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):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.
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.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.
6.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.
7.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.
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.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.
10.Gradual traction-unlocking closed reduction technique for Tile C old pelvic fractures
Jinchang WANG ; Hao GUO ; Junjun TANG ; Haibo LU ; Xingxing HU ; Jiawei CHENG ; Meijing DOU ; Shuangcheng LI ; Hua CHEN ; Qun ZHANG ; Peifu TANG
Chinese Journal of Orthopaedic Trauma 2023;25(6):478-484
Objective:To explore the technical points and efficacy of gradual traction-unlocking closed reduction technique (GT-UCRT) for Tile C old pelvic fractures.Methods:From August 2012 to June 2021, 6 patients with Tile C old pelvic fracture were treated and followed up at Department of Orthopedics, The Fourth Medical Center, General Hospital of Chinese PLA. They were 4 males and 2 females with an age of (35.8±10.5) years. By Tile classification: 4 cases of type C1.2, 1 case of type C1.3, and 1 case of type C2; time from injury to surgery: 153.8 (64.3, 204.8) days. The 6 patients were treated with GT-UCRT. The time for gradual traction reduction, operation time, hospital stay, intraoperative blood loss and complications were recorded. The modified Matta score was used to evaluate the reduction quality of pelvic fractures, and the Majeed score was used to evaluate the pelvic function at the last follow-up.Results:The 6 patients were followed up for (40.3±22.9) months (from 12 to 72 months) after surgery. The time for gradual traction reduction was (26.7±4.6) days, operation time (119.2±4.6) minutes, hospital stay (11.5±2.9) days, and intraoperative blood loss (533.3±189.6) mL. By the modified Matta score, the pelvic reduction after surgery was rated as satisfactory in 5 cases and as unsatisfactory in 1 case. The length disparity between both lower limbs in the 6 patients was (6.9±1.6) cm before surgery and (1.0±0.4) cm immediately after surgery, showing a statistically significant difference ( t=11.135, P<0.001). One fracture healed 3 months after surgery and 5 fractures 6 months after surgery. The Majeed pelvic score at the last follow-up was (80.8±9.0) points for the 6 patients, yielding 2 excellent cases, 3 good cases and 1 fair case. Delayed wound healing was reported in 1 patient, calf intermuscular venous thrombosis in 2 cases, and emotional anxiety and sleep disorder in 1 patient. No new lumbosacral plexus injury was found in any patient. Conclusions:In the treatment of Tile C old pelvic fractures, since our self-designed GT-UCRT combines the advantages of Ilizarov technique and unlocking closed reduction technique, it can not only protect the lumbosacral plexus but also obtain satisfactory reduction of the fracture.

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