1.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
2.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
3.Comparison of mid-to-long term outcomes between mitral valve repair and biological valve replacement in patients over 60 with rheumatic mitral valve disease based on a propensity score matching study
Wenbo ZHANG ; Jie HAN ; Tiange LUO ; Baiyu TIAN ; Fei MENG ; Wenjian JIANG ; Yuqing JIAO ; Xiaoming LI ; Jintao FU ; Yichen ZHAO ; Fei LI ; Xu MENG ; Jiangang WANG
Chinese Journal of Surgery 2024;62(11):1016-1023
Objective:To compare and discuss the mid-to-long-term outcomes of mitral valve repair (MVP) versus biological mitral valve replacement (bMVR) in patients aged 60 years and above with rheumatic mitral valve disease.Methods:This is a retrospective cohort study. A total of 765 patients aged 60 years and older, diagnosed with rheumatic mitral valve disease and who underwent MVP or bMVR at Beijing Anzhen Hospital from January 2010 to January 2023, were retrospectively included. Among them, 186 were male and 579 were female, with an age of (66.1±4.5) years (range: 60 to 82 years). Patients were divided into two groups based on the surgical method: the mitral valve repair group (MVP group, n=256) and the bioprosthetic mitral valve replacement group (bMVR group, n=509). A 1∶1 propensity score matching was performed using a caliper value of 0.2 based on preoperative data. Paired sample t-tests, χ2 tests, or Fisher′s exact tests were used for intergroup comparisons. Kaplan-Meier method was employed to plot survival curves and valve-related reoperation rate curves for both groups before and after matching, and Log-rank tests were used to compare the mid-to long-term survival rates and valve-related reoperation rates between the two groups. Results:A total of 765 patients who completed follow-up were ultimately included, with a follow-up period ( M(IQR)) of 5.1(5.0) years (range: 1.0 to 12.9 years). After matching, each group consisted of 256 patients. The incidence of early postoperative atrial fibrillation (39.1% vs. 49.2%, χ2=4.95, P=0.026) and early mortality rates (2.0% vs. 6.2%, χ2=4.97, P=0.026) were lower in the MVP group. Unadjusted Kaplan-Meier analysis showed significantly higher 5-year and 10-year survival rates for the MVP group (92.54% vs. 83.02%, 86.22% vs. 70.19%, Log-rank: P=0.001). After adjustment with propensity scores, the Kaplan-Meier analysis still indicated higher 5-year and 10-year survival rates in the MVP group compared to the bMVR group (92.54% vs. 85.89%, 86.22% vs. 74.83%, Log-rank: P=0.024). There were no significant differences in the rates of valve-related reoperation between the two groups before and after matching (5-year and 10-year reoperation rates pre-matching: 1.75% vs. 0.57%, 5.39% vs. 7.54%, Log-rank: P=0.207; post-matching: 1.75% vs. 0, 5.39% vs. 9.27%, Log-rank: P=0.157). Conclusion:For patients aged 60 years and above with rheumatic mitral valve disease, mitral valve repair offers better mid-to-long-term survival compared to biological valve replacement.
4.Comparison of mid-to-long term outcomes between mitral valve repair and biological valve replacement in patients over 60 with rheumatic mitral valve disease based on a propensity score matching study
Wenbo ZHANG ; Jie HAN ; Tiange LUO ; Baiyu TIAN ; Fei MENG ; Wenjian JIANG ; Yuqing JIAO ; Xiaoming LI ; Jintao FU ; Yichen ZHAO ; Fei LI ; Xu MENG ; Jiangang WANG
Chinese Journal of Surgery 2024;62(11):1016-1023
Objective:To compare and discuss the mid-to-long-term outcomes of mitral valve repair (MVP) versus biological mitral valve replacement (bMVR) in patients aged 60 years and above with rheumatic mitral valve disease.Methods:This is a retrospective cohort study. A total of 765 patients aged 60 years and older, diagnosed with rheumatic mitral valve disease and who underwent MVP or bMVR at Beijing Anzhen Hospital from January 2010 to January 2023, were retrospectively included. Among them, 186 were male and 579 were female, with an age of (66.1±4.5) years (range: 60 to 82 years). Patients were divided into two groups based on the surgical method: the mitral valve repair group (MVP group, n=256) and the bioprosthetic mitral valve replacement group (bMVR group, n=509). A 1∶1 propensity score matching was performed using a caliper value of 0.2 based on preoperative data. Paired sample t-tests, χ2 tests, or Fisher′s exact tests were used for intergroup comparisons. Kaplan-Meier method was employed to plot survival curves and valve-related reoperation rate curves for both groups before and after matching, and Log-rank tests were used to compare the mid-to long-term survival rates and valve-related reoperation rates between the two groups. Results:A total of 765 patients who completed follow-up were ultimately included, with a follow-up period ( M(IQR)) of 5.1(5.0) years (range: 1.0 to 12.9 years). After matching, each group consisted of 256 patients. The incidence of early postoperative atrial fibrillation (39.1% vs. 49.2%, χ2=4.95, P=0.026) and early mortality rates (2.0% vs. 6.2%, χ2=4.97, P=0.026) were lower in the MVP group. Unadjusted Kaplan-Meier analysis showed significantly higher 5-year and 10-year survival rates for the MVP group (92.54% vs. 83.02%, 86.22% vs. 70.19%, Log-rank: P=0.001). After adjustment with propensity scores, the Kaplan-Meier analysis still indicated higher 5-year and 10-year survival rates in the MVP group compared to the bMVR group (92.54% vs. 85.89%, 86.22% vs. 74.83%, Log-rank: P=0.024). There were no significant differences in the rates of valve-related reoperation between the two groups before and after matching (5-year and 10-year reoperation rates pre-matching: 1.75% vs. 0.57%, 5.39% vs. 7.54%, Log-rank: P=0.207; post-matching: 1.75% vs. 0, 5.39% vs. 9.27%, Log-rank: P=0.157). Conclusion:For patients aged 60 years and above with rheumatic mitral valve disease, mitral valve repair offers better mid-to-long-term survival compared to biological valve replacement.
