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.A laboratory model for evaluating the risk of thrombosis in patients with chronic venous insufficiency
Xiang XIAO ; Yongran SI ; Jingwei ZHANG ; Yan ZENG
Chinese Journal of Blood Transfusion 2024;37(6):632-637
Objective To explore the predictive value of combined thromboelastography(TEG),coagulation index and platelet parameters in evaluating the risk of thrombosis in patients with chronic venous insufficiency(CVI).Methods A total of 359 patients with CVI were enrolled in our hospital from November 2020 to March 2022,and divided into VTE group and non-VTE group according to the occurrence of venous thromboembolism(VTE).The baseline characteristics of the two groups and the value of combined TEG,coagulation index and platelet parameters in predicting the risk of VTE in patients with CVI were analyzed.The risk factors were screened by univariate logistic regression analysis,and the prediction model was constructed by multivariate logistic regression.The performance of the model was evaluated by area under the curve(AUC)and sensitivity specificity.Results Compared with the non-VTE group,the R value(3.27±0.71 vs 3.87±1.16,P<0.05),the prothrombin time(PT)(11.08±3.02 vs 12.86±3.48,P<0.001)and the platelet distribution width(PDW)(12.01±3.87 vs 13.98±3.20,P<0.001)of the VTE group decreased,while fibrinogen(Fib)(3.46 vs 3.10,P<0.05)and D-dimer(DD)(3.00 vs 1.12,P<0.001)increased.It was found that the area under the ROC curve of the thrombosis pre-diction model based on PT,DD,R value,Fib and PDW was 0.842 8,with the sensitivity and specificity of 36.78%and 95.59%,respectively.The decision curve analysis(DCA)indicated that patients would benefit when the model's predicted probability ranged from 0.1 to 0.7.Conclusion The combination of TEG,coagulation index and platelet parameters is ef-fective in predicting the risk of VTE in patients with CVI.
6.Prediction model of platelet transfusion refractoriness in patients with hematological disorders
Shuhan YUE ; Xiulan HUANG ; Yan ZENG ; Qiao LEI ; Mengzhen HE ; Liqi LU ; Shisong YOU ; Jingwei ZHANG
Chinese Journal of Blood Transfusion 2024;37(8):890-895,939
Objective To explore the risk factors for platelet transfusion refractoriness(PTR)in patients with hemato-logical disorders,construct a prediction model and validate the model efficacy.Methods Patients with hematological disor-ders who received platelet transfusion therapy in the Chengdu Second People's Hospital from December 2021 to December 2022 were retrospectively included to judge the effectiveness of platelet transfusion and screened for risk factors by univariate and multivariate logistic regression.A prediction model for PTR was constructed using receiver operating characteristic(ROC)curve,calibration curve and decision curve(DCA)to assess the differentiation,calibration and clinical value of the model,respectively.Results A total of 334 hematological patients were included,including 168 males and 176 females,with a PTR incidence of 40.4%.Univariate and multivariate logistic regression analysis showed that platelet transfusion vol-ume,erythrocyte transfusion volume,and neutrophil ratio were risk factors for PTR(P<0.05).A prediction model for PTR in hematological patients was established based on these risk factors.The area under the model's curve was 0.8377(95%CI:0.723-0.772),the sensitivity was 58.52%,and the specificity was 89.95%.The calibration curve showed that the S∶P was 0.964,the maximum absolute difference Emax was 0.032,and the average absolute difference Eavg was 0.009.The DCA a-nalysis showed that the model had clinical application value when the risk threshold ranged from 0.2 to 0.9.Conclusion The PTR prediction model based on platelet transfusion volume,erythrocyte transfusion volume and neutrophil ratio can pro-vide a basis for effective platelet transfusion in hematological patients.
7.Hypercalcium crisis and postoperative hungry bone syndrome caused by primary hyperparathyroidism: a case report.
Mengdi ZHANG ; Yifei ZENG ; Lei WANG ; Yian SUN ; Jingwei LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(5):389-392
To review the diagnosis and treatment of a case of hypercalcium crisis caused by primary hyperparathyroidism(PHPT) and prophylactic treatment of hungry bone syndrome. In a 32-year-old male with hypercalcemia, the main manifestations were loss of appetite, nausea, polyuria, polydipsia, fatigue, lethargy, etc. parathyroid hormone, serum calcium increased, thyroid function was normal, thyroid color ultrasound and MRI showed space-occupying behind the right thyroid, radionuclide examination showed abnormal imaging agent concentration in the right parathyroid area, there was a history of pathological fracture. Clinically diagnosed as hypercalcemia crisis secondary to PHPT.
