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.Design of Remote Slit Lamp Diagnosis Platform Based on IoT Technology
Tianxing QUE ; Sisi BAI ; Jingru LI ; Shuangshuang CAI ; Shuang LIAN ; Zhipeng YE ; Hao CHEN ; Peipei JIANG
Chinese Journal of Medical Instrumentation 2024;48(2):232-236
In order to realize the diagnosis of slit lamp in cross-regional patients and improve the real-time and convenience of diagnosis,a remote slit lamp diagnosis platform based on Internet of Things(IoT)technology is designed.Firstly,the feasibility of remote slit lamp is analyzed.Secondly,the IoT platform architecture of doctor/server/facility(D/S/F)is proposed and a remote slit lamp is designed.Finally,the performance of the remote slit lamp diagnostic platform is tested.The platform solves the communication problem of distributed slit lamps and realizes respectively numerical control of multi-area slit lamp by multi-eye experts.The test results show that the remote control delay of the platform is less than 20 ms,which supports multiple experts to diagnose multiple patients separately.
4.Effects of Guiqi Yiyuan Ointment on Immune Function in 12C6+ Beam Bystander-effect Rats
Tianxing MA ; Jintian LI ; Yi ZHANG ; Jianqing LIANG ; Shiyu CHEN
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(3):113-118
Objective To observe the effects and mechanism of Guiqi Yiyuan Ointment on immune function in 12C6+ beam bystander-effect rats.Methods Totally 60 Wistar rats were randomly divided into blank group,model group,positive control group,and TCM low-,medium-,and high-dosage groups,with 10 rats in each group.TCM low-,medium-,and high-dosage groups were given 1.2,2.4,and 4.8 g/kg Guiqi Yiyuan Ointment for gavage,and the blank group,model group and positive control group were given equal dose of sodium chloride solution for gavage for 14 days.Positive control group received intraperitoneal injection of amifostine 30 minutes before modeling.On the 15th day,except the blank group,the other groups were given 4 Gy 12C6+ beam of single irradiation on the right lung.After irradiation,each group was given gavage for 3 days.The general condition of rats was observed,peripheral blood leukocyte(WBC),red blood cell(RBC),hemoglobin(Hb),platelet(PLT)levels were detected,ELISA was used to detect the contents of serum interleukin(IL)-4 and interferon-γ(IFN-γ),lung and spleen organ indices were calculated,HE staining was used to observe the pathological morphology of left lung and spleen tissues,and flow cytometry was used to detect the proportion of CD4+ and CD8+ T lymphocytes in the spleen,qPCR was used to detect the expressions of T-bet and GATA-3 mRNA in right lung and spleen tissues.Results Compared with the blank group,the model group rats showed a decrease in peripheral blood WBC,an increase in RBC,Hb,PLT,and an decrease in serum IL-4 and IFN-γ contents;the organ indices of left lung and spleen was significantly reduced,the alveoli were deformed,the alveolar walls became thicker,the alveolar cavities shrank,the lung tissue was significantly bleeding,the spleen tissue structure was severely damaged,the splenic sinus cavity became narrower,and the splenic cord showed fibrous hyperplasia;the proportion of CD4+ T lymphocytes and CD4+/CD8+ ratio in spleen tissue of the model group decreased,while the proportion of CD8+ T lymphocytes increased,the expression of T-bet mRNA in the left lung and spleen tissues decreased,while the expression of GATA-3 mRNA increased,with statistical significance(P<0.05).Compared with the model group,the positive control group and TCM medium-and high-dosage groups showed an increase in peripheral blood WBC,an decrease in RBC,Hb,PLT,an increase in serum IL-4 and IFN-γ contents;the index of left lung and spleen organs increased in TCM high-dosage group;the pathological damage of left lung and spleen tissues in each treatment group alleviated to varying degrees,while the proportion of CD4+ T lymphocytes and CD4+/CD8+ ratio in spleen tissue of the positive control group and TCM high-dosage group increased,the proportion of CD8+ T lymphocytes decreased,the expression of T-bet mRNA in left lung and spleen tissues increased,and the expression of GATA-3 mRNA decreased,with statistical significance(P<0.05).Conclusion Guiqi Yiyuan Ointment can alleviate the lung and spleen injury of rats induced by 12C6+ beam radiation.Its mechanism is related to regulating the proportion of CD4+,CD8+ T lymphocytes and the expression of T-bet and GATA-3,and recovering cellular immune function.
