1.Effects of low-dose fractionated X-ray radiation on the senescence of L02 hepatocytes
Xin LAN ; Lina CAI ; Lingyu ZHANG ; Yashi CAI ; Linqian ZHOU ; Weiyi KE ; Weixu HUANG ; Jianming ZOU ; Huifeng CHEN
Chinese Journal of Radiological Health 2025;34(5):672-678
Objective To investigate the induction of senescence in L02 hepatocytes by low-dose fractionated X-ray radiation and its effects on oxidative stress, oxidative damage, and nuclear factor-κB (NF-κB) pathway protein levels. Methods L02 cells were subjected to fractionated X-ray irradiation at doses of 0.1, 0.2, and 0.5 Gy per fraction for a total of six fractions. Assays were performed 24 hours after the final irradiation. Measurements included SA-β-gal staining, the mRNAs of senescence-related genes p53 and p21 and their encoded proteins, mRNAs of genes encoding senescence-associated secretory phenotype factors (IL-6, IL-8, GM-CSF, MMP-15), reactive oxygen species, oxidative and anti-oxidative markers (malondialdehyde, glutathione, superoxide dismutase), DNA oxidative damage markers (8-OHdG and γ-H2AX), and NF-κB pathway protein levels. Results Compared with the control group, at 24 hours after the end of six irradiations, the number of cells positive in SA-β-gal staining was significantly increased in all dose groups. The mRNA and protein levels of p21 and p53 were significantly elevated in the 0.2 Gy × 6 and 0.5 Gy × 6 groups (P < 0.05). The mRNA levels of genes encoding IL-6, GM-CSF, and MMP-15 were significantly increased in all dose groups (P < 0.05). The mRNA levels of the gene encoding IL-8 were significantly increased in the 0.2 Gy × 6 and 0.5 Gy × 6 groups (P < 0.05). The levels of reactive oxygen species, malondialdehyde, and glutathione were significantly increased in all dose groups (P < 0.01). The level of superoxide dismutase was significantly increased in the 0.5 Gy × 6 group (P < 0.01). The levels of 8-OHdG were significantly increased in all dose groups (P < 0.05). In both the 0.2 Gy × 6 and 0.5 Gy × 6 groups, the expression levels of γ-H2AX and p-NF-κB p65 were significantly increased (P < 0.05), and the levels of IκBα were significantly decreased (P < 0.05). Conclusion Low-dose fractionated X-ray radiation can induce senescence and cause alterations in oxidative stress, oxidative damage, and the levels of NF-κB pathway proteins in L02 hepatocytes.
2.Interpretation of the Guideline for Plastic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Weiyi LU ; Yanggege LYU ; Lin YAO ; Rong CAI ; Hong JIN ; Hui YU ; Lei CHEN
Herald of Medicine 2025;44(7):1049-1054
Plastic pharmaceutical packaging materials are widely used in drug packaging,and the effective quality control of these materials is of great significance for ensuring the quality of drugs.The Guidelines for Plastic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China(hereinafter referred to as the guideline)is based on the characteristics of plastic pharmaceutical packaging materials and combined with the different uses of various products,clarifying the quality control requirements for different categories of products.The guideline not only improves the pharmacopoeia standard system,but also meets the needs of industrial development and drug regulation under the new situation,which is conducive to enterprises to better improve product quality.This article explains the main contents of the guideline in combination with the background,process,and ideas of its drafting,so as to provide guidance for the correct understanding and use of this standard by all parties in the industry.
3.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
4.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
5.Interpretation of the Guideline for Plastic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Weiyi LU ; Yanggege LYU ; Lin YAO ; Rong CAI ; Hong JIN ; Hui YU ; Lei CHEN
Herald of Medicine 2025;44(7):1049-1054
Plastic pharmaceutical packaging materials are widely used in drug packaging,and the effective quality control of these materials is of great significance for ensuring the quality of drugs.The Guidelines for Plastic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China(hereinafter referred to as the guideline)is based on the characteristics of plastic pharmaceutical packaging materials and combined with the different uses of various products,clarifying the quality control requirements for different categories of products.The guideline not only improves the pharmacopoeia standard system,but also meets the needs of industrial development and drug regulation under the new situation,which is conducive to enterprises to better improve product quality.This article explains the main contents of the guideline in combination with the background,process,and ideas of its drafting,so as to provide guidance for the correct understanding and use of this standard by all parties in the industry.
