Based on the etiology and clinical diagnostic criteria of type 2 diabetes mellitus （T2DM）， identification and typing of treatment from the perspective of traditional Chinese and western medicine， the criteria for evaluating the clinical compatibility of traditional Chinese and western medicine in animal models of T2DM were set up. The literature was reviewed to sort out and analyze the existing commonly used modeling methods， summarize the mechanism， compare the advantages and disadvantages， and calculate the consistency between the animal model and the clinical symptoms， syndromes， and indicators from the perspective of traditional Chinese and western medicine. The authors found that spontaneous animal models and high-fat diets combined with multiple low-dose streptozotocin （STZ） induction models were more in line with modern medical pathogenesis of T2DM. However， it fails to form some special syndromes required for traditional Chinese medicine （TCM） research. In addition， there are many methods of combining the etiology and pathogenesis of TCM， which can be divided into three categories： intervention carried out by drug administration， behavioral stimulation， or environmental changes according to TCM， or use of hormones according to clinical evidence and combination of the two methods mentioned above. All of them can successfully establish different types of animal models. However， different methods of establishing syndrome models have their own advantages and disadvantages， and there is no unified standard for the stability and evaluation of syndrome models. As for the clinical consistency criteria of traditional Chinese and western medicine established in this paper， the animal model with 100% consistency has not been calculated due to the conditions of incomplete symptoms and syndromes described in the studies and different selection indicators. Consequently， the establishment of a simple， easy-to-use， and affordable T2DM animal model with both traditional Chinese and western medicine disease characteristics and the improvement of the Chinese and western medicine evaluation system for different evidence types are of great significance for the future development of TCM research on T2DM.

Based on the etiology and clinical diagnostic criteria of type 2 diabetes mellitus （T2DM）， identification and typing of treatment from the perspective of traditional Chinese and western medicine， the criteria for evaluating the clinical compatibility of traditional Chinese and western medicine in animal models of T2DM were set up. The literature was reviewed to sort out and analyze the existing commonly used modeling methods， summarize the mechanism， compare the advantages and disadvantages， and calculate the consistency between the animal model and the clinical symptoms， syndromes， and indicators from the perspective of traditional Chinese and western medicine. The authors found that spontaneous animal models and high-fat diets combined with multiple low-dose streptozotocin （STZ） induction models were more in line with modern medical pathogenesis of T2DM. However， it fails to form some special syndromes required for traditional Chinese medicine （TCM） research. In addition， there are many methods of combining the etiology and pathogenesis of TCM， which can be divided into three categories： intervention carried out by drug administration， behavioral stimulation， or environmental changes according to TCM， or use of hormones according to clinical evidence and combination of the two methods mentioned above. All of them can successfully establish different types of animal models. However， different methods of establishing syndrome models have their own advantages and disadvantages， and there is no unified standard for the stability and evaluation of syndrome models. As for the clinical consistency criteria of traditional Chinese and western medicine established in this paper， the animal model with 100% consistency has not been calculated due to the conditions of incomplete symptoms and syndromes described in the studies and different selection indicators. Consequently， the establishment of a simple， easy-to-use， and affordable T2DM animal model with both traditional Chinese and western medicine disease characteristics and the improvement of the Chinese and western medicine evaluation system for different evidence types are of great significance for the future development of TCM research on T2DM.

Objective:To analyze the research and development of control system for airbag pressure of intelligent tracheal catheter,and its application effect in clinical practice.Methods:The hospital designed an intelligent self-adaptive control system for cuff pressure of tracheal catheter,which can rationally apply main components such as single chip microcomputer,display screen,control panel,pressure monitoring module,inflation device and solenoid valve,etc..This control system connected the measuring module of pressure through single chip microcomputer,so as to continuously detect the airbag pressure of tracheal catheter.An inflation and deflation algorithm was independently researched and developed to control air pump or solenoid valve to inject or release part of the gas to the airbag,so as to achieve intelligent control for the pressure of airbag.Sixty patients underwent endotracheal intubation who admitted to the department of general surgery of Wuhan Hospital of Traditional Chinese Medicine from January 2022 to January 2023 were selected as the study objects,and they were divided into control group(n=30)and observation group(n=30)according to random number table method.The cuff pressure of endotracheal intubation of patients in control group were managed by conventional method.The intelligent adaptive control system was adopted to manage the cuff pressure of endotracheal intubation for patients in the observation group.The complications,compliance rate of airbag pressure,the instantaneous maximum value of airbag pressure during sputum aspiration,insertion of gastric tube,and turning over of body were compared between the two groups after intubation.Results:The incidence of complication included cough,trachyphonia,dysphagia and bloody sputum after tracheal intubation in the observation group were 6.66%,which was significantly lower than 33.33%in the control group,and the difference was statistically significant(x2=6.667,P<0.05).The compliance rate of the pressure(25-30cmH2O)of airbag in the control group was 92.83%,which was significantly lower than 97.78%in the observation group,and the difference was statistically significant(x2=14.698,P<0.05).The instantaneous maximum values of airbag pressure during sputum aspiration,insertion of gastric tube and turning over were(28.24±3.65)cmH2O,(27.98±4.25)cmH2O and(28.65±4.87)cmH2O in observation group,respectively,which were significantly lower than those in control group,and the differences were significant(t=17.930,19.208,16.485,P<0.05).Conclusion:The application of intelligent adaptive control system for cuff pressure of tracheal catheter can maintain the airbag pressure of tracheal catheter at normal level(20-30 cmH2O),and reduce complications,and improve the compliance rate of airbag pressure.

