Objective To develop a reagent for detecting of 17α-hydroxyprogesterone(17α-OHP)in dried blood spots on filter paper fixed on vascular stent by Auto TRFIA-4 automatic fluorescence immunoanalyzer and evaluate its performance.Methods The microwell plate was coated with the sheep anti-rabbit IgG antibody as microwell reaction plate,the rabbit anti-human 17α-OHP antibody was diluted as intermediate antibody,and the 17α-OHP-bovine serum albumin conjugate was labeled by europium as europium marker.The concentration of 17α-OHP in dried blood spots on filter paper fixed on blood spots stent was quantitatively detected by Auto TRFIA-4 automatic fluorescence immunoanalyzer.The analysis sensitivity,accuracy,linearity,precision,specificity and stability were evaluated,and whether they met the requirements of the formulated industry standards were evaluated.A total of 227 neonatal heel blood filter paper samples from newborns who were born 72 hours after birth and within 7 days and fully breastfeeding were selected for reagent comparison test.The consistency was analyzed by χ2 test,Kappa test,t test,linear correlation analysis,regression analysis,Bland-Altman method analysis and predictive bias analysis of medical decision level,P<0.05 indicated statistically significant difference.Results The optimal coating concentration of sheep anti-rabbit IgG antibody was 3 μg/ml.The optimal dilution ratio of rabbit anti-human 17α-OHP antibody was 1∶1 500.The optimal dilution ratio of 17α-OHP europium marker mother liquor was 1∶2 500.The limit of blank,limit of detection,limit of quantification was 0.75,1.08 and 1.99 nmol/L,respectively.The relative deviations of the standard check test were within±15.00%,and the average recovery rate was 92.36%.The linear correlation coefficient was 0.997 1 in the range of 2.00 to 300.00nmo/L.The intra-assay and inter-assay coefficients of variation were all within 10.00%.The cross-reactivity rates of 100.00 ng/ml progesterone,17α-hydroxypreg nenolone and 11-deoxycortisol were within 0.089%to 0.64%.The performance of stability test met the requirements.The total coincidence rate was 100%compared with the results of contrast reagent.The quantitative results were highly correlated with the contrast reagent(r=0.999 4,tr=452.02,P<0.05).Conclusion The self-developed reagent has the advantages of high sensitivity,good accuracy,wide linear range,good precision,high specificity and good stability,which meets the requirements of the formulated industry standards,and has high correlation and consistency with the result of contrast reagent,which meets the needs of clinical detection.

Objective To explore the relationship between hemorheology and Carotid Atherosclerosis.Methods The clinical data of 153 patients who underwent both hemorheological testing and carotid artery ultrasound were divided into a CAS group(n=96)and a non-CAS group(n=57)based on ultrasound findings.Clinical data and laboratory indicators were compared between two groups.Multivariate logistic regression analysis was used to explore the influencing factors of CAS.The ROC curves graph were drawn to observe the role of hemorheological indicators in predicting CAS and select the optimal cutoff value based on the maximum Youden index.Results The CAS group demonstrated higher levels in age,BMI,RBC aggregation index,low&high shear reduced viscosity of whole blood,plasma viscosity and fibrinogen compared to the non-CAS group(P<0.05).The multivariate logistic regression analysis showed that plasma viscosity(OR=38.270,95%CI:1.206～1214.508),age(OR=1.119,95%CI:1.065～1.176)were risk factors for the occurrence of CAS(P<0.05).The ROC curves showed that the area under the curve(AUC)of plasma viscosity and age were 0.623、0.728.Conclusion CAS patients have high levels of plasma viscosity and advanged age compared to the patient without CAS.Elevated plasma viscosity and age is a risk factor for CAS,with plasma viscosity≥1.46 mPa·s,over the age of 56.5 as a significant value for predicting CAS.

