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.
6.Herbal Textual Research on Kochiae Fructus in Famous Classical Formulas
Huifang HU ; Liping YANG ; Fei CHEN ; Xiaohui MA ; Ling JIN ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):247-257
In this paper, by referring to ancient and modern literature, the textual research of Kochiae Fructus has been conducted to clarify the name, origin, distribution of production areas, quality specification, taste and efficacy, harvesting time, processing and compatibility taboo, so as to provide reference and basis for the development and utilization of related famous classical formulas. According to the investigation, it can be seen that Difuzi was first published in Sheng Nong's Herbal Classic, and has been used as the official name throughout history. It is also known by other names such as Dimai, Dikui, and Luozhou. The mainstream source of Difuzi in materia medica throughout history is the dried ripe fruit of Kochia scoparia, which is consistent throughout history. In the Han dynasty, it was recorded that Kochiae Fructus was produced in Jingzhou(Hubei province), while modern literature records its distribution throughout the country, so it does not have obvious geoherbalism. The harvesting period of Kochiae Fructus is mostly in the late autumn, and the quality is best when it is full, gray green in color, and no impurities. There are two processing methods for its origin:from the Southern and Northern dynasties to the Ming dynasty, it was dried in the shade, and after the founding of the People's Republic of China, it was dried in the sun. There are few records about the processing of Kochiae Fructus, and its clinical application is mostly based on raw products as medicine. The seedlings are harvested in February of the lunar calendar, and the leaves are taken in April and May, processing in the place of origin is shade drying, the processing methods include burning ash and frying frost, pounding juice and wine soaking. For internal use, it is mostly decocted or mashed, while for external use, it is mostly washed with decoction or taken in a soup bath. Throughout history, it has been recorded that Kochiae Fructus is bitter and cold, and is mainly used for treating bladder fever. After the founding of the People's Republic of China, most of the literature classified it as damp-clearing medicine. Since the 1985 edition of Chinese Pharmacopoeia, it has been recorded that Kochiae Fructus has a pungent and bitter taste, and a cold nature. Returning to the kidney and bladder meridians with functions of clearing heat and dampness, dispelling wind and relieving itching. The clinical contraindications are mainly prohibited for those with deficiency and no dampness and heat. Throughout history, it has been recorded that the taste of the seedlings and leaves is bitter and cold for treatment of dysentery. Since modern times, it has been used to regulate the liver, spleen and large intestine meridians, with functions such as clearing heat and detoxifying, and diuresis. Based on the textual research, it is recommended to use the dried ripe fruit of K. scoparia when developing the famous classical formulas containing Kochiae Fructus, and processing shall be carried out according to the original processing requirements. If the original formula does not specify the processing requirements, the raw products is taken into medicine.
7.Herbal Textual Research on Cnidii Fructus in Famous Classical Formulas
Huifang HU ; Liping YANG ; Fei CHEN ; Xiaohui MA ; Ling JIN ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):243-253
In this paper, by referring to ancient and modern literature, the textual research of Cnidii Fructus has been conducted to clarify the name, origin, distribution of production areas, quality specification, nature and flavour, efficacy, harvesting and processing, compatibility taboo and others, so as to provide reference and basis for the development and utilization of the relevant famous classical formulas. After textual research, it can be verified that Cnidii Fructus was first published in Sheng Nong's Herbal Classic, the materia medica of all dynasties was named Shechuangzi, and there are also aliases such as Shesu, Shemi, and Qiangmi. The main source for generations was the dried ripe fruit of Cnidium monnieri, and ancient and modern consistent. From the Eastern Han dynasty to Tang dynasty, the origin of Cnidii Fructus was Zibo, Shandong province. During the Five dynasties, it expanded to Yangzhou in Jiangsu province and Xiangyang in Hubei province, the Song dynasty added Shangqiu in Henan province, and it was considered that Yangzhou, Xiangyang and Shangqiu were its genuine producing areas. It was more widely distributed in Ming and Qing dynasties. After the founding of the People's Republic of China, the origin is clearly distributed throughout the country. For its quality evaluation, generally full grain, gray yellow color, strong aroma is the best. The harvesting period in the past dynasties was mostly the fifth lunar month, and the fruit was collected to remove impurities and dry. The mainstream processing in producing area of the past dynasties was net selection of raw products, mixing and steaming with the juice of Rehmanniae Radix and stir-frying were the mainstream processing methods in the past, there were also stir-frying with honey, stir-frying with salt and rice wine, immersing and steaming with rice wine and other methods. In recent times, it has been used in raw products as medicine. Sheng Nong's Herbal Classic recorded Cnidii Fructus was bitter, Supplementary Records of Famous Physicians recorded its acrid for the first time. It was recorded in the Ming dynasty that its nature was warm, acted on the kidney meridian, and had small toxicity. After the founding of the People's Republic of China, most of the literature classified it as a medicine to attack poison, kill insects and relieve itching with the functions of dispelling pathogenic wind and removing dampness, destroying parasites and elieving itching, warming kidney and activating Yang. Clinical contraindications are mainly contraindicated for people with damp-heat from the lower-jiao or kidney heat. Based on the textual research, it is suggested that when developing the famous classical formulas containing Cnidii Fructus, the source shall be the dried ripe fruit of C. monnieri, and then it shall be processed according to the original formulas. If there is no requirement for processing in the formulas, the raw products can be taken into medicine.
