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.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.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.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. 
		                        		
		                        		
		                        		
		                        	
5.Predicting the Risk of Arterial Stiffness in Coal Miners Based on Different Machine Learning Models.
Qian Wei CHEN ; Xue Zan HUANG ; Yu DING ; Feng Ren ZHU ; Jia WANG ; Yuan Jie ZOU ; Yuan Zhen DU ; Ya Jun ZHANG ; Zi Wen HUI ; Feng Lin ZHU ; Min MU
Biomedical and Environmental Sciences 2024;37(1):108-111
6.Evaluation of the clinical efficacy of microwave ablation combined with percutaneous osteoplasty in the treatment of flat bone metastases
Zhipeng LIN ; Xiaolong HU ; Dabei HUANG ; Xugong ZOU ; Yuan CHEN ; Kangshun ZHU ; Jian ZHANG ; Xiaoqun LI
Journal of Interventional Radiology 2024;33(9):976-982
		                        		
		                        			
		                        			Objective To evaluate the clinical efficacy,safety,and potency ratio of microwave ablation(MW A)combined with percutaneous osteoplasty(POP)for the treatment of flat bone metastases.Methods A total of 57 patients with flat bone metastases complicated by intractable pain,who underwent MWA combined with POP(combination therapy)or only POP(pure POP therapy)at the Zhongshan Municipal People's Hospital of China between January 2016 and January 2023,were enrolled in this study.The combination therapy group had 36 patients and the pure POP therapy group had 21 patients.Visual analog scale(VAS),Oswestry Disability Index(ODI),quality of life assessment scale(QOL)were used to evaluate the preoperative and the postoperative different period efficacy,and the results were compared between the two groups.The procedure-related complications in both groups were recorded.Results The technical success rate in the 57 patients was 100%,and no serious postoperative complications occurred.The mean follow-up time was(4.7±1.3)months(range of 3.4-7.2 months).The preoperative and the postoperative one-day,one-week,one-month and 3-month VAS scores in the combination therapy group were(7.39±1.09)points,(6.53±1.17)points,(1.94±0.70)points,(1.11±0.66)points and(1.39±0.59)points respectively,which in the pure POP therapy group were(7.52±1.01)points,(6.81±0.66)points,(3.38±0.65)points,(2.33±0.56)points and(2.52±0.50)points respectively.One week after operation,the VAS scores in the combination therapy group and the pure POP therapy group were decreased by(5.44±1.32)points and(4.14±0.96)points respectively.The differences in the postoperative one-week(t=-7.62,P<0.01),one-month(t=-7.28,P<0.01)and 3-month(t=-7.58,P<0.01)VAS scores between the two groups were statistically significant.The preoperative and the postoperative one-day,one-week,one-month and 3-month ODI scores in the combination therapy group were(44.33±2.91)points,(44.08±2.82)points,(15.92±3.04)points,(14.00±2.39)points and(16.08±3.61)points respectively,which in the pure POP therapy group were(45.67±3.03)points,(45.14±2.80)points,(22.38±3.09)points,(19.76±2.99)points and(22.10±3.10)points respectively.One week after operation,the ODI score in the combination therapy group was decreased by(28.42±4.23)points,which in the pure POP therapy group was decreased by(23.29±4.28)points.The differences in the postoperative one-week(t=-7.50,P<0.01),one-month(t=-7.37,P<0.01)and 3-month(t=-6.51,P<0.01)ODI scores between the two groups were statistically significant.The preoperative and the postoperative one-day,one-week,one-month and 3-month QOL scores in the combination therapy group were(24.69±3.92)points,(26.06±3.05)points,(38.67±3.00)points,(40.25±3.42)points and(39.58±3.99)points respectively,which in the pure POP therapy group were(24.43±3.53)points,(26.76±3.05)points,(32.81±2.17)points,(33.95±2.68)points and(31.19±4.27)points respectively.One week after operation,the QOL score in the combination therapy group was increased by(13.97±4.88)points,which in the pure POP therapy group was increased by(8.38±4.50)points.The differences in the postoperative one-week(t=8.34,P<0.01),one-month(t=7.56,P<0.01)and 3-month(t=7.18,P<0.01)QOL scores between the two groups were statistically significant.The mean operation cost in the combination therapy group was 10 480.43 Chinese yuan,which was higher than that in the pure POP therapy group.Conclusion For the treatment of flat bone metastases,both pure POP therapy and MWA combined with POP therapy are clinically safe and effective,which can significantly relieve pain and improve quality of life.Compared with pure POP therapy,the MWA combined with POP therapy is more effective but its medical cost is more expensive.
		                        		
		                        		
		                        		
		                        	
7.Impact of therapeutic plasma exchange intervention timing and liver injury periodization on the prognosis of pa-tients with exertional heat stroke
Zongzhong HE ; Min WANG ; Yuan ZHUANG ; Jie LIN ; Leiying ZHANG ; Liyang ZOU ; Lingling LI ; Chunya MA ; Xiaomin LIU ; Xiang QUAN ; Ying JIANG ; Mou ZHOU ; Hongjun KANG ; Yang YU
Chinese Journal of Blood Transfusion 2024;37(7):728-733
		                        		