5.Application of flipped classroom combined with online interactive teaching in clinical clerkship of cardiology
Fei ZHOU ; Li LI ; Lin TENG ; Xin′an WANG ; Wenbo ZOU ; Song LI
Chinese Journal of Medical Education Research 2022;21(2):179-182
Objective:To explore the application effect of flipped classroom combined with online interactive teaching in clinical clerkship of cardiology.Methods:The study collected 56 students from Batch 2017 five-year clinical medicine undergraduate class of Medical College of China Three Gorges University and they were randomly divided into experimental group and control group in average. The control group adopted the traditional teaching method while the experimental group adopted the combined teaching method. The differences of test scores after teaching were compared between the two groups and the feedback of students on the two methods was also analyzed. SPSS 12.0 was used for t test and chi-square test. Results:The final score of clinical thinking in the experimental group (84.38±3.18) was significantly higher than in the control group (75.43±5.85) ( P<0.05), and the satisfaction of the experimental group to the teaching mode was [86% (24/28)], which was significantly higher than that of the control group [50% (14/28)]. More than 80% of the students in the experimental group regarded that the combined teaching method was helpful to promote the interaction between teachers and students, master relevant knowledge, and improve learning interest and learning efficiency. Conclusion:This combined teaching method can enhance students' clinical thinking ability, learning enthusiasm and efficiency, and finally effectively improve the effect of clerkship.
7.Application of 256-slice CT coronary angiography in postoperative evaluation of graft patency after coronary artery bypass grafting in elderly patients
Bo CHEN ; Wenbo WU ; Mingying WU ; Ziqiang ZHOU ; Fei LIU
Chinese Journal of Geriatrics 2020;39(7):791-795
Objective:To investigate the value of 256-slice CT coronary angiography(CTA)in evaluating graft patency after coronary artery bypass grafting(CABG)in elderly patients.Methods:A total of 30 elderly patients under follow-up after CABG surgery in our hospital from May 2016 to May 2018 were randomly selected.During the same period, coronary angiography(CAG)and 256-slice CTA were performed to evaluate the patency of grafts.The diagnostic efficacy of CTA in evaluating the patency of bypass grafts was assessed by using CAG results as the gold standard.Results:In all, 82 grafts were observed on CAG, of which 31 were arterial grafts and 51 were saphenous vein grafts(SVG). Arterial grafts involved 27 original left internal mammary arteries(LIMA)→left anterior descending branch(LAD)grafts, 1 original right internal mammary artery(RIMA)→LAD graft, 1 aorta(AO)→LIMA→LAD graft, and 2 AO→radial arteries(RA)→right coronary artery(RCA)grafts.Venous grafts involved 9 AO→SVG→LAD grafts, 20 AO→SVG→left circumflex artery(LCX)grafts, and 22 AO→SVG→RCA grafts.CAG results showed that 28 arterial grafts were unobstructed with a patency rate of 90.3%, while 3 arterial grafts(9.7%)were occluded.Meanwhile, 34 venous grafts were unobstructed with a patency rate of 66.7%, 11 venous grafts(21.6%)had stenosis and 6 grafts(11.8%)were occluded.A total of 87 grafts were observed by using CTA.Based on the results from CAG, the overall sensitivity, specificity and Kappa value of CTA for the assessment of grafts were 95.1%, 97.6% and 0.93, respectively.The sensitivity, specificity and Kappa value of CTA were 96.8%, 95.0% and 0.90 for assessing unobstructed grafts, 81.8%, 97.2% and 0.79 for assessing stenosed grafts, and 100%, 98.6%, and 0.94 for assessing occluded grafts, respectively.Conclusions:256-slice CT coronary angiography can be used to accurately evaluate graft status and possesses advantages such as non-invasiveness, simplicity and low risk.Therefore, it should be recommended as the first choice in the evaluation of graft patency after CABG in elderly patients.
