Diabetic retinopathy（DR）， as one of the most common and serious microvascular complications of diabetes mellitus， seriously threatens human health， and belongs to "Xiaoke eye diseases" in traditional Chinese medicine（TCM）， which has been richly experienced by medical practitioners through the ages， but is mostly recorded in a piecemeal manner and has not been systematically researched. This disease is featured by long course and repeated attack， and is refractory， which belongs to the research category of "persistent illness entering collaterals". Systematic establishment of TCM collateral disease theory for guiding prevention and treatment of DR has important clinical value. On the basis of close correlation between tertiary collaterals at the terminal of collaterals and capillaries and microcirculation， the concept of "tertiary collaterals-microvascular" is proposed. It is pointed out that DR falls within the scope of "tertiary collaterals-microvascular" diseases， and presents four types of micro-pathological characteristics， including stasis， insufficiency， growth and bleeding of tertiary collaterals. It is concluded that "deficiency of both Qi and Yin" is the basic pathogenesis of DR， and "blood stasis and collateral obstruction" is the important pathogenesis and key factor. Thus， the treatment method of "dispersing blood stasis， dredging collateral， tonifying Qi and Yin， stopping hemorrhage and improving eyesight" is determined， and the formula of Tongluo Mingmu capsules is developed. The article tightly focuses on the pathological changes such as stasis， growth， insufficiency and bleeding of collaterals， addresses both symptoms and root causes， and plays a synergistic role of both dispersing stasis and stopping bleeding. In this way， it can realize the purpose of tonifying Qi and Yin to replenish the essence， dispersing stasis and dredging collaterals to meet the requirement， as well as stopping hemorrhage and improving eyesight to deal with changes. Fundamental researches demonstrate that Tongluo Mingmu capsules has synergy effects of protecting both retinal capillaries and retinal cells. Phase-Ⅲ clinical trial of new drug has proven definite clinical efficacy and good safety， which provides a new drug choice for enhancing clinical effect of DR， and further supports the scientific value of Luobing theory in preventing and treating DR and other clinically significant diseases.

Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.

Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.

Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

Objective To analyze the effect of neurofeedback training based on early start Denver model(ESDM)on children with autism spectrum disorder(ASD). Methods From August,2020 to May,2024,a total of 60 children with ASD from Hangzhou Children's Hospital were randomly divided into control group(n=30)and observation group(n=30).The control group received ESDM intervention,while the observation group received neurofeedback training in addition,for six months.They were assessed with Autism Treatment Evaluation Checklist(ATEC)and Psycho-Educational Profile-3rd Edition(PEP-3). Results After treatment,the score of ATEC was lower in the observation group than in the control group(t=3.545,P<0.05),the scores of cognition(t=2.236,P=0.029),emotional expression(t=2.293,P=0.025)and problem be-havior(Z=2.099,P=0.036)were higher in the observation group than in the control group.The score differenc-es of ATEC(Z=3.620,P<0.001),and cognition(Z=2.920,P<0.05)and problem behaviors(Z=4.209,P<0.05)of PEP-3 before and after intervention were higher in the observation group than in the control group. Conclusion Combination of neurofeedback training could improve the effect of ESDM on ASD.

Objective To explore the relationship between the intraoperative plasma transfusion volume,the changes of blood coagulation test values and the clinical prognosis of surgical patients,so as to provide a theoretical basis for guiding the rational use of blood during the operation.Methods The clinical data of 556 surgical patients who received plasma in-fusion from January 2017 to December 2020 in Sun Yat-sen Memorial Hospital were collected.Patients were divided into low plasma dose group(＜15 mL/kg)and high plasma dose group(≥15 mL/kg).The univariate regression analysis,logistic multivariate regression analysis and linear regression analysis were used to explore the relationship of plasma dose,the chan-ges of coagulation indicators and the clinical prognosis.Results A total of 556 surgical patients were included in the study and the median(interquartile range)of plasma transfusion volume for all patients during the operation was 10.5(8.5～14.0)mL/kg.In multivariate regression analysis,an increase of 1 mL/kg of intraoperative plasma dose resulted in an in-creased risk of red blood cell infusion within 24 hours after surgery[OR(95%CI)1.16(1.01,1.33),P＜0.05],an in-crease in the ICU stays[Mean(95%CI)0.19(0.03,0.35),P＜0.05]and an increase in the hospitalization days[Mean(95%CI)0.55(0.27,0.81),P＜0.05].The preoperative INR value increased the risk of red blood cell infusion within 24 hours after surgery[OR(95%CI)1.82(1.33,2.50),P＜0.05],and increased the hospital mortality of postoperative pa-tients[OR(95%CI)2.15(1.09,4.24),P＜0.05];the decrease in INR reduced the risk of red blood cell infusion in pa-tients 24 hours after surgery[OR(95%CI)0.47(0.27,0.84),P＜0.05]and reduced hospital mortality[OR(95%CI)0.23(0.13,0.50),P＜0.05].Conclusion In surgical patients undergoing intraoperative plasma infusion,abnormal preopera-tive INR value and high intraoperative plasma infusion are related to poor clinical prognosis,while INR decrease(preopera-tive-postoperative)was related to better clinical results.

[Objective]To assess the impact of intraoperative plasma infusion dose and coagulation test value INR on the clinical prognosis of patients undergoing cardiac surgery,providing a basis for guiding rational blood use during cardi-ac surgery.[Methods]The clinical data of 305 surgical patients who received fresh frozen plasma transfusion during cardiac surgery were collected in Sun Yat-sen Memorial Hospital of Sun Yat-sen University from January 2014 to December 2022.The patients were divided into low-dose group(plasma infusion dose<15 mL/kg,n=214)and high-dose group(plasma infusion dose≥15 mL/kg,n=91)based on the intraoperative plasma dose.Univariate analysis,correlation analysis and logistic multivariate regression analysis were used to analyze the relationship between plasma infusion dose,changes in INR before and after plasma transfusion,and the clinical prognosis of patients undergoing cardiac surgery.[Results]The median plasma infusion dose for all patients was 11.11(8.17-19.05)mL/kg,while the median plasma infusion dose in the high-dose group and the low-dose group was 17.78(15.69-20.91)mL/kg and 9.52(7.77-11.43)mL/kg,respectively,with a statistically significant difference(P<0.001).The median INR decrease in the high-dose and low-dose groups was 0.98(0.60-1.26)and 0.50(0.35-0.76),respectively,with a statistically significant difference(P<0.001).Logistic multi-variate regression analysis revealed that abnormally elevated preoperative INR values increased the risk of postoperative red blood cell transfusion within 24 hours in cardiac surgery patients(P<0.001),with an OR 95%CI of 6.757(3.068,14.822).Additionally,it also increased the risk of postoperative in-hospital mortality(P<0.001),with an OR 95%CI of 5.441(2.193,13.499).INR decrease reduced the risk of postoperative red blood cell transfusion within 24 hours in cardi-ac surgery patients(P=0.001),with an OR 95%CI of 0.244(0.107,0.558).Correlation analysis showed positive correla-tion between plasma infusion dose and postoperative ICU days(rs=0.569,P<0.001)and hospital days(rs=0.302,P<0.001)in cardiac surgery patients.[Conclusion]Among patients undergoing cardiac surgery who receive intraoperative plasma transfusion,high plasma infusion dose and abnormally elevated preoperative INR values are associated with poorer clinical outcomes,while patients who show a greater degree of INR correction after plasma transfusion exhibit better clini-cal results.