1.A Multi-dimensional Indicator-based Approach for Quality Evaluation of Chinese Patent Medicines
Shuangyan LI ; Siyuan LI ; Sha CHEN ; Yue GUO ; Jun ZHANG ; Cong GUO ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):229-237
Chinese patent medicines are the core preparations for disease prevention and treatment in clinical traditional Chinese medicine (TCM). Their quality is the key to ensuring safe and effective medication and promoting the high-quality development of the TCM industry. At present, the quality evaluation of Chinese patent medicines faces prominent problems, such as inadequate control of quality consistency, over-reliance on single indicators, one-sided evaluation dimensions, unstable statistical methods, and poor implementability of research findings. These defects lead to insufficient scientificity of evaluation results, making it difficult to support the implementation of policies including centralized procurement, high quality, and favorable prices for Chinese patent medicines. According to the core requirements of quality evaluation for Chinese patent medicines, this study established a four-dimensional comprehensive evaluation system encompassing consistency index(CI), content index(MI), effect index(EI), and preparation index(PI). All evaluation indicators were normalized to achieve horizontal comparability. Meanwhile, an improved radar chart was introduced to realize the visualization of evaluation results. This method can systematically integrate four types of core quality attributes: Quality consistency, component content, biological activity, and preparation characteristics. It can effectively distinguish quality differences among products of the same specification from different manufacturers. The evaluation results are unique, stable, and not affected by the addition or reduction of samples, which takes scientificity, objectivity, and operability into account. This method can provide scientific and technical support for screening high-quality Chinese patent medicines and implementing policies of centralized procurement, high quality, and favorable prices. Moreover, it has important practical significance for improving the quality evaluation system of Chinese patent medicines and advancing the standard and modern development of TCM.
2.Quality Evaluation of Commercially Available Huoxiang Zhengqi Preparations
Yue GUO ; Siyuan LI ; Qingxia XU ; Sha CHEN ; Shuangyan LI ; Jipeng DI ; An LIU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):238-247
ObjectiveTo establish a comprehensive evaluation framework combining multi-component quantification with daily intake in response to the challenges posed by multiple coexisting dosage forms, single-faceted quality evaluation, and ambiguous clinical equivalence of Huoxiang Zhengqi preparations, and to compare the quality differences and superiority among eight commercially available dosage forms. MethodsA total of 75 batches of Huoxiang Zhengqi preparations from 25 manufacturers were investigated. Ultra-performance liquid chromatography-triple quadrupole-tandem mass spectrometry (UPLC-QqQ-MS/MS) coupled with gas chromatography-triple quadrupole-tandem mass spectrometry (GC-QqQ-MS/MS) was adopted to simultaneously quantify 20 core marker components. Normalization was performed based on equivalent raw herb concentrations to eliminate interferences from dosage forms, excipients, and specifications. Considering the specified clinical dosage, the actual daily intake level was calculated to comprehensively evaluate component retention, content uniformity, and potential differences in in vivo exposure among different dosage forms. ResultsThe quality of Huoxiang Zhengqi preparations differed greatly among dosage forms and manufacturers. On the basis of the recommended daily doses in the package inserts, the total daily intake of the 20 tested components ranged from 3.14 to 614.30 mg·d-1, while that of hesperidin, a quality-control marker, ranged from 0.03 to 40.65 mg·d-1. Atractylodin was detected only in tinctures and soft capsules, with concentrations ranging from (2.68±0.01) to (5.73±0.37) mg·L-1. The soft capsules from manufacturer M22 had the highest atractylodin level, while atractylodin was not detected in the other dosage forms. Nucleosides were most abundant in the oral liquids and tinctures (M4 to M13). The tincture from manufacturer M5 showed the highest nucleoside level of 29.12 mg·L-1, whereas the granules had the lowest nucleoside levels, with that of M23 being only 3.48 mg·L-1. Perillae Folium-related components varied greatly among batches, with an relative standard deviation (RSD) of 87.55%. The daily intake of hesperidin from all three granule products was below 3.6 mg·d-1, the reference value calculated for Huoxiang Zhengqi Shui according to the 2025 edition of the Chinese Pharmacopoeia. ConclusionThe levels of active components differed significantly among different dosage forms of Huoxiang Zhengqi preparations. Tinctures contained more types and higher overall levels of active components, while soft capsules were better at preserving volatile components. Granules and dripping pills had lower overall levels of active components. The comprehensive evaluation method established in this study can provide a basis for the quality control, process optimization, and the selection of high-quality products.
