1.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.
2.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.
3.Problems and thinking of non-technical skill training of clinicians
Yang LIU ; Jing TIAN ; Jialiang SHI ; Jiayun XUE ; Oudong XIA
Chinese Journal of Medical Education Research 2025;24(1):132-136
Recently, continuing medical education has made progress under the support of national policies. However, the exploration of continuing medical education has overlooked the concept of non-technical skills. The lack of training in non-technical skills has become increasingly prominent, which seriously restricts the development of medical education. Drawing on the developmental trajectory and curriculum design experiences of non-technical skill training in Europe and the United States, this study examines the current situation and the problems of non-technical skill training in China. By establishing an effective curriculum support system to enhance engagement, improving the training process for non-technical skills to optimize the curriculum structure, and focusing on faculty cultivation targets to establish admission standards, this study aims to promote the steady and healthy advancement of non-technical skill training, and achieve a "win-win" situation in terms of patient safety and the sustainable development of continuing medical education.
4.Determination of Three Stereoisomers in Baloxavir Marboxil by Reversed-phase HPLC
Kai SHI ; Kai YAN ; Ting SUN ; Xue FENG ; Fugang ZHOU ; Yuxia HE ; Xueli LIU ; Jialiang ZHU
Herald of Medicine 2025;44(4):633-638
Objective To establish a reversed-phase HPLC method for determining three stereoisomers in baloxavir marboxil and provide a basis for the quality specification of baloxavir marboxil.Methods The chromatographic column was CHIRALPAK IC-3(4.6 mm × 150 mm,3 μm),The mobile phase was acetonitrile-0.1%formic acid aqueous solution-isopropanol(35:50:15).The column temperature was 40 ℃.The flow rate was 0.5 mL·min-1.The injection volume was 10 μL.The detection wavelength was 259 nm.Result The isomer peaks were completely separated from the principal component peak.The detection limits for stereoisomers 1,2 and 3 were 0.024 7,0.038 7,0.038 1 μg·mL-1 respectively.The quantitation limits for stereoisomers 1,2 and 3 were 0.049 4,0.077 3,0.076 1 μg·mL-1 respectively.There were good linear relationships between the concentrations and peak area within the ranges of the study,and the linearity concentration ranges of stereoisomers 1,2 and 3 were 0.049 5-0.989 0 μg·mL-1,0.051 6-1.031 0 μg·mL-1,0.050 8-1.015 0 μg·mL-1 respectively.The linear correlation coefficients were 0.999 4.The recovery was 92.28%-103.90%.The sample solution was stable in 48 h at room temperature.Conclusion The method is accurate and reliable for determining stereoisomers in baloxavir marboxil,and provide a guideline of quality standards of baloxavir marboxil and safety evalution.
5.Determination of Three Stereoisomers in Baloxavir Marboxil by Reversed-phase HPLC
Kai SHI ; Kai YAN ; Ting SUN ; Xue FENG ; Fugang ZHOU ; Yuxia HE ; Xueli LIU ; Jialiang ZHU
Herald of Medicine 2025;44(4):633-638
Objective To establish a reversed-phase HPLC method for determining three stereoisomers in baloxavir marboxil and provide a basis for the quality specification of baloxavir marboxil.Methods The chromatographic column was CHIRALPAK IC-3(4.6 mm × 150 mm,3 μm),The mobile phase was acetonitrile-0.1%formic acid aqueous solution-isopropanol(35:50:15).The column temperature was 40 ℃.The flow rate was 0.5 mL·min-1.The injection volume was 10 μL.The detection wavelength was 259 nm.Result The isomer peaks were completely separated from the principal component peak.The detection limits for stereoisomers 1,2 and 3 were 0.024 7,0.038 7,0.038 1 μg·mL-1 respectively.The quantitation limits for stereoisomers 1,2 and 3 were 0.049 4,0.077 3,0.076 1 μg·mL-1 respectively.There were good linear relationships between the concentrations and peak area within the ranges of the study,and the linearity concentration ranges of stereoisomers 1,2 and 3 were 0.049 5-0.989 0 μg·mL-1,0.051 6-1.031 0 μg·mL-1,0.050 8-1.015 0 μg·mL-1 respectively.The linear correlation coefficients were 0.999 4.The recovery was 92.28%-103.90%.The sample solution was stable in 48 h at room temperature.Conclusion The method is accurate and reliable for determining stereoisomers in baloxavir marboxil,and provide a guideline of quality standards of baloxavir marboxil and safety evalution.
