Objective To explore a standardized approach for indicating dosages in Chinese patent medicines (CPM) instructions. Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia) was conducted,focusing on three aspects: overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia. Results ①Overdose: Among the 1 378 reviewed formulas,146 (10.60%) were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms: Based on the conversion of the Ming-Qing dynasty dosage of one liang (Chinese traditional weight unit)to 36 g,the estimated daily dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs (75.60 g) was approximately five times that of the Yinqiao powder (15 g) listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder (23.868 g).Significant differences in dosage were observed among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules (52.50 g) had the highest dose,approximately 3-5 times that of tablets/capsules (11.20 g),soft capsules (13.44 g),and powders (15.00 g),but still 30% lower than the original prescription from ancient texts (75.6 g).Comparing the daily dose per component,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs: Among the 20 oral formulations containing Strychnos nux-vomica (Maqianzi) listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strychnosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg. Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the "Dosage and Administration" section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses (including: Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)." For CPM containing toxic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.

Objective To introduce the general testing methods for glass materials and containers for pharmaceutical packaging within the packaging material standard system in the 2025 Edition of the Chinese Pharmacopoeia, aiming to provide assistance for the implementation of these standards. Methods Introduce the general situation of the revision of general testing methods for glass materials and containers for pharmaceutical use. The improvement of new general testing method standards is summarized by contrasting the new version of the general testing methods for pharmaceutical glass materials and containers with the current standards. Results The general testing methods for pharmaceutical glass materials and containers in the Chinese Pharmacopoeia 2025 Edition are more scientific in structure, more rational and operational. Conclusion The 11 general testing methods will control the quality of pharmaceutical glass materials and containers, which could contribute to the enhancement of the quality and efficacy of drugs in our country.

Objective In this paper,the ethnic patent medicines (EPMs) in the Chinese Pharmacopeia,National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance Medicine List,and National Essential Medicine List (referred to as “one pharmacopeia and two lists”) were counted and analyzed. Methods The EPMs in “one pharmacopeia and two lists” were summarized,and the information of manufacturers,medicinal materials used in EPMs,and their current quality standards were collated,and their indicative function,adverse reactions,contraindications,and precautions were analyzed.The modern research level of the above EPMs was analyzed by searching relevant literature on CNKI and PubMed. Results A total of 142 EPMs in “one pharmacopeia and two lists” were included,and 68 of the EPMs had exclusive manufacturers and 98.75% of the medicinal materials had provincial-level or higher quality standards.There were issues such as the expression of indicative function in the instruction being mixed between medical terms,91.55% of the EPMs lacking sufficient information on adverse reactions,contraindications,and precautions,and modern basic research was weak. Conclusions In the development of EPMs,it is important to improve information on adverse reactions,contraindications,and precautions in the instructions.In expressing indicative function,it is necessary to avoid mixing medical terms,which is more conducive to the clinical promotion of EPMs.

Objective To explore the problems arising from the safety content in the instructions of Chinese patent medicines containing bitter almonds and to make suggestions. Methods By searching the Chinese patent medicines containing bitter almonds in the "National Basic Medical Insurance,Work Injury Insurance and Maternity Insurance Drug List (2022)" of the Medication Assistant and Yaozhi Online,the article collated their primary functions,composition,adverse reactions,contraindications to medication,warnings,and precautions.The article entered the collected information into the Excel 2021 version,analyzed the summarized data,and made suggestions for the safety warning information in the instructions of Chinese patent medicines containing bitter almonds based on the results of the statistics. Results Among the 1 381 kinds of patent medicines listed in the "National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List (2022)",there are 67 varieties of Chinese patent medicines containing bitter almonds,and there were missing safety contents in the collected instructions.Among them,only five types were clearly labeled with specific contents of warnings,17 types were clearly labeled with adverse reactions,24 types were clearly labeled with contraindications,and 58 types were clearly labeled with precautions.However,in terms of the content of bitter almonds and prescription ratio,the maximum daily dosage of 2 out of 67 Chinese patent medicines containing bitter almonds exceeded the dosage of the Chinese Pharmacopoeia,and the prescription ratio of 14 Chinese patent medicines exceeded 10%;in terms of the combination and dosing,25 out of 67 Chinese patent medicines containing bitter almond were dosed with other poisonous traditional Chinese medicines,and the above medicines have high safety risks.The information on their safety should be increased,and their safety information should be increased. Conclusions The safety-related warnings in the instructions for Chinese patent medicines containing bitter almonds are not comprehensive enough.It is recommended to strengthen the management of the whole life cycle of drugs,increase the warnings of level 1 high-risk varieties,and improve adverse reactions,contraindications,and precautions according to the Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions (Trial).

Rescue vehicles and nursing unit drug stock are important in the clinical rescue process.Strengthening the management of rescue vehicles and nursing unit drug stock is conducive to ensuring the safety of clinical medication and improving the quality of medical services.Based on scientificity, universality, guidance, and operability principles, the standard preparation team revealed relevant national policy documents, domestic and foreign standards specifications, and literature.It sorted the key contents of rescue vehicles and base drug management.After several rounds of opinion collection and expert argumentation, the social organization standard Pharmacy administration and pharmacy practice in healthcare institutions—Part 3-7-3: Pharmaceutical supply services—Key drugs management—Rescue vehicle and nursing unit drug stock management was proved.The main content of the standard includes 10 elements from 3 key parts: basic requirements, management processes, and quality management and evaluation improvement, to provide guidance in allocating, storing, and managing rescue vehicles and nursing unit drug stock.

