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  • Xiaoming YOU, Xingyu ZHU, Yun LI, Jianguo ZHU, Cheng XIE
    Chinese Pharmaceutical Journal. 2025, 60(8): 875-882.

    OBJECTIVE To investigate the characteristics of severe cutaneous adverse reactions (SCARs) induced by proton pump inhibitors (PPIs) and provide references for clinical safe use of drugs. METHODS Case reports of SCARs caused by PPIs were retrieved from Pubmed, CNKI, Wanfang and VIP databases up to June 2024. Information such as demographic characteristics, drug use, occurrence time, types, clinical manifestations, treatment measures and outcomes of patients was collected, and descriptive statistical analysis was conducted. RESULTS A total of 22 patients were included. There were 8 males (36.4%) and 14 females (63.6%), aged from 23 to 89 years, with an average age of years. The PPIs involved included omeprazole in 10 cases, esomeprazole in 6 cases, pantoprazole in 3 cases, and lansoprazole in 3 cases. SCARs occurred from 1 to 45 days, with an average time of days after treatment, and 18 cases (94.7%) within 3 weeks. Ten cases were diagnosed as Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), 7 cases were diagnosed as drug reaction with eosinophilia and systemic symptom (DRESS), and 5 cases were diagnosed as acute generalized exanthematous pustulosis (AGEP). The clinical symptoms and laboratory indicators of 18 patients (81.8%) were improved after discontinuation and treatment with glucocorticoid and/or globulin, but three patients died of multiple organ failure eventually, and one patient was discharged automatically. CONCLUSION SCARs can be caused by a variety of PPIs, with omeprazole and esomeprazole being relatively more common, and mainly manifest as SJS/TEN and DRESS. Patients should be closely monitored for any allergic symptoms such as fever and rash within 6 weeks of using PPIs. Once SCARs are suspected, the drug should be stopped in time, and symptomatic supportive treatment such as glucocorticoids should be provided if necessary.

  • Tangjie ZHANG, Zhenxin ZHU, Jing YAN, Minghe JIANG, Hongcun LIU, Juan MENG, Xuan ZHANG, Chaonan KONG, Lifang YANG
    Chinese Pharmaceutical Journal. 2025, 60(8): 793-800.

    OBJECTIVE To investigate the secondary metabolites and hypolipidemic properties of Irpex lacteus. METHODS Compounds were isolated and purified using silica gel column chromatography, preparative high-performance liquid chromatography (Pre-HPLC), and other chromatographic techniques. Structural identification was performed through nuclear magnetic resonance (NMR), high-resolution mass spectrometry, infrared (IR), and ultraviolet (UV) spectroscopy. HepG2 cell model with high lipid was established to test the hypolipidemic activity. RESULTS Twelve compounds were isolated from Irpex lacteus and identified as (2α, 4β, 5β, 7β, 10α)-2, 5, 11-eudesmanetriol(1), 11, 12-epoxy-5, 6-secotremula-1, 6(13)-dien-5-12-olide(2), 8α, 10α-di-O-acetyl-lactarorufin A(3), (+)-(2S, 3R, 6S, 7S)-tremul-1(10)-ene-2, 12- diol(4), conocenolide A(5), irpexolactin G(6)、2, 2'-oxybis(1, 4-di-tert-butylbenzene) (7), 4'-hydroxy-5, 7-dimethoxy-6-(3-methyl-2-butenyl)- isoflavone(8), cyclo(Ile-Val) (9)、cyclo(L-Pro-L-Leu) (10), cyclo(Ile-Leu) (11), cyclo(Ile-lle) (12). The results of hypolipidemic activity showed that compounds 1-4, 8 and 9 had hypolipidemic activities, and the reduction effect of TG content in each dose group of compounds 1, 4 and the high and medium dose groups of compounds 2, 3 and 8 was better than that of the positive drug group. CONCLUSION Compounds 1-4, 7-12 are isolated from this strain for the first time. Compounds 1-4, 8 and 9 have good hypolipidemic effects.

  • Min ZHANG, Xueyan HUANG, Qingxiang ZENG, Xiaoyu WU, Xiaoxia LIU, Xiaoli FENG, Wenrui FU, Shuchang WEI
    Chinese Pharmaceutical Journal. 2025, 60(8): 801-808.

