2 was treated with REM at concentrations of 0,20,40,80,160,and 320 μmol/L respectively.Cell survival rate was measured,and drug concentrations were screened.Based on the results of cell survival rate,the logarithmic phase cells were di-vided into five groups:Control group,low,medium,and high concentrations of remifentanil groups(REM-L,REM-M,REM-H groups;20,40 and 80 μmol/L),and high concentrations of remifentanil+SPHK1 activator group(REM-H+K6PC-5 group).MTT assay was used to detect the survival rate of HepG2 cells.Plate cloning experiment was performed to de-tect cell proliferation ability.Scratch experiment was performed to detect cell migration ability.Transwell chamber method was performed to detect cell invasion ability.Flow cytometry was used to detect cell apoptosis.Western blot was used to detect the SPHK1,S1P,S1PR3,Bax,and Bcl-2 proteins in cells.Results:For the Control group,the REM-L,REM-M,and REM-H groups showed that the number of HepG2 cell clones,scratch healing rate,invasion rate,Bcl-2,SPHK1,S1P,S1PR3,and N-cadherin proteins gradually decreased with increasing REM concentration,while the apoptosis rate and Bax,E-cadherin proteins showed an opposite trend(P<0.05).For the REM-H group,the REM-H+K6PC-5 group showed a clear increase in the number of HepG2 cell clones,scratch healing rate,invasion rate,Bcl-2,SPHK1,S1P,S1PR3,and N-cadherin proteins,and a clear decrease in the apoptosis rate and Bax,E-cadherin proteins(P<0.05).Conclusion:REM may inhibit the proliferation,migration,and invasion of hepatocellular carcinoma cells and promote cell apoptosis by suppressing SPHK1/S1P/S1PR3 signaling pathway.