The 2025 edition of the Chinese Pharmacopoeia Volume Ⅳ has added General Chapter 9211"Guidelines for the Application of Water Activity in Microbial Control of Non-sterile Pharmaceuticals".This guideline is rela-tively new in China's pharmaceutical industry,and it also serves as an important concept and measure to compre-hensively promote microbial process control of pharmaceuticals,conduct microbial quality risk management,and optimize microbial limit setting for non-sterile pharmaceuticals.This article elaborates and interprets the guidelines from four aspects:the background of establishing the guidelines,the necessity and significance of adding the guide-lines,the process of adding the guidelines,and the main framework and key content of the guidelines.It aims to guide enterprises to optimize formulations,formulate personalized microbial control strategies,and realize the trans-formation from terminal quality control to process control,so as to provide important tools and theoretical guidance for microbial quality risk management.

The 2025 edition of the Chinese Pharmacopoeia Volume Ⅳ has added General Chapter 9211"Guidelines for the Application of Water Activity in Microbial Control of Non-sterile Pharmaceuticals".This guideline is rela-tively new in China's pharmaceutical industry,and it also serves as an important concept and measure to compre-hensively promote microbial process control of pharmaceuticals,conduct microbial quality risk management,and optimize microbial limit setting for non-sterile pharmaceuticals.This article elaborates and interprets the guidelines from four aspects:the background of establishing the guidelines,the necessity and significance of adding the guide-lines,the process of adding the guidelines,and the main framework and key content of the guidelines.It aims to guide enterprises to optimize formulations,formulate personalized microbial control strategies,and realize the trans-formation from terminal quality control to process control,so as to provide important tools and theoretical guidance for microbial quality risk management.

Objective:To investigate differentially expressed lipid molecules and their associated metabolic pathways in lung tissue using lipidomic analysis in a rat model of acute lung injury (ALI).Methods:An ALI rat model was established via intratracheal instillation of lipopolysaccharide (LPS). Twenty rats were randomly allocated into an ALI group and a control group ( n = 10 per group). The left lung was subjected to histopathological evaluation, while the right lung underwent untargeted lipidomics analysis. Ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was employed for lipid profiling. Principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed to assess intergroup differences and determine variable importance in projection (VIP) scores. Differential lipids were screened based on VIP and fold change.Lipid identification and metabolic pathway analysis were conducted using MetaboAnalyst 5.0 and the Kyoto Encyclopedia of Genes and Genomes (KEGG) database. Results:Among 1 022 detected lipid molecules, 47 were differentially expressed (VIP > 1, FC > 2.0 or < 0.5, P< 0.05). Subsequent analysis identified 12 structurally annotated lipids ( P < 0.05), predominantly enriched in glycerophospholipid metabolism, linoleic acid metabolism, and α-linolenic acid metabolism pathways. Notably, phosphatidylcholines (PCs) and lysophosphatidylcholines (LPCs) exhibited significant alterations in the ALI group. Conclusions:The ALI model demonstrated substantial dysregulation of lipid metabolism, particularly involving PCs and LPCs, with prominent perturbations in glycerophospholipid metabolism. This provides a scienctific basis for indepth research on the pathogenesis mechanism of ALI/acute respiratory distress syndrome (ARDS) .

