1.Quality Evaluation of Gegen Qinlian Tablets Based on HPLC Multi-component Quantification Combined with Chemical Pattern Recognition and TOPSIS Analysis
Ping QIN ; Yingying LU ; Wenming ZHANG ; Zifang FENG ; Lihong GU ; Chenjie XIA ; Minmin HU ; Xiaowei CHEN ; Zhenhua BIAN ; Xiwan LU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):217-224
ObjectiveTo establish a high-performance liquid chromatography(HPLC) for the quantitative analysis of multiple components in Gegen Qinlian tablets, and to comprehensively evaluate the quality of samples from different manufacturers by integrating chemical pattern recognition and technique for order preference by similarity to ideal solution(TOPSIS), in order to provide a reference basis for quality evaluation and control of Gegen Qinlian tablets. MethodsHPLC was employed to determine the contents of 10 components in 28 batches of Gegen Qinlian tablets collected from 6 manufacturers, and taking the detection results as variables, SIMCA 14.1 and SPSS 26.0 were employed for cluster analysis(CA), principal component analysis(PCA), and orthogonal partial least squares-discriminant analysis(OPLS-DA) to identify key components affecting the quality. Then, TOPSIS analysis was employed to rank the quality of Gegen Qinlian tablets from the 6 manufacturers and establish a comprehensive quality evaluation method. ResultsA quantitative method for Gegen Qinlian tablets was established. After methodological validation, the method was found to be stable and reliable, and could be used for the quantitative analysis of this preparation. The contents of 3′-hydroxy puerarin, puerarin, 3′-methoxy puerarin, daidzein, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, berberine hydrochloride, palmatine hydrochloride and baicalin in 28 batches of samples were 3.58-7.35, 24.88-42.32, 4.20-9.36, 4.33-7.60, 2.52-6.44, 0.93-4.10, 0.58-3.05, 10.68-22.92, 0.82-4.82, 11.73-60.16 mg·g-1, respectively. Among them, puerarin, berberine hydrochloride and baicalin all met the limit requirements for this preparation specified in the 2025 edition of the Pharmacopoeia of the People's Republic of China. CA and PCA clustered the 28 batches of samples into 5 categories, PCA extracted 2 principal components with a cumulative variance contribution rate of 90.588%, and OPLS-DA screened out 4 differential markers with variable importance in the projection(VIP) values>1.0, namely baicalin, 3′-hydroxy puerarin, coptisine hydrochloride and palmatine hydrochloride, which might be the main components affecting the quality of Gegen Qinlian tablets. TOPSIS analysis showed that the comprehensive score of each evaluation index(Ci) values of different manufacturers were different. Among them, the Ci of manufacturer B was ranked higher, indicating potentially superior quality, while the Ci of manufacturer A was ranked lower, suggesting potentially inferior quality. ConclusionThis study establishes a quantitative method for Gegen Qinlian tablets, and the content uniformity of the same manufacturer is good, while there are differences in the contents of active components among different manufacturers. Through the chemical pattern recognition analysis, it is found that the content differences of Gegen Qinlian tablets may be related to baicalin, 3′-hydroxy puerarin, coptisine hydrochloride and palmatine hydrochloride.