    OBJECTIVE To ensure the equivalence of the ancient and modern processes, and optimize the alcohol extractionprocess of Erxian Decoction(EXD), using standard relation andanalytic hierarchy process(AHP)-entropy weight method combinedwith Box-Behnken response surface method. METHODS Taking phellodendrine, mangiferin, ferulic acid, berberine, curculigoside, epmedin A1, epmedin A, epmedin B, epmedin C, icariin content, dry extract rate and fingerprint similarity as the key quality factors, taking ethanol concetration, solid-liquid ratio and extraction time as the key process parameters, the best extraction process was obtained by Box-Behnken response surface method. RESULTS The optimal conditions were 75% ethanol, 1∶14 solid-liquid ratio (g∶mL) and 62 min extraction time. The verified experimental results showed that the average comprehensive score was 86.64, and the relative standard deviation(RSD) was 1.02%. CONCLUSION The alcohol extraction process of EXD is optimized using standard relation combined with AHP-entropy weight method, the fitted model is significant, and the quality of the standard decoction is highly consistent, which provids a reference for the change of dosage form in the later stage.

  • Yan SHI, Xianlong CHENG, Feng WEI
    Chinese Pharmaceutical Journal. 2025, 60(8): 866-874.

    OBJECTIVE To construct a scoring card capable of distinguishing between wild, semi-wild, and cultivated Astragali Radix. METHODS Six hundred batches of virtual data generated by TVAE deep learning were used as the training and validation sets. The training set data were binned, and the bins were adjusted and optimized to calculate the weight of evidence (WOE) for each bin. The data were encoded using WOE, and a logistic regression model was established. The model was trained on the training set and tuned using the validation set. A score of 50 was set as the threshold where the sample's positive and negative classification probabilities are equal. The baseline score and the scores corresponding to each bin were calculated using the formula and the logistic regression model equation. The sample score was determined by adding the base score and the scores corresponding to each bin for the sample, with a threshold of 50 used to judge the probability of the sample's positive or negative category. Card A and Card B were constructed to discriminate whether the Astragali Radix sample is wild or cultivated, respectively. RESULTS Sixty-four batches of real sample data were used as the test set to evaluate Card A and Card B, with classification accuracy rates of 0.86 and 0.80, respectively. CONCLUSION The scoring card can accurately discriminate the source of Astragali Radix samples, and the model is stable, reliable, easy to operate, and easy to promote.

  • Pan LIU, Jiejing KAI, Qingwei ZHAO
    Chinese Pharmaceutical Journal. 2025, 60(8): 839-846.

    OBJECTIVE This study aims to establish and characterize patient-derived colorectal cancer organoid models and evaluate their potential value in predicting chemotherapy responses through individualized drug sensitivity testing. METHODS Tumor tissues were obtained from surgical specimens of three patients who underwent radical surgery for colorectal cancer. Tumor cells were isolated through mechanical and enzymatic dissociation, and the resulting cell suspension was mixed with Matrigel and seeded into a three-dimensional culture system. The histopathological characteristics of the organoids were validated using hematoxylin-eosin (HE) staining and immunohistochemistry, and their genetic consistency was confirmed by short tandem repeat (STR) analysis, demonstrating that this model could reflect both intra- and inter-patient tumor heterogeneity. Standard clinical chemotherapy regimens were applied to the organoid models, and drug sensitivity was assessed using the CellTiter-Glo® 3D cell viability assay. RESULTS The cultured colorectal cancer organoids closely resembled their originating tumors in terms of histopathological and genetic characteristics. Drug sensitivity testing indicated that organoids derived from different patients exhibited varied sensitivities to commonly used chemotherapeutic agents. CONCLUSION The colorectal cancer organoid model successfully established in this study closely recapitulates the histological classification and genetic features of the parent tumors and shows potential for application in vitro chemotherapy sensitivity testing. This model could be used to predict colorectal cancer patients’ responses to chemotherapy, providing valuable reference for personalized medicine.

  • Yinyin YAO, Zhouzhou YE, Weiyu WANG, Mengting LIN, Mingqing HUANG, Yusheng LU
    Chinese Pharmaceutical Journal. 2025, 60(8): 818-827.

