Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China(2025 edition),built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines,thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.

The liver cancer ablation specialized disease database is an important tool for interventional practitioners to collect data and conduct scientific research for patients. This article will exemplify the application of a database for liver cancer ablation based on the establishment of a standardized structured disease database so as to elaborate its application in clinical and scientific research. The goal is to improve the management level of ablation data through the construction of specialized disease databases, providing a reference for clinical doctors and researchers in building ablation databases, and promoting the application of specialized disease databases in clinical research.

Aim To observe the effects of receptor interacting protein 2(RIP2)on macrophage inflammatory ac-tivation and polarity transformation,and to explore the mechanism of RIP2 in macrophage phagocytosis of oxidized low den-sity lipoprotein(ox-LDL).Methods THP-1 derived macrophages were treated with different doses(10,25 and 50 mg/L)of ox-LDL for 24 hours,and treated with 50 mg/L ox-LDL for 8,16 and 24 hours.Real-time quantitative PCR and Western blot were used to detect the expression of RIP2 mRNA and protein in THP-1 derived macrophages,and ELISA was used to detect the secretion of tumor necrosis factor-α(TNF-α)and monocyte chemoattractant protein-1(MCP-1).Three pairs of RIP2 siRNA were designed,transfecting them into cells using hiperfict transfection reagent,real-time quanti-tative PCR and Western blot were used to detect the expression of RIP2 mRNA and protein in THP-1 derived macrophages after transfection,in order to screen for the optimal siRNA transfection concentration and the most effective pair of siRNA.After transfection with the most effective RIP2 siRNA,cells were treated with 50 mg/L ox-LDL for 24 hours,ELISA was used to detect the secretion of TNF-α,MCP-1,interleukin-10(IL-10)and interleukin-12(IL-12),real-time quantitative PCR was used to detect the expression of inducible nitric oxide synthase(iNOS)and arginase-1(Arg-1),flow cytometry was used to detect the expression of cell surface antigens CD86,CD80 and CD163.Results Ox-LDL induced the ex-pression of RIP2 in macrophages in a dose-dependent and time-dependent manner.With the increase of ox-LDL treatment dose and time,the expression of RIP2 mRNA and protein increased.Among them,the expression of RIP2 protein in the 50 mg/L group was 7.6 times of the control group,and the expression of RIP2 protein in the 24 h group was 17.9 times of the control group(P＜0.001).The ELISA results showed that with the increase of ox-LDL treatment dose and time,the secretion of TNF-α and MCP-1 increased(P＜0.05).After transfection of RIP2 siRNA into cells,ELISA results showed that the secretion of TNF-α,MCP-1 and IL-10 in the ox-LDL group was 2.4 times,2.9 times and 1.8 times of the control group(P＜0.01),and the secretion of IL-12 decreased by 34.2％compared to the control group(P＜0.01);the secretion of TNF-α,MCP-1 and IL-10 in the siRNA+ox-LDL group decreased by 37.4％,45.3％and 27.4％,respectively,com-pared to the ox-LDL group(P＜0.01),while the secretion of IL-12 increased by 31.4％(P＜0.05).The results of flow cytometry and real-time quantitative PCR showed that the expression of CD86,CD80 and iNOS mRNA in the ox-LDL group was 14.2 times,33.8 times and 4.5 times of those of the control group,respectively,while the expression of CD163 and Arg-1 mRNA decreased by 33.4％and 43.0％,respectively,compared with the control group(P＜0.05);the expression of CD86,CD80 and iNOS mRNA in the siRNA+ox-LDL group decreased by 27.6％,29.3％and 34.3％,respectively,compared to the ox-LDL group,while the expression of CD163 and Arg-1 mRNA increased by 30.3％and 38.6％,respec-tively(P＜0.05).Conclusion RIP2 expression in macrophages can be induced by ox-LDL in a dose-dependent and time-dependent manner.RIP2 gene silencing can inhibit ox-LDL induced M1 macrophage transformation.