		                        			
		                        			Objective To explore the prognostic impact and clinical application value of therapeutic plasma exchange(TPE)intervention timing and liver injury periodization in patients with exertional heat stroke(EHS).Methods Data of 127 EHS patients from the First Medical Center of the General Hospital of the People′s Liberation Army from January 2011 to December 2023 were collected,then divided into the death group and the survival group based on therapeutic outcomes and into 5 stages according to the dynamic changes of ALT,AST,TBIL and DBIL.According to propensity score matching analysis,11 patients in the survival group and 12 patients in the death group were included in the statistical analysis,and 20 of them were treated with TPE.The changes in indicators and clinical outcomes before and after TPE were observed,in order to evaluate the impact of intervention timing on prognosis.Results Among the 23 patients,14 had no liver injury or could progress to the repair phase,resulting in 3 deaths(with the mortality rate of 21.43%),while 9 patients failed to pro-gress to the repair phase,resulting in 9 deaths(with the mortality rate of 100%),with significant differences(P<0.05).The mortality rate of the first TPE intervention before the third stage of liver injury was 23.08%(3/13),while that of interven-tion after reaching or exceeding the third stage was 85.71%(6/7),and the difference was statistically significant(P<0.05).Conclusion TPE should be executed actively in EHS patients combined with liver injury before the third phase to lock its pathological and physiological processes,thereby improving prognosis and reducing mortality.
		                        		
		                        		
		                        		
		                        	
8.Exercise regulates bone metabolism via microRNAs.
Yu YUAN ; Lin-Zhen RAO ; Shi-Hua ZHANG ; Yang XU ; Ting-Ting LI ; Jun ZOU ; Xi-Quan WENG
Acta Physiologica Sinica 2023;75(3):429-438
		                        		
		                        			
		                        			It has been well documented that exercise can improve bone metabolism, promote bone growth and development, and alleviate bone loss. MicroRNAs (miRNAs) are widely involved in the proliferation and differentiation of bone marrow mesenchymal stem cells, osteoblasts, osteoclasts and other bone tissue cells, and regulation of balance between bone formation and bone resorption by targeting osteogenic factors or bone resorption factors. Thus miRNAs play an important role in the regulation of bone metabolism. Recently, regulation of miRNAs are shown to be one of the ways by which exercise or mechanical stress promotes the positive balance of bone metabolism. Exercise induces changes of miRNAs expression in bone tissue and regulates the expression of related osteogenic factors or bone resorption factors, to further strengthen the osteogenic effect of exercise. This review summarizes relevant studies on the mechanism whereby exercise regulates bone metabolism via miRNAs, providing a theoretical basis for osteoporosis prevention and treatment with exercise.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			MicroRNAs/metabolism*
		                        			;
		                        		
		                        			Osteogenesis/genetics*
		                        			;
		                        		
		                        			Cell Differentiation
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		                        			Osteoblasts
		                        			;
		                        		
		                        			Bone Resorption/metabolism*
		                        			
		                        		
		                        	
9.Allogeneic hematopoietic stem cell transplantation for MDS secondary to Shwachman-Diamond syndrome: a case report.
Ming ZHOU ; Yuan Wen JIANG ; Jian Jun CHEN ; Chao WU ; Bin Bin ZOU ; Zhao CHEN ; Lin LI ; Ping LEI ; Guang Hua LIU ; Yan Yan TIAN ; Man Li ZHU ; Can LIU
Chinese Journal of Hematology 2023;44(1):80-80
10.Value of direct immunohistochemical staining in assisting intraoperative frozen diagnosis of bronchiolar adenoma.
Bo ZHENG ; Shuan Mei ZOU ; Lin YANG ; Xue Min XUE ; Chang Yuan GUO ; Long WANG ; Wen Chao LIU ; Zhao Zhao ZHOU ; Xin LIU ; Li Yan XUE
Chinese Journal of Pathology 2023;52(2):142-146
		                        		
		                        			
		                        			Objective: To explore the feasibility and application value of intraoperative direct immunohistochemical (IHC) staining in improving the diagnosis accuracy in difficult cases of bronchiolar adenoma (BA). Methods: Nineteen cases with single or multiple pulmonary ground-glass nodules or solid nodules indicated by imaging in Cancer Hospital of Chinese Academy of Medical Sciences from January to July 2021 and with difficulty in differential diagnosis at frozen HE sections were selected. In the experimental group, direct IHC staining of cytokeratin 5/6 (CK5/6) and p63 was performed on frozen sections to assist the differentiation of BA from in situ/micro-invasive adenocarcinoma/adenocarcinoma/invasive mucinous adenocarcinoma. In the control group, two pathologists performed routine frozen HE section diagnosis on these 19 cases. The diagnostic results of paraffin sections were used as the gold standard. The sensitivity and specificity of BA diagnosis, consistency with paraffin diagnosis and time used for frozen diagnosis were compared between the experimental group and the control group. Results: The basal cells of BA were highlighted by CK5/6 and p63 staining. There were no basal cells in the in situ/microinvasive adenocarcinoma/adenocarcinoma/invasive mucinous adenocarcinoma. In the experimental group, the sensitivity and specificity with aid of direct IHC staining for BA were 100% and 86.7%, respectively, and the Kappa value of frozen and paraffin diagnosis was 0.732, and these were significantly higher than those in the control group (P<0.05). The average time consumption in the experimental group (32.4 min) was only 7 min longer than that in the control group (25.4 min). Conclusions: Direct IHC staining can improve the accuracy of BA diagnosis intraoperatively and reduce the risk of misdiagnosis, but require significantly longer time. Thus frozen direct IHC staining should be restricted to cases with difficulty in differentiating benign from malignant diseases, especially when the surgical modalities differ based on the frozen diagnosis.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			Paraffin
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		                        			Sensitivity and Specificity
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		                        			Adenocarcinoma in Situ
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		                        			Adenoma/diagnosis*
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		                        			Adenocarcinoma, Mucinous/surgery*
		                        			;
		                        		
		                        			Frozen Sections/methods*
		                        			
		                        		
		                        	
            
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