Male
;
Humans
;
Adult
;
Hypercalcemia/diagnosis*
;
Hyperparathyroidism, Primary/surgery*
;
Parathyroid Hormone
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Hypocalcemia/complications*
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Thyroid Gland
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Calcium
8.Study on Improvement Effects and Mechanism of Guizhi Fuling Pills on Phlegm-dampness Type PCOS Model Rats
Jingwei YU ; Xiaoying ZHONG ; Lei ZENG ; Yongxia ZHENG
China Pharmacy 2021;32(1):39-45
OBJECTIVE:To stu dy the improvem ent effect and mechanism of Guizhi fuling pill (GZFLP) on rats with phlegm-dampness type polycystic ovary syndrome (PCOS).METHODS:Totally fifty female SD rats with regular estrous cycle were randomly divided into blank control group (n=10) and model group (n=40). The model group received letrozole intragastrically [1 mg/(kg·d),for 21 d ] to induce phlegm-damp PCOS rat model. Forty model rats were randomly divided into model group ,metformin group [positive control ,0.135 g/(kg·d)] and GZFLP low-dose ,high-dose groups [4.49,17.96 g/(kg· d)],with 10 rats in each group. Each medicine group was given intragastric administration ,once a day ,for 30 consecutive days. Blank control and model group were given intragastric administration of equal volume normal saline.After last medication ,oral glucose tolerance test (OGTT)was used to detect the level of blood glucose in rats at 0,30,60 and 120 min. ELISA assay was used to detect the levels of follicle-stimulating hormone (FSH),luteinizing hormone (LH),estradiol(E2)and testosterone (T); body weight ,the weight of uterus ,bilateral ovaries and paragonadal fat were weighed. HE staining was used to observe morphological changes of ovarian tissue sections. RT-PCR method and Western blotting assay were used to detect mRNA and protein expression of CYP 19a1 in ovary and Glut 4 in uterine. RESULTS :Compared with blank control group ,the levels of blood glucose 30,60,120 min after intragastric administration of glucose solution as well as serum levels of LH ,E2 and T were increased significantly in model group (P<0.05);the body weight ,the weight of uterus ,bilateral ovaries and paragonadal fat were increased significantly (P<0.05);the volume of thecal cells increased significantly and showed spherical shape ;the mRNA and protein expression of CYP 19a1 in ovarian tissue and Glut 4 in uterine tissue were decreased significantly (P<0.05 or P<0.01). Compared with model group ,above indexes of administration groups were improved significantly (P<0.05 or P<0.01);the thickness of theca cell layer and the volume of theca cells in GZFLP low-dose and high-dose groups were also improved. CONCLUSIONS:GZFLP can up-regulate the expression of CYP19a1 in ovary and Glut4 in uterus ,so as to improve the abnormal glucose metabolism in phlegm-dampness type PCOS model rats ,reduce insulin resistance ,lower serum estrogen levels ,and reduce the degree of polycystic changes in ovary ,thereby playing a role in the treatment of PCOS.
9.The relationship between air quality improvement and the onset of type 2 diabetes mellitus: a prospective cohort study
Hao YU ; Lihong FENG ; Changchun HOU ; Qiang ZENG ; Fei WANG ; Yan ZHAO ; Yuwen WANG ; Xianwei ZHANG ; Jingwei ZHANG
Journal of Public Health and Preventive Medicine 2020;31(1):11-15
Objective To explore the effect of decreased air pollutants concentrations on the incidence of Type 2 Diabetes Mellitus (T2DM). Methods A prospective cohort was designed in Tianjin where the air quality gradually improved from 2014 to 2018. A total of 5 077 community residents (18-90 years old) were recruited as the baseline population from 2013 to 2014. From 2014 to 2018 follow-up was carried out year by year to observe the new incidence of T2DM in the cohort. The HR and 95%CI (95% confidence interval) were calculated with the multiple Cox proportional hazard regression model to evaluate the effect of the decrease in the concentrations of SO2, NO2, and particulate matters with diameters <10μm and <2.5μm (PM10, PM2.5) on the incidence of T2DM. Results The cohort was followed up year by year from 2014 to 2018, with a cumulative follow-up of 25 385 person-years over the 5 years. At the same time, the air quality of Tianjin was significantly improved. Statistical analysis results after covariate adjustment revealed that the risk of T2DM in the population decreased by 0.172, 0.124, and 0.210 times, for a decrease of 10 μg/m3 in the annual average concentrations of SO2, PM10, and PM2.5 each, respectively (SO2:HR=0.828,95%CI=0.757-0.907;PM10:HR=0.876,95%CI=0.816-0.941;PM2.5:HR=0.790,95%CI=0.694-0.899). Conclusion The implementation of environmental protection measures to improve air pollution could reduce the risk of T2DM in the population and control the increasing prevalence.
10.Role of digital subtraction angiography in surgical treatment of intracranial arteriovenous malformations in children
Deqiu CUI ; Gao ZENG ; Jianxin DU ; Xinglong ZHI ; Jingwei LI
Chinese Journal of Cerebrovascular Diseases 2017;14(8):429-433
Objective To investigate the safety and effectiveness of digital subtraction angiography (DSA) in the surgical treatment of intracranial arteriovenous malformations (AVMs) in children.Methods Between December 2015 and February 2017,the clinical and imaging data of 9 children with AVM (2-14 years) underwent hybrid surgery at the Department of Neurosurgery,Xuanwu Hospital,Capital Medical University were analyzed retrospectively.According to the Spetzler-Martin grade,there were 2 patients with grade Ⅰ,3 with grade Ⅱ,2 with grade Ⅲ,and 2 with grade Ⅳ.All the children were treated with microsurgery,and their AVMs were removed by real-time assistance using DSA technique during the operation.The imaging cure rate of surgical treatment and the complications of intraoperative angiography of the children were analyzed.The children were followed up clinically after procedure.According to the modified Rankin scale (mRS) score,their prognoses were evaluated.Results Intraoperative angiography revealed that the AVMs in 8 of 9 children were resected completely,and 1 had a residual lesion,then it was resected completely.Immediately after the resection of the nidi,the angiography confirmed that the nidi of 9 children were resected completely.No related complications caused by intraoperative angiography were observed.Nominal aphasia occurred in 1 child after procedure,and he recovered gradually after 6 months.Pulmonary infection occurred in 2 children,and they were cured after anti-infection treatments.Postoperative follow-up mRS scores were 0-1 in 8 children,2 in 1 child,and no rebleeding was observed.Conclusions In children undergoing AVM surgery,initial observation of DSA is safe and effective.Intraoperative angiography can guide the complete resection of the lesions in real time,improve the surgical cure rate of AVMs,and improve the prognosis of children.


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