3.Treatment of Granulation Tissue Hyperplasia after Tracheostomy Based on the Kenang (窠囊) Theory
Yue YUAN ; Siyuan LEI ; Jiajia WANG ; Jiansheng LI
Journal of Traditional Chinese Medicine 2025;66(7):746-749
Granulation tissue hyperplasia after tracheotomy is a common clinical complication. Endoscopic treatment can temporarily relieve airway obstruction, however, it is associated with a high recurrence rate and poor long-term prognosis. Based on the traditional Chinese medicine (TCM) Kenang (窠囊) theory and combined with modern pathological mechanisms, this paper explores its correlation with the pathogenesis of post-tracheotomy granulation tissue hyperplasia. Drawing from clinical experience in applying the Kenang theory for treatment, this paper proposes that the fundamental pathogenesis of this condition lies in qi deficiency and organ dysfunction, while phlegm and blood stasis interlocking serve as the symptomatic manifestations. The treatment focuses on resolving phlegm and promoting blood circulation, dispersing nodules and eliminating stagnation, regulating qi flow, and reinforcing the body's vital energy while expelling pathogenic factors. This approach aims to dissolve phlegm and blood stasis, dissipate the Kenang, and ultimately prevent and treat granulation tissue hyperplasia.
4.WANG Jianmin's Experience in Treating Cathartic Colon from the Perspective of "Keeping Sweet to Return Liquid"
Siyuan ZHANG ; Ming LI ; Kun TANG ; Ran TANG ; Yueyue ZHANG ; Yue ZHAO ;
Journal of Traditional Chinese Medicine 2025;66(11):1104-1108
To summarize Professor WANG Jianmin's experience in cathartic colon from "keeping sweet to return liquid". It is believed that the key to the pathogenesis of cathartic colon is fluid consumption and intestinal dryness, including yin depletion of spleen earth, and lack of sources for body fluids production; discordance of water and fire in kidneys, and irregular distribution of body fluids; and closure of the lungs and liver leads to inability of the flow of fluids. The treatment is based on the principle of "keeping sweet to return liquid", using sweet medicinals mainly, assistant with sour, bland and acrid medicinals, and self-prescribed Lipi Shengjin Decoction (理脾生津汤), Wenshen Runchang Decoction (温肾润肠汤), Kaifei Shunchang Decoction (开肺顺肠汤), Rougan Tongbian Decoction (柔肝通便汤) could be used to regulate spleen yin by the sweet and bland, and establish qi and promote fluid production; the sweet and warm medicinals can replenish water and fire, transform into qi, and distribute body fluids; the acrid and sweet can open lung depression, descend qi, and flow the body fluids; the sour and sweet can emolliate liver, move qi, and transform fluids.
5.Clinical efficacy of serum beta-amyloid 42 detection and accuracy verification of test kit
Kun JIANG ; Yue TAO ; Minqi CAI ; Dezhu CHEN ; Yiqiang CHEN ; Siyuan LIU ; Bing BAI
Journal of Clinical Medicine in Practice 2025;29(19):1-5,11
Objective To retrospectively analyze the results of serum beta-amyloid 42(Aβ42)tests conducted in the laboratory and explore potential issues associated with this testing.Methods All the Aβ42 test data collected up to the initiation of this study were compiled,and the positive rates for various diagnoses,including Alzheimer's disease(AD),cognitive decline,and dementia were ana-lyzed.Accuracy of the test kit was preliminarily validated using the kit's own reference,mouse brain tissue,and in vitro cultured cell-based reference samples.Results Data from 546 patients were col-lected,with 166 positive cases(positive rate of 30.4%).Among them,3 out of 6 AD patients tested positive;among 149 patients diagnosed with cognitive decline and 59 dementia patients,there were 29 and 24 positive cases respectively,with positive rates of 19.5%and 40.7%.The kit's detection of its own reference was affected by the serum matrix and failed to effectively detect positive mouse brain tissue and cellular reference samples.The kit's detection was generally unaffected by the amyloid precursor protein(APP)of Aβ,but it did not demonstrate good recovery rates for its own reference samples added to various clinical serum specimens.Conclusion The positive rate of serum Aβ42 test results in laboratory is lower than expected,and the accuracy of the test kit may require further improvement.