6.Prevalence and influencing factors on food allergy among children aged 0-5 years in China
Lahong JU ; Liyun ZHAO ; Xiaoqi WEI ; Hongyun FANG ; Jiaxi LI ; Xingxing WU ; Xiaoli XU ; Shuya CAI ; Weiyi GONG ; Dongmei YU
Chinese Journal of Epidemiology 2024;45(6):817-823
Objective:To describe the prevalence of food allergy among children aged 0-5 years in China and to explore related influencing factors.Methods:Multistage stratified random sampling method was used to collect data from 275 surveillance sites of the China National Nutrition and Health Survey of Chinese children and lactating mothers programs in 31 provinces (autonomous regions and municipalities) of China in 2016-2017. A total of 70 107 participants aged 0-5 years were included in this study. The study collected information of participants' demographic characteristics and food allergies by face-to-face questionnaire. The prevalence of food allergy was analyzed, using the complex data weighting method. The logistic regression models were used to analyze the influencing factors related to food allergy.Results:The overall prevalence of self-reported food allergy among children aged 0-5 years was 4.81%. Prevalence rates in infants aged 0-5 months, and 6-23 months and preschool children aged 2-5 years were 0.81%, 4.68% and 5.26%, respectively. The results of logistic analysis showed that there was a significantly positive correlation between factors including children from 6 months to 5 years old, urban area, southwest area, first-born, mothers with college education or above, and the prevalence of food allergy in children. Shrimp, poultry eggs, crab shellfish, fruit, milk and fish appeared the common allergic foods in children aged 0-5 years, with prevalence rates of self-reported food allergy as 1.55%, 1.25%, 0.99%, 0.97%, 0.87% and 0.86%, respectively. The proportion of single food allergy in children with allergies was 69.85%.Conclusions:Among children aged 0-5 years, the prevalence of self-reported food allergy increases with age, in China. Foods that is prone to allergies include fish, shrimp, crab, shellfish, poultry eggs, milk and fruits, etc. Most allergies were only caused by single food in children, under observation.
7.Macrogenomics-based study of the mechanism of GeGen QinLian Decoction in ameliorating dysbiosis in a rat model of antibiotic-associated diarrhea
Qiumei TANG ; Xue HAN ; Guangyong YANG ; Rui CHEN ; Wenjia WANG ; Xiaohua TU ; Weiyi TIAN ; Yanpeng CAI ; Chi CHEN ; Guangzhi HE
Acta Laboratorium Animalis Scientia Sinica 2024;32(11):1379-1389
Objective To investigate changes in the intestinal flora and function in rats with antibiotic-associated diarrhea(A AD)treated with GeGen QinLian Decoction(GQD).Methods Sixty male or female SPF-grade SD rats were fed for 7 days and then divided randomly into Control(Con)and modeling groups(1∶5 ratio).Rats in the modeling group received clindamycin 250 mg/kg by gavage once a day for 7 consecutive days.After successful modeling,the rats were divided randomly into model(Mod),high-dose GQD(GQD-H,10.08 g/kg),medium-dose GQD(GQD-M,5.04 g/kg),low-dose GQD(GQD-L,2.52 g/kg),and live Bifidobacterium power(LBP,0.15 g/kg)groups(n=10 rats per group).GQD and LBP were administered by gavage,and the Con and Mod groups were given an equal volume of saline by gavage once a day.Feces were collected after 7 consecutive days of administration for macrogenomics sequencing analysis.Results α diversity and β diversity suggested that intestinal microbial diversity differed between the Mod and GQD-treated groups.GQD increased the abundance of thick-walled bacteria and decreased the abundance of Aspergillus at the phylum level,and increased the relative abundances of the intestinal mucus bacteria Blautia,Bacteroides,Thomasclavelia,and Mediterraneibacter,and decreased the relative abundances of Adlercreutzia,Muribaculum,and Escherichia at the genus level.GQD also up-regulated the amino acid,carbohydrate,and immune disease pathways.Conclusions GQD improves the abundance ratio of beneficial and pathogenic intestinal bacteria in rats with antibiotic-associated diarrhea,which in turn reduces the intestinal inflammatory response and repairs the intestinal immune system.
