1.Quality Evaluation of Naomaili Granules Based on Multi-component Content Determination and Fingerprint and Screening of Its Anti-neuroinflammatory Substance Basis
Ya WANG ; Yanan KANG ; Bo LIU ; Zimo WANG ; Xuan ZHANG ; Wei LAN ; Wen ZHANG ; Lu YANG ; Yi SUN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):170-178
ObjectiveTo establish an ultra-performance liquid fingerprint and multi-components determination method for Naomaili granules. To evaluate the quality of different batches by chemometrics, and the anti-neuroinflammatory effects of water extract and main components of Naomaili granules were tested in vitro. MethodsThe similarity and common peaks of 27 batches of Naomaili granules were evaluated by using Ultra performance liquid chromatography (UPLC) fingerprint detection. Ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology was used to determine the content of the index components in Naomaili granules and to evaluate the quality of different batches of Naomaili granules by chemometrics. LPS-induced BV-2 cell inflammation model was used to investigate the anti-neuroinflammatory effects of the water extract and main components of Naomaili granules. ResultsThe similarity of fingerprints of 27 batches of samples was > 0.90. A total of 32 common peaks were calibrated, and 23 of them were identified and assigned. In 27 batches of Naomaili granules, the mass fractions of 14 components that were stachydrine hydrochloride, leonurine hydrochloride, calycosin-7-O-glucoside, calycosin,tanshinoneⅠ, cryptotanshinone, tanshinoneⅡA, ginsenoside Rb1, notoginsenoside R1, ginsenoside Rg1, paeoniflorin, albiflorin, lactiflorin, and salvianolic acid B were found to be 2.902-3.498, 0.233-0.343, 0.111-0.301, 0.07-0.152, 0.136-0.228, 0.195-0.390, 0.324-0.482, 1.056-1.435, 0.271-0.397, 1.318-1.649, 3.038-4.059, 2.263-3.455, 0.152-0.232, 2.931-3.991 mg∙g-1, respectively. Multivariate statistical analysis showed that paeoniflorin, ginsenoside Rg1, ginsenoside Rb1 and staphylline hydrochloride were quality difference markers to control the stability of the preparation. The results of bioactive experiment showed that the water extract of Naomaili granules and the eight main components with high content in the prescription had a dose-dependent inhibitory effect on the release of NO in the cell supernatant. Among them, salvianolic acid B and ginsenoside Rb1 had strong anti-inflammatory activity, with IC50 values of (36.11±0.15) mg∙L-1 and (27.24±0.54) mg∙L-1, respectively. ConclusionThe quality evaluation method of Naomaili granules established in this study was accurate and reproducible. Four quality difference markers were screened out, and eight key pharmacodynamic substances of Naomaili granules against neuroinflammation were screened out by in vitro cell experiments.
2.Effect of Ningying Formula (宁瘿方) Combined with Low-Dose Antithyroid Drugs on Reducing Relapse Risk for Patients with Graves' Hyperthyroidism in Remission Stage:A Retrospective Cohort Study
Yuqin HUANG ; Mingshuai ZHANG ; Shijian LIU ; Feng TAO ; Yi CHEN
Journal of Traditional Chinese Medicine 2026;67(1):45-52
ObjectiveTo evaluate the effect of Ningying Formula (宁瘿方) combined with low-dose antithyroid drugs (ATDs) on the relapse risk for patients with Graves' hyperthyroidism (GH) during the remission phase, and to analyze the related factors between GH relapse and thyrotropin receptor antibody (TRAb) negativity, so as to provide evidence for the standardized management of GH in remission stage. MethodsA single-center retrospective cohort study was conducted, including 269 GH patients in the remission stage. After propensity score matching (PSM), 102 matched pairs (204 patients) were established. The control group received low-dose ATDs as maintenance therapy, while the exposure group received the core Ningying Formula in addition to low-dose ATDs. The primary outcome was the GH recurrence rate; the secondary outcome was the thyrotropin receptor antibody (TRAb) negativity rate (TRAb<1.75 IU/L). Safety outcomes included treatment-related adverse events. Differences between groups were assessed using Cox regression models and Kaplan-Meier curves, with sensitivity analysis performed using inverse probability of treatment weighting (IPTW). ResultsThe median follow-up in the matched cohort was 28.07 months. Regarding the GH recurrence outcome, the recurrence rate in the exposure group (18/102, 17.6%) was significantly lower than that in the control group (31/102, 30.4%; χ²=4.539, P=0.033); regarding the TRAb negativity outcome, the TRAb negativity rate in the exposure group (50/102, 49.0%) was significantly higher than that in the control group (23/102, 22.5%; χ²=15.551, P<0.001). Multivariate Cox regression analysis for recurrence showed that Ningying Formula treatment reduced the risk of recurrence [HR=0.324, 95%CI(0.170, 0.617), P<0.001]. Male [HR=2.209, 95%CI(1.079, 4.520), P=0.030], higher initial TRAb level [per 1 IU/L increase: HR=1.033, 95%CI(1.003, 1.064), P=0.032], and larger thyroid volume [per 