This study systematically compares the characteristics and chemical compositions of various botanical sources of the medicinal and edible Chinese herb Lycii Fructus, elucidates its pharmacological activities and mechanisms of action, and reviews the current status of related medicinal and edible product development. It aims to provide a theoretical basis for the in-depth development and scientific application of Lycii Fructus resources. Based on classical herbal texts and modern pharmacological research, this study compares and analyzes the botanical characteristics and chemical composition of Ningxia goji (Lycium barbarum L.) and Chinese goji (L. chinense Mill.). It summarizes their primary active constituents and associated pharmacological effects, along with their underlying molecular mechanisms. Furthermore, it reviews their current applications within the health food and functional beverage sectors. Research indicates that chemical compositions vary among different botanical origins of Lycii Fructus. Yet, all are rich in key bioactive compounds, including polysaccharides, alkaloids, and carotenoids, demonstrating significant potential for antioxidant activity, immune modulation, and visual protection. Presently, health products developed from Lycii Fructus encompass multiple functional areas, including immune enhancement, alleviation of physical fatigue, and regulation of glucose and lipid metabolism. Future research should further clarify their efficacy differences and appropriate applications, deepen systematic investigation of multi-targeted mechanisms of action, and establish standardized quality control systems for goji-based health foods. This will advance the precise development and scientific application of goji-related health industries.

OBJECTIVE To evaluate the effect of Ginseng Drop Pills on invigorating Qi and explore its mechanism based on the changes of intestinal flora. METHODS The model of Qi deficiency syndrome in mice was established by exhaustive swimming, food restriction and cyclophosphamide. By measuring the exhaustive swimming time, serum lactic acid, immunoglobulin IgA content, peripheral blood T cells, B cells content and organ index, the effect of Ginseng Drop Pills on invigorating Qi was evaluated. In order to investigate the effect of Ginseng Drop Pills on the intestinal flora structure of mice, the contents of mice cecum were sequenced on Illumina MiSeq and Illumina NovaSeq platform by 16S rDNA and metagenome. RESULTS Compared with the model group, exhaustive swimming time and the content of B cells in peripheral blood of the mice in the Ginseng Dripping Pill group increased significantly (P<0.05). Thymus index and serum IgA content tend to increase. The content of serum lactic acid decreased significantly (P<0.05). Ginseng Drop Pills can reduce the relative abundance of Candidatus_Saccharimonas and NK4A214_group, and increase the relative abundance of Odoribacter. Its endemic species are mainly Pseudokineococcus, Naematelia, Herpetosiphon and Crenothrix. Correlation analysis shows that the exhaustive swimming time, blood lactic acid content, serum immunoglobulin IgA and peripheral blood B cells (CD19⁺) are significantly correlated with the abundance of intestinal flora communities. KEGG function annotation showed that compared with the model group, the abundance of genes enriched in galactose metabolism pathway in the Ginseng Dropping Pill group was significantly reduced(P<0.05). CONCLUSION Ginseng Drop Pills can improve Qi deficiency to a certain extent, and its mechanism may be related to improving the balance of intestinal flora.

OBJECTIVE To address the issues of fresh Rehmanniae Radix's poor storability, its impact on clinical dispensing and the lack of comprehensive quality standards, this study aims to establish a processing method for preparing dried slices from the fresh herb and to construct a complete quality control standard for it. METHODS Using catalpol, rehmannioside D, and seven saccharides (D-fructose, glucose, sucrose, melibiose, raffinose, manninotriose, and stachyose) as evaluation indicators, the effects of different pre-treatment methods, blanching times, and drying temperatures on the quality of the fresh Rehmanniae Radix (FRR) slices were investigated through a single-factor experiment to determine the optimal preparation process. Furthermore, based on the quality characteristics of multiple batches of slices prepared by the new method, a quality control standard was established (catalpol 1.99%-3.65%; rehmannioside D 0.230%-0.530%; stachyose 51.2%-61.9%; extractives 73.4%-85.7%; moisture 7.43%-10.1%; total ash 2.31%-3.73%; acid-insoluble ash 0.102%-0.268%). RESULTS The finalized preparation process was as follows: fresh Rehmanniae Radix is washed, cut into thick slices, blanched in boiling water for 1 min, removed, and then dried at 60 ℃ for 24 h. Based on the test results from 10 batches, the proposed quality control standards are: catalpol ≥2.60%, rehmannioside D ≥0.200%, stachyose ≥50.0%, moisture ≤10.0%, water-soluble extractives ≥65.0%, total ash ≤4.00%, acid-insoluble ash ≤0.300%; catalpol and acteoside should be detectable by TLC. CONCLUSION The preparation method established and optimized in this study is simple, practical, and easy to popularize. The resulting quality control standard for the new slices is scientifically justified and reasonable. This research not only provides a model for preparing fresh herbal slices in traditional Chinese medicine but also lays a foundation for the high-quality development of Rehmanniae Radix industry.

