1.Optimization of Quality Standards for Polygalae Radix Based on Characteristic Chromatograms and QAMS for Xanthones
Humin XIE ; Xiaoqing CUI ; Weihong FENG ; Yu LU ; Xiaoqian LIU ; Xiaoli SUN ; Yanrong LI ; Zhimin WANG ; Chun LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):196-204
ObjectiveTo address the limitations of the current quality standard for Polygalae Radix(PR), which relies on a single component for quality assessment and struggles to holistically control its intrinsic quality, by constructing a comprehensive quality evaluation system integrating "macro-characterization of chemical profile, synchronous quantification of multiple index components, and quantitative analysis of multi-components by single marker(QAMS) for key component groups". This study aims to facilitate the scientific revision of the quality standard for PR. MethodsHigh performance liquid chromatography(HPLC) characteristic chromatograms were established for 11 batches of PR medicinal materials(YZ), 10 batches of PR decoction pieces(YP), and 10 batches of licorice-processed PR decoction pieces(ZYZ), followed by similarity evaluation and identification of common peaks. HPLC-QAMS was developed for xanthones(sibiricaxanthone B, polygalaxanthone Ⅺ, polygalaxanthone Ⅲ) in the characteristic chromatograms. Simultaneously, the external standard method(ESM) was used to determine the contents of the corresponding xanthones and 3,6'-disinapoyl sucrose in YZ, YP, and ZYZ, followed by multivariate statistical analysis and Spearman correlation analysis. ResultsThe similarity between the characteristic chromatograms of 31 batches of PR samples and the reference chromatogram was>0.9. A total of 13 common peaks were identified, and 10 of these peaks were characterized through reference standard comparison. The successfully constructed QAMS method showed that the relative correction factors(RCFs) of sibiricaxanthone B and polygalaxanthone Ⅺ to polygalaxanthone Ⅲ were 0.76 and 0.88, and their relative retention times(RRTs) were 0.85 and 0.97, respectively. The results calculated by the QAMS method showed no significant difference from those obtained by the ESM. According to the limit standard for polygalaxanthone Ⅲ in the 2020 edition of the Pharmacopoeia of the People's Republic of China(hereinafter referred to as the Chinese Pharmacopoeia), the pass rate of 31 batches of samples was only 19.35%. Multivariate statistical analysis indicated certain compositional differences between different batches of YZ and YP, as well as between YP and ZYZ, with 3,6'-disinapoyl sucrose identified as the main differentiating component. Furthermore, correlation analysis revealed that the content of polygalaxanthone Ⅲ was positively correlated with the contents of sibiricaxanthone B and polygalaxanthone Ⅺ, but showed no association with the content of 3,6'-disinapoyl sucrose. ConclusionIt is recommended that the content limit for polygalaxanthone Ⅲ in YZ,YP and ZYZ be revised to not less than 0.07%, or the total content of polygalaxanthone Ⅲ, sibiricaxanthone B and polygalaxanthone Ⅺ be not less than 0.18%. The newly established triple quality control model of "holistic control via characteristic chromatograms, precise quantification of oligosaccharide esters, and efficient detection of xanthones by QAMS" provides a systematic and precise solution for quality evaluation of PR and similar Chinese herbal medicines.
2.Research Progress on the Risk of Excipients-Related Adverse Reactions in Pharmaceutical Preparations for IBD Treatment
Yanru ZHANG ; Qiuyue TU ; Ping WANG ; Zelin FENG ; Huizhen LI ; Yushan ZHU ; Haojia LIN ; Xinyue WEI ; Qinghua YI ; Hetong ZHANG ; Yueting LI ; Xiaoqin LI ; Yu WANG ; Dong XIE ; Xiaocang CAO
Medical Journal of Peking Union Medical College Hospital 2026;17(4):1135-1142
Patients with inflammatory bowel disease (IBD) require long-term pharmacotherapy. Due to the wide variety of clinically available drugs, medication safety has become increasingly concerning. As an indispensable component of pharmaceutical formulations, drug excipients may induce various adverse reactions, including rash, allergic responses, and gastrointestinal discomfort, and may even lead to severe organic injury. However, they are often overlooked in clinical practice. Therefore, identifying and managing excipient-related adverse reactions is crucial for ensuring medication safety. To address this issue, this article systematically reviews common excipients in IBD therapeutics, the underlying mechanisms of excipient-induced adverse reactions, and corresponding management strategies, aiming to enhance clinicians' awareness of excipient-related issues, improve their ability to recognize and manage such reactions, and ultimately ensure patient safety.
