1.Color Space Method Combined with Chemometrics to Determine Processing Degree of Angelicae Sinensis Radix Carbonisata
Liuying QIN ; Yao HUANG ; Lifan GAN ; Yuanjun LIU ; Congyou DENG ; Dongmei SUN ; Lijin LIANG ; Lin ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):201-210
ObjectiveTo study the changing law of appearance color and physicochemical properties of Angelicae Sinensis Radix Carbonisata(ASRC) during the processing by color space method combined with statistical analysis, so as to provide reference for determining the processing endpoint and evaluating the quality of the decoction pieces. MethodsTaking processing time(4, 8, 12, 16 min) and temperature(180, 200, 220, 240 ℃) as factors, ASRC decoction pieces with different processing degrees were prepared in a completely randomized design. Then, the brightness value(L*), red-green value(a*), yellow-blue value(b*), and total chromaticity value (E*ab) of the decoction pieces were determined by spectrophotometer, the color difference value(ΔE) was calculated, and the data of colorimetric values were analyzed by discriminant analysis. At the same time, the pH, charcoal adsorption, and contents of tannins, 5-hydroxymethylfurfural(5-HMF), tryptophan, chlorogenic acid, ferulic acid, senkyunolide I, senkyunolide H and ligustilide of ASRC with different processing degrees were determined by pH meter, ultraviolet and visible spectrophotometry and ultra-high performance liquid chromatography(UPLC). Principal component analysis(PCA) was used to analyze the data of physicochemical indexes, after determining the processing technology of ASRC, the canonical discriminant function was established to distinguish the decoction pieces with different processing degrees, and leave-one-out cross validation was conducted. Finally, Pearson correlation analysis was used to explore the correlation between various physicochemical indexes and chromaticity values. ResultsWith the prolongation of the processing time, L*, a*, b* and E*ab all showed a decreasing trend, and the established discriminant model based on color parameters was able to distinguish ASRC with different processing degrees. The pH showed an increasing trend with the prolongation of processing time, and the charcoal adsorption, and the contents of tannins, 5-HMF, and tryptophan all showed an increasing and then decreasing trend. Among them, the charcoal adsorption, contents of tannin and 5-HMF reached their maximum values successively after processing for 8-12 min. While the contents of chlorogenic acid, ferulic acid, senkyunolide I, senkyunolide H and ligustilide decreased with the increase of processing time, with a decrease of 60%-80% at 8 min of processing. Therefore, the optimal processing time should be determined to be 8-12 min. PCA could clearly distinguish ASRC with different processing degrees, while temperature had no significant effect on the processing degree. The 12 batches of process validation results(10 min, 180-240 ℃) showed that except for 3 batches identified as class Ⅱ light charcoal, all other batches were identified as class Ⅲ standard charcoal, and the chromaticity values of each batch of ASRC were within the reference range of class Ⅱ-Ⅲ sample chromaticity values. The correlation analysis showed that the chromaticity values were negatively correlated with pH and charcoal adsorption, and positively correlated with contents of tryptophan, chlorogenic acid, ferulic acid, senkyunolide I, senkyunolide H, and ligustilide. And both pH and charcoal adsorption were negatively correlated with the contents of the above components, but the charcoal adsorption was positively correlated with the content of 5-HMF. ConclusionThe chromaticity values and the contents of various physicochemical indicators of ASRC undergo significant changes with the prolongation of processing time, and there is a general correlation between chromaticity values and various physicochemical indicators. Based on the changes in color and physicochemical indicators, the optimal processing time for ASRC is determined to be 8-12 min. This study reveals the dynamic changes of the relevant indexes in the processing of ASRC, which can provide a reference for the discrimination of the processing degree and the quantitative study of the processing endpoint.
2.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
3.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
4.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
5.Seroprevalence of the specific antibody against Toxoplasma gondii among patients with hematological diseases
Donghui GAN ; Jinqing FAN ; Jinfang ZENG ; Jun LIN ; Xiaojun CHEN
Chinese Journal of Schistosomiasis Control 2024;36(1):83-86
Objective To investigate the seroprevalence of Toxoplasma gondii infections among patients with hematological diseases, so as to provide insights into improving the prognosis and quality of life among patients with hematological diseases. Methods A total of 240 patients with hematological diseases (including 170 patients with hematological tumors and 70 patients with non-tumor hematological diseases) admitted to The Affiliated Hospital of Putian University during the period from January 1, 2021 through October 10, 2023 and 500 healthy volunteers in the hospital during the same period were enrolled. Subjects’ demographics and serum samples were collected, and serum specific IgG and IgM antibodies against T. gondii were detected using the chemiluminescence assay, with any of a positive IgG or IgM antibody defined as a positive T. gondii infection. The seroprevalence of specific IgG and IgM antibodies against T. gondii was compared between patients with hematological diseases and healthy volunteers. Results The mean age (F = 2.034, P > 0.05) and gender distribution (χ2 = 0.462, P > 0.05) were comparable among patients with hematological tumors, patients with non-tumor hematological diseases and healthy volunteers, and there was no significant difference in the proportion of history of cat or dog contacts between patients with hematological diseases and healthy volunteers (χ2 = 0, P > 0.05). The seroprevalence of anti-T. gondii antibody was significantly higher among patients with hematological diseases than among healthy volunteers (15.8% vs. 0.6%; χ2 = 71.902, P < 0.01), and there was a significant difference in the seroprevalence of anti-T. gondii antibody among patients with hematological tumors (18.2%), patients with non-tumor hematological diseases (10.0%) and healthy volunteers (χ2 = 78.327, P < 0.01). The seroprevalence of anti-T. gondii antibody was significantly higher among patients with hematological tumors and non-tumor hematological diseases than among healthy volunteers (both P values < 0.05), while no significant difference was seen in the seroprevalence of anti-T. gondii antibody between patients with hematological tumors and non-tumor hematological diseases (P > 0.05). In addition, the proportion of history of cat or dog contacts was significantly higher among patients with hematological diseases that were positive for serum anti-T. gondii anti-body than among those negative for serum anti-T. gondii antibody (21.1% vs. 5.4%; χ2 = 8.653, P < 0.05). Conclusions There is a high seroprevalene rate of T. gondii infections among hematological diseases, which is significantly greater than that among healthy volunteers.