Objective To develop a reagent for detecting of 17α-hydroxyprogesterone(17α-OHP)in dried blood spots on filter paper fixed on vascular stent by Auto TRFIA-4 automatic fluorescence immunoanalyzer and evaluate its performance.Methods The microwell plate was coated with the sheep anti-rabbit IgG antibody as microwell reaction plate,the rabbit anti-human 17α-OHP antibody was diluted as intermediate antibody,and the 17α-OHP-bovine serum albumin conjugate was labeled by europium as europium marker.The concentration of 17α-OHP in dried blood spots on filter paper fixed on blood spots stent was quantitatively detected by Auto TRFIA-4 automatic fluorescence immunoanalyzer.The analysis sensitivity,accuracy,linearity,precision,specificity and stability were evaluated,and whether they met the requirements of the formulated industry standards were evaluated.A total of 227 neonatal heel blood filter paper samples from newborns who were born 72 hours after birth and within 7 days and fully breastfeeding were selected for reagent comparison test.The consistency was analyzed by χ2 test,Kappa test,t test,linear correlation analysis,regression analysis,Bland-Altman method analysis and predictive bias analysis of medical decision level,P<0.05 indicated statistically significant difference.Results The optimal coating concentration of sheep anti-rabbit IgG antibody was 3 μg/ml.The optimal dilution ratio of rabbit anti-human 17α-OHP antibody was 1∶1 500.The optimal dilution ratio of 17α-OHP europium marker mother liquor was 1∶2 500.The limit of blank,limit of detection,limit of quantification was 0.75,1.08 and 1.99 nmol/L,respectively.The relative deviations of the standard check test were within±15.00%,and the average recovery rate was 92.36%.The linear correlation coefficient was 0.997 1 in the range of 2.00 to 300.00nmo/L.The intra-assay and inter-assay coefficients of variation were all within 10.00%.The cross-reactivity rates of 100.00 ng/ml progesterone,17α-hydroxypreg nenolone and 11-deoxycortisol were within 0.089%to 0.64%.The performance of stability test met the requirements.The total coincidence rate was 100%compared with the results of contrast reagent.The quantitative results were highly correlated with the contrast reagent(r=0.999 4,tr=452.02,P<0.05).Conclusion The self-developed reagent has the advantages of high sensitivity,good accuracy,wide linear range,good precision,high specificity and good stability,which meets the requirements of the formulated industry standards,and has high correlation and consistency with the result of contrast reagent,which meets the needs of clinical detection.

Objective To explore the relationship between hemorheology and Carotid Atherosclerosis.Methods The clinical data of 153 patients who underwent both hemorheological testing and carotid artery ultrasound were divided into a CAS group(n=96)and a non-CAS group(n=57)based on ultrasound findings.Clinical data and laboratory indicators were compared between two groups.Multivariate logistic regression analysis was used to explore the influencing factors of CAS.The ROC curves graph were drawn to observe the role of hemorheological indicators in predicting CAS and select the optimal cutoff value based on the maximum Youden index.Results The CAS group demonstrated higher levels in age,BMI,RBC aggregation index,low&high shear reduced viscosity of whole blood,plasma viscosity and fibrinogen compared to the non-CAS group(P<0.05).The multivariate logistic regression analysis showed that plasma viscosity(OR=38.270,95%CI:1.206～1214.508),age(OR=1.119,95%CI:1.065～1.176)were risk factors for the occurrence of CAS(P<0.05).The ROC curves showed that the area under the curve(AUC)of plasma viscosity and age were 0.623、0.728.Conclusion CAS patients have high levels of plasma viscosity and advanged age compared to the patient without CAS.Elevated plasma viscosity and age is a risk factor for CAS,with plasma viscosity≥1.46 mPa·s,over the age of 56.5 as a significant value for predicting CAS.

Objective:To evaluate the feasibility of using a fully automated iodine analyzer to measure urinary iodine.Methods:A fully automated iodine analyzer was used to determine the urinary iodine content, a methodological evaluation was conducted on the linear relationship, detection limit, precision, and accuracy (urinary iodine standard substances GBW109m, GBW110e within the range of 0 - 300 μg/L, and GBW111m, GBW112h within the range of 300 - 1 200 μg/L) of the standard curve within the ranged from 0 to 1 200 μg/L (low concentration standard series: 0 - 300 μg/L, high concentration standard series: 300 - 1 200 μg/L). A method comparison experiment with the manual measurement results of arsenic cerium catalytic spectrophotometry was conducted.Results:The fully automated iodine analyzer had a good linear relationship for the determination of urinary iodine within the standard curve ranges of 0 - 1 200 μg/L, with│ r│ > 0.999 0; the minimum detection limit was 3.17 μg/L. Among them, the coefficients of variation for low, medium, and high concentrations of urinary iodine standard substances in the range of 0 - 300 μg/L were 6.79%, 2.53% and 1.20%, respectively; and the recovery rate ranged from 94.8% to 101.2%. The coefficients of variation for low and high concentrations of urinary iodine standard substances within the range of 300 - 1 200 μg/L were 1.21% and 1.62%, respectively; and the recovery rate ranged from 100.6% to 105.1%. The determination results of urinary iodine standard substances GBW109m, GBW110e, GBW111m, and GBW112h were all within the given standard value ± uncertainty range [(69.7 ± 9.0), (210 ± 15), (574 ± 17), (794 ± 28) μg/L]. There was no statistically significant difference between the results obtained by using a fully automated iodine analyzer and the manual measurement results of arsenic cerium catalytic spectrophotometry ( P > 0.05). Conclusion:The fully automated iodine analyzer detection method can be fully automated, with simple and time-saving operation, high system accuracy, and good precision, suitable for large-scale urine iodine sample detection.