8.Research status of risk prediction model of post-endoscopic retrograde cholangiopancreatography pancreatitis
Zhe-Yu ZHU ; Yi-Yu HU ; Peng CHEN ; Fei-Fan WU ; Si-Yu WANG ; Wei-Min WANG ; Chun-Mu MIAO ; Yun-Bing WANG ; Xiong DING
Journal of Regional Anatomy and Operative Surgery 2024;33(12):1105-1109
Post-endoscopic retrograde cholangiopancreatography pancreatitis(PEP)is one of the most common complications after endoscopic retrograde cholangiopancreatography(ERCP).Numerous PEP prediction models have been established based on different statistical methods at home and abroad.The PEP prediction model,as a tool for evaluating and screening high-risk populations,can provide a basis for medical staff to find high-risk PEP patients early and take effective preventive measures.In recent years,new PEP prediction models have appeared one after another,but there is still a lack of recognized reliable prediction models in clinic.This article reviews the research status of PEP risk prediction models,aim to provide a direction for establishing a more reliable,accurate,and practical PEP risk prediction model in the later period.
9.Mediating effect of postpartum depression in fathers on their parenting competence and breastfeeding support
Fei SUN ; Min LIU ; Shanshan HU ; Huijuan CHEN ; Zhaona SUN ; Huiya BI
Chinese Journal of Modern Nursing 2024;30(8):1061-1066
Objective:To explore the mediating effect of postpartum depression in fathers on their parenting competence and breastfeeding support.Methods:From March to October 2022, convenience sampling was used to select 337 fathers of infants aged 4 to 8 weeks in Wuxi Women and Enfants Care Hospital as the research subject. A survey was conducted using the Edinburgh Postnatal Depression Scale (EPDS), Chinese version of Parenting Sense of Competence Scale (C-PSOC), and maternal spouse version Partner Breastfeeding Influence Scale (PBIS). Spearman correlation was used to explore the correlation between postpartum depression in fathers and their parenting competence and breastfeeding support, and the PROCESS plugin was used for mediation effect testing.Results:A total of 337 questionnaires were distributed and 337 were collected, including 314 valid questionnaires with an effective response rate of 93.18% (314/337). Among 314 infant fathers, the EPDS, C-PSOC, and maternal spouse version PBIS scores were 3.00 (2.00, 6.00), 66.00 (62.00, 71.00), and 83.00 (74.00, 90.00), respectively. Father's parenting competence was negatively correlated with father's postpartum depression ( r=-0.435, P<0.01), and positively correlated with father's breastfeeding support ( r=0.480, P<0.01). Father's postpartum depression was negatively correlated with father's breastfeeding support ( r=-0.423, P<0.01). The mediating effect analysis showed that the mediating effect of postpartum depression in fathers between parenting competence and breastfeeding support was 0.341, accounting for 39.51% of the total effect. Conclusions:Postpartum depression in fathers is a mediating variable between their parenting competence and their breastfeeding support. Medical and nursing workers should develop perinatal education programs for fathers, enhance their parenting competence, alleviate their negative emotions, and promote their breastfeeding support.
10.Impact of embryonic uveitis exposure on response of mouse offspring to interphotoreceptor retinoid-binding protein-induced experimental autoimmune uveitis
Fei XU ; Jianping LIU ; Shifang DONG ; Hui HUANG ; Xinyi GONG ; Kaijiao HU ; Feilan CHEN
Acta Laboratorium Animalis Scientia Sinica 2024;32(3):297-306
Objective To investigate the effect of embryonic inflammatory exposure on the response of mouse offspring to interphotoreceptor retinoid-binding protein(IRBP)-induced experimental autoimmune uveitis(EAU).Methods RNA transcriptome sequencing data from eyeballs of C57BL/6J mouse offspring born to mothers with active EAU were used to screen immune-associated differentially expressed genes in the eyes of the exposed offspring.Gene fragments overlapping in the two datasets were screened using Gene Ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analyses to identify biological pathways associated with the gene fragments.Hub genes were identified from these intersecting genes by protein-protein interaction network analysis.EAU models of maternal uveitis were established by immunization with IRBP651-670,and expression levels of the pivotal genes in the offspring exposed to inflammation by maternal uveitis were examined by fluorescence quantitative polymerase chain reaction.EAU severity,T lymphocyte proliferation,and serum cytokines were detected to investigate the immune effect in offspring from mothers with an active inflammation response to IRBP induction.Results Microarray analysis identified 72 immune-related differentially expressed genes in exposed samples compared with the findings in control samples.These genes were mainly enriched in Toll-like receptor signaling,mitogen-activated protein kinase signaling,and B cell receptor signaling pathways.Protein-protein interaction network interaction analysis screened out four hub genes,Psmc5,Psmc3,Psmd4,and Psmd8,and mRNA levels of these four genes were increased in the adult offspring from mothers with active uveitis compared with the findings in healthy offspring.In addition,the group induced with 150 μg IRBP showed an increase in the severity of clinical and pathological outcomes in offspring with EAU affected by active inflammation,compared with the healthy offspring group(P=0.0087,P=0.0410).Meanwhile,T cell proliferation in the offspring was enhanced during the inflammatory activity stage and secretion of the inflammatory cytokines interleukin(IL)-17 and IL-6 was increased(P=0.0450,P=0.0300).Conclusions Psmc5,Psmc3,Psmd4,and Psmd8 may be important genes exacerbating uveitis in offspring of mothers with active uveitis,associated with increased T cell proliferation and production of IL-17 and IL-6.

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