6.Correlation analysis of inflammation,nutrition indexes and hypoproteinemia in patients with AECOPD
Feng LI ; Haiyue LIU ; Yihua LIN ; Jiayi WANG ; Wanzhen YANG ; Yixuan ZHENG ; Zhonglin GAN
Chongqing Medicine 2024;53(4):517-521
Objective To analyze the correlation between inflammation,nutritional indicators and hy-poproteinemia in patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Meth-ods The clinical data of patients with AECOPD admitted to the Department of Respiratory and Critical Care Medicine of the First Affiliated Hospital of Xiamen University from January 2020 to September 2022 were ret-rospectively analyzed,and the patients were divided into the hypoproteinemia group(n=73)and the non-hy-poproteinemia group(n=141)according to whether the serum albumin(ALB)was lower than 35 g/L.The clinical data,inflammatory indicators and nutritional indicators of the two groups were compared,Spearman correlation analysis was performed,and binary logistic regression analysis was performed to analyze the influ-encing factors of patients with AECOPD complicated with hypoproteinemia.Results There were statistically significant differences in age,length of hospital stay,and body weight between the two groups(P<0.05).There were no significant differences in gender,number of hospitalizations in the past 1 year,height,diabetes,hypertension and proportion of coronary heart disease(P>0.05).Compared with the non-hypoproteinemia group,the hypoproteinemia group had longer hospital stays and higher levels of C-reactive protein,neutrophil/albumin ratio(NAR),neutrophil to lymphocyte ratio(NLR),platelet-lymphocyte ratio(PLR),and systemic immunoinflammatory index(SII).The prognostic nutritional index(PNI),body mass index(BMI),hemoglo-bin and total protein levels were lower,and the difference was statistically significant(P<0.05).Body weight,BMI,hemoglobin,total protein,PNI and AECOPD patients with hypoproteinemia were negatively cor-related(P<0.05),while age,length of hospital stay,C-reactive protein,NAR,NLR,PLR,SII and AECOPD patients with hypoproteinemia were positively correlated(P<0.05).Binary logistic regression analysis showed that PNI,SII and NLR were the influencing factors of hypoproteinemia in AECOPD patients.Conclusion In clinical practice,attention should be paid to and timely correction of hypoproteinemia in pa-tients with AECOPD,improvement of inflammatory indicators and nutritional status of patients,and preven-tion of acute exacerbation.
7.Genome-wide CRISPR screening identifies critical role of phosphatase and tensin homologous(PTEN)in sensitivity of acute myeloid leukemia to chemotherapy
LIN LIMING ; TAO JINGJING ; MENG YING ; GAN YICHAO ; HE XIN ; LI SHU ; ZHANG JIAWEI ; GAO FEIQIONG ; XIN DIJIA ; WANG LUYAO ; FAN YILI ; CHEN BOXIAO ; LU ZHIMIN ; XU YANG
Journal of Zhejiang University. Science. B 2024;25(8):700-710,中插5-中插6
Although significant progress has been made in the development of novel targeted drugs for the treatment of acute myeloid leukemia(AML)in recent years,chemotherapy still remains the mainstay of treatment and the overall survival is poor in most patients.Here,we demonstrated the antileukemia activity of a novel small molecular compound NL101,which is formed through the modification on bendamustine with a suberanilohydroxamic acid(SAHA)radical.NL101 suppresses the proliferation of myeloid malignancy cells and primary AML cells.It induces DNA damage and caspase 3-mediated apoptosis.A genome-wide clustered regularly interspaced short palindromic repeats(CRISPR)library screen revealed that phosphatase and tensin homologous(PTEN)gene is critical for the regulation of cell survival upon NL101 treatment.The knockout or inhibition of PTEN significantly reduced NL101-induced apoptosis in AML and myelodysplastic syndrome(MDS)cells,accompanied by the activation of protein kinase B(AKT)signaling pathway.The inhibition of mammalian target of rapamycin(mTOR)by rapamycin enhanced the sensitivity of AML cells to NL101-induced cell death.These findings uncover PTEN protein expression as a major determinant of chemosensitivity to NL101 and provide a novel strategy to treat AML with the combination of NL101 and rapamycin.