Oral liquid pharmaceutical plastic bottles and components are widely used in related preparation packaging.This article elaborates on the rationale behind the development of the guidelines and the framework of the standards,while discussing critical quality control considerations for these containers based on their practical applications.Compared with existing national standards for pharmaceutical packaging materials,the newly established guidelines demonstrate broader applicability and more comprehensive quality control requirements for oral liquid pharmaceutical plastic bottles and components,fully addressing the packaging needs of such products and thereby enhancing the overall regulatory oversight of pharmaceutical packaging materials in China.

Plastic pharmaceutical packaging materials are widely used in drug packaging,and the effective quality control of these materials is of great significance for ensuring the quality of drugs.The Guidelines for Plastic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China(hereinafter referred to as the guideline)is based on the characteristics of plastic pharmaceutical packaging materials and combined with the different uses of various products,clarifying the quality control requirements for different categories of products.The guideline not only improves the pharmacopoeia standard system,but also meets the needs of industrial development and drug regulation under the new situation,which is conducive to enterprises to better improve product quality.This article explains the main contents of the guideline in combination with the background,process,and ideas of its drafting,so as to provide guidance for the correct understanding and use of this standard by all parties in the industry.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Oral liquid pharmaceutical plastic bottles and components are widely used in related preparation packaging.This article elaborates on the rationale behind the development of the guidelines and the framework of the standards,while discussing critical quality control considerations for these containers based on their practical applications.Compared with existing national standards for pharmaceutical packaging materials,the newly established guidelines demonstrate broader applicability and more comprehensive quality control requirements for oral liquid pharmaceutical plastic bottles and components,fully addressing the packaging needs of such products and thereby enhancing the overall regulatory oversight of pharmaceutical packaging materials in China.

Plastic pharmaceutical packaging materials are widely used in drug packaging,and the effective quality control of these materials is of great significance for ensuring the quality of drugs.The Guidelines for Plastic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China(hereinafter referred to as the guideline)is based on the characteristics of plastic pharmaceutical packaging materials and combined with the different uses of various products,clarifying the quality control requirements for different categories of products.The guideline not only improves the pharmacopoeia standard system,but also meets the needs of industrial development and drug regulation under the new situation,which is conducive to enterprises to better improve product quality.This article explains the main contents of the guideline in combination with the background,process,and ideas of its drafting,so as to provide guidance for the correct understanding and use of this standard by all parties in the industry.

Objective:To analyze the research and development of control system for airbag pressure of intelligent tracheal catheter,and its application effect in clinical practice.Methods:The hospital designed an intelligent self-adaptive control system for cuff pressure of tracheal catheter,which can rationally apply main components such as single chip microcomputer,display screen,control panel,pressure monitoring module,inflation device and solenoid valve,etc..This control system connected the measuring module of pressure through single chip microcomputer,so as to continuously detect the airbag pressure of tracheal catheter.An inflation and deflation algorithm was independently researched and developed to control air pump or solenoid valve to inject or release part of the gas to the airbag,so as to achieve intelligent control for the pressure of airbag.Sixty patients underwent endotracheal intubation who admitted to the department of general surgery of Wuhan Hospital of Traditional Chinese Medicine from January 2022 to January 2023 were selected as the study objects,and they were divided into control group(n=30)and observation group(n=30)according to random number table method.The cuff pressure of endotracheal intubation of patients in control group were managed by conventional method.The intelligent adaptive control system was adopted to manage the cuff pressure of endotracheal intubation for patients in the observation group.The complications,compliance rate of airbag pressure,the instantaneous maximum value of airbag pressure during sputum aspiration,insertion of gastric tube,and turning over of body were compared between the two groups after intubation.Results:The incidence of complication included cough,trachyphonia,dysphagia and bloody sputum after tracheal intubation in the observation group were 6.66%,which was significantly lower than 33.33%in the control group,and the difference was statistically significant(x2=6.667,P<0.05).The compliance rate of the pressure(25-30cmH2O)of airbag in the control group was 92.83%,which was significantly lower than 97.78%in the observation group,and the difference was statistically significant(x2=14.698,P<0.05).The instantaneous maximum values of airbag pressure during sputum aspiration,insertion of gastric tube and turning over were(28.24±3.65)cmH2O,(27.98±4.25)cmH2O and(28.65±4.87)cmH2O in observation group,respectively,which were significantly lower than those in control group,and the differences were significant(t=17.930,19.208,16.485,P<0.05).Conclusion:The application of intelligent adaptive control system for cuff pressure of tracheal catheter can maintain the airbag pressure of tracheal catheter at normal level(20-30 cmH2O),and reduce complications,and improve the compliance rate of airbag pressure.