6.Problems and thinking of non-technical skill training of clinicians
Yang LIU ; Jing TIAN ; Jialiang SHI ; Jiayun XUE ; Oudong XIA
Chinese Journal of Medical Education Research 2025;24(1):132-136
Recently, continuing medical education has made progress under the support of national policies. However, the exploration of continuing medical education has overlooked the concept of non-technical skills. The lack of training in non-technical skills has become increasingly prominent, which seriously restricts the development of medical education. Drawing on the developmental trajectory and curriculum design experiences of non-technical skill training in Europe and the United States, this study examines the current situation and the problems of non-technical skill training in China. By establishing an effective curriculum support system to enhance engagement, improving the training process for non-technical skills to optimize the curriculum structure, and focusing on faculty cultivation targets to establish admission standards, this study aims to promote the steady and healthy advancement of non-technical skill training, and achieve a "win-win" situation in terms of patient safety and the sustainable development of continuing medical education.
7.Clinical value of peripheral immune function status in the assessment of'Deficiency of Vital Qi'in lung cancer metastasis
Fan XU ; Jianhui TIAN ; Youjun LIU ; Zhenyang CHENG ; Zujun QUE ; Bin LUO ; Yun YANG ; Jialiang YAO ; Wang YAO ; Xinyi LU ; Yao LIU ; Yiyang ZHOU ; Jianchun WU ; Yingbin LUO ; Minghua LI ; Wenfei SHI ; Yajing CUI ; Wenji SHANGGUAN ; Yan LI
Chinese Journal of Cancer Biotherapy 2025;32(10):1065-1070
Objective:To investigate the association between peripheral immune function status and lung cancer metastasis,and to identify peripheral blood immune biomarkers for'Deficiency of Vital Qi'assessment in lung cancer metastasis.Methods:A retrospective analysis was conducted on peripheral blood immune markers collected before treatment from lung cancer patients admitted into Shanghai Municipal Hospital of Traditional Chinese Medicine,affiliated to Shanghai University of Traditional Chinese Medicine,between March 2023 and April 2025.Patients were categorized into the non-metastatic and the metastatic groups based on the presence of distant metastasis,and the differences in the expressions of immune cells and cytokines between groups were compared.Peripheral blood immune markers with P<0.05 in univariate analysis were incorporated into a multivariate binary logistic regression model to identify independent predictors of lung cancer metastasis.Results:A total of 193 lung cancer patients were included(101 in the non-metastatic group and 92 in the metastatic group).There were no statistically significant differences between the two groups in terms of gender,age,smoking history,drinking history,or pathological type(all P>0.05).Univariate analysis revealed significant differences in multiple immune markers between the non-metastatic and metastatic groups(all P<0.05),including:lymphocyte count,CD3+,CD4+,and CD8+T,CD19+B cells,absolute counts of CD3-CD16+CD56+NK cells,percentages of Treg cells,CD8+CD28+Treg cells,G-MDSC,and CD3-CD16+CD56+dim NK cells,and levels of cytokine IL-1β,IL-6,and IL-10.Binary logistic regression analysis of differential indicators suggested that the percentage of Treg cells and CD8+CD28+Treg cells in peripheral blood were independent predictors of distant metastasis in lung cancer(OR=1.193,95%CI[1.047,1.36],P<0.01;OR=0.978,95%CI[0.957,0.999],P<0.05).Conclusion:Peripheral blood immune dysfunction is the biological basis for'qi deficiency'in lung cancer metastasis.This study quantitatively demonstrates the correlation between peripheral immune function status and lung cancer metastasis,providing empirical evidence for the theories of'qi deficiency and hidden toxicity'and'metastatic state of tumors'.
