OBJECTIVE To prepare an intelligent responsive liposome-hydrogel nanopreparation co-loaded with gambogic acid （GA）， and characterize its antitumor activity in vitro . METHODS GA-ICG-Lip-gel was prepared by ethanol injection and cold dissolution， incorporating GA and the photosensitizer indocyanine green （ICG）. The appearance and microscopic morphology of GA-ICG-Lip-gel were observed， its encapsulation efficiency and drug loading capacity were measured， and its photothermal conversion performance， photothermal stability， and infrared imaging properties were investigated， along with the determination of its in vitro release profile. Human breast cancer MCF-7 cells were used as objects to investigate the effects of GA-ICG-Lip-gel （or with near-infrared light irradiation） on cell viability， migration ability， and the cellular uptake capacity of GA-ICG-Lip-gel. RESULTS GA-ICG-Lip-gel existed in a solution state at room temperature and transformed into a gel state at 37 ℃. Its microstructure was dense with small pores， and its encapsulation efficiency and drug loading were （96.07±0.86） % and （6.28±1.16） %， respectively. After exposure to near-infrared light， the temperature of GA-ICG-Lip-gel rose above 42 ℃， with no significant attenuation observed in the heating curve. The heating efficiency was dependent on both the irradiation time and drug concentration. Compared to media without gelatinase， the cumulative release rate of GA-ICG-Lip-gel increased in media containing gelatinase. In vitro studies showed that GA-ICG-Lip-gel could be efficiently taken up by MCF-7 cells； GA-ICG-Lip-gel significantly inhibited the viability and migration ability of MCF-7 cells （ P ＜0.05）， and this inhibitory effect was further enhanced under near-infrared light irradiation. CONCLUSIONS This study successfully prepares GA-ICG-Lip-gel， which exhibits favorable photothermal conversion properties and temperature/enzyme dual-responsive drug release characteristics， and demonstrates significant inhibitory effects on the proliferation and migration of breast cancer cells.

Objective: To explore a simple, effective, and safe method for excluding false positives and identifying infections by comprehensively evaluating blood donors with reactive HIV screening results, thereby providing a basis for developing management strategies for such donors. Methods: HIV testing data of blood donors from our laboratory from January 2022 to December 2024 were collected. The results of ELISA and nucleic acid testing (NAT) were combined with confirmatory results from the CDC and analyzed. Results: A total of 605 929 samples were tested for HIV over the three-year period, with 682 reactive samples (reactive rate: 11.25 per 10 000). All were sent to the CDC for Western blot (WB) confirmation, resulting in 53 confirmed positives ((confirmed positive rate: 7.77%). Among these, 619 samples showed isolated HIV Ag&Ab reactivity with non-reactive NAT (HIV Ag&Ab+-&HIV RNA or NAT NR), with a confirmed infection rate of 0%; 9 samples showed dual HIV Ag&Ab reactivity with non-reactive NAT (HIV Ag&Ab++&HIV RNA NR or NAT NR), also with 0% confirmed infection; 52 samples showed dual HIV Ag&Ab reactivity and reactive NAT (HIV Ag&Ab++&HIV RNA R or NAT R), all confirmed as positive (100% infection rate); and 2 HIV Ag&Ab dual-reactive samples without NAT detection were also confirmed infected (100%). For all four HIV Ag&Ab assays, the S/CO values in the true positive group with dual reactivity were significantly higher than those in the false-positive groups (P<0.05). The S/CO distributions for both single-reactive false positives and dual-reactive false positives were narrow, with the upper box (Q3, 75th percentile) below optimal cutoff values in all cases (The optimal cutoff values for the four reagents were 5.00, 11.67, 8.50, and 20.90, respectively). Conclusion: Blood donors with positive NAT results in HIV blood screening are permanently deferred. Donors with dual positive HIV Ag&Ab but negative NAT results are classified and managed based on the S/CO values of HIV Ag&Ab and the optimal screening thresholds. Donors with single positive HIV Ag&Ab but negative NAT results are placed under evaluation status and retain their eligibility to donate blood. Optimizing the management measures for blood donors and establishing a scientific stratified management and assessment mechanism can effectively maintain the stability of the blood donor team.

Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.

Objective To compare the quality of liquids dispensed by intelligent dispensing robot and traditional manual in PIVAS,to ensure the safety of clinical infusion.Methods Using omeprazole and ambroxol as the main drugs and 5％glucose injection and 0.9％sodium chloride solution as the solvent,a number of quality indexes including drug residues and the number of insoluble particles were evaluated in the two modes of manual and robotic dispensing,respectively.Results Under the robot dispensing mode and manual dispensing mode,the residual amount of drugs was less than 5％,the insoluble particles were far less than the limit,the pH value was in line with the human infusion range,and the endotoxin and aseptic culture were negative results,with no statistical significance(P＞0.05).Conclusions The quality of liquid dispensed under the robotic dispensing mode is guaranteed,and there is no significant difference in the quality of liquid dispensed with the traditional manual dispensing mode,which provides a reliable guarantee for the large-scale application of robotic dispensing in intravenous admixture service.

Objective To compare the quality of liquids dispensed by intelligent dispensing robot and traditional manual in PIVAS,to ensure the safety of clinical infusion.Methods Using omeprazole and ambroxol as the main drugs and 5％glucose injection and 0.9％sodium chloride solution as the solvent,a number of quality indexes including drug residues and the number of insoluble particles were evaluated in the two modes of manual and robotic dispensing,respectively.Results Under the robot dispensing mode and manual dispensing mode,the residual amount of drugs was less than 5％,the insoluble particles were far less than the limit,the pH value was in line with the human infusion range,and the endotoxin and aseptic culture were negative results,with no statistical significance(P＞0.05).Conclusions The quality of liquid dispensed under the robotic dispensing mode is guaranteed,and there is no significant difference in the quality of liquid dispensed with the traditional manual dispensing mode,which provides a reliable guarantee for the large-scale application of robotic dispensing in intravenous admixture service.

Objective: To analyze the changing trend and distribution characteristics of hepatitis C virus (HCV) infection among blood donors in Hebei, thereby providing data to support strategy and procedure adjustment for blood collection and supply institutions. Methods: Data from 12 blood stations in Hebei Province from 2012 to 2021 were collected. These data were analyzed to determine trends in anti-HCV antibody double reagent reactive rate and to characterize its distribution among different donor categories, genders and birth cohorts. Results: During the period from 2012 to 2021, a total of 7.4576 million samples were tested at 12 blood stations in Hebei Province, with 3.4659 million (46.47%) from first-time donors, and 3.9917 million (53.53%) from repeat donors. The number (of anti-HCV double reagent reactive samples was 7167 (9.61/10 000). The anti-HCV double reagent reactive rate showed a annual downward trend (P<0.05), from 17.40/10 000 at the beginning to 4.95/10 000 at the end of the study period. Additionally, the double reagent reactive rate of repeat blood donors had remained below 1/10 000 since 2017. The double reagent reactive rate of first-time blood donors (19.42/10 000) was higher than in repeat donors (1.09/10 000) (P<0.05), and the double-reagent reactive rate of female first-time blood donors (20.98/10 000) was higher than that of male first-time blood donors (18.49/10 000) (P<0.05). The anti-HCV double reagent reactive rate among first-time donors exhibited two distinct peaks within the pre-1976 and 1989-1994 birth cohorts, with notable gender differences observed in both peak periods. The rate of double reagent reactive in females born before 1976 (52.22/10 000) was higher than that in males (32.28/10 000) (P<0.05), while that of males born in 1989-1994 was higher (25.75/10 000) than that of females (14.28/10 000) (P<0.05). Conclusion: The prevalenc of HCV infection among blood donors in Hebei Province has shown a consistent year-over-year decline over the study period. The majority of infected individuals are found among the first-time blood donors born before 1995. These trends and characteristics provide valuable insights for developing pre-blood collection screening strategies, analyzing nucleic acid test data in blood screening, adjusting blood screening procedures, and provide evidence for targeted screening of high-risk populations as part of public health initiatives to eliminate hepatitis C.