6.Clinical management and outcomes of respiratory distress syndrome in preterm infants <32 weeks′ gestation from the Chinese Neonatal Network from 2019 to 2023
Yue HE ; Xiao CHEN ; Lijiao ZU ; Zhicheng ZHU ; Jieru SHEN ; Jie YANG ; Siyuan JIANG ; Jianguo ZHOU ; Chao CHEN ; Lin YUAN
Chinese Journal of Pediatrics 2025;63(8):870-878
Objective:To analyze the current status and trends in the clinical management and outcomes of respiratory distress syndrome (RDS) in preterm infants <32 weeks′ gestation admitted to the Chinese Neonatal Network (CHNN) from 2019 to 2023.Methods:A cross-sectional study was conducted from November 2024 to January 2025 using the CHNN cohort of very preterm and extremely preterm infants. A total of 30 869 RDS infants with gestational age <32 weeks were admitted within 1 day after birth to CHNN centers from 2019 to 2023. Data on demographics, perinatal management, early complications within 7 days of age, and in-hospital outcomes were collected. Yearly groups were defined by admission year. Trends by year were evaluated by Cochran-Armitage trend test, linear regression model and median regression model.Results:The gestational age at birth of 30 869 RDS infant was 28.9 (27.1, 30.7) weeks and the birth weight was 1 259 (932, 1 586) g. Males account for 56.5% (17 363/30 757). From 2019 to 2023, the prevalence of RDS was 73.8% (5 503/7 461), 74.5% (5 490/7 368), 79.8% (5 884/7 372), 81.6% (6 435/7 889), and 86.0% (7 557/8 789), respectively, showing an increasing trend year by year ( P<0.001). The overall rate of pulmonary surfactant administration was 72.4% (22 359/30 869), fluctuating between 71.2% (5 381/7 557) and 74.3% (4 089/5 503) over the 5-year period. Antenatal corticosteroids were administered to 82.3% (24 357/29 597) mothers of RDS infants and 23.6% (7 218/30 565) RDS infants received noninvasive positive end-expiratory pressure support in the delivery room, both showing a increasing trend over the 5 years (both P<0.001). The incidence of pneumothorax and the use rate of inhaled nitric oxide within 7 days of age were 1.3% (393/30 846) and 1.4% (436/30 869), respectively, both showing increasing trends over the 5 years (both P<0.001). The rate of complete course of antenatal corticosteroids administration was 64.6% (14 458/22 382), the rates of discharge against medical advice and mortality within 7 days of age were 5.3% (1 635/30 869) and 2.7% (724/26 803), respectively, all showing a decreasing trend over time (all P<0.05). Regarding in-hospital outcomes, mortality rate of RDS infants was 4.6% (1 228/26 803), showing a downward trend year by year ( P=0.005). The incidence of bronchopulmonary dysplasia (BPD) was 35.0% (9 417/26 919), and the combined incidence of death or BPD was 36.4% (9 763/26 803), both showing an increasing trend year by year (both P<0.001). Conclusions:RDS prevalence increased annually in preterm infants <32 weeks′ gestation from 2019 to 2023, with declining mortality but rising BPD rates. While antenatal steroid use and noninvasive positive end-expiratory pressure support application improved, full-course antenatal steroid compliance decreased. These findings highlight the need for standardized perinatal management protocols to improve the clinical management of RDS.
7.A diarrhea-predominant irritable bowel syndrome mouse model induced via sennae folium gavage combined with chronic restraint stress
Yanqiu LI ; Yue HE ; Yujun HOU ; Fangli LUO ; Xiangyun YAN ; Zhaoxuan HE ; Ying LI ; Siyuan ZHOU
Acta Laboratorium Animalis Scientia Sinica 2025;33(7):958-967
Objective This study sought to establish a diarrhea-predominant irritable bowel syndrome(IBS-D)mouse model by gavage different mass concentrations sennae folium combined with chronic restraint stress,and to determine the appropriate mass concentration of sennae folium to establish IBS-D mouse model.Methods The mass concentration of sennae folium used for the IBS-D mouse model followed suggested amounts in the literature and on that basis,the mass concentration gradient was established prior to conducting the experiment.Female C57BL/6 mice were divided into a normal group(Group N),a low-dose group(Group L;0.25 g/mL sennae solution),a medium-dose group(Group M;0.50 g/mL sennae solution),and a high-dose group(Group H;1.0 g/mL sennae solution),with 10 mice per group.After 14 days,the defecation,diarrhea index,visceral sensitivity,and morphological changes in the colonic tissue in each group were observed and recorded to compare the differences among models established with varying mass concentrations of sennae folium.Results Compared with Group N(42.90±11.90)%,Group L(80.30±5.77)%,Group M(80.50±3.44)%,and Group H(81.90±2.68)%had significantly higher 6 h fecal water content(P<0.01).Compared with Group N(0.00±0.00),the diarrhea index of mice in Group L(0.57±0.16),Group M(0.62±0.23),and Group H(0.60,0.23)also increased significantly(P<0.01).Compared with Group N(0.65(0.60,0.65)),Group M(0.32(0.24,0.39))and Group H(0.34(0.27,0.47))had significantly lower visceral pain threshold and higher visceral sensitivity(P<0.01).Additionally,the first blue stool time in Group M(98.15(93.41,100.44)min)was significantly shorter than that in Group N(186.81(109.28,192.05)min)(P<0.01),and the total number of stools in Group M(22.4±3.73)was significantly higher than that in Group N(17.90±4.48)(P<0.05).Conclusions Compared with 0.25 and 1.0 g/mL,0.50 g/mL sennae folium gavage,combined with chronic restraint stress,can better simulate the clinical symptoms of IBS-D.