2.Construction of a community-family management model for older adults with mild cognitive impairment
Junli CHEN ; Han ZHANG ; Yefan ZHANG ; Yanqiu ZHANG ; Runguo GAO ; Qianqian GAO ; Weiqin CAI ; Haiyan LI ; Lihong JI ; Zhiwei DONG ; Qi JING
Chinese Journal of Rehabilitation Theory and Practice 2026;32(1):90-100
ObjectiveTo develop a community-family management model for older adults with mild cognitive impairment (MCI) and to formulate detailed application specifications, and to fully leverage the initiative of communities and families under limited resource conditions, for achieving community-based early detection and early intervention for older adults with MCI. MethodsA systematic literature review was conducted to identify pertinent publications. Corpus-based research methodologies were employed to extract, refine, integrate and synthesize management elements, thereby establishing the specific content and service processes for each stage of the management model. Utilizing the 5W2H analytical framework, essential elements such as management stakeholders, target populations, content and methods for each stage were delineated. The model and its application guidelines were finalized through expert consultation and demonstration. ResultsAn expert evaluation of the management model yielded mean scores of 4.84, 4.32 and 4.84 for acceptability, feasibility and systematicity, respectively. By integrating the identified core elements with expert ratings and feedback, the final iteration of the community-family management model for older adults with MCI was formulated. This model comprised of five stages: screening and identification, comprehensive assessment, intervention planning, monitoring and referral pathways to ensure implementation, and enhanced support for communities, family members and caregivers. Additionally, it included 18 specific application guidelines. ConclusionThe proposed management model may theoretically help delay cognitive decline, improve cognitive function and potentially promote reversal from MCI to normal cognition. It may also enhance the awareness and coping capacity of older adults and their families, strengthen community healthcare professionals' ability to early identify and manage MCI.
3.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
4.Study on HPLC fingerprint and multi-component determination of Ziziphus jujuba stir-fried with Coptis chinensis juice from Longsha Medical School
Ping QIN ; Yingying LU ; Wenming ZHANG ; Zifang FENG ; Lihong GU ; Chenjie XIA ; Minmin HU ; Xiaowei CHEN ; Tulin LU ; Yiting ZHANG ; Zhenhua BIAN
China Pharmacy 2026;37(15):1974-1978
OBJECTIVE To establish a high-performance liquid chromatography(HPLC) fingerprint and a multi-component content determination method for Ziziphus jujuba stir-fried with Coptis chinensis juice, a characteristic processed product of Longsha Medical School, and to provide a basis for the inheritance and clinical application of this distinctive variety. METHODS HPLC method was employed to establish the fingerprints of 12 batches of Z. jujuba stir-fried with C. chinensis juice. Similarity evaluation and common peak identification were subsequently carried out. Quantitative determination was performed on coclaurine, magnoflorine, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, spinosin, berberine hydrochloride, palmatine hydrochloride, 6"'-feruloylspinosin, and jujuboside A of samples. RESULTS The fingerprint similarities of all 12 batches of samples were higher than 0.960. A total of 17 common peaks were calibrated, among which 9 peaks were identified as coclaurine, magnoflorine, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, spinosin, berberine hydrochloride, palmatine hydrochloride, and 6"'-feruloylspinosin, respectively. The quantitative results showed that the mass fractions of coclaurine, magnoflorine, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, spinosin, berberine hydrochloride, palmatine hydrochloride, 6"'-feruloylspinosin, and jujuboside A in the 12 batches of samples were 0.044-0.091, 0.908-1.698, 0.325-0.549, 0.163-0.287, 0.103-0.172, 0.712-0.952, 1.185-1.843, 0.341-0.598, 0.228-0.405, and 0.050-0.091 mg/g, respectively. CONCLUSIONS The established HPLC fingerprint and multi-component determination method is stable and reliable, and can provide a basis for the quality standard formulation and clinical application of Z. jujuba stir-fried with C. chinensis juice.