3.Effects of MAGED4 overexpression on proliferation, migration, and adhesion of hepatocellular carcinoma
Sheng ZHANG ; Zhibi ZHANG ; Xiaoqing YU ; Xiaoqiong ZOU ; Yuhang LIU ; Hao LÜ ; Feng LI ; Yanjing WANG ; Bin LUO ; Xiaoxun XIE ; Qingmei ZHANG
Acta Universitatis Medicinalis Anhui 2026;61(9):1558-1567
ObjectiveTo investigate the impact of melanoma-associated antigen D4 (MAGED4) on the malignant biological behavior of hepatocellular carcinoma (HCC), providing experimental evidence for its evaluation as a potential therapeutic target in HCC. MethodsGenes positively correlated with MAGED4 expression in HCC were screened using the LinkedOmics database, followed by GO functional and KEGG pathway enrichment analyses. Endogenously low-expressing SMMC-7721 and Huh7 cells were selected, with normal hepatic LO2 cells serving as controls. Stable overexpression cell lines were established via lentiviral infection (MAGED4 overexpression group), with RT-PCR and Western blot validating overexpression efficiency. The effects of MAGED4 overexpression on cell proliferation, cell cycle distribution, migration, and adhesion were systematically analyzed using CCK-8 assays, flow cytometry, scratch healing assays, Transwell migration assays, and cell adhesion assays. ResultsBioinformatics analysis indicated that MAGED4 co-expressed genes were significantly enriched in biological processes closely associated with tumor proliferation and metastasis, including cell-cell adhesion, extracellular matrix organization, and the PI3K-Akt signaling pathway. A stable MAGED4 overexpression cell model was successfully established. In vitro functional assays demonstrated that MAGED4-overexpressing SMMC-7721 and Huh7 cells exhibited a mesenchymal-like morphology, whereas LO2 cells maintained an epithelial-like morphology. Compared with the empty-virus control groups, the MAGED4-overexpressing groups showed significantly increased proliferative activity (48 h: t=3.887, 22.070, 8.866, all P<0.05; 72 h: t=3.231, 23.840, 9.848, all P<0.05; 96 h: t=5.123, 49.800, 5.909, P<0.05, P<0.01, P<0.05), wound healing rates (12 h: F=40.90, 44.00, 200.50, all P<0.001; 24 h: F=112.00, 34.89, 249.20, all P<0.001), and numbers of migrated cells (F=239.20, 59.79, 132.80, all P<0.001), along with significantly decreased numbers of adherent cells (F=73.65, 85.91, 138.00, all P<0.001), while no significant differences were observed in cell cycle phase distribution in all three cell lines. ConclusionMAGED4 enhances proliferation and migration while suppressing adhesion in both HCC and normal hepatocytes, however, induces mesenchymal-like morphological changes exclusively in HCC cells, suggesting that MAGED4 is capable of driving HCC progression and may serve as a potential therapeutic target for HCC.
4.Interpretation and Enlightenment of Expert Consensus on Clinical Application of Yifei Zhike Capsules
Wenye FENG ; Hongchun ZHANG ; Xuefeng YU ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Jing REN ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(23):178-185
ObjectiveTo interpret the main contents of the Expert Consensus on Clinical Application of Yifei Zhike Capsules (hereinafter referred to as the Consensus), analyze its evidence basis, and explore future research directions, thus providing a reference for rational drug use in clinical practice. MethodsThe core contents of the Consensus are summarized. Focusing on clinical issues, this paper summarizes the recommendations and consensus suggestions in the Consensus and explains them from aspects such as indications, key advantages, usage and dosage, combined medication, contraindications, precautions, and safety. ResultsThe Consensus clearly states that Yifei Zhike capsules can be used for acute or chronic bronchitis, pulmonary tuberculosis and other respiratory system diseases. It for the first time proposes that the applicable TCM syndrome of Yifei Zhike capsules is Qi-Yin deficiency together with combined phlegm and stasis. For different diseases, the Consensus provides specific usage instructions, dosage, and treatment course recommendations, supplementing the contents not covered in the drug instructions. In terms of combined medication, the Consensus emphasizes the principle of using this drug in combination with standardized chemotherapy regimens or conventional Western medicines and the applicability for the treatment of pulmonary tuberculosis and moderate to severe acute or chronic bronchitis. In terms of safety, the Consensus proposes methods for identifying common adverse reactions, drug contraindications, and precautions based on a review of the existing data and preliminarily builds a risk management framework. However, the evidence on which the Consensus is based are mostly early studies, with small sample sizes, which result in the low evidence grades (mainly C and D) of some recommendations. ConclusionThe Consensus provides specific guidance for the clinical use of Yifei Zhike capsules. However, due to the limited quality of the existing research evidence, more high-quality clinical studies are needed in the future to further verify its efficacy, safety, and explore its broader application prospects.