    OBJECTIVE To investigate the role and mechanism of phellopterin in preventing breast cancer metastasis. METHODS The cytotoxicity of phellopterin was evaluated by CCK-8 assay and flow cytometry for cell cycle and apoptosis. The effect of phellopterin on the adhesion between cancer cells and vascular endothelial cells was detected by immunofluorescence. The effect of phellopterin on the expression of cell adhesion molecules (CAMs) on the surface of HUVECs was detected by flow cytometry. The effect of phellopterin on the expression of epithelial-mesenchymal transition(EMT) regulatory proteins in cancer cells was detected by Western blot and quantitative real-time reverse transcription polymerase chain reaction(qRT-PCR). The inhibitory effect of phellopterin on lung metastasis of breast cancer in mice was evaluated by a mouse cancer metastasis model. RESULTS Phellopterin exhibits relatively low cytotoxicity and can inhibit the adhesion of cancer cells to HUVECs by reducing the expression of CAMs, such as vascular cell adhesion molecule-1(VCAM-1), intercellular cell adhesion molecule-1(ICAM-1), and E-selectin, which are induced by the inflammatory factor TNF-α. Additionally, phellopterin suppresses the expression of regulatory factors associated with EMT transformation and metastasis-promoting proteins, including tripartite motif containing 22(TRIM22), thrombospondin-1(THBS1), and KIT ligand(KITLG). In a mouse model of cancer metastasis, phellopterin was shown to significantly inhibit breast cancer lung metastasis and enhance the activity of anti-tumor immune cells (cytotoxic T lymphocytes and natural killer cells) in peripheral blood. CONCLUSION Phellopterin shows a significant preventive effect on breast cancer metastasis and holds substantial potential for further development and application.

  • Hui LI, Beiming XU, Xiaolan BIAN
    Chinese Pharmaceutical Journal. 2025, 60(8): 883-890.

    OBJECTIVE To multi-dimensionally analyze the characteristics of adverse drug reaction (ADR) reports of medical institutions at different levels by the method of Pareto anlysis to provide accurate data reference for ADR monitoring and safe drug use in clinic thus to better guarantee public medication safety. METHODS ADR reports of 5 tertiary medical institutions, 7 secondary medical institutions, and 12 primary medical institutions and 7 private medical institutions in a district of Shanghai from 2021 to 2023 were retrospectively collected. The characteristics of ADRs were first explored from the time and the medical institution level dimensions. Then, these collected ADR reports were further analyzed using the method of Pareto diagram analysis to identify the mainly and high-frequencily involved drug categories and organ systems. RESULTS A total of 4 279 ADR reports were collected in this study. General ADRs accounted for 85.91% and chemical drug-induced ADRs accouted for 79.48%. From temporal perspective, the number of ADR reports displayed increasing tendency from 2021 to 2023. The elderly were the most involved age groups of human population. Females were more involved than males. From the perspective of medical institution level, ADR reports of tertiary and secondary medical institutions were much more than primary and private medical institutions. In tertiary and secondary medical institutions, the majority of ADRs were induced by anti-infective drugs, anti-tumor and tumor adjuvant drugs, and medication for mental illnesses. Diseases of skin and its subcutaneous tissues, as well as gastrointestinal system were the most common ADR symptoms. In primary medical units, ADRs were most commonly occurred in elderly people, accounting for 81.58%. The majority of ADRs were induced by traditional Chinese medicine (TCM)preparations and cardiovascular drugs, accounting for 29.26% and 23.07%, respectively. Diseases of gastrointestinal symptoms accounted for 34.21% which were the most common ADR symptoms. CONCLUSION Based on the criteria of Pareto classification, there are significant differences in the main drug categories causing ADRs in different levels of medical institutions, but no significant differences were found in the ADR-involved organ systems. Pareto analysis is a reliable menthod to identify drug categories and ADR symptoms needing intensive monitoring. It would facilitate precise adverse reaction monitoring and enhance clinical medication safety.

  • Hekun DUAN, Xuexin WEI, Xiaowei LU, Yuhui LIU, Jiajia XU, Wei XIONG, Xinli LIANG, Fei HAN
    Chinese Pharmaceutical Journal. 2025, 60(8): 847-855.

    OBJECTIVE To prepare carvacrol (CAR) mixed micelles with temperature-responsive characteristics, optimize the preparation process, and evaluate their properties. METHODS CAR mixed micelles were prepared using the thin-film dispersion method with vitamin E polyethylene glycol 1000 succinate (TPGS) and poly(N-isopropyl acrylamide) (PNIPAM) as carrier materials. The analytic hierarchy process (AHP)-variation coefficient method was employed to assign weights to individual indicators, yielding an overall desirability (OD) score as an evaluation parameter. This score was combined with the response surface method (RSM) to optimize the CAR mixed micelles preparation process, followed by characterization of their physicochemical properties. RESULTS The optimal conditions for preparing CAR mixed micelles were determined as follows: the mass ratio of TPGS to PNIPAM was 9∶1, the amount of carrier was 11 mg, the hydration medium was ultrapure water, the hydration temperature was 50 ℃, the hydration volume was 9.48 mL, and the hydration time was 1 hour. Validation testing showed that the critical micelle concentration (CMC) of CAR mixed micelles was 0.025 mg·mL-1, the encapsulation efficiency was (86.36±2.29)%, the drug loading was (5.54±0.53)%, the particle size was (19.83±1.69) nm, the polydispersity index (PDI) was (0.242±0.080), and the Zeta potential was (-0.105±0.046) mV. The calculated OD value was (87.72±1.03)%, closely approximating the predicted value (86.92%), indicating reliable prediction. The CAR mixed micelles exhibited a spherical shape, uniform distribution without aggregation, and demonstrated good stability. Fourier transform infrared spectroscopy and differential scanning calorimetry confirmed the CAR's presence within the mixed micelles. Temperature sensitivity tests revealed that the CAR mixed micelles had a lower critical solution temperature (LCST) of 37.64 ℃, indicating their temperature-responsive properties. CONCLUSION The optimized CAR mixed micelles exhibit excellent stability and temperature sensitivity, providing a solid experimental foundation and reference for future formulation research.