1 ml increase: HR=1.045, 95%CI(1.003, 1.088), P=0.035] were identified as independent risk factors for recurrence; multivariate Cox regression analysis for TRAb negativity indicated that Ningying Formula treatment promoted TRAb negativity [HR=1.826, 95%CI(1.091, 3.056), P=0.022], while a higher initial TRAb level was associated with a lower probability of negativity [HR=0.974, 95%CI(0.950, 0.998), P=0.032]. Survival analysis showed significant differences in relapse rate between groups (Log-Rank P=0.003) and in TRAb outcomes (Log-Rank P=0.034). The incidence of treatment-related adverse events was similar between groups (P=0.757). The IPTW sensitivity analysis was consistent with the primary analysis, indicating robust results. ConclusionThe Ningying Formula combined with low-dose ATDs can significantly reduce the risk of recurrence and can improve the TRAb negativity rate in GH patients during the remission stage, without increasing common adverse events, making it an optional strategy for reducing relapse risk during remission. Male gender, higher baseline TRAb level, and larger thyroid volume indicate a higher risk of recurrence, warranting focused follow-up and stratified management.
3.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.
4.Progress in the application of poloxamer in new preparation technology
Xue QI ; Yi CHENG ; Nan LIU ; Zengming WANG ; Hui ZHANG ; Aiping ZHENG ; Dongzhou KANG
China Pharmacy 2025;36(5):630-635
Poloxamer, as a non-ionic surfactant, exhibits a unique triblock [polyethylene oxide-poly (propylene oxide)-polyethylene oxide] structure, which endows it with broad application potential in various fields, including solid dispersion technology, nanotechnology, gel technology, biologics, gene engineering and 3D printing. As a carrier, it enhances the solubility and bioavailability of poorly soluble drugs. In the field of nanotechnology, it serves as a stabilizer etc., enriching preparation methods. In gel technology, its self-assembly behavior and thermosensitive properties facilitate controlled drug release. In biologics, it improves targeting efficiency and reduces side effects. In gene engineering, it enhances delivery efficiency and expression levels. In 3D printing, it provides novel strategies for precise drug release control and the production of high-quality biological products. As a versatile material, poloxamer holds promising prospects in the pharmaceutical field.
5.Finite element analysis of three internal fixation modalities for treatment of Pauwels type Ⅲ femoral neck fractures under different loading conditions
Zhenggang LI ; Xuehong SHANG ; Zhang WU ; Hong LI ; Chaojun SUN ; Huadong CHEN ; Zhe SUN ; Yi YANG
Chinese Journal of Tissue Engineering Research 2025;29(3):455-463
BACKGROUND:There is still no consensus on the optimal internal fixation for the treatment of Pauwels Ⅲ femoral neck fracture,and most of the related finite element analyses have been performed using a single simplified loading condition,and the biomechanical properties of commonly used internal fixation devices need to be further investigated. OBJECTIVE:To analyze the biomechanical characteristics of Pauwels Ⅲ femoral neck fractures treated with cannulated compression screw,dynamic hip screw,and femoral neck system by finite element method under different loading conditions of single-leg standing loads and sideways fall loads. METHODS:The DICOM data of healthy adult femur were obtained by CT scanning,imported into Mimics 15.0 software to obtain the rough model of bone tissue.The data exported from Mimics were optimized by Geomagics software,and then three internal fixation models were built and assembled with the femur model according to the parameters of the clinical application of the cannulated compression screw,dynamic hip screw,and femoral neck system by using Pro/E software.Finally,the three internal fixation models were imported into Ansys software for loading and calculation to analyze the stress distribution and displacement of the femur and the internal fixation under different working conditions of single-leg standing loads and sideways fall loads,as well as the stress characteristics of the calcar femorale and Ward's triangle. RESULTS AND CONCLUSION:(1)Under the single-leg standing load and the sideways fall load,the proximal femoral stress of the three internal fixation models was mainly distributed above the fracture end of the femoral neck.The peak stress of the proximal femoral end,fracture end,Ward triangle,and calcar femorale of the three internal fixation models were the smallest in the femoral neck system model and the largest in the cannulated compression screw model.(2)Under the single-leg standing load and the sideways fall load,the peak displacement of the proximal femur of the three internal fixation models was all located at the top of the femoral head,and the peak displacement was the smallest in the femoral neck system model and the largest in the cannulated compression screw model.