Non-clinical drug research has long been entrenched in the perception that animal experiments represent the “gold standard.” Their low translatability to humans, ethical controversies, and high development costs have become core bottlenecks limiting the efficiency of new drug discovery and development, driving the scientific community and regulatory agencies to pursue transformative changes. New approach methodologies (NAMs), a new generation of animal replacement technologies that have advanced rapidly over the past decade, integrate diverse tools including AI modeling, organoids, organ-on-chips, and multi-omics analysis. With their high physiological relevance to humans, high throughput, and reduced ethical constraints, NAMs are becoming a strategic priority in global drug regulatory science and a core enabler of the paradigm shift in non-clinical drug research. This transformation is not merely a technical update, but a conceptual revolution to the century-old linear drug development model: target identification-animal testing-clinical trials. Currently, NAMs in China are still in the early stage, with key shortcomings including an immature technical system, industrial cognitive bias, and an incompatible regulatory framework. Against the global trend and international perspective of drug regulatory science, this paper begins with the formation and limitations of path dependence on animal experiments. It systematically summarizes the background, regulatory practices, and transformative significance of NAMs, and conducts an in-depth and critical analysis of their scientific connotations, technical characteristics, and key challenges. Further, based on an analysis of the development gaps, urgency, and feasibility of NAMs in China, this paper proposes countermeasures and suggestions to accelerate the large-scale implementation of NAMs: establishing a NAMs standardization system suited to China's national conditions, building an integrated NAMs tool integration framework, formulating a regulatory coordination mechanism adapted to the NAMs system, promoting large-scale industrial application of NAMs, and fostering a“NAMs prioritized”environment for pharmaceutical innovation. Accelerating the development of a NAMs system with Chinese characteristics and promoting its large-scale application and paradigm shift in China will support the implementation of the new national science and technology major project for innovative drug discovery and the high-quality development of the pharmaceutical industry. It will achieve a win-win between“scientific innovation”and“life protection”, enhance China's voice in global pharmaceutical regulation, and contribute Chinese wisdom and solutions to the transformative restructuring and innovative development of the global drug R&D paradigm.

This article reviews the latest progress in inhalation preparations and their in vitro-in vivo correlation (IVIVC). Firstly, it introduces the classification of inhalation preparations, including aerosols, sprays, dry powder inhalers, and inhalable liquid preparations, and systematically elaborates on the characteristics, formulation composition, mechanism of action, and clinical application scenarios of each type. Furthermore, it deeply analyzes the core connotation of IVIVC research on inhalation preparations, comprehensively sorts out the common technologies and methods for in vitro data collection, in vivo data collection, model construction and validation in this field, and simultaneously introduces the research status of combining traditional research methods with cutting-edge technologies such as computational fluid dynamics (CFD) and organoids. It further analyzes the key restrictive factors currently faced by IVIVC research, including the differences between in vitro models and the real physiological environment of the human body, the influence of individual physiological and pathological heterogeneity and technical limitations on in vivo research, and the lack of standardization in modeling methods and validation systems. Finally, it puts forward targeted breakthrough paths, namely, developing personalized 3D respiratory tract models and optimizing the IVIVC research system. Studies have shown that IVIVC research is the core technology to promote the formulation optimization, drug delivery system upgrading and clinical medication guidance of inhalation preparations, but its existing research system still has limitations in in vitro simulation, in vivo implementation and model validation. In the future, it is necessary to improve the prediction accuracy and practical value of IVIVC models through multi-technology integration and interdisciplinary collaboration, so as to provide more solid support for the innovative research and clinical transformation of inhalation preparations.