5.Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B: Detailed Analysis of Treatment-Naive and Experienced Patients
Yu-Xuan SONG ; Guang-Jun SONG ; Hui MA ; Bo FENG ; Yan-Di XIE
The Korean Journal of Gastroenterology 2025;85(1):64-72
Background/Aims:
This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings.
Methods:
Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study.
Results:
One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log10IU/mL vs. 3.97 log10IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m2 (p=0.02) and HBsAg <3.3 log10IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log10IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups.
Conclusions
Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m2 and HBsAg <3.3 log10IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.
6.Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B: Detailed Analysis of Treatment-Naive and Experienced Patients
Yu-Xuan SONG ; Guang-Jun SONG ; Hui MA ; Bo FENG ; Yan-Di XIE
The Korean Journal of Gastroenterology 2025;85(1):64-72
Background/Aims:
This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings.
Methods:
Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study.
Results:
One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log10IU/mL vs. 3.97 log10IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m2 (p=0.02) and HBsAg <3.3 log10IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log10IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups.
Conclusions
Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m2 and HBsAg <3.3 log10IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.
7.Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B: Detailed Analysis of Treatment-Naive and Experienced Patients
Yu-Xuan SONG ; Guang-Jun SONG ; Hui MA ; Bo FENG ; Yan-Di XIE
The Korean Journal of Gastroenterology 2025;85(1):64-72
Background/Aims:
This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings.
Methods:
Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study.
Results:
One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log10IU/mL vs. 3.97 log10IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m2 (p=0.02) and HBsAg <3.3 log10IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log10IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups.
Conclusions
Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m2 and HBsAg <3.3 log10IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.
8.Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B: Detailed Analysis of Treatment-Naive and Experienced Patients
Yu-Xuan SONG ; Guang-Jun SONG ; Hui MA ; Bo FENG ; Yan-Di XIE
The Korean Journal of Gastroenterology 2025;85(1):64-72
Background/Aims:
This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings.
Methods:
Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study.
Results:
One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log10IU/mL vs. 3.97 log10IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m2 (p=0.02) and HBsAg <3.3 log10IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log10IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups.
Conclusions
Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m2 and HBsAg <3.3 log10IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.
9.Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B: Detailed Analysis of Treatment-Naive and Experienced Patients
Yu-Xuan SONG ; Guang-Jun SONG ; Hui MA ; Bo FENG ; Yan-Di XIE
The Korean Journal of Gastroenterology 2025;85(1):64-72
Background/Aims:
This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings.
Methods:
Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study.
Results:
One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log10IU/mL vs. 3.97 log10IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m2 (p=0.02) and HBsAg <3.3 log10IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log10IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups.
Conclusions
Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m2 and HBsAg <3.3 log10IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.
10.Gas Chromatography-Infrared Spectroscopy Assisted Gas Chromatography-Mass Spectrometry for Identification of Alkyl Phosphonate Isomers
Mei-Qi ZHAO ; Yu-Long LIU ; Qin LIU ; Wei YOU ; Jian-Feng WU ; Hai-Xia WU ; Jia CHEN ; Jian-Wei XIE
Chinese Journal of Analytical Chemistry 2025;53(2):269-277
Organophosphorus nerve agents are the most threatening chemical warfare agents and terrorist agents.The number of nerve agents and their related chemicals involved in the verification of Chemical Weapon Convention(CWC)exceeds ten million,with the majority being isomers.Accurate structural identification of these chemicals has always been one of the challenges in CWC related verification analysis.In this work,a total of 17 kinds of alkyl phosphonate isomers and structural analogs from 5 groups were designed and synthesized,and then analyzed by gas chromatography-mass spectrometry(GC-MS)and gas chromatography-infrared spectroscopy(GC-FTIR).The spectra of isomers or structural analogs obtained from two techniques as well as the structural information provided therein were compared and analyzed.The results showed that for isomers or structural analogs with similar MS spectra,FTIR spectra could provided more structural fingerprint information of compounds and had advantages in confirming structures.Combined with the excellent separation ability of GC,GC-FTIR can be used to assist GC-MS in the structural confirmation of alkyl phosphates,achieving rapid and accurate identification of isomers or structural analogues.

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