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 Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
3.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
4.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
5.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
6.The Role of Gut Microbiota in Male Erectile Dysfunction of Rats
Zhunan XU ; Shangren WANG ; Chunxiang LIU ; Jiaqi KANG ; Yang PAN ; Zhexin ZHANG ; Hang ZHOU ; Mingming XU ; Xia LI ; Haoyu WANG ; Shuai NIU ; Li LIU ; Daqing SUN ; Xiaoqiang LIU
The World Journal of Men's Health 2025;43(1):213-227
Purpose:
Erectile dysfunction (ED) is a common male sexual dysfunction. Gut microbiota plays an important role in various diseases. To investigate the effects and mechanisms of intestinal flora dysregulation induced by high-fat diet (HFD) on erectile function.
Materials and Methods:
Male Sprague–Dawley rats aged 8 weeks were randomly divided into the normal diet (ND) and HFD groups. After 24 weeks, a measurement of erectile function was performed. We performed 16S rRNA sequencing of stool samples. Then, we established fecal microbiota transplantation (FMT) rat models by transplanting fecal microbiota from rats of ND group and HFD group to two new groups of rats respectively. After 24 weeks, erectile function of the rats was evaluated and 16S rRNA sequencing was performed, and serum samples were collected for the untargeted metabolomics detection.
Results:
The erectile function of rats and the species diversity of intestinal microbiota in the HFD group was significantly lower, and the characteristics of the intestinal microbiota community structure were also significantly different between the two groups. The erectile function of rats in the HFD-FMT group was significantly lower than that of rats in the ND-FMT group. The characteristics of the intestinal microbiota community structure were significantly different. In the HFD-FMT group, 27 metabolites were significantly different and they were mainly involved in the several inflammation-related pathways.
Conclusions
Intestinal microbiota disorders induced by HFD can damage the intestinal barrier of rats, change the serum metabolic profile, induce low-grade inflammation and apoptosis in the corpus cavernosum of the penis, and lead to ED.
7.RCAN-DDI: Relation-aware cross adversarial network for drug-drug interaction prediction.
Yuanyuan ZHANG ; Xiaoyu XU ; Baoming FENG ; Haoyu ZHENG ; Ci'ao ZHANG ; Wentao XU ; Zengqian DENG
Journal of Pharmaceutical Analysis 2025;15(9):101159-101159
Drug-drug interaction (DDI) refers to the interaction between two or more drugs in the body, altering their efficacy or pharmacokinetics. Fully considering and accurately predicting DDI has become an indispensable part of ensuring safe medication for patients. In recent years, many deep learning-based methods have been proposed to predict DDI. However, most existing computational models tend to oversimplify the fusion of drug structural and topological information, often relying on methods such as splicing or weighted summation, which fail to adequately capture the potential complementarity between structural and topological features. This loss of information may lead to models that do not fully leverage these features, thus limiting their performance in DDI prediction. To address these challenges, we propose a relation-aware cross adversarial network for predicting DDI, named RCAN-DDI, which combines a relationship-aware structure feature learning module and a topological feature learning module based on DDI networks to capture multimodal features of drugs. To explore the correlations and complementarities among different information sources, the cross-adversarial network is introduced to fully integrate features from various modalities, enhancing the predictive performance of the model. The experimental results demonstrate that the RCAN-DDI method outperforms other methods. Even in cases of labelled DDI scarcity, the method exhibits good robustness in the DDI prediction task. Furthermore, the effectiveness of the cross-adversarial module is validated through ablation experiments, demonstrating its superiority in learning multimodal complementary information.
8.Exploration on Syndrome Differentiation Thinking for Stress Sensitization-induced Depression from the Perspective of"Deficient Qi with Stagnation and Heat"
Xu CHEN ; Jing CAO ; Qianlin JIA ; Lingyun XI ; Yang BAI ; Haoyu PANG ; Xia HONG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(1):11-14
TCM proposes that the core pathological mechanism of depression is"deficient qi with stagnation and heat",with the following pathogenic characteristics and evolution patterns:"deficient qi"as the nature,and deficiency in nature is in spleen,and deficiency in superficiality is in brain;"stagnation"is the superficiality,and qi stagnation,phlegm stagnation,and blood stagnation are in the brain collaterals;"heat"fires the brain collaterals,depression raised the heat,and excessive heat accumulated to stagnation.Based on the understanding of the pathogenesis of depression caused by stress sensitization in modern medicine,this article explored the potential association between this mechanism and the core pathogenesis of"deficient qi with stagnation and heat".It proposed that tonifying deficiency,promoting circulation,and clearing heat are the basic treatment principles for depression.By inhibiting inflammatory reactions and improving the stress sensitization state of neurons and glial cells,TCM compound formulas can exert multi-target and multi-dimensional therapeutic characteristics.
