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.

Type 2 diabetes mellitus is a chronic metabolic disease characterized by a high prevalence rate，a significant disease burden，and the need for long-term standardized management.The latest national epidemiological data reveal that in Jiangsu Province in 2023，the age-standardized prevalence of diabetes has reached 16.35%，ranking among the highest among provincial-level administrative regions in China and highlighting the severe challenges of diabetes prevention and control in Jiangsu Province.Effective pharmacological treatment is crucial for controlling blood glucose levels，delaying complications，and improving patients' quality of life.Based on the latest domestic and international authoritative guidelines for the diagnosis and treatment of adult type 2 diabetes，this consensus focuses on the selection of pharmacological treatment strategies at different stages of disease progression.It refines the medication regimens recommended in the guidelines in the form of a structured pathway，clarifies the therapeutic positioning，target populations，dosage ranges，and administration regimens of various classes of hypoglycemic drugs，while emphasizing the standardization and timeliness of pharmacological treatment.The aim is to establish a standardized pharmacological treatment pathway，bridge the gap between clinical guidelines and practice，provide clinicians with pathway-based treatment strategies，and offer solutions for rational drug use in clinical settings.

To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China (referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.

In this study, the similarities and differences of plasma collection and quality control in China and abroad were analyzed by comparing the related regulations, standards, guidelines and literatures. Rational and constructive suggestions were proposed, aiming to optimize domestic plasma management and promote the improvement of plasma-related standards. There was little difference on facilities and safety control process of plasma between China and the developed countries (United States, EU and Japan), However, significant differences existed on plasma station setting,donor screening standards,collection interval,volume limits, plasma testing modes and tests, plasma quarantine standard and utilization of recovered plasma. The United States sets the industry benchmark and is worthy of reference for our country both in plasma collection and quality control.

Venous thromboembolism (VTE) is a common complication and a significant cause of mortality in hospitalized patients,characterized by high incidence,high mortality,and high medical burden.This expert consensus,based on the latest domestic and international evidence-based medical evidence and graded using the Grading of Recommendations,Assessment,Development,and Evaluation (GRADE) system,focuses on VTE prevention and control during the perioperative period.From a pharmacist's perspective,it systematically evaluates the rational use of anticoagulant drugs and the key points of pharmaceutical care across different departments and disease populations.Specific recommendations are provided for 16 clinical issues,including the establishment of a multi-disciplinary VTE management model during the perioperative period,the role and responsibilities of clinical pharmacists,commonly used anticoagulant drugs and their management in perioperative VTE prevention and control,and pharmaceutical care for special populations.The aim is to provide a reference for the standardized use of anticoagulants in perioperative VTE prevention and treatment in Chinese medical institutions,thereby improving healthcare quality and ensuring patient safety.

The blood products industry, both domestically and internationally, exhibits distinct features in product research, development, and technological innovation. International companies possess extensive expertise in developing immunoglobulins, coagulation factors, and recombinant plasma protein products, demonstrating continuous advancements-particularly in specific immunoglobulin development, long-acting formulation optimization, and manufacturing process improvements. In recent years, Chinese enterprises have also achieved notable progress in related fields, especially in immunoglobulin process refinement and the development of novel recombinant coagulation factor products.However, there remains significant scope for improvement in areas such as the application of recombinant protein technologies, efficient utilization of plasma resources, and the adoption of advanced manufacturing techniques. Additional challenges include the accumulation of patented technologies, the supply of critical raw materials, and access to comprehensive epidemiological data. Driven by ongoing advances in gene recombination technologies, innovations in drug delivery systems, digital transformation, and the rise of personalized medicine, the blood products industry is poised for broader development prospects. To foster sustained and stable domestic industry growth and enhance global competitiveness, Chinese blood product enterprises should intensify their technological accumulation, upgrade manufacturing processes, and optimize plasma resource utilization.

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.

