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.

Conventional chemotherapy based on cytotoxic drugs is facing tough challenges recently following the advances of monoclonal antibodies and molecularly targeted drugs. It is critical to inspire new potential to remodel the value of this classical therapeutic strategy. Here, we fabricate bisphosphonate coordination lipid nanogranules (BC-LNPs) and load paclitaxel (PTX) to boost the chemo- and immuno-therapeutic synergism of cytotoxic drugs. Alendronate in BC-LNPs@PTX, a bisphosphonate to block mevalonate metabolism, works as both the structure and drug constituent in nanogranules, where alendronate coordinated with calcium ions to form the particle core. The synergy of alendronate enhances the efficacy of paclitaxel, suppresses tumor metastasis, and alters the cytotoxic mechanism. Differing from the paclitaxel-induced apoptosis, the involvement of alendronate inhibits the mevalonate metabolism, changes the mitochondrial morphology, disturbs the redox homeostasis, and causes the accumulation of mitochondrial ROS and lethal lipid peroxides (LPO). These factors finally trigger the ferroptosis of tumor cells, an immunogenic cell death mode, which remodels the suppressive tumor immune microenvironment and synergizes with immunotherapy. Therefore, by switching paclitaxel-induced apoptosis to mevalonate metabolism-triggered ferroptosis, BC-LNPs@PTX provides new insight into the development of cytotoxic drugs and highlights the potential of metabolism regulation in cancer therapy.

Objective:To analyze the anatomical characteristics of the adrenal veins through adrenal venography to improve the success rate of adrenal venography (AVS).Methods:This study was a cross-sectional study. Patients who were diagnosed with primary aldosteronism and underwent AVS from January 2019 to October 2023 at the First Affiliated Hospital of Dalian Medical University were included. Adrenal vein imaging was collected from the enrolled patients. We performed statistical analysis on the adrenal vein orifice position, inflow angle, and adrenal venography morphology. The adrenal venous orifice was defined as the location where the catheter was placed at the end of the calm inhalation. Spearman correlation analysis was used to explore the relationship between the positions of bilateral adrenal vein orifices and body mass index (BMI).Results:A total of 282 patients with successful bilateral AVS and complete bilateral adrenal vein imaging were enrolled, of whom 57.1% (161/282) were male and the age was (53.3±10.7) years old. The orifice of the left adrenal vein was located between the middle segment of the 11 th thoracic vertebra and the upper segment of the 2 nd lumbar vertebra. The inflow angle relative to the position of the orifice was all leftward and upward. The orifice of the right adrenal vein was located between the upper segment of the 11 th thoracic vertebra and the lower segment of the 1 st lumbar vertebra, and 91.1% (257/282) had a rightward and downward angle of inflow relative to the position of the orifice. The position of the adrenal vein orifices on both the left ( r=0.211, P<0.001) and right ( r=0.196, P=0.001) showed positive correlation with BMI. The position of the right adrenal vein orifice also increased with the position of the left adrenal orifice ( r=0.530, P<0.001). The most common adrenal venography morphology on the right side was triangular (36.5%, 103/282), while the most common venography morphology on the left side was glandular (66.3%, 187/282). Conclusions:The anatomical morphology of adrenal veins are diverse. Being familiar with the morphological characteristics of the adrenal vein and identifying the adrenal vein accurately during surgery has important clinical value in improving the success rate of AVS.

Objective:To study the correlation between zinc finger protein A20 (A20) and basic fibroblast growth factor (BFGF) and liver fibrosis in chronic hepatitis B.Methods:A retrospective study was conducted to select 120 patients with chronic hepatitis B diagnosed and treated in the Fifth Hospital of Shijiazhuang City from January 2019 to December 2020, all of whom underwent liver tissue biopsy, and 25 cases of liver pathological specimens who underwent liver hemangioma resection were selected. The correlation between the expression of A20 and BFGF in liver tissue and the stage of hepatic fibrosis and inflammation were analyzed.Results:The expression of A20 in the S1 - S4 phase was higher than that in the S0 phase: (6.12 ± 1.22)%, (10.18 ± 2.43)%, (16.94 ± 5.06)%, (25.99 ± 7.57)% vs. (0.81 ± 0.29)%; the expression of BFGF in the S1 - S4 phase was higher than that in the S0 phase: (6.12 ± 1.22)%, (10.18 ± 2.43)%, (16.94 ± 5.06)%, (25.99 ± 7.57)% vs. (0.81 ± 0.29)%, there were statistical differences ( P<0.05). The expression of A20 in the G1 - G4 phase was higher than that in the G0 phase: (6.56 ± 1.87)%, (10.01 ± 3.29)%, (15.54 ± 5.01)%, (25.86 ± 8.02)% vs. (0.85 ± 0.71)%; the expression of BFGF in the G1 - G4 phase was higher than that in the G0 phase: (5.91 ± 1.52)%, (9.65 ± 2.48)%, (15.03 ± 4.86)%, (24.62 ± 7.22)% vs. (0.79 ± 0.41)%, there were statistical differences ( P<0.05). The results of Pearson test showed that there was a positive correlation between liver A20 and BFGF ( r = 0.824, P<0.05). Conclusions:The expressions of A20 and BFGF in liver tissue increase with the aggravation of liver pathological fibrosis and inflammation, which can be used as important indicators to evaluate the severity of liver fibrosis.