(3)The peak displacement of the three internal fixation models was all located at the top of the internal fixation device under the single-leg standing and sideways fall loading conditions,and the peak displacement values were the smallest in the femoral neck system internal fixation model and the largest in the cannulated compression screw internal fixation model.(4)The internal fixation stress of the three internal fixation models was mainly distributed in the area near the fracture end of the internal fixation device under the single-leg standing and sideways fall loads,and the peak value of internal fixation stress was the smallest in the femoral neck system model and the largest in the cannulated compression screw model.(5)These results suggest that the mechanical stability of the femoral neck system is the best,but there may be a risk of stress shielding of the fracture end and calcar femorale.The stress of the internal fixation device of the femoral neck system is more dispersed,and the risk of internal fixation break is lower.
6.Effect of Various Factors on Non-suicidal Self-injury in Adolescent Depression
Yi MIAO ; Junyi LI ; Peishan HUANG ; Ke WANG ; Xuelin ZHANG ; Qiangli DONG
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(1):123-131
ObjectiveTo investigate the non-suicidal self-injury (NSSI) behaviors in adolescents with depressive disorder, analyze related influencing factors, and provide theoretical basis and reference for the prevention and treatment of NSSI. MethodsAccording to DSM-5 criteria, 95 depressive adolescents were divided into two groups: one with NSSI (NSSI group) and one without NSSI (nNSSI group). All patients were assessed with Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ), Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Simplified Coping Style Questionnaire (SCSQ), Experiences in Close Relationships-Relationship Structures Scale (ECR-RS), and Childhood Trauma Questionnaire-Short Form (CTQ-SF). The inter-group differences were compared. The influencing factors of NSSI were analyzed by using binary logistic regression. ResultsOf the 95 depressive adolescents, 59 cases of NSSI were identified, with a detection rate of 62.11%. NSSI group had higher scores than nNSSI group on SDS, SAS, negative coping style, paternal attachment anxiety, maternal attachment anxiety and avoidance, CTQ-SF total score, emotional neglect, physical neglect, emotional abuse, and sexual abuse (all P<0.05). Binary logistic regression analysis showed that anxiety, negative coping style, maternal attachment avoidance and emotional abuse increased the risk of NSSI among adolescents with depressive disorders (all P< 0.05). ConclusionsAdolescents with depression have a high incidence of NSSI behaviors, which is related to anxiety, negative coping style, maternal attachment avoidance and emotional abuse. In addition to improving patients' depression and anxiety in clinical setting, attention should also be paid to patients' coping styles, parent-child relationship and childhood trauma to reduce the occurrence of NSSI behaviors.
7.Shikonin attenuates blood–brain barrier injury and oxidative stress in rats with subarachnoid hemorrhage by activating Sirt1/ Nrf2/HO-1 signaling
Guanghu LI ; Yang'e YI ; Sheng QIAN ; Xianping XU ; Hao MIN ; Jianpeng WANG ; Pan GUO ; Tingting YU ; Zhiqiang ZHANG
The Korean Journal of Physiology and Pharmacology 2025;29(3):283-291
Subarachnoid hemorrhage (SAH) is a serious intracranial hemorrhage characterized by acute bleeding into the subarachnoid space. The effects of shikonin, a natural compound from the roots of Lithospermum erythrorhizon, on oxidative stress and blood–brain barrier (BBB) injury in SAH was evaluated in this study. A rat model of SAH was established by endovascular perforation to mimic the rupture of intracranial aneurysms. Rats were then administered 25 mg/kg of shikonin or dimethylsulfoxide after surgery. Brain edema, SAH grade, and neurobehavioral scores were measured after 24 h of SAH to evaluate neurological impairment. Concentrations of the oxidative stress markers superoxide dismutase (SOD), glutathione (GSH), and malondialdehyde (MDA) in the brain cortex were determined using the corresponding commercially available assay kits. Evans blue staining was used to determine BBB permeability. Western blotting was used to quantify protein levels of tight junction proteins zonula occludens-1, Occludin, and Claudin-5. After modeling, the brain water content increased significantly whereas the neurobehavioral scores of rats with SAH decreased prominently. MDA levels increased and the levels of the antioxidant enzymes GSH and SOD decreased after SAH. These changes were reversed after shikonin administration. Shikonin treatment also inhibited Evans blue extravasation after SAH. Furthermore, reduction in the levels of tight junction proteins after SAH modeling was rescued after shikonin treatment. In conclusion, shikonin exerts a neuroprotective effect after SAH by mitigating BBB injury and inhibiting oxidative stress in the cerebral cortex.