5.Antibacterial effects in vitro of low-intensity pulsed ultrasound combined with 3.5 g/L povidone-iodine on the biofilm of methicillin-resistant staphylococcus aureus
Tianxing WANG ; Guoqing LI ; Yang WANG ; Baochao JI ; Yongjie CHEN ; Haikang ZHOU ; Li CAO
Chinese Journal of Orthopaedic Trauma 2024;26(9):818-823
Objective:To explore the in vitro antibacterial effects of low-intensity pulsed ultrasound (LIPUS) combined with 3.5 g/L povidone iodine solution on the biofilm of methicillin-resistant staphylococcus aureus (MRSA). Methods:Immature (cultured for 24 hours) and mature (cultured for 72 hours) MRSA biofilms were established on the surfaces of glass slides or confocal dishes. They were randomly divided into 4 groups ( n=9) according to different intervention methods. In the control group, glass slides or confocal dishes were placed in 500 mL of physiological saline for 3 minutes; in the PI group, glass slides or confocal dishes were placed in 500 mL of 3.5 g/L povidone iodine solution for 3 minutes; in the LIPUS group, glass slides or confocal dishes were placed in 500 mL of physiological saline and simultaneously intervened with LIPUS for 3 minutes; in the LIPUS & PI group, glass slides or confocal dishes were placed into 500 mL of 3.5 g/L povidone iodine solution and simultaneously intervened with LIPUS for 3 minutes. After intervention, confocal microscopy (CLSM) and scanning electron microscopy (SEM) were used to observe and compare the structure, morphology, bacterial survival, and viable cell count of the MRSA biofilms among the 4 groups. Results:On the MRSA biofilms cultured for 24 and 72 hours, CLSM and SEM observed sparse biofilms in the LIPUS group and LIPUS & PI group, and also a large number of dead bacteria in the LIPUS & PI group. On the MRSA biofilms cultured for 24 hours, the bacterial colony counts in the control group, PI group, LIPUS group, and LIPUS & PI group were (1.21±0.45)×10 6 CFU/mL, (3.38±2.81)×10 3 CFU/mL, (1.82±0.37)×10 3 CFU/mL, and (69.67±27.93) CFU/mL, respectively. Except for the comparison between PI group and LIPUS group, which showed no statistically significant difference ( P>0.05), there were statistically significant differences between the other groups when compared pairwise ( P<0.05). On the MRSA biofilms cultured for 72 hours, the bacterial colony counts in the control group, PI group, LIPUS group, and LIPUS & PI group were (3.01±0.70)×10 6 CFU/mL, (1.80±1.52)×10 5 CFU/mL, (2.10±0.52)×10 3 CFU/mL, and (68.67±19.55) CFU/mL, respectively. There were statistically significant differences between the 4 groups when compared pairwise ( P<0.05). Conclusions:Application of LIPUS or 3.5 g/L povidone iodine alone for 3 minutes on the immature or mature MRSA biofilms in vitro only leads to partial antibacterial activity. However, LIPUS can enhance the in vitro antibacterial effect of 3.5 g/L povidone iodine on the MRSA biofilms at different maturity levels.
6.Comparison of 68Ga-FAPI and 18F-FDG PET/CT for the diagnosis of primary and metastatic gastric signet-ring cell carcinoma
Long ZHAO ; Yizhen PANG ; Weizhi XU ; Tinghua MENG ; Jiayu CAI ; Tianxing PENG ; Zuoming LUO ; Long SUN ; Hua WU ; Haojun CHEN
Chinese Journal of Nuclear Medicine and Molecular Imaging 2023;43(6):325-330
Objective:To investigate the clinical utility of 68Ga-labeled fibroblast activation protein inhibitor (FAPI) PET/CT in the detection of primary and metastatic gastric signet-ring cell carcinoma (GSRCC) and compared the results with those of 18F-FDG PET/CT. Methods:A total of 21 patients (10 males, 11 females, average age 52 years) with primary and metastatic GSRCC who underwent 68Ga-FAPI and 18F-FDG PET/CT at the First Affiliated Hospital of Xiamen University from June 2020 to May 2022 were retrospectively analyzed. Pathological results of surgery and (or) biopsy were used as the " gold standard" for final diagnosis. In cases whose surgery or tissue biopsies were not available, clinical and radiographic follow-up results were used as the reference standards. Wilcoxon signed-rank test was used to compare the SUV max of 18F-FDG and 68Ga-FAPI. McNemar χ2 test was used to compare the detection rate between 18F-FDG and 68Ga-FAPI PET/CT. Results:68Ga-FAPI PET/CT showed higher SUV max than 18F-FDG in primary tumors (5.3(2.4, 15.7) vs 2.4(1.8, 2.5); z=2.31, P=0.021), local recurrences (7.8(6.0, 8.9) vs 2.4(1.9, 3.4); z=2.20, P=0.028), lymph nodes metastases (7.7(4.5, 12.2) vs 2.4(1.9, 3.6); z=6.01, P<0.001) and bone/visceral metastases (6.7(5.3, 11.1) vs 2.4(2.0, 3.4); z=11.36, P<0.001). Regarding diagnostic accuracy, 68Ga-FAPI PET/CT showed higher sensitivities than 18F-FDG for primary tumors (7/9 vs 2/9; χ2=3.20, P=0.063) and local recurrences (7/7 vs 2/7; χ2=3.20, P=0.063). It also demonstrated higher lesion detection rates than 18F-FDG for suspicious lymph node metastases (86%(65/76) vs 32%(24/76); χ2=31.37, P<0.001) and bone/visceral metastases (99%(184/185) vs 39%(73/185); χ2=107.08, P<0.001). Conclusions:68Ga-FAPI PET/CT showed higher tumor uptake and lesion detection rate than 18F-FDG in the primary and metastatic GSRCC. 68Ga-FAPI PET/CT demonstrates good diagnostic performance for tumor detection, staging, and restaging of GSRCC, which is helpful to further guide clinical treatment strategy.
