Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.

Objective To determine the related substances in ornidazole active pharmaceutical ingredient(API)and injections using high performance liquid chromatography(HPLC)and to study the impurity profile of ornidazole using liquid chromatography-tandem mass spectrometry(LC-MS/MS)combined with forced degradation tests,aiming to clarify the sources of impurities and their correlation with the prescription and production process and providing technical support for the unified evaluation and quality control of this product.Methods A Phenomenex Luna C18column(4.6 mm×250 mm,5 μm)was used for the separation of ornidazole and its impurities,with 0.000 5%formic acid as mobile phase A and methanol as mobile phase B under gradient elution.The impurity content of 4 batches of APIs,3 batches of reference preparations,and 11 batches of domestic generic preparations were determined.The structure of unknown impurities was predicted using Jet Stream Ion Focusing Electrospray Ionization-Time of Flight Mass Spectrometry(AJS-TOF-MS/MS),and the sources of impurities were identified combined with forced degradation experiments,the prescription and the production process of various manufacturers.Results Ornidazole and its known impurities were well separated under the chromatographic conditions.The structures of five unknown impurities were inferred,and the sources of the impurities were identified.Conclusion This study provides a reference for impurity analysis,quality control,and overall evaluation of ornidazole API and injection.

Objective To identify potential quality risks of Xiaoer Huatan Zhike Granules(Pediatric Phlegm-Resolving and Cough-Relieving Granules)through National Drug Sampling and Inspection,evaluate their overall quality,and propose improvements to the quality standards.Methods Samples from 34 manufacturers were tested using official standards.Exploratory methods were developed to enhance risk analysis,including thin-layer chromatography(TLC)identification,content uniformity testing,quantitative assays,and screening for unauthorized additives(e.g.,colorants).Results All batches met the official standards(100.0%compliance rate).However,deficiencies were observed:most manufacturers lacked controls for ephedrine hydrochloride content uniformity and quantification,omitted key ingredient identifications(e.g.,herbal components),and exhibited insufficient TLC specificity(e.g.,TLC of Ipecac tincture showed only one spot instead of multiple alkaloid-specific spots).Exploratory studies revealed risks in total emetine/cephaeline content,morroniside A/platycodin D content,ephedrine hydrochloride uniformity,and unauthorized colorant addition.Conclusions The overall quality of this variety is good,but the enterprise should improve the quality control measures throughout the entire process and establish stricter internal control standards;The official standards,unchanged for approximately 30 years,fail to address current regulatory requirements.The statutory quality standards need to be revised and improved.Qualitative or quantitative indicators for all drug flavors in the prescription should be added,and the content uniformity inspection of ephedrine hydrochloride should be increased.

Natural antimicrobial peptides(AMPs)are promising candidates for the development of a new gener-ation of antimicrobials to combat antibiotic-resistant pathogens.They have found extensive applications in the fields of medicine,food,and agriculture.However,efficiently screening AMPs from natural sources poses several challenges,including low efficiency and high antibiotic resistance.This review focuses on the action mechanisms of AMPs,both through membrane and non-membrane routes.We thoroughly examine various highly efficient AMP screening methods,including whole-bacterial adsorption binding,cell membrane chromatography(CMC),phospholipid membrane chromatography binding,membrane-mediated capillary electrophoresis(CE),colorimetric assays,thin layer chromatography(TLC),fluorescence-based screening,genetic sequencing-based analysis,computational mining of AMP data-bases,and virtual screening methods.Additionally,we discuss potential developmental applications for enhancing the efficiency of AMP discovery.This review provides a comprehensive framework for identifying AMPs within complex natural product systems.

Objective To investigate the protective effect of cerebrospinal fluid(CSF)on the spinal cord in patients with scoliosis and evaluate its buffering effect during gravitational traction surgery and in daily life,so as to provide a theoretical guidance for surgical planning and postoperative rehabilitation of scoliosis.Methods A three-dimensional coupled spinal cord-CSF finite element model was established to simulate the biomechanical responses of the spine under two scenarios:gravitational traction surgery and daily life.Comparative analyses were conducted for conditions with and without CSF,and the buffering effect of CSF was quantitatively assessed.Results During simulated gravitational traction surgery,CSF significantly reduced the stress and deformation of the spinal cord,with the stress in spinal cord white and gray matter decreasing by 65％-90％and deformation decreasing by 70％-95％.In the daily life scenario,CSF provided greater protective effects in lateral flexion and anterior-posterior flexion directions,with stress reductions of 60％-85％.However,in torsion,the buffering effect of CSF was relatively weaker,with stress reductions of only 10％-25％.Conclusions CSF significantly reduces spinal cord stress and deformation during gravitational traction surgery and in daily life,reducing the risk of injury.

Bladder-preserving treatment has become a research focus due to its potential to balance therapeutic efficacy and quality of life.In recent years,the rapid development of immunotherapy has brought new opportunities for bladder-sparing strategies.In high-risk non-muscle invasive bladder cancer(HR-NMIBC),emerging regimens such as bacillus calmette-guérin-based immunoenhancement,immuno-chemotherapy combinations,targeted therapy,and gene therapy have demonstrated encouraging efficacy and safety in trials like GU-123 and TRUCE-02,with complete remission rate ranging from 42％-100％.In muscle-invasive bladder cancer(MIBC),immunotherapy is being integrated with trimodal therapy,radiotherapy,chemotherapy,and antibody-drug conjugates,as evidenced by studies such as ReBirth and BTCRC-GU15-023,which reported significant improvements in bladder-intact event-free survival,progression-free survival,and complete remission rate.This review summarizes the latest advances in immunotherapy-based bladder-preserving strategies for both HR-NMIBC and MIBC,aiming to provide insights for future individualized treatment approaches.