Objective:To evaluate the feasibility of using a fully automated iodine analyzer to measure urinary iodine.Methods:A fully automated iodine analyzer was used to determine the urinary iodine content, a methodological evaluation was conducted on the linear relationship, detection limit, precision, and accuracy (urinary iodine standard substances GBW109m, GBW110e within the range of 0 - 300 μg/L, and GBW111m, GBW112h within the range of 300 - 1 200 μg/L) of the standard curve within the ranged from 0 to 1 200 μg/L (low concentration standard series: 0 - 300 μg/L, high concentration standard series: 300 - 1 200 μg/L). A method comparison experiment with the manual measurement results of arsenic cerium catalytic spectrophotometry was conducted.Results:The fully automated iodine analyzer had a good linear relationship for the determination of urinary iodine within the standard curve ranges of 0 - 1 200 μg/L, with│ r│ > 0.999 0; the minimum detection limit was 3.17 μg/L. Among them, the coefficients of variation for low, medium, and high concentrations of urinary iodine standard substances in the range of 0 - 300 μg/L were 6.79%, 2.53% and 1.20%, respectively; and the recovery rate ranged from 94.8% to 101.2%. The coefficients of variation for low and high concentrations of urinary iodine standard substances within the range of 300 - 1 200 μg/L were 1.21% and 1.62%, respectively; and the recovery rate ranged from 100.6% to 105.1%. The determination results of urinary iodine standard substances GBW109m, GBW110e, GBW111m, and GBW112h were all within the given standard value ± uncertainty range [(69.7 ± 9.0), (210 ± 15), (574 ± 17), (794 ± 28) μg/L]. There was no statistically significant difference between the results obtained by using a fully automated iodine analyzer and the manual measurement results of arsenic cerium catalytic spectrophotometry ( P > 0.05). Conclusion:The fully automated iodine analyzer detection method can be fully automated, with simple and time-saving operation, high system accuracy, and good precision, suitable for large-scale urine iodine sample detection.

Objective:To assess the effectiveness of a 6-month Ba Duan Jin exercise program in improving the balance of community-dwelling older adults.Methods:A two arms, parallel-group, cluster randomized controlled trial was conducted in 1 028 community residents aged 60-80 years in 40 communities in 5 provinces of China. Participants in the intervention group (20 communities, 523 people) received Ba Duan Jin exercise 5 days/week, 1 hour/day for 6 months, and three times of falls prevention health education, and the control group (20 communities, 505 people) received falls prevention health education same as the intervention group. The Berg balance scale (BBS) score was the leading outcome indicator, and the secondary outcome indicators included the length of time of standing on one foot (with eyes open and closed), standing in a tandem stance (with eyes open and closed), the closed circle test, and the timed up to test.Results:A total of 1 028 participants were included in the final analysis, including 731 women (71.11%) and 297 men (28.89%), and the age was (69.87±5.67) years. After the 3-month intervention, compared with the baseline data, the BBS score of the intervention group was significantly higher than the control group by 3.05 (95% CI: 2.23-3.88) points ( P<0.001). After the 6-month intervention, compared with the baseline data, the BBS score of the intervention group was significantly higher than the control group by 4.70 (95% CI: 4.03-5.37) points ( P<0.001). Ba Duan Jin showed significant improvement ( P<0.05) in all secondary outcomes after 6 months of exercise in the intervention group compared with the control group. Conclusions:This study showed that Ba Duan Jin exercise can improve balance in community-dwelling older adults aged 60-80. The longer the exercise time, the better the improvement.