8.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
9.Mechanism of Xuefu Zhuyutang in Intervening in Ferroptosis in Rats with Coronary Heart Disease with Blood Stasis Syndrome Based on ACSL4 Signalling Pathway
Yi LIU ; Yang YANG ; Chang SU ; Peng TIAN ; Mingyun WANG ; Ruqian ZHONG ; Xuejiao XIE ; Qing YAN ; Qinghua PENG ; Qiuyan ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):27-38
ObjectiveTo investigate the mechanism of ferroptosis mediated by long-chain acyl-CoA synthetase 4 (ACSL4) signalling pathway in rats with coronary heart disease with blood stasis syndrome and the intervention effect of Xuefu Zhuyutang. MethodsSPF male SD rats were randomly divided into normal group, sham-operation group, model group, trimetazidine group (5.4 mg·kg-1), low-, medium-, and high-dose group (3.51, 7.02,14.04 g·kg-1) of Xuefu Zhuyutang. The coronary artery left anterior descending ligation method was used to prepare a model of coronary heart disease with blood stasis syndrome, and continuous treatment for 7 d was conducted, while the sham-operation group was only threaded and not ligated. The general macroscopic symptoms of the rats were observed, and indicators such as electrocardiogram, echocardiography, and blood rheology were detected. The pathological morphology of myocardial tissue was observed by hematoxylin-eosin (HE) staining, and the changes in mitochondria in myocardial tissue were observed by transmission electron microscopy. The level of iron deposition in myocardial tissue was observed by Prussian blue staining. The levels of 12-hydroxyeicosatetraenoic acid (12-HETE) and 15-HETE were detected in serum by enzyme-linked immunosorbent assay. A biochemical colourimetric assay was used to detect the levels of Fe2+, lipid peroxidation (LPO), glutathione (GSH), and T-GSH/glutathione disulfide (GSSG) in myocardial tissue. DCFH-DA fluorescence quantitative assay was employed to detect the levels of reactive oxygen species (ROS). Western blot and Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was adopted to detect the protein and mRNA expressions of glutathione peroxidase 4 (GPX4), ferritin heavy chain 1 (FTH1), ACSL4, and ly-sophosphatidylcholine acyltransferase3 (LPCAT3) in myocardial tissue. ResultsCompared with those in the normal group, the rats in the model group were poor in general macroscopic symptoms. The electrocardiogram showed widened QRS wave amplitude and increased voltage, bow-back elevation of the ST segments, elevated T waves, J-point elevation, and accelerated heart rate. Echocardiography showed a significant reduction in left ventricular ejection fraction (LVEF) and left ventricular fraction shortening (LVFS) (P<0.01). Blood rheology showed that the viscosity of the whole blood (low, medium, and high rate of shear) was significantly increased (P<0.01). HE staining showed an abnormal structure of myocardial tissue. There was a large area of myocardial necrosis and inflammatory cell infiltration and a large number of connective tissue between myocardial fibers. Transmission electron microscopy showed that the mitochondria were severely atrophy or swelling. The cristae were reduced or even broken, and the matrix was flocculent or even vacuolated. Prussian blue staining showed that there were a large number of iron-containing particles, and the iron deposition was obvious. The content of 12-HETE and 15-HETE in the serum was significantly increased (P<0.01). The content of Fe2+, LPO, and ROS in myocardial tissue was significantly increased (P<0.01). The content of GSH was significantly decreased (P<0.01), and T-GSH/GSSG was decreased (P<0.01). The protein and mRNA expressions of GPX4 and FTH1 in myocardial tissue were both significantly decreased (P<0.05, P<0.01), while those of ACSL4 and LPCAT3 increased significantly (P<0.01). Compared with the model group, the general macroscopic symptoms and electrocardiogram results of rats in low-, medium- and high-dose groups of Xuefu Zhuyutang were alleviated, and the differences in LVEF/LVFS ratios were all significantly increased (P<0.05, P<0.01). The differences in whole-blood viscosity (low, medium, and high