8.Research progress on intestinal barrier in irritable bowel syndrome pathogenesis
Yue HE ; Kexin CHENG ; Yanqiu LI ; Yujun HOU ; Siyuan ZHOU
The Journal of Practical Medicine 2025;41(16):2597-2603
Irritable bowel syndrome(IBS)is a prevalent functional gastrointestinal disorder characterized by a complex etiology involving multiple interacting factors.Accumulating evidence in recent years has indicated that intestinal barrier dysfunction may play a crucial role in the pathogenesis of IBS.This review systematically ex-amines the impact of intestinal barrier dysfunction on IBS,analyzing its associations with the mechanical,im-mune,chemical,and microbial components of the gut barrier,as well as current clinical treatment approaches.Moreover,this paper highlights the potential of intestinal barrier repair mechanisms as therapeutic targets,which may provide novel insights and directions for understanding the underlying pathophysiological mechanisms and de-veloping effective interventions for IBS.
9.Research progress on intestinal barrier in irritable bowel syndrome pathogenesis
Yue HE ; Kexin CHENG ; Yanqiu LI ; Yujun HOU ; Siyuan ZHOU
The Journal of Practical Medicine 2025;41(16):2597-2603
Irritable bowel syndrome(IBS)is a prevalent functional gastrointestinal disorder characterized by a complex etiology involving multiple interacting factors.Accumulating evidence in recent years has indicated that intestinal barrier dysfunction may play a crucial role in the pathogenesis of IBS.This review systematically ex-amines the impact of intestinal barrier dysfunction on IBS,analyzing its associations with the mechanical,im-mune,chemical,and microbial components of the gut barrier,as well as current clinical treatment approaches.Moreover,this paper highlights the potential of intestinal barrier repair mechanisms as therapeutic targets,which may provide novel insights and directions for understanding the underlying pathophysiological mechanisms and de-veloping effective interventions for IBS.
10.A diarrhea-predominant irritable bowel syndrome mouse model induced via sennae folium gavage combined with chronic restraint stress
Yanqiu LI ; Yue HE ; Yujun HOU ; Fangli LUO ; Xiangyun YAN ; Zhaoxuan HE ; Ying LI ; Siyuan ZHOU
Acta Laboratorium Animalis Scientia Sinica 2025;33(7):958-967
Objective This study sought to establish a diarrhea-predominant irritable bowel syndrome(IBS-D)mouse model by gavage different mass concentrations sennae folium combined with chronic restraint stress,and to determine the appropriate mass concentration of sennae folium to establish IBS-D mouse model.Methods The mass concentration of sennae folium used for the IBS-D mouse model followed suggested amounts in the literature and on that basis,the mass concentration gradient was established prior to conducting the experiment.Female C57BL/6 mice were divided into a normal group(Group N),a low-dose group(Group L;0.25 g/mL sennae solution),a medium-dose group(Group M;0.50 g/mL sennae solution),and a high-dose group(Group H;1.0 g/mL sennae solution),with 10 mice per group.After 14 days,the defecation,diarrhea index,visceral sensitivity,and morphological changes in the colonic tissue in each group were observed and recorded to compare the differences among models established with varying mass concentrations of sennae folium.Results Compared with Group N(42.90±11.90)%,Group L(80.30±5.77)%,Group M(80.50±3.44)%,and Group H(81.90±2.68)%had significantly higher 6 h fecal water content(P<0.01).Compared with Group N(0.00±0.00),the diarrhea index of mice in Group L(0.57±0.16),Group M(0.62±0.23),and Group H(0.60,0.23)also increased significantly(P<0.01).Compared with Group N(0.65(0.60,0.65)),Group M(0.32(0.24,0.39))and Group H(0.34(0.27,0.47))had significantly lower visceral pain threshold and higher visceral sensitivity(P<0.01).Additionally,the first blue stool time in Group M(98.15(93.41,100.44)min)was significantly shorter than that in Group N(186.81(109.28,192.05)min)(P<0.01),and the total number of stools in Group M(22.4±3.73)was significantly higher than that in Group N(17.90±4.48)(P<0.05).Conclusions Compared with 0.25 and 1.0 g/mL,0.50 g/mL sennae folium gavage,combined with chronic restraint stress,can better simulate the clinical symptoms of IBS-D.

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