Objective:To develop an EGFR-targeting nanobody engineered exosome drug delivery system and evaluate its antitumor efficacy for colorectal cancer.Methods:The HEK293T cell line stably expressing the pan-cancer inhibitor miR-204-5p, previously established by our group, was selected as a tool cell line to prepare miR-204-5p-enriched exosomes. Using metabolic glycoengineering combined with bioorthogonal reaction strategy, these exosomes were modified with the EGFR-specific nanobody 7D12. Western blot, electron microscopy, and dynamic light scattering were used to characterize the engineered exosomes. The tumor target potential of engineered exosomes was evaluated using immunofluorescence and RT-qPCR. The in vitro anti-tumor activities of engineered exosomes were evaluated using cell growth curves, colony formation, Transwell, and apoptosis analyses. The in vivo anti-tumor activity and safety of engineered exosomes were evaluated using a nude mouse xenograft tumor model. Results:The particle size of 7D12-hExo was (116.8±36.8) nm, with a potential of around -10 mV, and there was no significant change compared with the unmodified hExo. Immunofluorescence assay showed that the fluorescence intensity of the hExo group, 7D12-hExo group, and 7D12+7D12-hExo group were 48.4±3.9, 141.0±6.6, and 38.7±3.2 in EGFR + HCT116 cells, respectively. Compared with the hExo group, the fluorescence intensity of HCT116 cells in the 7D12-hExo group was significantly enhanced ( P＜0.05). Compared with the 7D12-hExo group, the fluorescence intensity in HCT116 cells in the 7D12+7D12-hExo group was significantly decreased ( P＜0.05). However, there was no significant difference in the uptake of hExo and 7D12-hExo in EGFR - SW620 colorectal cancer cells. The number of cell clones, invasion, and migration of HCT116 cells in the hExo (204) group was 215.0±14.0, 862.3±61.4, and 1 197.0 ± 36.7, respectively, with an apoptosis rate of (14.1±1.4)%. The number of cell clones, invasion, and migration of HCT116 cells in the 7D12-hExo (204) group was (65.0±15.1), (232.0±27.9), (725.7±32.7), respectively, with an apoptosis rate of (29.3±1.0)%. The 7D12-hExo (204) significantly inhibited the proliferation, invasion, and migration ability of HCT116 cells ( P＜0.05), resulting in promoting the apoptosis of HCT116 cells ( P＜0.05). Nude mouse experiments showed that 7D12-hExo (204) significantly inhibited the growth of tumors transplanted with HCT116 cells, with the inhibition rate being 82.8%. However, there was no significant change in mouse weight, and H&E staining of major organs such as heart, liver, spleen, lung, and kidney did not show any abnormalities. Conclusion:Naturally miR-204-5p-loaded exosomes were successfully modified with nanobody 7D12, which can efficiently deliver miR-204-5p into EGFR + tumor cells, thereby exerting good anti-tumor therapeutic effects.

Objective The biomechanical performance of Ilizarov fixator models with different configurations for humeral shaft defect was compared,so as to provide a biomechanical basis for selecting the appropriate circular external fixation structure for the clinical treatment of humeral shaft defects using Ilizarov technology.Methods Based on CT data of the humerus from a healthy volunteer,the external fixators with three configurations,namely,hybrid frame,semi-ring frame and 90° fan frame were established.The finite element method was used to simulate the displacement and stress distribution under different loading conditions,and the finite element results were validated by biomechanical tests.Results Finite element analysis results:in terms of displacement,under compression,tensile and torque conditions,the displacement of 90° fan model was smaller than that of hybrid and semi-ring models.In terms of stress,the 90° fan model had the smallest displacement under tensile condition.In compression and torque tests,the semi-annular model had the lowest stress.Biomechanical test results:the semi-ring model exhibited the smallest displacement under axial compression,but there was no significant difference between the three models(P＞0.05).Conclusions The semi-ring and 90° fan frames can achieve a similar stability as the traditional hybrid frame through the strategy of'reducing the ring and increasing the stem'.The unilateral structure of the 90° fan frame has the advantages of small size,light weight,and structural stability,as well as a small impact on the shoulder and elbow joints,which makes it more valuable in clinical applications.

This article combined the current status of the industry and standards for pharmaceutical composite films and bags,and summarized the relevant content of the guiding principles for the Pharmacopoeia of the People's Republic of China(2025 Edition)on pharmaceutical composite films and bags.It analyzed the production requirements,usage requirements,key quality attributes,and control requirements improvement details,providing reference for assisting relevant parties to understand and use the pharmacopoeia guiding principles,and helping to improve the quality control level of the industry.

Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China(2025 edition),built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines,thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.

