1.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
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.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
3.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):101183-101183
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 medicine (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 therapeutic strategies, and new drug research in this field.
4.Biological exposure and health risks of arsenic species from medicinal leeches at major exposure points in humans.
Yaolei LI ; Jing FAN ; Hailiang LI ; Xianlong CHENG ; Hongyu JIN ; Feng WEI ; Shuangcheng MA
Journal of Pharmaceutical Analysis 2025;15(7):101177-101177
Image 1.
5.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.
6.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.
7.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
Yiling FAN ; Ran ZHU ; Yan YANG ; Bo JIANG ; Minghui SONG ; Jing WANG ; Qiongqiong LI ; Gaomin LI ; Shujuan WANG ; Hong SHAO ; Shihong MA ; Xiaoyun CAO ; Changqin HU ; Shuangcheng MA ; Meicheng YANG ; Jun ZHANG
Drug Standards of China 2025;26(1):93-98
Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
8.Bio-soft matter derived from traditional Chinese medicine:Characterizations of hierarchical structure,assembly mechanism,and beyond
Yang GUIYA ; Liu YUE ; Hu YUYING ; Yuan YUE ; Qin YUNAN ; Li QUAN ; Ma SHUANGCHENG
Journal of Pharmaceutical Analysis 2024;14(6):823-839
Structural and functional explorations on bio-soft matter such as micelles,vesicles,nanoparticles,ag-gregates or polymers derived from traditional Chinese medicine(TCM)has emerged as a new topic in the field of TCM.The discovery of such cross-scaled bio-soft matter may provide a unique perspective for unraveling the new effective material basis of TCM as well as developing innovative medicine and biomaterials.Despite the rapid rise of TCM-derived bio-soft matter,their hierarchical structure and as-sembly mechanism must be unambiguously probed for a further in-depth understanding of their pharmacological activity.In this review,the current emerged TCM-derived bio-soft matter assembled from either small molecules or macromolecules is introduced,and particularly the unambiguous elucidation of their hierarchical structure and assembly mechanism with combined electron microscopic and spectroscopic techniques is depicted.The pros and cons of each technique are also discussed.The future challenges and perspective of TCM-derived bio-soft matter are outlined,particularly the requirement for their precise in situ structural determination is highlighted.
9.Early effectiveness of computer navigation system-assisted transiliac-transsacral screws placement for posterior pelvic ring injuries.
Wenhao CAO ; Zhengguo ZHU ; Hongzhe QI ; Junjun TANG ; Wei ZHANG ; Jiaqi LI ; Shuangcheng LI ; Zhonghe WANG ; Changda LI ; Feng ZHOU ; Haoyang LIU ; Hua CHEN ; Peifu TANG
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(9):1049-1054
OBJECTIVE:
To investigate the early effectiveness of transiliac-transsacral screws internal fixation assisted by augmented reality navigation system HoloSight (hereinafter referred to as "computer navigation system") in the treatment of posterior pelvic ring injuries.
METHODS:
A retrospective analysis was made in the 41 patients with posterior pelvic ring injuries who had been treated surgically with transiliac-transsacral screws between June 2022 and June 2023. The patients were divided into navigation group (18 cases, using computer navigation system to assist screw implantation) and freehand group (23 cases, using C-arm X-ray fluoroscopy to guide screw implantation) according to the different methods of transiliac-transsacral screws placement. There was no significant difference in gender, age, body mass index, causes of injuries, Tile classification of pelvic fracture, days from injury to operation, usage of unlocking closed reduction technique between the two groups ( P>0.05). The time of screw implantation, the fluoroscopy times, the guide wire adjustment times of each screw, and the incidence of complications were recorded and compared between the two groups. The position of the transiliac-transsacral screw was scanned by CT within 2 days after operation, and the position of the screw was classified according to Gras standard.
RESULTS:
The operation was successfully completed in both groups. The time of screw implantation, the fluoroscopy times, and the guide wire adjustment times of each screw in the navigation group were significantly less than those in the freehand group ( P<0.05). There were 2 cases of incision infection in the freehand group, and the incision healed by first intention after active dressing change; there was no screw-related complication in the navigation group during operation and early period after operation; the difference in incidence of complications between the two groups (8.7% vs. 0) was not significant ( P=0.495). According to the Gras standard, the screw position of the navigation group was significantly better than that of the freehand group ( P<0.05).
CONCLUSION
Compared with the traditional freehand method, the computer navigation system assisted transiliac-transsacral screws internal fixation in the treatment of posterior pelvic ring injuries has advantages of improving the accuracy of screw implantation and reducing radiation damage and the time of screw implantation.
Humans
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Retrospective Studies
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Surgical Wound Infection
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Replantation
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Body Mass Index
10.New Strategy of High-quality Development of TCM Industry in Sichuan Driven by TCM Regulatory Science
Hua HUA ; Qingmao FANG ; Qingmiao LI ; Jianyuan TANG ; Shuangcheng MA ; Junning ZHAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(7):2241-2247
Traditional Chinese medicine(TCM)regulatory science,as an emerging interdisciplinary science,evaluates the safety,effectiveness,quality,and risk-benefit profile of regulated Chinese medicinal products,including Chinese medicinal materials,Chinese medicinal slices,and Chinese patent medicines.It highlights the development of new tools,standards,and methods that align with the unique characteristics of TCM.TCM regulatory science plays a crucial role in establishing a TCM scientific regulatory system that suits the features of TCM,accelerating the transformation of emerging TCM technologies and facilitating innovation in the inheritance and development of TCM.Sichuan,known as the"hometown of TCM therapies and the treasure trove of TCM",has built the first national modernized TCM technology industrial base and one of the first national comprehensive TCM reform demonstration zones.It plays a demonstrative and leading role in the high-quality development of the TCM industry in China.Based on the latest progress in new tools,standards,and methods of TCM regulatory science,this article overviewed its significant role and prospects in enhancing the efficiency of TCM regulation,accelerating the transformation and application of new TCM technologies and products,and promoting the high-quality development of the TCM industry in Sichuan.It is of great significance for ensuring and improving the regulatory capabilities of TCM and driving the healthy development of the TCM industry.

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