Objective To explore the effect of repetitive transcranial magnetic stimulation(rTMS)on the sleep disorder and examination results of recruits.Methods At a training base,the Pittsburgh Sleep Quality Index(PSQI)was used to screen the recruits with sleep disorders(total score of PSQI>7).The recruits were randomly assigned to rTMS group or sham rTMS group.Both groups received cognitive and behavioral intervention therapy,including sleep health education and relaxation training.Moreover,the rTMS group was treated with rTMS at the right posterior parietal lobe by continuous theta burst stimulation(cTBS)twice a day at an interval of at least 50 min for 5 consecutive days as a course of treatment with an interval of 2 days for a total of 2 courses of treatment.The coil position and stimulus intensity of sham rTMS group were consistent with the rTMS group,but the head of subjects was perpendicular to the coil plane and there was no effective stimulation.Before and after treatment,PSQI,self-rating depression scale,generalized anxiety disorder-7 and health questionnaire-15 were used to evaluate the sleep,mood and physical state of the recruits.The training result was assessed one month after treatment.The total effective rate of PSQI improvement and examination results were compared between the two groups.The independent influencing factors of excellent examination result were analyzed.Results Among 351 recruits,83 with sleep disorders completed treatment and follow-up.There were 40 patients in the rTMS group and 43 patients in the sham rTMS group.There was no significant difference between the two groups at baseline.After treatment,the total effective rate of PSQI improvement in the rTMS group was higher than that in the sham rTMS group(77.50%vs 53.49%,P=0.022).The average examination score and excellent rate of the rTMS group were higher than those of the sham rTMS group(91.58±3.19 vs 89.47±4.67,P=0.020;85%vs 65.12%,P=0.037).Logistic regression analysis showed that the treatment mode(rTMS group)was the independent influencing factor of excellent examination results(P=0.032).Conclusion rTMS can effectively and safely improve the sleep disorders and examination results of recruits.rTMS may play a positive role in improving the learning and training effect of recruits,which needs to be further proved.

Objective:To evaluate the efficacy of almonertinib,a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI),as a first-line treatment for patients with EGFR-mutated advanced non-small cell lung cancer(NSCLC)in the real-world clinical practise,and to systematically analyze the independent risk factors influencing their prognosis.Methods:This retrospective cohort study enrolled 73 patients with EGFR-mutated advanced NSCLC who received first-line treatment with aumolertinib from April 1,2020 to December 31,2021.Survival curves were generated by using the Kaplan-Meier method,and intergroup comparisons were performed via log-rank test.Univariate and multivariate analyses of prognostic factors were conducted by using the COX proportional hazards regression model,with a focus on identifying prognostic factors in the subgroup of baseline brain metastases.Results:Among 73 patients,the median progression-free survival(mPFS)was 19.4 months,and the disease control rate(DCR)was 93.2%.Multivariate COX regression analysis revealed that central nervous system(CNS)metastasis status,EGFR mutation subtype,ECOG performance status(PS)score,and gender might be independent risk factors for PFS.Among 33 patients with baseline brain metastases,combined almonertinib with radiotherapy or bevacizumab,maximum diameter of brain metastases(≥3 cm),and ECOG PS score might be independent risk factors of PFS.Conclusion:This first real-world study confirms that aumolertinib demonstrates favorable efficacy as first-line treatment for EGFR-mutated locally advanced or metastatic NSCLC patients,aligning with findings from phase Ⅲ clinical trials.For patients in subgroup of baseline brain metastases,combining almonertinib with radiotherapy or bevacizumab is recommended to optimize outcomes.

Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.