rate of shear) were all significantly decreased (P<0.01). The results of HE staining and transmission electron microscopy showed that the morphology, structure, and mitochondria of cardiomyocytes were improved. The content of 12-HETE and 15-HETE in serum was reduced to different degrees in low-, medium-, and high-dose groups of Xuefu Zhuyutang (P<0.05, P<0.01). The content of Fe2+, LPO, and ROS was significantly reduced in the medium- and high-dose groups of Xuefu Zhuyutang (P<0.05, P<0.01), and the content of GSH and T-GSH/GSSG was significantly increased (P<0.05, P<0.01). The protein and mRNA expressions of GPX4 and FTH1 were significantly increased to varying degrees in the medium- and high-dose groups of Xuefu Zhuyutang (P<0.05, P<0.01), and ACSL4 and LPCAT3 were decreased to different degrees in the low-, medium-, and high-dose groups of Xuefu Zhuyutang (P<0.05, P<0.01). ConclusionXuefu Zhuyutang can regulate iron metabolism and anti-lipid oxidation reaction to mediate ferroptosis through the ACSL4 signalling pathway, thus exerting a protective effect on rats with coronary heart disease with blood stasis syndrome.
10.Clinical Observation of Guben Quyu Jiedu Prescription in Treating Nocturnal Hypoxemia of COPD Combined with OSAHS
Yi HE ; Ziyu LI ; Wenjiang ZHANG ; Jinzhu GAO ; Changzheng FAN ; Beibei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):146-153
ObjectiveTo observe the clinical efficacy and safety of Guben Quyu Jiedu prescription in treating nocturnal hypoxemia of chronic obstructive pulmonary disease (COPD) combined with Obstructive sleep apnea hypopnea syndrome ( OSAHS ) (deficiency of lung, spleen and kidney with blood stasis and toxicity). MethodsThe paper used a forward-looking, random double-blind, placebo-controlled design method to select 96 patients with COPD combined with OSAHS, and their traditional Chinese medicines (TCM) syndrome differentiation was deficiency of lung, spleen and kidney with blood stasis and toxicity. These patients were randomly divided into the observation group and the control group, with 48 cases in each group. Based on conventional Western medicine treatment, the observation group was treated with Guben Quyu Jiedu prescription and the control group was treated with traditional Chinese medicine placebo. Both courses of treatment were 90 days. Then the paper compared the changes in minimum pulse oxygen saturation (SpO2) during the night, apnea index (AHI), OSAHS efficacy evaluation, TCM syndrome efficacy evaluation, and TCM symptom score before and after treatment between the two groups. ResultsThere were 5 withdrawals in the observation group and 8 withdrawals in the control group, so 43 cases in the observation group and 40 cases in the control group completed the trial. Compared with the condition before treatment, the minimum SpO2 during the night and AHI in the observation group were significantly improved at night (P<0.01) and were better than those in the control group (P<0.01). OSAHS efficacy in the observation group was better than in the control group (χ2=7.085, P<0.05). In terms of TCM syndrome efficacy, the total effective rate was 81.40% (35/43) in the observation group, significantly higher than that in the control group, which was 15.00% (6/40) (χ2=36.78, P<0.01). The TCM symptom scores of the two groups were improved compared with the condition before treatment, and the effect of the two groups was similar in the four main symptoms of snoring, choking, lethargy, and cough. However, the observation group was better than the control group in 10 details such as dizziness, headache, chest tightness, chest pain, wheezing, dry mouth, and thirst (P<0.05). ConclusionUsing Guben Quyu Jiedu prescription combined with conventional Western medicine can treat COPD combined with OSAHS hypoxemia at night (deficiency of lung, spleen and kidney with blood stasis and toxicity). In this way, the minimum pulse oxygen saturation (SpO2) of patients, the level of disease control, and the quality of life of patients can be improved, and the clinical symptoms can be relieved.

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