The legal and regulatory system for the import of blood products in China has undergone a three-stage evolution of "safety first, demand-driven and standard upgrading", ultimately forming a dual control framework that centers on infectious disease prevention and control as well as quality approval. While the current policy effectively ensures biosafety, it also faces several deep-seated contradictions. These include the worsening imbalance between supply and demand, limited access to clinically needed blood products, and insufficient alignment with international standards. Moreover, strict regulation has also constrained technological innovation and market diversification. To address these challenges, it is suggested to establish a synergy mechanism that integrates a "clinical urgent need list," hierarchical supervision, and mutual recognition of Good Manufacturing Practice (GMP). By implementing dynamic access, risk classification management, and international certification mutual recognition, it is possible to achieve compatible development between the safety baseline and medical accessibility.

To promote the understanding of the requirements of sheet for oral solid preparation in the Pharmacopoeia of the People's Republic of China (2025 edition) and improve the quality control level of related parties in production and use,the key quality control items specified in Pharmacopoeia of the People's Republic of China and the testing points were analyzed and discussed combined with the current situation of sheet for oral solid preparation industry and relevant standards at home and abroad.Suggestion was given that quality control should be carried out according to product characteristics, application,production process,and risk assessment,and reasonable limits should be set.

Objective To analyze the development and implementation of nutritional drug treatment pathways abroad,and to provide insights for the establishment of similar pathways in China.Methods A search was conducted in international literature and guideline databases for studies on nutritional therapy pathways up until December 1st,2024.The search focused on aspects such as pathway development methods,the composition of development teams,and implementation outcomes.Results A total of 29 relevant articles were identified,including 12 clinical practice guidelines and 17 research papers.The guidelines were all issued by the European Society for Clinical Nutrition and Metabolism,while the research papers showed significant heterogeneity,spanning multiple countries,regions,and medical conditions,primarily from developed countries in Europe and North America.The analysis reveals that nutritional therapy pathways typically include components such as nutritional assessment,formulation of nutritional plans,integration with other drug therapies,development of follow-up plans,pathway implementation teams,and the reassessment and updating of pathways.Conclusions China can benefit from the practices of developed countries,particularly those in Europe and North America.Key recommendations include the establishment of multidisciplinary teams,the promotion of a tiered treatment model,and the involvement of medical associations in forming expert groups to develop and implement nutritional drug treatment pathways,thereby enhancing the quality of nutritional treatment in China.

The drug therapy pathway is an important part of the clinical pathway,aiming to enhance the efficiency and quality of healthcare services,optimize the allocation of healthcare resources,enhance patients' adherence to treatment,reduce the rate of medical errors,and ultimately improve patients' treatment outcomes through clear steps of drug therapy.The drug therapy pathway in the United States emphasizes multidisciplinary teamwork,and pharmacists play a key role in the formulation and implementation of the pathway;the drug therapy pathway in the United Kingdom is jointly formulated by the National Health Service of the United Kingdom and the National Institute for Health and Clinical Excellence of the United Kingdom,and pharmacists provide professional advice in the formulation and implementation of the pathway;and the management of the drug therapy pathway in Japan is the responsibility of the Japan Clinical Pathway Society,and pharmacists play an important role in the promotion and implementation of the pathway.Pharmacists play an important role in the promotion and implementation of pathways.This article analyzes the experiences and models of the United States,the United Kingdom,and Japan in the development of drug therapy pathways,to provide a reference for the development of drug therapy pathways in China.

The blood products industry in China, the United States, the European Union and Japan are at different stages of development, with very different laws, regulations and regulatory systems. This paper uses methods such as literature review, policy comparison, and case study. By analyzing and comparing the blood product regulatory policies in various countries, it is found that compared with the United States, the European Union and Japan, China has differences in several areas, including plasma quarantine period, plasma fractionation processes and intermediate products, segmented production of blood products, and import management policies. It is suggested that we should learn from foreign regulatory experiences, and explore the establishment of blood product regulatory policies suitable for China's national conditions. Recommendations include optimizing China's source plasma quarantine period and blood product production process management policies, promoting multiple sites and segmented production of blood products, and establishing flexible blood product import and export management systems. These measures aim to provide references for promoting the development of the blood product industry and improving the accessibility of medications for the public.