  • Jingjing WANG, Rui NI, Ziwei LI, Qiuying WU, Shiqi CHENG, Yao LIU, Tongbao LIU
    Chinese Pharmaceutical Journal. 2025, 60(8): 856-865.

    OBJECTIVE To prepare chitosan (CS)/sodium alginate (SA) hydrogel (GelCA@LUT) loaded with luteolin (LUT) nanoparticles (NPs@LUT) as a wound dressing and evaluate its physicochemical properties, as well as its safety. METHODS NPs@LUT were prepared by an emulsion-solvent evaporation method, and hydrogels (GelCA) with different contents of cross-linking agents (genipin) and different CS/SA quality ratios were prepared. Then, the wound dressing (GelCA@LUT) was obtained by coating NPs@LUT on the surface of GelCA. The properties of the hydrogel were evaluated by measuring water vapor transmission rate, water content, water retention, swelling properties, porosity, and rheological properties. The structure and morphology of the hydrogel were characterized using Fourier transform infrared spectroscopy (FTIR), transmission (TEM), and scanning electron microscopy (SEM). The release profiles of LUT from NPs@LUT and GelCA@LUT was examined in different concentrations of hydrogen peroxide/PBS buffer; hemocompatibility and cytotoxicity were tested by hemolytic and cytotoxicity assays, respectively. RESULTS The characterization results showed that the average particle size of NPs@LUT was (234.3±4.7) nm, the drug loading rate was (9.54±0.10)%, and the encapsulation efficiency was (85.35±0.95)%. GelCA with a mass ratio of CS to SA at 1∶2 and a cross-linking agent dosage of 1.0 mg was successfully constructed. Both NPs@LUT and GelCA@LUT could release LUT stably, and GelCA@LUT had good biocompatibility. CONCLUSION GelCA@LUT can accelerate wound regeneration by substantially improving the wound microenvironment.

  • Cheng LI, Weiwei ZHA, Jiangwen SHEN, Qing XIA, Ting LI, Lin LI, Zhenyu HU, Hongli JIANG, Puxun TIAN, Xulong CHEN
    Chinese Pharmaceutical Journal. 2025, 60(7): 680-694.

    Chronic kidney disease(CKD)is a major disease that seriously endangers human health and life, with high morbidity and mortality. It is an urgent problem to find effective treatment methods to control the development. many studies have found that intestinal flora and its metabolites are closely related to the occurrence and development of CKD. Curcumin(CUR)have been shown to be effective in acute kidney injury and CKD. However, CUR has extremely low bioavailability after oral administration and absorption, and the material basis and process mechanism of its pharmacological effects have been controversial. In recent years, the regulatory effect of CUR on intestinal microecology has been extensively studied. It has been reported that high concentrations of CUR exist in the gastrointestinal tract after oral administration, which may mainly play a direct regulatory role in the gastrointestinal tract. Furthermore, a newly proposed theory suggests that CUR may exert its renal protective effects indirectly by affecting the “gut-kidney axis”. Therefore, this review will mainly discuss the close relationship between gut microbiota and its metabolites with CKD, and the therapeutic strategies of CUR targeting gut microbiota to improve CKD, including regulating the composition of gut microbiota, protecting the intestinal mucosal barrier, regulating intestinal inflammatory signal transduction, increasing the content of short-chain fatty acids(SCFAs), and enhancing of gut microbiota-mediated biotransformation of CUR. The future prospect is assessed by us that the metabolites of CUR and microorganisms can beneficially delay the onset and progression of CKD by targeting the intestinal flora and propose the unresolved scientific issues in this area.