8.Research on Water Extraction Process of Flos Lonicerae-Fructus Forsythuae Based on Network Pharmacology and Design Space
Ting CUI ; Meizhou LI ; Lifan GAN ; Jiaming LIN ; Lijin LIANG ; Xingpeng HUANG ; Zhipeng ZHANG
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(1):47-60
OBJECTIVE To optimize the water extraction process of Flos Lonicerae-Fructus Forsythuae and determine the range of water extraction process parameters.METHODS The active components were screened by network pharmacology,and the indica-tor ingredients were determined in combination with the quality markers under the relevant terms of Chinese Pharmacopoeia 2020 edition and the literature.Take extraction yield and the extraction rate of the indicative component as the critical quality attributes of the water extraction process to screen critical process parameters.The mathematical model was established by Box-Behnken experimental design to investigate the interaction between CQAs and CPPs and build the design space of the water extraction process of Flos Lonicerae-Fruc-tus Forsythuae.RESULTS The extraction percentages of phenolic acids,forsythoside A and forsythin were screened as the index components;specifications of medicinal slices,extraction time and water addition were the key process parameters.Based on the estab-lishment and optimization of the design space,the optimum water extraction process was obtained as follows:the medicinal slice of Lian-Qiao was broken into 0.8-1.2 cm,adding 12 times the amount of water in the first and extract for 30-50 min,10 times the a-mount of water in the second and extract for 25-30 min.CONCLUSION The verification results show that the measured value ob-tained by using the design space method to optimize the water extraction process is close to the predicted value,indicating that the method is stable and reliable,which can provide ideas for its further process development and quality control for the couple medicines of Flos Lonicerae-Fructus Forsythuae.
9.Impact of Triangle hierarchical management on cardiopulmonary function,self-efficacy and quality of life in patients with acute non-ST-segment elevation myocardial infarction after PCI
Ming-Zhu HU ; Di YANG ; Gan-Lin DA
Chinese Journal of cardiovascular Rehabilitation Medicine 2024;33(4):485-489
Objective:To explore the clinical effect of Triangle hierarchical management in patients with acute non-ST-segment elevation myocardial infarction(NSTEMI)after percutaneous coronary intervention(PCI).Methods:A total of 107 NSTEMI patients who underwent PCI in our hospital from Jan 2019 to Dec 2022 were selected.Ac-cording to the random number table method,patients were divided into control group(n=53)and observation group(n=54).Patients in the control group received routine rehabilitation training,while observation group re-ceived Triangle hierarchical management based on control group,both groups were intervened for 6 months.Car-diopulmonary function indexes,scores of myocardial infarction dimensional assessment scale(MIDAS)and general self-efficacy scale(GSES)before and after intervention,and incidence of adverse events during follow-up were compared between two groups.Results:During study period,two cases were lost in the control group and one case withdrew in the observation group,with 51 and 53 cases finally enrolled in each group,respectively.Compared with the control group after intervention,there were significant rise in forced expiratory volume in one second(FEV1)[(2.98±0.27)L vs.(3.30±0.35)L],FEV1/forced vital capacity(FVC)[(72.65±4.31)%vs.(77.06±3.95)%]and GSES score[(18.53±2.63)points vs.(26.89±3.19)points],and significant reduction in MIDAS total score[(65.53±4.86)points vs.(56.26±4.38)points]in observation group(P<0.001 all).There was no significant difference in the incidence rate of adverse events between control group and observation group during fol-low-up(13.73%vs.7.55%,P=0.306).Conclusion:Triangle hierarchical management may significantly improve lung function,self-efficacy and quality of life with high safety in patients with acute non-ST-segment elevation myocardial infarction after PCI,suggesting that it worths promoting in clinical practice.
10.Thoughts and suggestions on digital services to enhance the level of vaccination management
Lin LUAN ; Na LIU ; Benfeng ZHENG ; Zhuoyu ZHANG ; Yifan SONG ; Li LI ; Ming GAN ; Lei CAO ; Zhuoying HUANG ; Jiakai YE ; Zhaonan ZHANG ; Xiaoxue LIU ; Junlei CHEN ; Changshuang WANG ; Bi CAI ; Wenzhou YU
Chinese Journal of Preventive Medicine 2024;58(2):159-165
With the development of information technology and the increasing demand for vaccination services among the people, it is a definite trend to enhance the quality of vaccination services through digitization. This article starts with a clear concept of digital services for vaccination, introduces the current development status in China and abroad, analyzes the advantages and disadvantages of existing models in leading regions, takes a glean from the summation, and proposes targeted solutions. This study suggests establishing a departmental coordination mechanism for data interconnection and sharing, formulating data standards and functional specifications, enhancing the functionalities of the immunization planning information system, strengthening data collection and analytical usage, and intensifying appointment management and science and health education to provide expert guidance for the construction of digital vaccination services across the country in the future.

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