5.Clinical Efficacy of Acupuncture in the Treatment of Adolescent Depression and Its Mechanism Revealed by Functional Magnetic Resonance Imaging and Serum Proteomics:A Multicenter,Double-Blind,Randomized Controlled Trial
Lihong LI ; Peiyun ZHANG ; Xingyu CHEN ; Lu HAN ; Fengling LIANG ; Jesús M. CORTÉS
Journal of Traditional Chinese Medicine 2026;67(17):1858-1867
ObjectiveTo evaluate the clinical efficacy of acupuncture in the treatment of adolescent depression and to explore its potential mechanisms based on functional magnetic resonance imaging (fMRI) and serum proteomics. MethodsA randomized, double-blind, sham acupuncture-controlled trial design was conducted. A total of 100 adolescents with depression were enrolled and randomly assigned to an acupuncture group and a sham acupuncture group, with 50 participants in each group. In addition, 20 healthy subjects were recruited as healthy controls. Participants in the acupuncture group received acupuncture at Baihui (GV 20), Yintang (GV 29), Zhongwan (CV 12), Qihai (CV 6), bilateral Tianshu (ST 25), bilateral Neiguan (PC 6), bilateral Zusanli (ST 36), and bilateral Taichong (LR3). The sham acupuncture group received intervention using a blunt placebo needle without skin penetration. Both groups received 30-min treatments three times per week for 4 weeks. The primary outcome was the reduction rate of the 24-item Hamilton Depression Rating Scale (HAMD-24) score. Secondary outcomes included changes in HAMD-24 scores before and after treatment, covering nine factors (anxiety/somatization, cognitive impairment, sleep disturbance, psychomotor retardation, hopelessness, fatigue, weight change, diurnal mood variation, and suicidal ideation), response rate and remission rate after treatment, and symptom severity before and after treatment. Subgroup analyses of total HAMD-24 scores were performed according to concomitant medication use and the number of medications taken. During the study period, all adverse events were monitored and recorded to evaluate safety. Patients who volunteered and met the eligibility criteria for imaging examinations were selected to undergo brain fMRI scanning and serum proteomic analysis to investigate changes in functional connectivity among brain regions and differential proteins. ResultsA total of 49 participants in the acupuncture group and 50 participants in the sham acupuncture group were included in the efficacy analysis. Among them, 20 participants in the acupuncture group and 21 in the sham acupuncture group completed fMRI scans, while 19 participants in the acupuncture group and 21 in the sham acupuncture group completed serum proteomic analyses. After 4 weeks of treatment, the mean reduction rate of HAMD-24 score in the acupuncture group was significantly higher than that in the sham acupuncture group [(58±24)% vs.(26±19)%, P<0.01]. Compared to baseline, scores for anxiety/somatization, cognitive impairment, psychomotor retardation, and hopelessness, and the total HAMD-24 score significantly decreased in both groups. In addition, the acupuncture group showed significant reductions in sleep disturbance, fatigue, and suicidal ideation scores (P<0.01). After treatment, the response rate and remission rate were 67.35% (33/49) and 24.48% (12/49) in the acupuncture group, respectively, significantly higher than 6.00% (3/50) and 0 in the sham acupuncture group (P<0.01). The proportion of participants with moderate symptoms was lower, whereas the proportion with mild symptoms was higher in the acupuncture group than the sham acupuncture group (P<0.01). Among those receiving acupuncture alone, acupuncture combined with medication, or fewer than three medications, the total HAMD-24 scores decreased after treatment in both the acupuncture subgroup and the sham acupuncture subgroup, with significantly lower scores in the acupuncture subgroup (P<0.01). During the study period, four mild adverse events were reported, including one case in the acupuncture group and three cases in the sham acupuncture group; none of these events affected the continuation of treatment. fMRI results showed that acupuncture enhanced functional connectivity between the prefrontal cortex and cerebellar-limbic system-related brain regions. Proteomic analysis identified 24 differentially expressed proteins associated with acupuncture treatment, mainly enriched in pathways related to neuroinflammation and energy metabolism. ConclusionAcupuncture can significantly improve depressive symptoms in adolescents with depression. Its therapeutic effects may be achieved by modulating emotion-related brain networks and regulating pathways associated with neuroinflammation and energy metabolism.
6.Analysis on appraisal of ophthalmic medical malpractice
Weizhen CHEN ; Zhitao GE ; Shi LIU ; Zhihu ZHANG ; Lihong LIU ; Jiaqi ZHANG ; Shuangxue HAN
Chinese Journal of Forensic Medicine 2025;40(4):415-419
Objective To identify the key points of forensic appraisal in ophthalmic medical-injury compensation cases and propose targeted measures to prevent disputes.Methods A retrospective analysis was conducted of the appraisal conclusions from 15 ophthalmology medical-injury liability lawsuits handled at a single tertiary hospital over the past five years.We summarized the constitutive characteristics of liability cases,causes of medical injury,and issues encountered during appraisal.Results Among cases undergoing medical-injury liability appraisal,retinal diseases and ocular tumors predominated.The main issues included inadequate informed consent,failure to exercise due care during surgery/treatment,non-standard medical record documentation,insufficient attention to medical risks,and inadequate clinical assessment.Conclusions By summarizing common faults in ophthalmic disputes and problems revealed by forensic appraisal,targeted responses can be implemented to ensure patient safety and promote high-quality medical services.