Objective To determine the related substances in ornidazole active pharmaceutical ingredient(API)and injections using high performance liquid chromatography(HPLC)and to study the impurity profile of ornidazole using liquid chromatography-tandem mass spectrometry(LC-MS/MS)combined with forced degradation tests,aiming to clarify the sources of impurities and their correlation with the prescription and production process and providing technical support for the unified evaluation and quality control of this product.Methods A Phenomenex Luna C18column(4.6 mm×250 mm,5 μm)was used for the separation of ornidazole and its impurities,with 0.000 5%formic acid as mobile phase A and methanol as mobile phase B under gradient elution.The impurity content of 4 batches of APIs,3 batches of reference preparations,and 11 batches of domestic generic preparations were determined.The structure of unknown impurities was predicted using Jet Stream Ion Focusing Electrospray Ionization-Time of Flight Mass Spectrometry(AJS-TOF-MS/MS),and the sources of impurities were identified combined with forced degradation experiments,the prescription and the production process of various manufacturers.Results Ornidazole and its known impurities were well separated under the chromatographic conditions.The structures of five unknown impurities were inferred,and the sources of the impurities were identified.Conclusion This study provides a reference for impurity analysis,quality control,and overall evaluation of ornidazole API and injection.

Objective To identify potential quality risks of Xiaoer Huatan Zhike Granules(Pediatric Phlegm-Resolving and Cough-Relieving Granules)through National Drug Sampling and Inspection,evaluate their overall quality,and propose improvements to the quality standards.Methods Samples from 34 manufacturers were tested using official standards.Exploratory methods were developed to enhance risk analysis,including thin-layer chromatography(TLC)identification,content uniformity testing,quantitative assays,and screening for unauthorized additives(e.g.,colorants).Results All batches met the official standards(100.0%compliance rate).However,deficiencies were observed:most manufacturers lacked controls for ephedrine hydrochloride content uniformity and quantification,omitted key ingredient identifications(e.g.,herbal components),and exhibited insufficient TLC specificity(e.g.,TLC of Ipecac tincture showed only one spot instead of multiple alkaloid-specific spots).Exploratory studies revealed risks in total emetine/cephaeline content,morroniside A/platycodin D content,ephedrine hydrochloride uniformity,and unauthorized colorant addition.Conclusions The overall quality of this variety is good,but the enterprise should improve the quality control measures throughout the entire process and establish stricter internal control standards;The official standards,unchanged for approximately 30 years,fail to address current regulatory requirements.The statutory quality standards need to be revised and improved.Qualitative or quantitative indicators for all drug flavors in the prescription should be added,and the content uniformity inspection of ephedrine hydrochloride should be increased.

Objective To investigate the protective effect of cerebrospinal fluid(CSF)on the spinal cord in patients with scoliosis and evaluate its buffering effect during gravitational traction surgery and in daily life,so as to provide a theoretical guidance for surgical planning and postoperative rehabilitation of scoliosis.Methods A three-dimensional coupled spinal cord-CSF finite element model was established to simulate the biomechanical responses of the spine under two scenarios:gravitational traction surgery and daily life.Comparative analyses were conducted for conditions with and without CSF,and the buffering effect of CSF was quantitatively assessed.Results During simulated gravitational traction surgery,CSF significantly reduced the stress and deformation of the spinal cord,with the stress in spinal cord white and gray matter decreasing by 65％-90％and deformation decreasing by 70％-95％.In the daily life scenario,CSF provided greater protective effects in lateral flexion and anterior-posterior flexion directions,with stress reductions of 60％-85％.However,in torsion,the buffering effect of CSF was relatively weaker,with stress reductions of only 10％-25％.Conclusions CSF significantly reduces spinal cord stress and deformation during gravitational traction surgery and in daily life,reducing the risk of injury.

Bladder-preserving treatment has become a research focus due to its potential to balance therapeutic efficacy and quality of life.In recent years,the rapid development of immunotherapy has brought new opportunities for bladder-sparing strategies.In high-risk non-muscle invasive bladder cancer(HR-NMIBC),emerging regimens such as bacillus calmette-guérin-based immunoenhancement,immuno-chemotherapy combinations,targeted therapy,and gene therapy have demonstrated encouraging efficacy and safety in trials like GU-123 and TRUCE-02,with complete remission rate ranging from 42％-100％.In muscle-invasive bladder cancer(MIBC),immunotherapy is being integrated with trimodal therapy,radiotherapy,chemotherapy,and antibody-drug conjugates,as evidenced by studies such as ReBirth and BTCRC-GU15-023,which reported significant improvements in bladder-intact event-free survival,progression-free survival,and complete remission rate.This review summarizes the latest advances in immunotherapy-based bladder-preserving strategies for both HR-NMIBC and MIBC,aiming to provide insights for future individualized treatment approaches.