1.The anti-hyperuricemia potential of bioactive natural products and extracts derived from traditional Chinese medicines:A review and perspective
Yaolei LI ; Zhijian LIN ; Hongyu JIN ; Feng WEI ; Shuangcheng MA ; Bing ZHANG
Journal of Pharmaceutical Analysis 2025;15(7):1497-1511
Hyperuricemia(HUA)and gout became typical metabolic disorders characterized by multiple pathogenic factors.Their incidence increased annually,affecting younger populations.Given that uric acid(UA)and inflammation were the primary disease mechanisms,the search for effective and low-side-effect UA-lowering and anti-inflammatory drugs became a pressing scientific priority.Traditional Chinese medi-cine(TCM)encompassed a rich array of theoretical and practical experience,along with a diverse range of chemical substances,making herbs or their components potential sources for therapeutic drugs.Despite the significant role that modern herbal medicines played in treating HUA and gout,the existing research literature remained fragmented,lacking comprehensive and systematic reviews.In this review,we focused on the regulation of UA and summarized the discovery of UA-lowering pharmacodynamic components or ingredients derived from herbs and formulas,as well as their multi-targeted mechanisms of action.Emphasizing this focus,we proposed that,compared to acute inflammation,low-grade inflammation may play a relatively"unnoticed"role in the disease process.In contrast to Western medicine,we discussed the risks and benefits of herbal medicines and their ingredients for treatment,drawing from theoretical insights and clinical practice.This review offered comprehensive perspectives on the research into anti-HUA and gout treatments using herbal medicines and their natural products.Additionally,it provided a forward-looking view on natural product discovery,the exploration of ther-apeutic strategies,and new drug research in this field.
2.Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition
Xiaoxu HONG ; Zonghua SONG ; Shuangcheng MA ; Fen LAN ; Rong SHU
Drug Standards of China 2025;26(1):1-10
The Pharmacopoeia of the People's Republic of China 2025 edition is to be issued in March 2025.Chinese Pharmacopoeia is the basic requirements on the drug manufacture,drug testing,drug use and drug admin-istration.The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included,establishing the standards system,standards conversion and application of drug quality control for the new technology,new method&new tool,drug control on the safety and effectiveness as well as the drug standard international harmonization.It will take important role on improving the drug quality,ensuring the safety of drugs for public use,strengthen technical support for drug administration,promoting the high-quality development of Chi-na's medical and pharmaceutical industry.This paper introduces the development and revision of the Chinese Phar-macopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.
3.The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
Fei WANG ; Zonghua SONG ; Shuangcheng MA ; Rong SHU
Drug Standards of China 2025;26(1):11-16
Objective:Introduce and briefly describe the status,characteristics,and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition,providing reference and suggestions for better understanding and imple-mentation of the Chinese Pharmacopoeia 2025 edition.Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main con-tents.Results:Compared with other pharmacopoeias of various countries,Chinese Pharmacopoeia includes stand-ards for traditional Chinese medicine,chemical drugs,biological products and excipients,pharmaceutical packa-ging materials,etc.Each section of Chinese Pharmacopoeia has its own general notice,with 34 to 48 items arranged in 11 to 12 chapters.Depending on the type of products included and the development history,the general notice in each section present differences in format and content.Given the importance and significance of the stand-ards in Chinese Pharmacopoeia,it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia.With the introduction and revision of regulations,changes in the content of phar-macopoeias,and the application of new technologies,methods,and concepts in drug quality control,considering the unique characteristics of various drugs in quality control and supervision,Chinese Pharmacopoeia has compre-hensively standardized relevant requirements.While taking into account the characteristics of the first,second,third,and fourth parts of the pharmacopoeia,it retains the characteristics of relative uniformity and the content of each part,achieving the unified standardization of the general rules of each general notice in the Chinese Pharmaco-poeia 2025 edition and the coordination and consistency of common content.Conclusion:The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content.By introdu-cing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition,pharma-copoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
4.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ)
Hao LI ; Mingrui SHEN ; Peng ZHANG ; Weimin ZHAI ; Long NI ; Bo HAO ; Yuxin ZHAO ; Yi HE ; Shuangcheng MA ; Rong SHU
Drug Standards of China 2025;26(1):17-22
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research,production,use,and administration of drugs.At present,the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented.This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ),to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.
5.Introduction of the main addition and revision of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅱ)
Yi ZHOU ; Zhijun WANG ; Zhihua YUE ; Qilei CHENG ; Ruiqi YUE ; Xi YANG ; Wei GUO ; Shuangcheng MA
Drug Standards of China 2025;26(1):23-27
The Pharmacopeia of the People's Republic of China 2025 Edition(referred to as the Chinese Pharmaco-poeia 2025 Edition,ChP 2025)will be promulgated and implemented.This article introduces the process of devel-opment of ChP 2025 Edition(Volume Ⅱ),including the selection,the revision of general notices,the addition and revision of drug monographs,etc.,and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition(Volume Ⅱ).
6.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
Jun ZHANG ; Baoming NING ; Shifeng WEI ; Haoyu SHEN ; Yue SHANG ; Ran ZHU ; Xinyi XU ; Lei CHEN ; Tingting LIU ; Shuangcheng MA
Drug Standards of China 2025;26(1):34-44
To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
7.Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
Xinyi XU ; Shifeng WEI ; Qiming ZHANG ; Langchong HE ; Jun ZHANG ; Shuangcheng MA
Drug Standards of China 2025;26(1):45-50
Objective:To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.Methods:Intro-duce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.Results:The general chapters of physi-cal and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guide-lines of the ICH Q series,and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety,efficacy,and quality controllability is further increased.Conclusion:The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China's drugs to go international,standardized testing technology support for achieving full process quality control,and better meet the needs of drug research and development,production,quality control,and supervision in China.
8.The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
Lei CHEN ; Yanming LIU ; Yaozuo YUAN ; Ying CHEN ; Hong DAI ; Jun ZHANG ; Shuangcheng MA
Drug Standards of China 2025;26(1):51-57
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 has been completed.Among them,52 new pharmaceutical excipients monographs have been added,and the total number has reached 387.245 pharmaceutical excipients monographs have been revised,of which 109 monographs have only textual revisions and 136 monographs have substantive revi-sions.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025,which can contribute to accurately understand and utilize the stand-ards in Chinese Pharmacopoeia.
9.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
Lei CHEN ; Ying CHEN ; Jiasheng TU ; Yanming LIU ; Luxia ZHENG ; Jun ZHANG ; Shuangcheng MA
Drug Standards of China 2025;26(1):58-66
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 Edition has been completed.Among them,52 new pharmaceutical excip-ients monographs have been added,an increase of 15.5%compared with the 2020 Edition,and the total number has reached 387.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition,which can contribute to accurately under-stand and utilize the standards in Chinese Pharmacopoeia.
10.The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition
Lei CHEN ; Lin WANG ; Gongchen ZHANG ; Shihong MA ; Jun ZHANG ; Shuangcheng MA
Drug Standards of China 2025;26(1):77-82
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the standards system of Water for Pharmaceutical Purposes has been perfected.This article focuses on the Work Background,Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025,which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

Result Analysis
Print
Save
E-mail