Obesity has become a critical global public health concern. Excessive weight caused by multifactorial obesity not only imposes significant physical burdens but also elevates risks of cardiovascular diseases such as hypertension and hyperlipidemia. This study investigates the weight-loss mechanisms of active components in traditional Chinese medicine (TCM), which include suppressing appetite to reduce energy intake, inhibiting fat digestion and absorption, regulating lipid synthesis and storage, promoting energy expenditure, and improving gut microbiota imbalance. The findings aim to explore the potential applications of TCM active ingredients in combating obesity-related disorders, providing valuable insights for developing TCM-based therapies to manage weight and promote healthy weight control.

OBJECTIVE To address issues such as weak signal intensity, signal absence, and peak broadening in the ¹H and ¹³C-NMR spectra of purine derivatives, this study aims to establish effective spectral optimization methods. METHODS Eight purine derivatives, including mercaptopurine, guanine, and azathioprine, were selected as subjects. The study involved the optimization of deuterated solvents, protonation modulation, and variable-temperature experiments, to determine the optimal experimental conditions for ¹H and ¹³C-NMR and elucidate the NMR spectral optimization mechanisms for this class of compounds. RESULTS Solvent screening identified DMSO-d₆ as the optimal deuterated solvent, enabling effective dissolution of purine derivatives and yielding high-quality NMR spectra. Protonation experiments demonstrated that trifluoroacetic acid(TFA) significantly sharpened broadened peaks and restored missing signals without altering molecular structure. Variable-temperature experiments established 293 K to 303 K as the optimal range for acquiring high-quality NMR spectra. CONCLUSIONS The anomalous ¹H and ¹³C-NMR signals in purine derivatives primarily originate from the combined effects of ¹⁴N nuclear quadrupole relaxation, tautomerism, and dynamic hydrogen-bonding exchange. A synergistic strategy employing TFA protonation combined with temperature control effectively suppresses these dynamic processes and markedly enhances spectral quality. This approach provides a valuable reference for resolving ¹H and ¹³C-NMR signal anomalies and structural identification challenges in purine derivatives.

OBJECTIVE To study the effect and mechanism of baishouwu benzophenone on intestinal urate excretion. METHODS The mice with hyperuricemia induced by potassium oxonate were given intragastrically with the drug for 7 days, twice daily. At the end of the experiment, the mice were placed in the mouse metabolic cage, and the feces were collected. Blood was collected from orbital veins to determine uric acid. The jejunum and ileum were immediately removed and frozen in liquid nitrogen, and stored in the -80 ℃ refrigerator. The uric acid level in the jejunum and ileum were determined. The gene and protein expression levels of ABCG2, GLUT9, CNT2, PDZK1 and MRP4 in the jejunum were detected by qPCR and Western blotting. RESULTS ①Compared with model group, the serum uric acid level was significantly decreased in baishouwu benzophenone (4.0, 8.0, 16.0 mg·kg^-1) groups, the level of fecal uric acid were significantly increased in baishouwu benzophenone (8.0 and 16.0 mg·kg^-1) groups, and the uric acid levels of jejunum and ileal tissue were significantly decreased in the baishouwu benzophenone (16.0 mg·kg^-1) group. ②Baishouwu benzophenone could significantly up-regulated the gene and protein expression levels of ABCG2 and down-regulated the protein expression levels of GLUT9 and CNT2. CONCLUSION Baishouwu benzophenone increases the intestinal uric acid excretion, that might through up-regulating the gene and protein expression level of ABCG2, and inhibiting the protein expression level of intestinal GLUT9 and CNT2 in hyperuricemic mice.