Objective The biomechanical performance of Ilizarov fixator models with different configurations for humeral shaft defect was compared,so as to provide a biomechanical basis for selecting the appropriate circular external fixation structure for the clinical treatment of humeral shaft defects using Ilizarov technology.Methods Based on CT data of the humerus from a healthy volunteer,the external fixators with three configurations,namely,hybrid frame,semi-ring frame and 90° fan frame were established.The finite element method was used to simulate the displacement and stress distribution under different loading conditions,and the finite element results were validated by biomechanical tests.Results Finite element analysis results:in terms of displacement,under compression,tensile and torque conditions,the displacement of 90° fan model was smaller than that of hybrid and semi-ring models.In terms of stress,the 90° fan model had the smallest displacement under tensile condition.In compression and torque tests,the semi-annular model had the lowest stress.Biomechanical test results:the semi-ring model exhibited the smallest displacement under axial compression,but there was no significant difference between the three models(P＞0.05).Conclusions The semi-ring and 90° fan frames can achieve a similar stability as the traditional hybrid frame through the strategy of'reducing the ring and increasing the stem'.The unilateral structure of the 90° fan frame has the advantages of small size,light weight,and structural stability,as well as a small impact on the shoulder and elbow joints,which makes it more valuable in clinical applications.

This article combined the current status of the industry and standards for pharmaceutical composite films and bags,and summarized the relevant content of the guiding principles for the Pharmacopoeia of the People's Republic of China(2025 Edition)on pharmaceutical composite films and bags.It analyzed the production requirements,usage requirements,key quality attributes,and control requirements improvement details,providing reference for assisting relevant parties to understand and use the pharmacopoeia guiding principles,and helping to improve the quality control level of the industry.

Aim To observe the effects of receptor interacting protein 2(RIP2)on macrophage inflammatory ac-tivation and polarity transformation,and to explore the mechanism of RIP2 in macrophage phagocytosis of oxidized low den-sity lipoprotein(ox-LDL).Methods THP-1 derived macrophages were treated with different doses(10,25 and 50 mg/L)of ox-LDL for 24 hours,and treated with 50 mg/L ox-LDL for 8,16 and 24 hours.Real-time quantitative PCR and Western blot were used to detect the expression of RIP2 mRNA and protein in THP-1 derived macrophages,and ELISA was used to detect the secretion of tumor necrosis factor-α(TNF-α)and monocyte chemoattractant protein-1(MCP-1).Three pairs of RIP2 siRNA were designed,transfecting them into cells using hiperfict transfection reagent,real-time quanti-tative PCR and Western blot were used to detect the expression of RIP2 mRNA and protein in THP-1 derived macrophages after transfection,in order to screen for the optimal siRNA transfection concentration and the most effective pair of siRNA.After transfection with the most effective RIP2 siRNA,cells were treated with 50 mg/L ox-LDL for 24 hours,ELISA was used to detect the secretion of TNF-α,MCP-1,interleukin-10(IL-10)and interleukin-12(IL-12),real-time quantitative PCR was used to detect the expression of inducible nitric oxide synthase(iNOS)and arginase-1(Arg-1),flow cytometry was used to detect the expression of cell surface antigens CD86,CD80 and CD163.Results Ox-LDL induced the ex-pression of RIP2 in macrophages in a dose-dependent and time-dependent manner.With the increase of ox-LDL treatment dose and time,the expression of RIP2 mRNA and protein increased.Among them,the expression of RIP2 protein in the 50 mg/L group was 7.6 times of the control group,and the expression of RIP2 protein in the 24 h group was 17.9 times of the control group(P＜0.001).The ELISA results showed that with the increase of ox-LDL treatment dose and time,the secretion of TNF-α and MCP-1 increased(P＜0.05).After transfection of RIP2 siRNA into cells,ELISA results showed that the secretion of TNF-α,MCP-1 and IL-10 in the ox-LDL group was 2.4 times,2.9 times and 1.8 times of the control group(P＜0.01),and the secretion of IL-12 decreased by 34.2％compared to the control group(P＜0.01);the secretion of TNF-α,MCP-1 and IL-10 in the siRNA+ox-LDL group decreased by 37.4％,45.3％and 27.4％,respectively,com-pared to the ox-LDL group(P＜0.01),while the secretion of IL-12 increased by 31.4％(P＜0.05).The results of flow cytometry and real-time quantitative PCR showed that the expression of CD86,CD80 and iNOS mRNA in the ox-LDL group was 14.2 times,33.8 times and 4.5 times of those of the control group,respectively,while the expression of CD163 and Arg-1 mRNA decreased by 33.4％and 43.0％,respectively,compared with the control group(P＜0.05);the expression of CD86,CD80 and iNOS mRNA in the siRNA+ox-LDL group decreased by 27.6％,29.3％and 34.3％,respectively,compared to the ox-LDL group,while the expression of CD163 and Arg-1 mRNA increased by 30.3％and 38.6％,respec-tively(P＜0.05).Conclusion RIP2 expression in macrophages can be induced by ox-LDL in a dose-dependent and time-dependent manner.RIP2 gene silencing can inhibit ox-LDL induced M1 macrophage transformation.