This article analyzes the development and current status of clinical pathways (CPs) in the United States,the European Union,and Japan.CPs are standardized treatment models based on medical evidence and guidelines,aiming to improve therapeutic outcomes,reduce costs,ensure treatment consistency,enhance medical service efficiency,and increase patient satisfaction.The United States has promoted CPs since 1985,driving their development through legislation and professional associations to improve service quality and reduce medical expenditures.The European Union supports the development and evaluation of CPs through the European Pathway Association,emphasizing the improvement of patient treatment outcomes.Japan uses CPs as a tool to improve the quality of medical services,with an emphasis on multidisciplinary collaboration.All three have shown positive effects of CPs in improving medical service efficiency and reducing costs.However,they also face challenges such as overemphasis on cost control,lack of transparency,and physician cooperation.China can draw on these experiences to promote the development of CPs and enhance the quality and efficiency of medical services.

To further interpret the 2025 edition of the Pharmacopoeia of the People's Republic of China for plastic composite tube system and components for external ointment, and to provide help for the understanding and implementation of the standard, this article gave an in-depth interpretation of the standard from three aspects: industry status, domestic and foreign standards, and the relevant requirements of the 2025 edition of the Chinese Pharmacopoeia.Specific toxic substances and raw material requirements were discussed.The standard adheres to the concept of source control and whole life cycle risk management, and provided a comprehensive basis and guidance for enterprises from the aspects of production, use, and category key quality attributes, from raw material selection, process optimization, to product quality control.The standard effectively controls product risks and key quality attributes, while taking into account product diversity and innovation requirements, reflected the unity of effective risk control and flexibility, and played a positive role in promoting product safety and industry innovation and development.

Blood products play a pivotal role in modern medical treatment and healthcare system, and the clinical demand in China continues to grow. However, there is a significant supply gap for raw plasma domestically, with over 60% of human albumin relying on imports. The regulatory framework for imported blood products in China has undergone multiple rounds of adjustments, establishing a comprehensive lifecycle oversight system centered around the 《Law of the People's Republic of China on the Administration of Drugs》 and the 《Measures for the Administration of Batch Release of Biological Products》. While ensuring safety, this framework has also led to issues such as insufficient clinical supply and elevated corporate costs because of stringent market access requirements, complex approval procedures, and tariff barriers. Specifically, import market access barriers have imposed a 'dual-certification' burden, and tariff barriers have increased the costs of some products, exacerbating the financial burden on patients. In response to these challenges, it is recommended to establish an interdepartmental information-sharing platform, promote mutual recognition of international quality standards, form a rapid approval team for urgently needed medications, and reduce or exempt tariffs for clinically critical products.

Modern medical treatments for obesity primarily focus on symptomatic approaches like pharmacotherapy and surgery, which often cause adverse reactions, side effects, and a high recurrence rate. Traditional Chinese Medicine (TCM) interventions, guided by the principles of holism and syndrome differentiation, deliver personalized treatments based on clinical patterns. Through multi-component and multi-target regulation, TCM offers proven efficacy with minimal side effects, demonstrating unique advantages. TCM treatment protocols for obesity have been established in the Obesity Diagnosis and Treatment Guidelines (2024 Edition),expert Consensus on TCM Diagnosis and Treatment of Obesity, and Multidisciplinary Diagnosis and Treatment Consensus for Obesity Based on Clinical Practice (2021 Edition). These guidelines recommend herbal formulas such as Shenling Baizhu San, Xiaoyao San, Peilian Mahuang Tang, and Maren Wan for obesity management. From the perspective of TCM pattern differentiation involving the spleen, stomach, liver, and kidney. This review summarizes clinical applications of the recommended formulas based on Chinese literature published between 2003 and 2025, aiming to provide references for clinical formula selection and medication.