OBJECTIVE To investigate the molecular mechanism by which histone demethylase PHF8 upregulates SNAI1 to mediate epithelial-mesenchymal transition (EMT), thereby affecting the proliferation, invasion, and metastasis of prostate cancer (PCa). METHODS Human PCa cell lines (PC-3, DU145) and normal prostate epithelial cell line (RWPE-1) were used as research objects. The expression differences of PHF8 and SNAI1 were detected by qRT-PCR and Western blot. Cells and animals were randomly divided into control group (Vector), PHF8 knockdown group (shPHF8), and PHF8 knockdown+SNAI1 overexpression group (shPHF8+SNAI1-OE). Cell proliferation was analyzed by CCK-8 and EdU assays; apoptosis was detected by flow cytometry; migration and invasion abilities were assessed by Transwell assay; Western blot was used to detect the expression of EMT-related proteins. The regulatory effect of PHF8 on SNAI1 promoter activity was verified by dual-luciferase reporter assay. Immunohistochemistry (IHC) and hematoxylin-eosin (HE) staining were employed to examine changes in EMT markers, Ki67 expression, and the number of lung metastatic nodules in animal experiments. RESULTS The mRNA and protein levels of PHF8 and SNAI1 in PC-3 and DU145 cells were significantly higher than those in RWPE-1 cells (all P<0.05). Compared with the Vector group, the shPHF8 group showed significantly reduced cell proliferation viability, number of migrating and invading cells, and expression of N-cadherin and vimentin (all P<0.05), while the apoptosis rate and E-cadherin expression were significantly increased (P<0.05). Overexpression of SNAI1 reversed these phenotypes (all P<0.05). The dual-luciferase assay confirmed that PHF8 enhanced the promoter activity of SNAI1 (P<0.05). In vivo experiments showed that, compared with the Vector group, the shPHF8 group had significantly reduced tumor volume, weight, and number of lung metastases in nude mice (P<0.05), upregulated E-cadherin expression, and downregulated N-cadherin, vimentin, and proliferation marker Ki67 expression. The shPHF8+SNAI1-OE group restored tumor growth and metastatic ability and reversed the changes in EMT markers and Ki67 expression (all P<0.05). CONCLUSION Histone demethylase PHF8 can promote the proliferation, invasion, and metastasis of prostate cancer by upregulating SNAI1 to activate epithelial-mesenchymal transition, providing a new strategy for targeted therapy of PCa.

OBJECTIVE To prepare a porous gelatin sustained-release microspheres loaded with Cichorium glandulosum extract. METHODS Firstly, calcium carbonate-containing microspheres were prepared by emulsification cross-linking method and then etched to empty porous microspheres by citric acid solution; optimization of preparation process by Box-Benhnken design-response surface method; the related indexes such as drug loading rate, encapsulation rate, particle size and external appearance were characterised; and finally, the drug release property was investigated. RESULTS The factors that have a greater influence on the forming rate and drug loading rate of the porous microspheres were found to be the oil-water ratio, gelatin-to-calcium carbonate ratio, and emulsifier ratio; the optimal preparation process was found to have a gelatin-to-calcium carbonate ratio of 5.055∶1, an oil-water ratio of 2.859∶1, an emulsifier ratio of 1.254%, an emulsification temperature of 50 ℃, and a rotational speed of 400 r·min^-1; and porous microspheres with a uniform size and a drug loading rate of 16.25% were obtained. The porous microspheres were produced with uniform size and 16.25% drug loading rate. CONCLUSION This method has the characteristics of low cost, simple operation and rapidity to prepare a kind of porous gelatin microspheres, which provides a preliminary research basis for the formulation development of Cichorium glandulosum.

OBJECTIVE To develop a competitive enzyme-linked immunosorbent assay for anti-D antibody titer of anti-D immunoglobulin and validate the method. METHODS Referring to the European Pharmacopoeia, a competitive enzyme-linked immunosorbent assay for anti-D antibody was established, and the specificity, accuracy, precision, linearity and range, and robustness of the method were verified. RESULTS The concentration of alkaline phosphatase-streptavidin diluted 250 times was the optimum enzyme concentration. When the titer of anti-D antibody was in the range of 60-0.937 5 IU·mL^-1, the four-parameter logistic regression method can be used. No anti-D antibody was detected in subcutaneous injection human immunoglobulin, intravenous injection human immunoglobulin (pH4) and tetanus human immunoglobulin. The relative bias (RB) of the anti-D antibody titer test results ranged from -1.02% to 9.39%. The repeatability test results of anti-D antibody showed that the CV value was 2.19%-11.74%, and the precision test results showed that the GCV value was 2.19%-12.43%. The relative titer linear range was 26.21%-244.14%, covering the quality standard range of relative titer (80%-150%). The CV value of the results of the durability test was less than 15%. CONCLUSIONS This method has a wide linear range, good repeatability and precision, high accuracy of detection results, and meets the standard of durability,which can be used to test the titer of anti-D antibody.