Circulating tumor DNA (ctDNA) is cell-free DNA released by tumors or circulating tumor cells, containing abundant tumor-specific information that can serve as biomarkers for cancer early screening, monitoring, prognosis, and prediction of treatment response. This is particularly attractive in the field of gastric cancer, where high-quality screening, monitoring, and prediction methods are currently lacking. Gastric cancer exhibits significant tumor heterogeneity, with large differences in genetic and epigenetic characteristics among different subgroups. Methylated ctDNA has high sensitivity and specificity, which can help clarify tumor genotyping and facilitate the formulation of precise diagnostic and therapeutic strategies. Furthermore, numerous studies have confirmed the unique advantages of methylated DNA in predicting treatment response, adjuvant therapy, and drug resistance assessment, which may be used in the future to enhance the efficacy of chemotherapy regimens and improve patient chemotherapeutic response, and even treat multidrug resistance. However, there are several challenges associated with methylated ctDNA, such as low sensitivity and specificity at single-target sites, limited association between some gastric cancer subtypes and ctDNA, off-target risks, and the lack of large-scale and high-quality clinical research evidence. This review mainly summarizes current research on the methylation status of ctDNA in gastric cancer and connects these findings to early screening, recurrence monitoring, and potential treatment opportunities for gastric cancer. With advances in technology and the deepening of interdisciplinary research, ctDNA detection will reveal more disease information and become an essential foundation for gastric cancer research and precision medicine treatment.

Circulating tumor DNA (ctDNA) is cell-free DNA released by tumors or circulating tumor cells, containing abundant tumor-specific information that can serve as biomarkers for cancer early screening, monitoring, prognosis, and prediction of treatment response. This is particularly attractive in the field of gastric cancer, where high-quality screening, monitoring, and prediction methods are currently lacking. Gastric cancer exhibits significant tumor heterogeneity, with large differences in genetic and epigenetic characteristics among different subgroups. Methylated ctDNA has high sensitivity and specificity, which can help clarify tumor genotyping and facilitate the formulation of precise diagnostic and therapeutic strategies. Furthermore, numerous studies have confirmed the unique advantages of methylated DNA in predicting treatment response, adjuvant therapy, and drug resistance assessment, which may be used in the future to enhance the efficacy of chemotherapy regimens and improve patient chemotherapeutic response, and even treat multidrug resistance. However, there are several challenges associated with methylated ctDNA, such as low sensitivity and specificity at single-target sites, limited association between some gastric cancer subtypes and ctDNA, off-target risks, and the lack of large-scale and high-quality clinical research evidence. This review mainly summarizes current research on the methylation status of ctDNA in gastric cancer and connects these findings to early screening, recurrence monitoring, and potential treatment opportunities for gastric cancer. With advances in technology and the deepening of interdisciplinary research, ctDNA detection will reveal more disease information and become an essential foundation for gastric cancer research and precision medicine treatment.

Vaccines are among the most effec-tive measures for preventing infectious diseases and play a crucial role in controlling the spread of these diseases.Adjuvants,serving as auxiliary com-ponents in vaccines,are indispensable in the vac-cine development process.Ideal adjuvants not only enhance the immune response,enabling the body to achieve optimal protective immunity but also play important roles in reducing the dosage of im-munogens and lowering vaccine production costs.To meet the demands of novel vaccines,many new types of adjuvants have been developed.However,there is still a lack of adjuvants that are safe,effec-tive,easy to prepare,highly pure,and suitable for a variety of vaccines in clinical settings.This article categorizes adjuvants and summarizes their mecha-nisms of action and characteristics,focusing on tra-ditional aluminum salt adjuvants and more modern lipid-based and nucleic acid-based adjuvants.The summary is based on a computer search of data-bases including PubMed,Embase,The Cochrane Li-brary,CNKI(China National Knowledge Infrastruc-ture),VIP Database,and Wanfang Database,using English search keywords such as Adjuvants,Vac-cine,Vaccine Adjuvant,aluminum salts,MF59,AS03,Toll-like receptor agonist,etc.,and corre-sponding Chinese search terms.The aim is to pro-vide references for the development and applica-tion of adjuvants.

