1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
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, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily 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 environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug 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.
2.The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; LUI Yanming ; YUAN Yaozuo ; CHEN Ying ; DAI Hong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):051-057
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 revisions. 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 standards in Chinese Pharmacopoeia.
3.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
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 excipients 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 understand and utilize the standards in Chinese Pharmacopoeia.
4.The introduction on standards system of the pharmaceutical packaging materials in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; YU Hui ; WANG Yan ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):067-076
The standard of Pharmaceutical packaging materials is an important part of the Chinese Pharmacopoeia. This article focuses on working background, general idea, working process, main framework, and its role and significance of the pharmaceutical packaging materials standards system in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia 2025 Edition.
5.The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; WANG Lin ; ZHANG Gongchen ; MA Shihong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):077-082
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.
6.Application of "balance-shaped sternal elevation device" in the subxiphoid uniportal video-assisted thoracoscopic surgery for anterior mediastinal masses resection
Jinlan ZHAO ; Weiyang CHEN ; Chunmei HE ; Yu XIONG ; Lei WANG ; Jie LI ; Lin LIN ; Yushang YANG ; Lin MA ; Longqi CHEN ; Dong TIAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):308-312
Objective To introduce an innovative technique, the "balance-shaped sternal elevation device" and its application in the subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for anterior mediastinal masses resection. Methods Patients who underwent single-port thoracoscopic assisted anterior mediastinal tumor resection through the xiphoid process at the Department of Thoracic Surgery, West China Hospital, Sichuan University from May to June 2024 were included, and their clinical data were analyzed. Results A total of 7 patients were included, with 3 males and 4 females, aged 28-72 years. The diameter of the tumor was 1.9-17.0 cm. The operation time was 62-308 min, intraoperative blood loss was 5-100 mL, postoperative chest drainage tube retention time was 0-9 days, pain score on the 7th day after surgery was 0-2 points, and postoperative hospital stay was 3-12 days. All patients underwent successful and complete resection of the masses and thymus, with favorable postoperative recovery. Conclusion The "balance-shaped sternal elevation device" effectively expands the retrosternal space, providing surgeons with satisfactory surgical views and operating space. This technique significantly enhances the efficacy and safety of minimally invasive surgery for anterior mediastinal masses, reduces trauma and postoperative pain, and accelerates patient recovery, demonstrating important clinical significance and application value.
7.The role of circulating inflammatory cytokines in cardiopulmonary bypass-related organs injuries and the treatments
Jinghan ZHANG ; Lei DU ; Daming GOU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(01):129-135
Systemic inflammatory response (SIR) evoked by cardiopulmonary bypass (CPB) is still one of the major causes of postoperative multiple organs injuries. Since the concentrations of circulating inflammatory factors are positively associated with postoperative adverse events, removal or inhibition of inflammatory factors are considered as effective treatments to improve outcomes. After more than 20 years of research, however, the results are disappointed as neither neutralization nor removal of circulating inflammatory factors could reduce adverse events. Therefore, the role of circulating inflammatory factors in CPB-related organs injuries should be reconsidered in order to find effective therapies. Here we reviewed the association between circulating inflammatory factors and the outcomes, as well as the current therapies, including antibody and hemadsorption. Most importantly, the role of circulating inflammatory factors in SIR was reviewed, which may be helpful to develop new measures to prevent and treat CPB-related organs injuries.
8.Advances in the application of AI-assisted 3D reconstruction in thoracoscopic pulmonary nodule resection surgery
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):252-257
In thoracoscopic pulmonary nodule resection surgery, precise preoperative planning is crucial. Artificial intelligence (AI)-assisted three-dimensional (3D) reconstruction technologies have shown great potential in this area. AI-assisted 3D reconstruction technologies can provide accurate, personalized models of the pulmonary vasculature and bronchial anatomy, assisting surgeons in detailed surgical planning and thus enhancing the precision and safety of surgeries. This article reviews the application progress of AI-assisted 3D reconstruction technologies in pulmonary nodule surgery, including their applications in preoperative diagnosis, surgical planning, and intraoperative navigation, as well as the advancements in AI-assisted 3D reconstruction technologies. It analyzes the technical features of all kinds of 3D reconstruction methods, their clinical applications, and the challenges they face.
9.Advances of clinical trials related to Resmetirom as an approved new drug for metabolic dysfunction-associated steatohepatitis
Aifang LIU ; Lei LUO ; Wenlong YANG
Journal of Clinical Hepatology 2025;41(1):145-150
Metabolic dysfunction-associated steatotic liver disease is the largest liver disease around the world and is a serious public health hazard, but there has always been a lack of drugs approved for treatment. On March 14, 2024, Resmetirom became the first drug approved by the US Food and Drug Administration for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This article summarizes the mechanism of action of Resmetirom in the treatment of MASH, related clinical trial designs, and some research results and analyzes shortcomings and future prospects. Current data have shown that Resmetirom is effective in improving steatohepatitis and liver fibrosis, but there is still a large gap between Resmetirom and the ideal drug for the treatment of MASH, and it is expected to develop more effective drugs for MASH.
10.Research advances in pancreaticobiliary maljunction
Xiaoxuan TANG ; Lei WANG ; Bin ZHANG
Journal of Clinical Hepatology 2025;41(1):189-194
Pancreaticobiliary maljunction (PBM) is a rare congenital developmental defect of the biliary-pancreatic system characterized by a junction of the pancreatic and bile ducts outside the duodenal wall, forming an extended common channel. This anatomical anomaly compromises the normal function of Oddi’s sphincter, weakens defenses against reflux, and thus triggers a series of biliary and pancreatic complications. Although there is a relatively low incidence rate of PBM, its insidious clinical symptoms often lead to delayed diagnosis, which increases the difficulties in treatment and the risk of poor prognosis. For PBM patients with marked bile duct dilatation, surgical intervention, especially cholecystectomy combined with extrahepatic bile duct resection and bile duct-jejunum Roux-en-Y anastomosis, remains the standard treatment at present. For PBM without marked bile duct dilatation, there are still controversies over related treatment strategies, and most experts are in favor of cholecystectomy, while there is still a lack of consensus on the management of extrahepatic bile ducts, which requires further research and exploration. Endoscopic retrograde cholangiopancreatography (ERCP) is currently the gold standard for diagnosing PBM and assessing pancreaticobiliary abnormalities, and it can not only clarify the nature of lesion, but also collect the bile and biliary duct tissue for pathological examination. ERCP also has the function of interventional treatment, such as stenting, expansion, and drainage, thereby bringing benefits to patients comorbid with biliary neoplasms. However, the application of ERCP in screening is limited by its invasiveness, with increases in technique complexity and the risk of complications in the pediatric population. This article summarizes the definition, classification, pathogenesis, and epidemiological features of PBM and the research advances in current diagnosis and treatment strategies, in order to provide guidance for clinical practice.

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