OBJECTIVE To analyze and explore the characteristics of drug-induced liver injury (DILI) induced by oral anticoagulants (OACs), and provide references for clinical safety of drug use. METHODS Case reports of DILI caused by OACs published in Pubmed, Embase, CNKI, Wanfang, and VIP databases up to July 2025 were retrieved. Key information, and conducted a systematic literature review and descriptive analysis based on the case reports were collected. RESULTS A total of 68 cases from 45 articles were identified, including 34 males (50.0%) and 33 females (48.5%). The patients were aged from 20 to 91 years with an average age of (67.2±16.0) years, and 48 patients (70.6%) were 60 years or older. The OACs involved included warfarin in 13 cases (19.1%), dabigatran in 6 cases (8.8%), apixaban in 4 cases (5.9%) and rivaroxaban in 45 cases (66.2%). DILI occurred from 1 to 586 days with an average of (56.1±99.8) days after treatment, and 41 cases (60.3%) within 5 to 90 days. The types of DILI were mainly hepatocellular injury type (33 cases, 48.5%), followed by cholestatic type (17 cases, 25.0%) and mixed type (11 cases, 16.2%). Most cases were of grade 1 (18 cases, 26.5%) and grade 2 (26 cases, 38.2%) severity. The main clinical manifestations were jaundice (31 cases, 45.6%), nausea (17 cases, 25.0%), fatigue (10 cases, 14.7%), vomiting (8 cases, 11.8%) and pruritus (8 cases, 11.8%). After 3 to 365 with an average of (49.6±80.5) days of treatment including drug withdrawal, liver protection, administration of specific antagonists and adjustment of anticoagulant therapy regimens, 63 patients (92.6%) improved and 5 patients (7.4%) died. CONCLUSIONS Various OACs except edoxaban can cause DILI. DILI induced by OACs mostly occurs in patients aged 60 years and older, and is mainly characterized by mild-to-moderate hepatocellular injury. Clinicians should pay close attention to the liver function and the presence of symptoms such as jaundice, nausea, and fatigue within 90 days after medication. Once DILI is suspected, the drug should be discontinued promptly and symptomatic treatment should be given.

OBJECTIVE To mine and compare the disparities in adverse event signals among three classes of acid-suppressing drugs—proton pump inhibitors (PPIs), H₂ receptor antagonists (H₂RAs), and potassium-competitive acid blockers (P-CABs)—using data from the US FDA Adverse Event Reporting System (FAERS) database. METHODS Data spanning from the first quarter of 2004 to the second quarter of 2025 were extracted from FAERS. Reports where the target drugs were designated as the ‘primary suspect’ were identified. Signal detection was conducted employing four established algorithms: the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the multi-item gamma poisson shrinker (MGPS), and the Bayesian confidence propagation neural network (BCPNN). RESULTS A total of 191 662 reports were included in the analysis. PPIs were associated with the highest number of positive signals and the broadest range of system organ classes (SOC). Signals were particularly prominent for PPIs in the domains of renal and urinary disorders, gastrointestinal system disorders, and metabolism and nutrition disorders. In contrast, H₂RAs yielded fewer signals, which were primarily concentrated in cardiac and immune system disorders. Although the total signal count for the P-CAB vonoprazan was relatively limited, it demonstrated significant signal strengths associated with hypergastrinemia and gastric mucosal lesions. CONCLUSIONS The safety signal profiles distinctly differ among the three drug classes. These findings suggest that enhanced monitoring of renal function and electrolytes is warranted for patients on long-term PPI therapy. For patients receiving vonoprazan, clinical attention should be directed toward gastrin levels and associated gastrointestinal changes.