Objective To investigate the mechanism of pancreatic lipid metabolism of Gegen Qinlian Decoction (GQD) on insulin resistance (IR) and hypoxia in obese type 2 diabetes mellitus (T2DM) rats. Methods A total of 54 SD rats were randomly divided into normal control group and high fat group. The normal control group and the high-fat group were fed the normal diet for 13 weeks, and the serum IR index and HIF-2α content of rats were detected to establish the IR with hypoxia model. The model rats were randomly divided into model control group, positive drug group (rosiglitazone 5 mg·kg^-1) and GQD high and low dose group (14.86, 1.65 g·kg^-1). The model rats continued to be fed high-fat diet, while the normal control group was fed ordinary diet, and were given continuous gavage for 16 weeks. After administration, fasting insulin levels (FINS) were detected by radioimmunoassay, HIF-2α was detected by enzyme-linked immunosorbent assay (ELISA), fasting blood glucose (FBG) was detected by automatic biochemical analyzer. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of pancreas. UPLC-Q-TOF-MS was used to collect pancreatic lipid metabolism data, and principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were used to analyze the lipid metabolism of rat pancreatic tissue samples, and the markers of pancreatic metabolic difference were identified. Metabolic pathway analysis of potential biomarkers was performed using the Metabo Analyst 5.0 online website.The protein expressions of iPLA2 and CerS6 in pancreatic tissue were detected by Western blotting.Results ① Compared with model control group, FPG, IR index and HIF-2α of GQD high-dose and low-dose groups were significantly decreased,and the protein expressions of iPLA2 and CerS6 were also decreased (P<0.05, P<0.01), and irregular morphology of pancreatic islets of positive group and Gegen Qinlian decoction high-dose and low-dose groups were improved. ② The results of pancreatic metabolomics showed that there were 24 potential biomarkers in the model group, of which 3 biomarkers significantly increased and 21 biomarkers significantly decreased. GQD intervention could make the above biomarkers reverse. The 24 potential biomarkers of pancreatic lipids mainly regulate 7 metabolic pathways, including glycerophospholipid metabolism, sphingolipid metabolism, glycosyl phosphatidylinositol anchored biosynthesis, linoleic acid metabolism, unsaturated fatty acid biosynthesis, steroid hormone biosynthesis and α-linolenic acid metabolism. Conclusion The intervention of GQD on IR with anoxia in obese type 2 diabetes may improve the lipid metabolism disorders by regulating the contents of phospholipids, unsaturated fatty acids and steroid hormones in pancreas and their metabolic pathways.

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.

The rising prevalence of obesity poses a major challenge to global public health. Obesity not only contributes to various metabolic disorders including hypertension, diabetes, cardiovascular and cerebrovascular diseases,but is also closely linked to an elevated risk of malignancies, multi-organ damage, and reduced life expectancy, placing a substantial burden on both individuals and society. Lifestyle management remains the cornerstone of obesity treatment, with dietary intervention emerging as a central strategy for chronic disease prevention and control. This article categorized different weight-loss dietary patterns into “energy-restricted”, “nutritionally structured” and “diet-quality optimized” types, reviewing their underlying mechanisms and practical effectiveness. Furthermore, it examined their effects on key metabolic markers such as blood glucose, insulin resistance, and lipid profiles, thereby providing valuable insights for addressing the ongoing obesity epidemic.

With the continuous development of China's medical and health sector,the demands for scientific rigor and regulatory compliance in drug evaluation and selection within medical institutions have markedly increased. Building upon recent advancements in the pharmaceutical field and evolving national drug policies,the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Third Edition),hereinafter referred to as the “Guide”,revises and refines the drug evaluation indicators based on its first and second editions. On one hand,it employs a quantitative scoring system to enhance the differentiation of drug priorities within medical institutions,ensuring that evaluation criteria are closely aligned with national policy directions. On the other hand,it further details the scoring criteria,thereby improving operational feasibility and reducing implementation complexity in clinical practice. The Guide facilitates a quantitative scoring of drugs across five dimensions:effectiveness (28 points),safety (27 points),pharmaceutical characteristics (27 points),economy (10 points),and other attributes (8 points). This approach shifts the focus of drug evaluation back to clinical value,assisting medical institutions in conducting objective drug selection and evaluation.