9.Study on the predictive value of the CT pulmonary angiography parameters from the 2022 ESC/ERS guidelines for chronic thromboembolic pulmonary hypertension
Wenqing XU ; Haoyu YANG ; Anqi LIU ; Mei DENG ; Linfeng XI ; Qiang HUANG ; Wanmu XIE ; Min LIU
Journal of Practical Radiology 2024;40(7):1056-1061
Objective To assess the predictive value of computed tomography pulmonary angiography(CTPA)cardiovascular parame-ters for chronic thromboembolic pulmonary hypertension(CTEPH)under the 2022 European Society of Cardiology/European Respiratory Society(ESC/ERS)guidelines,and to compare with the 2021 Chinese guidelines.Methods A total of 201 suspected CTEPH patients were retrospectively selected.All patients underwent right heart catheterization(RHC)and CTPA evaluation.According to the Euro-pean guidelines,they were divided into three groups:mean pulmonary artery pressure(mPAP)≤20 mmHg control group(63 cases)(1 mmHg=0.133 kPa),mPAP>20 mmHg CTEPH group(138 cases),and mPAP≥25 mmHg CTEPH group(123 cases).Inter-group comparison of CTPA cardiovascular parameters was performed,and receiver operating characteristic(ROC)curve analysis was performed for each parameter.Results Under the 2022 European guidelines,the diagnostic efficacy of the diameter of the main pulmonary artery trunk(MPAd)was the highest[area under the curne(AUC)was 0.933].The binary logistic regression analysis revealed that the MP Ad,right ventricular free wall thickness(RVWT),and interventricular septal angle(IVSA)were inde-pendent risk factors for the diagnosis of CTEPH(P<0.05).Under both the Chinese and European guidelines,the MPAd,the transverse diameter and area of the right atrium,the transverse diameter and area of the bi-ventricle,the RVWT,and the IVSA showed significant statistical differences in CTEPH and control groups(P<0.05).Conclusion Under both the Chinese and European guidelines,the MP Ad measured by CTPA has the highest diagnostic efficacy for CTEPH,while the IVSA has the strongest correlation with clinical prognostic indicators.The right atrium structure also has evaluation value.
10.Cytokines expression in intraocular fluid in neovascular glaucoma: a meta-analysis
Shuqing ZHU ; Jinyuan CHEN ; Mengtian ZHOU ; Jie DU ; Shuxia XU ; Haoyu LI ; Yuanbo LIANG
Chinese Journal of Experimental Ophthalmology 2024;42(6):538-546
Objective:To systemically evaluate the characteristics of cytokine levels in intraocular fluid of neovascular glaucoma (NVG).Methods:Literature on the detection of cytokine levels in NVG published before June 2022 was searched in PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang databases, and China Science and Technology Journal Database (VIP).Two investigators independently completed the literature search, inclusion, and data extraction following the inclusion and exclusion criteria.Quantitative analyses were performed using Stata 16.0 software.Study heterogeneity was assessed using the I2 test, and effects were combined using the appropriate effect model to complete the meta-analysis. Results:A total of 24 studies were screened, including 771 NVG cases and 727 age-related cataract cases (control group).The standardized mean difference ( SMD) of the combined effect value of vascular endothelial growth factor (VEGF) mass concentration in the aqueous humor between the two groups was 8.79, with a 95% confidence interval ( CI) of 6.43 to 11.14.The SMD of interleukin-6 (IL-6) between the two groups was 12.50, with a 95% CI of 9.41 to 15.58.The VEGF and IL-6 levels in aqueous humor and vitreous humor were significantly higher in NVG group than in control group (all at P<0.05).The pigment epithelium-derived factor (PEDF) level in aqueous humor was lower in NVG group than in control group ( SMD: -3.03, 95% CI: -5.50--0.55, P<0.05).The levels of IL-8 ( SMD: 3.99, 95% CI: 1.14-6.85), erythropoietin (EPO) ( SMD: 9.62, 95% CI: 0.44-18.79), placental growth factor (PIGF) ( SMD: 2.62, 95% CI: 1.38-3.86), tumor necrosis factor-α (TNF-α) ( SMD: 3.37, 95% CI: 1.87-4.87) were all significantly higher in NVG group than in control group (all at P<0.05).There was no significant difference in IL-1β level in aqueous humor between the two groups ( P>0.05). Conclusions:In NVG patients, VEGF, IL-6, IL-8, EPO, PIGF, TNF-α levels are obviously increased and PEDF level is obviously decreased.These biomarkers can be used as potential predictors or therapeutic targets for NVG.

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