Objective:To explore the effect of virtual reality (VR) technology in postoperative pain management for surgical patients.Methods:The literature on VR technology for relieving postoperative pain in surgical patients was electronically retrieved from eight databases, including PubMed, Web of Science and so on. The search period was from database establishment to November 19, 2023. Two researchers independently screened literature, extracted data, and conducted literature quality evaluation, using RevMan 5.4 for Meta-analysis.Results:A total of 18 articles were included. Meta-analysis results showed that VR technology could reduce postoperative resting pain scores [ MD=-1.13, 95% CI (-1.29, -0.96), P<0.001], postoperative 12 hour pain scores [ MD=-0.49, 95% CI (-0.73, -0.24), P<0.001], postoperative 24 hour pain scores [ MD=-0.73, 95% CI (-0.92, -0.54), P<0.001], postoperative 48 hour pain scores [ MD=-0.69, 95% CI (-0.84, -0.53), P<0.001], postoperative 72 hour pain scores [ MD=-0.37, 95% CI (-0.59, -0.16), P<0.001], and postoperative pain scores during dressing changes [ MD=-1.11, 95% CI (-2.06, -0.16), P=0.02], and could improve patient postoperative comfort [ MD=8.31, 95% CI (6.57, 10.06), P<0.001] . Conclusions:As a non-pharmacological intervention, VR technology can alleviate postoperative pain and improve patient comfort in surgical patients. In the future, large-scale and high-quality research is still needed to further verify the effectiveness of VR technology.

Objective:To investigate the effects of ovarian cancer domain containing protease-1 (OTUD1) gene on the typeⅠ interferon signaling pathway, and its impact on the antiviral effects of IFN-α.Methods:Dual-luciferase reporter assay was performed to detect the effects of OTUD1 gene on the transcriptional activity of interferon-stimulated response element (ISRE) promoter. Quantitative real-time PCR (qPCR) was used to detect the effects of OTUD1 on IFN-α-induced expression of interferon-stimulated genes (ISGs). The effects of OTUD1 gene on the expression of key proteins in the IFN-α signal transduction pathway were analyzed by Western blot, and its effects on IFN-α-mediated inhibition of hepatitis B virus replication were detected by qPCR and ELISA.Results:In HEK293T and Huh7.0 cells, OTUD1 down-regulated the transcriptional activity of ISRE promoter in the interferon signaling pathway and the expression of antiviral genes such as ISG15 and ISG56. In HEK293T cells, OTUD1 reduced the expression of phospho-Jak1 (p-JAK1) at protein level, but the catalytic inactive mutant of OTUD1 (C320S) could not regulate the expression of ISGs or p-JAK1. In Huh7.0 cells, OTUD1 antagonized the inhibitory effect of IFN-α on hepatitis B virus replication.Conclusions:OTUD1 with the ubiquitination activity can inhibit the interferon JAK-STAT signaling pathway and the expression of ISGs by down-regulating the expression of p-JAK1 protein. OTUD1 antagonizes the effect of IFN-α on viral replication and that may be related to the interferon-induced JAK-STAT signaling pathway.

Compared with conventional radiotherapy, FLASH radiotherapy has advantages in protecting normal tissues, while the dose rate is increased by more than 100 times. If the shielding design of the treatment room is carried out according to the existing standard, the thickness and cost of the shielding wall will be significantly increased, or even hardly to meet the requirement of the standards, resultsing in the failure of the application of FLASH radiotherapy. By investigating the domestic and foreign standards and literature, this paper analyzes the challenges brought by FLASH radiotherapy technology to the shielding design of radiotherapy treatment room in China. Dose rate control standards adopted by different countries in the shielding design are emphatically compared as well. In several countries, the average dose rate under the actual treatment conditions was considered in the shielding design. In China, the method of instantaneous dose rate taking acount of occupancy factor is adopted. However, if FLASH radiotherapy technology is applied, the requirement of instantaneous dose rate will be difficult to meet. In order to improve the high dose rate radiotherapy technology such as FLASH radiotherapy, the revision of the existing standards is advised if the authorized limits are not changed. To use the average dose rate limit within a certain period of time for control, or to raise the control standard in the case of flash radiotherapy, are also avaliable.