Objective Interpret the method of determining the shading property for colored glass containers in the Chinese Pharmacopoeia (2025 edition) in detail,and provide theoretical guidance and technical support for the implementation of standards. Methods By summarizing and analyzing the related abroad standards for shading property of colored glass containers, combining with the results of experimental verification, the method for determining the shading property of colored glass containers was established in accordance with the requirements of the construction of the pharmaceutical packaging material system in the Chinese Pharmacopoeia. An explanation was provided for the selection of instruments and equipment, the requirements for the preparation of the samples, and the way of expressing the results. Results The method of determining the shading property for colored glass containers, formulated in conjunction with international standards, proposed scientifically reasonable operational requirements based on solid experimental verification data, and solved the problem of having no “method” to follow in the domestic shading property measurement. Conclusion The proposal of the method for determining the shading property of colored glass containers filled the industry gap, improved the pharmaceutical packaging material standard system, standardized the method operation, and was conducive to promoting industrial development and ensuring the safety of formulations.

Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis. Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards; the critical quality attributes of pre-filled syringe container systems were identified. Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China. Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility, meeting regulatory needs and facilitating industry development.

The drugs used to improve brain metabolism mainly include ergotamine derivatives, GABA derivatives, vitamin B₆ derivatives, neuropeptides, morpholines, hormones and other. However, these drugs may have adverse reactions during clinical application. This article focuses on the adverse effects of commonly used drugs for brain metabolism, and reviews the studies on the new state of pharmaceutical substances, such as drug combination, chiral resolution of isomers, crystal form of dominant drugs, co-crystal drugs and nanodrugs, with the aim of reducing adverse reactions. By summarizing the research on modifying the solid state of drugs to mitigate adverse reactions, this article provides new research insights for obtaining new drug with less adverse reaction and greater clinical value.

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.

Objective The content of the relevant safety items in the instructions of Chinese patent medicines is "Not Clear" to provide a reliable reference for improving the safety and effectiveness of Chinese patent medicines. Methods Search the Chinese Pharmacopoeia 2020,National Essential Medicines List,Handbook of Selected Chinese Patent Drugs in Various Clinical Subjects,and Handbook of Modern Chinese Patent Drugs.Conduct random sampling according to Chinese patent medicines' different efficacy and dosage forms and collect complete basic information and versions.There are a total of 105 latest drug instructions.The safety information in each drug instruction is extracted and entered into Excel 2019.The annotations are summarized and statistically analyzed one by one. Results After summarizing,most instructions are marked with safety item information such as adverse events,contraindications,pharmacology,and toxicology.However,the degree of detail of each content varies greatly.Common problems include non-standard terminology description,content "avoiding the important and light,passing it off " or inconsistent content with the labeling,and insufficient clinical data research. Conclusions There is a severe lack of research content in the package insert of Chinese patent medicines,and it is still necessary to further strengthen the discussion and research on the mechanism of action of medicines to revise and improve the safety information of the instructions and ensure the safety of clinical use.

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.

In recent years, the demand for single enantiomer drugs has gradually increased, and the separation technology of chiral drugs has also been developed rapidly. In this article, we summarized the application and progress of cocrystal technology in chiral drug resolution, focusing on the existence forms of cocrystal former formations (single compound molecules, ions, and claths), the common preparation methods of cocrystal resolution, the physical and chemical factors affecting the resolution efficiency (co-formed chirality, solvent system, temperature) and the computer-aided prediction method of chiral cocrystal in the process of chiral drug resolution, to provide a reference for related research on chiral resolution using cocrystal technology.

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.

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.

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.

Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system. Methods A thorough review of the framework, scope, and quality control key points of the 2015 national pharmaceutical packaging material standards (abbreviated as YBB standards), the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted. Comparative analysis was employed to reveal the similarities and differences among the three, thereby uncovering the unique characteristics of each. Results The YBB standards emphasize quality control for prefilled syringes, offering clear and operational guidelines that provide companies with precise directives for production and testing. However, the scope of these standards is relatively limited. ISO standards apply to a wide range of products, featuring comprehensive coverage and a degree of flexibility. They emphasize the universality of products and compatibility with other international standards, which facilitates global production and trade. USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach. Conclusion By thoroughly studying and drawing upon the quality control philosophies, standard frameworks, and key control points of prefilled syringes from both domestic and international standards, we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

Managing look-alike/sound-alike medications is important to medical institutions' pharmaceutical management and pharmacy services.Based on national policies and regulations,this standard focuses on the whole life cycle of look-alike/sound-alike medications in medical institutions.It is developed based on the principles of scientific validity,universality,guidance,and applicability,formed by sorting out problems,soliciting opinions,expert argumentation,and deliberation.It is the first group standard to standardize the management of look-alike/sound-alike medications.This paper introduced and analyzed the team composition,problem sorting and compilation process,and various elements of the standard in the process of formulating the standard,to provide a reference for medical institutions to use this standard.

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.

Solid forms, such as polymorphs and co-crystals, can improve the physicochemical properties of drugs without changing their molecular structure, increasing their solubility, bioavailability, stability, and thus affecting their original pharmacodynamic activity. Estradiol and its derivatives ethinylestradiol and estriol, contain steroidal parent nucleus, which results in a very low water solubility. Researches showed that polymorphism and co-crystal studies could enhance the water solubility of estradiol and its derivatives. This paper reviews the research progress on the solid forms of estradiol and its derivatives in last decade.

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.