7.Novel STING-targeted PET radiotracer for alert and therapeutic evaluation of acute lung injury.
Duo XU ; Fan YANG ; Jiayao CHEN ; Tianxing ZHU ; Fen WANG ; Yitai XIAO ; Zibin LIANG ; Lei BI ; Guolong HUANG ; Zebo JIANG ; Hong SHAN ; Dan LI
Acta Pharmaceutica Sinica B 2023;13(5):2124-2137
Acute lung injury (ALI), as a common clinical emergency, is pulmonary edema and diffuse lung infiltration caused by inflammation. The lack of non-invasive alert strategy, resulting in failure to carry out preventive treatment, means high mortality and poor prognosis. Stimulator of interferon genes (STING) is a key molecular biomarker of innate immunity in response to inflammation, but there is still a lack of STING-targeted strategy. In this study, a novel STING-targeted PET tracer, [18F]FBTA, was labeled with high radiochemical yield (79.7 ± 4.3%) and molar activity (32.5 ± 2.9 GBq/μmol). We confirmed that [18F]FBTA has a strong STING binding affinity (Kd = 26.86 ± 6.79 nmol/L) and can be used for PET imaging in ALI mice to alert early lung inflammation and to assess the efficacy of drug therapy. Our STING-targeted strategy also reveals that [18F]FBTA can trace ALI before reaching the computed tomography (CT) diagnostic criteria, and demonstrates its better specificity and distribution than [18F]fluorodeoxyglucose ([18F]FDG).
8.Prospective cohort study and risk factor analysis of language delay based on outpatient in Xiamen
Shanshan ZHAO ; Yonghua YAO ; Jinping XU ; Ling CHEN ; Jianqi HUANG ; Tianxing GUO ; Haitao BAI
Chinese Journal of Applied Clinical Pediatrics 2021;36(14):1094-1097
Objective:To analyze the social family factors influencing language delay in children with the age ranging from 18 to 42 months in Xiamen.Methods:A prospective cohort study was conducted to evaluate children with language delay (case group) and normal controls (control group) in Child Health Clinic and Developmental Behavior Clinic of the First Affiliated Hospital of Xiamen University between July 2017 and July 2019 via a self-made questionnaire and a language development scale, and the case-control ratio was 1∶4.The chi- square test, Logistic regression and generalized multifactor dimensionality reduction (GMDR) were adopted for statistical analysis, and the correction analysis was performed with Bonferroni correction. Results:A total of 126 children with language delay were collected in the case group, with the ratio of male to female being 2.05∶1.00. The control group was included 504 cases.There was no significant difference in gender and age between both groups.The chi- square test showed that there were statistical differences in maternal culture and screen time distribution between both groups ( P<0.05/13). Besides, the multivariate Logistic regression analysis suggested that significant risk factors for language delay in children included maternal culture, maternal-child interaction, and screen time.The GMDR analysis showed that screen time was the optimal single-mode for children at risk of language delay, while maternal culture and screen time constituted a statistically different two-factor model.Moreover, the marital-child interaction was included into the three-factor model. Conclusions:Screen time and maternal culture were the most important risk factors for language delay in children of Xiamen, and both factors would interact with maternal-child interaction, which could exert impacts on language delay in children.
9.Application of Three-dimensional Reconstruction in Single Utility-port Thoracoscopic Segmentectomy for Early Stage Non-small Cell Lung Cancer: A Propensity Score-matched Analysis
Peilin YOU ; Wenshu CHEN ; Lilan ZHAO ; Tianxing GUO ; Lihuan ZHU ; Pengjie TU ; Jianyuan HUANG ; Xiaojie PAN
Cancer Research on Prevention and Treatment 2021;48(4):387-392
Objective To evaluate the clinical value of 3D reconstruction in the single utility-port thoracoscopic segmentectomy of early stage NSCLC by propensity score matching (PSM). Methods We retrospectively analyzed clinical data of 150 early stage NSCLC patients undergoing single utility-port thoracoscopic segmentectomy. The patients were divided into reconstruction group (
10.Establishment of a non-venous bypass orthotopic liver transplantation model in Bama miniature pigs
Qiao SU ; Zhenyu YU ; Wenwen LI ; Linsen YE ; Tianxing DAI ; Rongpu LIANG ; Rongqiang LIU ; Guozhen LIN ; Guangyin ZHAO ; Wuguo LI ; Guoying WANG ; Guihua CHEN
Organ Transplantation 2019;10(1):55-
Objective To establish a non-venous bypass orthotopic liver transplantation model in Bama miniature pigs with high repeatability and stability. Methods Twelve Bama miniature pigs were randomly divided into the donor group (

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