8.The efficacy of staged carotid artery stenting and coronary artery bypass grafting in the treatment of coronary heart disease complicated with carotid stenosis
Tao SHI ; Lequn TENG ; Yongbao ZHANG ; Jie FANG ; Jialiang LI ; Chenyang SHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(07):1014-1019
Objective To evaluate the efficacy of staged carotid artery stenting and coronary artery bypass grafting in the treatment of coronary heart disease complicated with carotid stenosis. Methods The clinical data of patients with coronary heart disease and carotid stenosis treated in Fuwai Hospital from November 2019 to September 2021 were retrospectively analyzed. All patients underwent staged carotid artery stenting and coronary artery bypass grafting. The incidence and risk factors of severe complications such as myocardial infarction, cerebral infarction and death during the perioperative period and follow-up were analyzed. Results A total of 58 patients were enrolled, including 47 males and 11 females with an average age of 52-77 (64.2±5.6) years. No complications occurred before coronary artery bypass grafting. There was 1 myocardial infarction, 1 cerebral infarction and 1 death after the coronary artery bypass grafting. The early complication rate was 5.2%. During the follow-up of 18.3 months, 1 cerebral infarction and 2 deaths occurred, and the overall complication rate was 10.3%. According to Kaplan-Meier survival curve analysis, patients with symptomatic carotid stenosis (log-rank, P=0.037) and placement of close-cell (log-rank, P=0.030) had a higher risk of postoperative ischemic cerebrovascular event, and patients with previous cerebral infarction had a higher risk of postoperative severe complications (log-rank, P=0.044). Conclusion Staged carotid artery stenting and coronary artery bypass grafting is safe and feasible for the treatment of coronary heart disease complicated with carotid stenosis.
9.Effects of Immune Acupuncture and Moxibustion on Infection and Outcome in Stroke Inpatients
Xiangbo MENG ; Yan SHI ; Tianxiao CHEN ; Jialiang YANG ; Lina CHEN ; Yuanbiao LIU
Chinese Journal of Rehabilitation Theory and Practice 2017;23(1):85-88
Objective To observe the effects of immune acupuncture and moxibustion on the infection in hospital and the outcome of re-habilitation after stroke. Methods From January, 2014 to January, 2016, 100 patients following acute stroke were randomly divided into ob-servation group (n=50) and control group (n=50). The control group accepted routine medications, rehabilitation and acupuncture, while the observation group accepted acupuncture and moxibustion on Guanyuan (RN4), Qihai (RN6) and Zusanli (ST36) in addition. The nosocomi-al infection rate was recorded 90 days after treatment, and the T lymphocyte subsets, scores of Fugl-Meyer Assessment (FMA) and modified Barthel index (MBI) were measured before and after treatment. Results The nosocomial infection rate was 20% in the observation group, less than 42% in the control group (χ2=5.657, P<0.05). The contribution of CD3+ and CD4+ T lymphocytes, and the scores of FMA and MBI increased after treatment in both groups (t>2.463, P<0.05), and increased more in the observation group than in the control group (t>2.225, P<0.05). Conclusion Immune acupuncture and moxibustion therapy can reduce the incidence of nosocomial infection, and promote the func-tion of the immune system and outcome in patients after acute stroke.
10.Observations on the Efficacy of Combined Acupuncture and Medicine plus Ultrashort Wave Diathermy in Treating Post-stroke Complicated Urinary Tract Infection
Xiangbo MENG ; Yan SHI ; Tianxiao CHEN ; Jialiang YANG ; Lina CHEN
Shanghai Journal of Acupuncture and Moxibustion 2015;(11):1024-1026
Objective To investigate the clinical efficacy of combined acupuncture and medicine plus ultrashort wave diathermy in treating post-stroke complicated urinary tract infection.Methods One hundred and twenty patients with post-stroke complicated urinary tract infection were randomly allocated to groups A, B and C, 40 cases each. Group A received acupuncture, ultrashort wave diathermy and treatment with anti-infective drugs; group B, ultrashort wave diathermy and treatment with anti-infective drugs; group C, treatment with anti-infective drugs alone. The clinical therapeutic effects and the recurrence rates were compared between the three groups.Results The total efficacy rate was 92.5% in group A, 90.0% in group B and 72.5% in group C. There was a statistically significant difference in the total efficacy rate between group A or B and group C (P<0.05). The recurrence rate was 8.1% in group A, 27.8% in group B and 31.0% in group C. There was a statistically significant difference in the recurrence rate between group A and group B or C (P<0.05).Conclusion Combined use of acupuncture and medicine plus ultrashort wave diathermy is an effective way to treat post-stroke complicated urinary tract infection.

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