8.Clinical Effect of Internal Combined with External Fixation on Pelvic Fracture and Serum ALP, TNF-α and TGF-β Levels
Lipeng DUAN ; Guoju MA ; Heyi ZHAO ; Jing ZHANG ; Wenbo ZHANG ; Fei GAO
Progress in Modern Biomedicine 2017;17(22):4338-4341
Objective:To study the clinical effect of internal combined with external fixation in the treatment of pelvic fracture and its effect on the serum alkaline phosphatase (ALP),tumor necrosis factor-a (TNF-α) and transforming growth factor-β (TGF-β).Methods:Eighty-six patients with pelvic fractures admitted in our hospital from August 2014 to July 2015 were selected and divided into the observation group and control group according to the admission order.Conventional internal fixation was used in the control group,and the internal combined with extemal fixation was performed in the observation group.The clinical curative effect,operative time,blood loss,fracture healing time and incidence of complication were compared between two groups.The levels of serum ALP,TNF-α and TGF-β in the two groups were compared before and after treatment between two groups.Results:The excellent rate of observation group was significantly higher than that of the control group [81.40% (35/43) vs 41.86% (18/43)] (P <0.05).The operative time,blood loss and fracture healing time in the observation group were significantly shorter or less than those of the control group (P<0.05).There was no significant difference in the serum ALP,TNF-α and TGF-β levels between the two groups before treatment (P>0.05).After treatment,the serum ALP levels in the two groups were significantly higher than before treatment (P<0.05).The levels of TNF-α and TGF-β were significantly lowe than those before treatment(P<0.05),the ALP levels in the observation group was significantly higher than that of the control group (P <0.05),and the levels of TNF-c and TGF-β were significantly lower than those of the control group 0.05).The incidence of complications of observation group was significantly lower than that of the control group [0.00% (0/43) vs 11.63% (5/43)] (P <0.05).Conclusion:Internal and external fixation was effective and safe in the treatment of pelvic fractures,which could significantly increase the serum ALP level and reduce the levels of TNF-α and TGF-β.
9.Effect of exogenous L-arginie on survival of extended dorsal perforator flaps in rats.
Wenbo LI ; Dingding JIA ; Fei WANG ; Chao ZHANG ; Jie SHI ; Hong ZHANG ; Lujia WU ; Qiuming GAO
Journal of Zhejiang University. Medical sciences 2017;46(6):656-661
Objective: To investigate the effect of exogenous L-Arg on the survival of extended perforator flap in rats. Methods: Sixteen male Sprague Dawley rats were randomly divided into L-Arg group (n=8) and control group(n=8). The extended dorsal three-vascular territory perforator flaps were made in rats. L-Arg (400 mg·kg-1·d-1) was injected intraperitoneally in L-Arg group 1d before operation, immediately and 1-7 d after operation, while the same volume of saline was injected intraperitoneally in control group at the same time points. The appearance and distribution of blood vessels were observed, and the flap survival areas were measured 7d after operation. The tissue samples were harvested from choke zone Ⅱ for histological study and the expression of vascular endothelial growth factor (VEGF) was detected by immunohistochemistry and Western blot, respectively. Results: After 7d, the clearer vascular structure and more new vessels in choke zone Ⅱ were observed in L-Arg group. The survival rate of flap in L-Arg group was (88.42±4.19)%, which was significantly higher than that in control group[(76.52±5.37)%, t=3.707, P<0.01]. The microvessel density and caliber of choke zone Ⅱ in L-Arg group was (29.47±5.28)/mm2 and(47.27±5.32)μm, which were significantly higher than those in control group (t=2.694 and 2.389, P<0.05 or P<0.01). The immunohistochemistry and Western blot showed that the expression of VEGF in choke zone Ⅱ of L-Arg group was significantly higher than that in control group (t=9.428 and -3.054,P<0.05 or P<0.01). Conclusion: Exogenous L-Arg can increase the survival rate of extended dorsal perforator skin flap through promoting vascularization and dilatation of vessels in choke zone Ⅱ in rats.
Animals
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Arginine
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pharmacology
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Graft Survival
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drug effects
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Male
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Neovascularization, Physiologic
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drug effects
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Perforator Flap
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blood supply
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Random Allocation
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Rats
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Rats, Sprague-Dawley
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Skin
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drug effects
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Vascular Endothelial Growth Factor A
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metabolism

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