7.Analysis of the Theory of"Liver Essence Yin and Function Yang"in Liver and the Progressive Progress of Cirrhosis
Journal of Zhejiang Chinese Medical University 2025;49(1):34-39
[Objective]To analyze the pathogenesis of liver cirrhosis and provide ideas for clinical treatment.[Methods]Through the exposition of the theory of"liver essence Yin and function Yang"and the application of"taking images and comparing classes"thinking mode,the macroscopic and microcosmic mechanism of liver cirrhosis progression was analyzed.[Results]Liver cirrhosis is the final stage of many liver diseases.Liver apraxia is an important pathological mechanism of progressive progression of liver cirrhosis.Macroscopically,it can lead to pathological changes such as Qi stagnation,water stagnation,blood stasis and so on.Microscopically,it can lead to the degeneration and necrosis of hepatocytes,the formation of extracellular matrix(ECM),the reduction of liver sinusoidal endothelial cell(LSEC)window,sinusoidal capillarization and other pathological mechanisms.These are important factors in the progression of liver cirrhosis.Therefore,based on the theory of"liver essence Yin and function Yang",the methods of nourishing Yin and soothing the liver,activating blood circulation and removing blood stasis,invigorating Qi and spleen can be adopted in the treatment of patients with liver cirrhosis.[Conclusion]The theory of liver essence Yin and function Yang is a high summary of the physiological characteristics of the liver and has an enlightening effect on the clinical diagnosis and treatment of liver cirrhosis.
8.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
;
Drug Monitoring/methods*
;
Humans
;
Organ Transplantation
;
Immunosuppressive Agents/administration & dosage*
;
Delphi Technique
10.Establishment and application of MALDI-TOF MS technique for detecting HPA-29-35w
Jierun CHEN ; Yan ZHOU ; Lilan LI ; Zhoulin ZHONG ; Lihong JIANG ; Tingting MA ; Hengcong LI ; Qiuhong MO
Chongqing Medicine 2025;54(1):101-107,113
Objective To establish the genetic typing detection technique of matrix-assisted laser de-sorption ionization-time or flight mass spectrometry(MALDI-TOF MS),and to apply it to investigate the polymorphism of the human platelet antigen(HPA)-29-35w low-frequency gene in blood donor population from Guangxi area.Methods The RS number of 7 target gene mutation sites in dbSNP and 21 primers were designed by using Assay Design Suite(ADS)of MassARRAY platform online primer design tool.Seven over-expression vectors inserting into HPA-29-35bb mutant sequence were constructed.Twenty-nine blood donors were randomly selected among the blood donors team in Guangxi area.The samples and vectors conducted the iPLEX Pro multiple genotyping analysis and mass spectrometric detection.Meanwhile,the above samples were sequenced and the sequencing results conducted the comparison validation with the mass spectrometric detec-tion results,then the MALDI-TOF MS genotyping detection technology was established.Then adopting this technology conducted the platelet antigen HPA-29-35W genotyping detection and polymorphism analysis in the samples from 588 blood donors in Guangxi area.Results The MALDI-TOF MS HPA genotyping detec-tion results were consistent with the sequencing results.The HPA-29-35w genotyping results showed that theHPA-29-35w genotype of 588 blood donors in Guangxi area was aa homozygote.Conclusion The genotype detection method of MALDI-TOF MS for HPA-29-35w is successfully established and applied to the screening of HPA-29-35w gene among the blood donor population in Guangxi area.

Result Analysis
Print
Save
E-mail