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.

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.

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.

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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.

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.

OBJECTIVE To put forward suggestions on strengthening the quality supervision of Chinese patent drugs and preventing and controlling safety risks by analyzing the current quality situation and quality risks of sampling inspection of Chinese patent drugs. METHODS Reviewed the quality status of Chinese patent drugs for national drug sampling and testing over the past years, introduced the supervision concept and mode of Chinese patent drugs, conducted an overall analysis of the overall quality of Chinese patent drugs for national drug sampling and testing in 2021, focused on the mining and analysis of the main quality problems and risks identified. RESULTS Although the qualified rate of sampling inspection of Chinese patent medicines had shown a positive trend year by year, through exploratory research, it was found that there were still some potential quality risks in the quality of Chinese patent medicines in terms of process prescriptions, internal control standards, raw medicinal materials, excipients, harmful substance residues, illegal addition, etc. CONCLUSION Drug quality sampling and testing plays an important role in strengthening the quality and safety supervision of traditional Chinese medicine. According to the characteristics of different industrial chains of traditional Chinese medicine, different regulatory strategies should adopt, build a more scientific and reasonable regulatory model for Chinese patent medicine, and improve the quality control level and industry standards of Chinese patent medicine.

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 ; Retrospective Studies ; Surgical Wound Infection ; Replantation ; Body Mass Index

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.

Objective:To evaluate the clinical efficacy of cannulated screws with sutures in the treatment of patellar transverse fractures.Methods:A retrospective analysis was performed of the data of 70 patients with patellar transverse fracture who had been admitted to Senior Department of Orthopedics, The Fourth Medical Center of Chinese PLA General Hospital from January 2017 to March 2021. According to the construction methods for the tension band, the patients were divided into 3 groups. In group A of 21 cases subjected to fixation with cannulated screws with sutures (Fiber-Tape), there were 8 males and 13 females with a median age of 55.0 (48.0, 65.0) years; in group B of 32 cases subjected to fixation with Kirschner wire tension band, there were 15 males and 17 females with a median age of 52.5 (41.5, 63.0) years; in group C of 17 cases subjected to fixation with Cable-Pin system, there were 5 males and 12 females with a median age of 55.0 (37.0, 65.0) years. The 3 groups were compared in terms of complications, secondary surgery (removal of internal fixation), operation time, intraoperative blood loss and knee function rated by the Lysholm and B?stman scores at the last follow-up.Results:There were no significant differences in the preoperative general data between the 3 groups, showing they were comparable ( P > 0.05). There was no significant difference in the operation time, intraoperative blood transfusion or follow-up time among the 3 groups ( P > 0.05). The incidence of soft tissue irritation [4.8% (1/21)] and the secondary operation rate [4.8% (1/21)] in group A were significantly lower than those in group B [43.8% (14/32) and 37.5% (12/32)] and group C [41.2% (7/17) and 35.3% (6/17)] ( P < 0.05), but there was no statistically significant difference between group B and group C ( P > 0.05). In groups A, B and C, respectively, the Lysholm knee score was 84.0 (69.0, 88.0), 89.0 (71.5, 95.0) and 82.0 (63.0, 90.0), and the B?stman knee score 26.0 (23.0, 28.0), 26.5 (24.0, 27.5) and 26.0 (22.0, 28.0), showing no significant difference ( P > 0.05). There was no significant difference either in the incidence of other complications among the 3 groups ( P > 0.05). Conclusion:In the treatment of patellar transverse fractures, compared with the Kirschner wire tension band and Cable-Pin system, cannulated screws with sutures (Fiber-Tape) may lead to a lower incidence of soft tissue irritation and a lower rate of secondary surgery, but no significant differences in operation time, intraoperative blood loss, other complications or postoperative functional scores.