Saponins associated with Panax notoginseng (P. notoginseng) demonstrate significant therapeutic efficacy across multiple diseases. However, certain high-yield saponins face limited clinical applications due to their reduced pharmacological efficacy. This study synthesized and evaluated 36 saponin-1,2,3-triazole derivatives of ginsenosides Rg1/Rb1 and notoginsenoside R1 for anti-adipogenesis activity in vitro. The research revealed that the ginsenosides Rg1-1,2,3-triazole derivative a17 demonstrates superior adipogenesis inhibitory effects. Structure-activity relationships (SARs) analysis indicates that incorporating an amidyl-substituted 1,2,3-triazole into the saponin side chain via Click reaction enhances anti-adipogenesis activity. Additionally, several other derivatives exhibit general adipogenesis inhibition. Compound a17 demonstrated enhanced potency compared to the parent ginsenoside Rg1. Mechanistic investigations revealed that a17 exhibits dose-dependent inhibition of adipogenesis in vitro, accompanied by decreased expression of preadipocytes. Peroxisome proliferator-activated receptor γ (PPARγ), fatty acid synthase (FAS), and fatty acid binding protein 4 (FABP4) adipogenesis regulators. These findings establish the ginsenoside Rg1-1,2,3-triazole derivative a17 as a promising adipocyte differentiation inhibitor and potential therapeutic agent for obesity and associated metabolic disorders. This research provides a foundation for developing effective therapeutic approaches for various metabolic syndromes.
Adipogenesis/drug effects* ; Triazoles/chemical synthesis* ; Ginsenosides/chemical synthesis* ; Saponins/chemical synthesis* ; Animals ; Mice ; Structure-Activity Relationship ; PPAR gamma/genetics* ; 3T3-L1 Cells ; Adipocytes/metabolism* ; Panax notoginseng/chemistry* ; Drug Design ; Molecular Structure ; Humans ; Cell Differentiation/drug effects* ; Fatty Acid-Binding Proteins/genetics*

Objective:To systematically integrate the best available evidence on non-pharmacological management of functional gastrointestinal symptoms (FGIDs) in patients with inflammatory bowel disease (IBD), providing evidence-based support for clinical practice.Methods:Evidence related to non-pharmacological management of FGIDs in IBD patients, including guidelines, clinical decision documents, evidence summaries, expert consensus statements, and systematic reviews, was systematically retrieved from domestic and international professional websites and databases. The search period covered February 27, 2016 to February 27, 2025. Literature was screened and appraised for quality.Results:A total of 15 studies were included. A total of 32 items of evidence were summarized across 10 aspects: multidisciplinary management, screening, assessment, dietary management, exercise management, psychological management, skin care, traditional Chinese medicine interventions, physical interventions, and health education and follow-up.Conclusions:The summarized best evidence for non-pharmacological management of FGIDs in IBD patients provides scientific and systematic guidance for healthcare professionals, helping them better identify and manage FGIDs in this population.

Objective:To systematically integrate the best available evidence on non-pharmacological management of functional gastrointestinal symptoms (FGIDs) in patients with inflammatory bowel disease (IBD), providing evidence-based support for clinical practice.Methods:Evidence related to non-pharmacological management of FGIDs in IBD patients, including guidelines, clinical decision documents, evidence summaries, expert consensus statements, and systematic reviews, was systematically retrieved from domestic and international professional websites and databases. The search period covered February 27, 2016 to February 27, 2025. Literature was screened and appraised for quality.Results:A total of 15 studies were included. A total of 32 items of evidence were summarized across 10 aspects: multidisciplinary management, screening, assessment, dietary management, exercise management, psychological management, skin care, traditional Chinese medicine interventions, physical interventions, and health education and follow-up.Conclusions:The summarized best evidence for non-pharmacological management of FGIDs in IBD patients provides scientific and systematic guidance for healthcare professionals, helping them better identify and manage FGIDs in this population.

Objective:To establish ICP-MS method for determining the Class 1 and Class 2A elemental impurities in pharmaceutical excipients polysorbates according to ICH Q3D(R2)Guidelines.Class 1 elemental impurities include As,Cd,Hg and Pb;Class 2A elemental impurities include Co,Ni and V.Methods:The analysis was performed using ICP-MS with the following parameters.Plasma mode:HMI-8,carrier gas:He,sampling depth:10.0 mm.RF power:1 600 W,the carrier gas flow,the nebulizer gas flow and the auxiliary gas flow were all 0.8 L·min-1.The plasma gas flow was 15.0 L·min-1.The speed of nebulizer pump was0.10 r·min-1.The temperature of atomizer chamber was 2.0℃.Analytical method:internal standard method.Results:The correla-tion coefficient for all elemental impurities was not less than 0.999.Spiked recoveries ranged between 85%-115.0%,with RSD is not more than 5.0%.The RSD of precision rate was not more than 10.0%.The contents of 7 elemental impurities in 15 batches of the samples were all less than PDE for injection set by ICH Q3D(R2)guidelines.Conclusion:The developed ICP-MS method demonstrates high sensitivity,good precision,and accuracy,making it suitable for controlling the Class 1 and Class 2A elemental impurities in polysorbate pharma-ceutical excipients.The results shows low risks of elemental impurities in commercial pharmaceutical excipients polysorbates.

Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.

Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

Objective To observe the value of contrast-enhanced ultrasound(CEUS)for evaluating DeBakey Ⅰ aortic dissection involved renal artery.Methods Totally 137 patients with DeBakey Ⅰ aortic dissection involved renal artery were retrospectively enrolled,including 132 cases involved unilateral and 5 cases involved bilateral renal arteries.The opening of totally 274 renal arteries in bilateral kidneys were observed.Taken CT angiography(CTA)as reference standard,the renal artery opened in true lumen was considered as unaffected,while opened in false lumen or true-false lumen were both considered as affected.Relative CEUS manifestations were observed,and their value for evaluating involved renal artery or not were analyzed.Results CTA showed that 132 renal arteries opened in true lumens,90 opened in false lumens and 52 opened in true-false lumens.CEUS diagnosed 131 renal arteries opened in true lumens,111 opened in false lumens and 32 opened in true-false lumens,and the sensitivity for diagnosing DeBakey Ⅰ aortic dissection involved renal artery was 90.84％,81.08％and 90.63％,respectively.The consistency between CEUS and CTA for evaluating renal artery opened in true lumen or false lumen was good(Kappa=0.786).Logistic regression analysis showed that the time to peak(TTP)and peak intensity(PI)of time intensity curve(TIC)were both impact factors for differentiating renal artery opened in true lumen or false lumen,as well as true lumen or true-false lumen(both P＜0.05),while the area under the curve(AUC)of TIC was impact factor for differentiating renal artery opened in true lumen or false lumen(P＜0.05).The AUC of receiver operating characteristic curve of the combination of TTP,PI and AUC of TIC for differentiating renal artery opened in true lumen or false lumen,true lumen or true-false lumen and false lumen or true-false lumen was 0.703,0.686 and 0.493,respectively.Conclusion CEUS was helpful for evaluating DeBakey Ⅰ aortic dissection involved renal artery.

Objective To observe the value of contrast-enhanced ultrasound(CEUS)for evaluating DeBakey Ⅰ aortic dissection involved renal artery.Methods Totally 137 patients with DeBakey Ⅰ aortic dissection involved renal artery were retrospectively enrolled,including 132 cases involved unilateral and 5 cases involved bilateral renal arteries.The opening of totally 274 renal arteries in bilateral kidneys were observed.Taken CT angiography(CTA)as reference standard,the renal artery opened in true lumen was considered as unaffected,while opened in false lumen or true-false lumen were both considered as affected.Relative CEUS manifestations were observed,and their value for evaluating involved renal artery or not were analyzed.Results CTA showed that 132 renal arteries opened in true lumens,90 opened in false lumens and 52 opened in true-false lumens.CEUS diagnosed 131 renal arteries opened in true lumens,111 opened in false lumens and 32 opened in true-false lumens,and the sensitivity for diagnosing DeBakey Ⅰ aortic dissection involved renal artery was 90.84％,81.08％and 90.63％,respectively.The consistency between CEUS and CTA for evaluating renal artery opened in true lumen or false lumen was good(Kappa=0.786).Logistic regression analysis showed that the time to peak(TTP)and peak intensity(PI)of time intensity curve(TIC)were both impact factors for differentiating renal artery opened in true lumen or false lumen,as well as true lumen or true-false lumen(both P＜0.05),while the area under the curve(AUC)of TIC was impact factor for differentiating renal artery opened in true lumen or false lumen(P＜0.05).The AUC of receiver operating characteristic curve of the combination of TTP,PI and AUC of TIC for differentiating renal artery opened in true lumen or false lumen,true lumen or true-false lumen and false lumen or true-false lumen was 0.703,0.686 and 0.493,respectively.Conclusion CEUS was helpful for evaluating DeBakey Ⅰ aortic dissection involved renal artery.

Objective:To establish ICP-MS method for determining the Class 1 and Class 2A elemental impurities in pharmaceutical excipients polysorbates according to ICH Q3D(R2)Guidelines.Class 1 elemental impurities include As,Cd,Hg and Pb;Class 2A elemental impurities include Co,Ni and V.Methods:The analysis was performed using ICP-MS with the following parameters.Plasma mode:HMI-8,carrier gas:He,sampling depth:10.0 mm.RF power:1 600 W,the carrier gas flow,the nebulizer gas flow and the auxiliary gas flow were all 0.8 L·min-1.The plasma gas flow was 15.0 L·min-1.The speed of nebulizer pump was0.10 r·min-1.The temperature of atomizer chamber was 2.0℃.Analytical method:internal standard method.Results:The correla-tion coefficient for all elemental impurities was not less than 0.999.Spiked recoveries ranged between 85%-115.0%,with RSD is not more than 5.0%.The RSD of precision rate was not more than 10.0%.The contents of 7 elemental impurities in 15 batches of the samples were all less than PDE for injection set by ICH Q3D(R2)guidelines.Conclusion:The developed ICP-MS method demonstrates high sensitivity,good precision,and accuracy,making it suitable for controlling the Class 1 and Class 2A elemental impurities in polysorbate pharma-ceutical excipients.The results shows low risks of elemental impurities in commercial pharmaceutical excipients polysorbates.

Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.