8.Macrogenomics-based study of the mechanism of GeGen QinLian Decoction in ameliorating dysbiosis in a rat model of antibiotic-associated diarrhea
Qiumei TANG ; Xue HAN ; Guangyong YANG ; Rui CHEN ; Wenjia WANG ; Xiaohua TU ; Weiyi TIAN ; Yanpeng CAI ; Chi CHEN ; Guangzhi HE
Acta Laboratorium Animalis Scientia Sinica 2024;32(11):1379-1389
Objective To investigate changes in the intestinal flora and function in rats with antibiotic-associated diarrhea(A AD)treated with GeGen QinLian Decoction(GQD).Methods Sixty male or female SPF-grade SD rats were fed for 7 days and then divided randomly into Control(Con)and modeling groups(1∶5 ratio).Rats in the modeling group received clindamycin 250 mg/kg by gavage once a day for 7 consecutive days.After successful modeling,the rats were divided randomly into model(Mod),high-dose GQD(GQD-H,10.08 g/kg),medium-dose GQD(GQD-M,5.04 g/kg),low-dose GQD(GQD-L,2.52 g/kg),and live Bifidobacterium power(LBP,0.15 g/kg)groups(n=10 rats per group).GQD and LBP were administered by gavage,and the Con and Mod groups were given an equal volume of saline by gavage once a day.Feces were collected after 7 consecutive days of administration for macrogenomics sequencing analysis.Results α diversity and β diversity suggested that intestinal microbial diversity differed between the Mod and GQD-treated groups.GQD increased the abundance of thick-walled bacteria and decreased the abundance of Aspergillus at the phylum level,and increased the relative abundances of the intestinal mucus bacteria Blautia,Bacteroides,Thomasclavelia,and Mediterraneibacter,and decreased the relative abundances of Adlercreutzia,Muribaculum,and Escherichia at the genus level.GQD also up-regulated the amino acid,carbohydrate,and immune disease pathways.Conclusions GQD improves the abundance ratio of beneficial and pathogenic intestinal bacteria in rats with antibiotic-associated diarrhea,which in turn reduces the intestinal inflammatory response and repairs the intestinal immune system.
9.Effects of low-dose radiation on oxidative stress and damage repair in HBE cells
Linqian ZHOU ; Weixu HUANG ; Lina CAI ; Weiyi KE ; Lingyu ZHANG ; Yashi CAI ; Sufen ZHANG ; Ping YANG ; Jianming ZOU ; Huifeng CHEN
Chinese Journal of Radiological Health 2023;32(2):150-155
Objective To investigate the effects of lowdose ionizing radiation (LDIR) on oxidative stress and damage repair in human bronchial epithelial (HBE) cells. Methods HBE cells were divided into 0, 50, 100, and 200 mGy groups, and cultured for 24 and 48 h after X-ray irradiation, respectively. The cell viability, levels of glutathione (GSH), malondialdehyde (MDA), and 8-hydroxy-2’-deoxyguanosine (8-OHdG), and transcriptional levels of DNA damage repair genes PPP2R2D and TP53 were measured. Results At 24 h after irradiation, there was no significant difference in the cell viability between the dose groups and the control group (P > 0.05); all dose groups had significantly increased MDA level, dose-dependently decreased GSH level, dose-dependently increased 8-OHdG level, and significantly increased mRNA level of PPP2R2D gene (all P < 0.05); the mRNA expression level of TP53 gene was significantly increased in the 50 mGy group (P < 0.05). At 48 h after irradiation, there were the highest cell viability, significantly decreased MDA and 8-OHdG levels, and significantly increased mRNA expression levels of PPP2R2D and TP53 genes in the 50 mGy group compared with the control group (all P < 0.05); the GSH level in the 100 mGy group was significantly increased (P < 0.05). Conclusion LDIR, especially radiation at 50 mGy, can affect the oxidative-antioxidant level in HBE cells and the transcript-level differential expression of DNA damage repair genes.
10.Oxidative stress and its correlation with nuclear factor-κB and transforming growth factor-β1 in liver injury induced by different doses of X-rays in mice
Lina CAI ; Sufen ZHANG ; Weixu HUANG ; Lingyu ZHANG ; Yashi CAI ; Linqian ZHOU ; Weiyi KE ; Huifeng CHEN ; Yuhua YANG ; Ri’an YU
Journal of Environmental and Occupational Medicine 2023;40(2):202-208
Background Radiation-induced liver damage is a major complication for primary liver cancer and other upper abdominal tumors during radiation therapy. The early biological effects of radiation-induced liver damage at different doses of radiation and its mechanisms of action have not yet been elucidated. Objective To establish X-ray-induced radioactive mouse liver damage model and explore the level of oxidative stress and its correlation with nuclear factor-κB (NF-κB) and transforming growth factor-β1 (TGF-β1). Methods A total of 24 male C57BL/6J mice aged 6 weeks were randomly divided into 4 groups (control, 0.8 Gy, 1.6 Gy, and 4 Gy), with 6 mice in each group. X-rays irradiated the whole body of mice singly in each dose group. At 24 h after radiation, histopathological changes in mouse liver were evaluated; peripheral blood cell count, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels, as well as liver tissue superoxide dismutase (SOD) activity, malondialdehyde (MDA) level, reduced glutathione (GSH) level, and 8-hydroxy-2′-deoxyguanosine (8-OHdG) level were measured; real-time fluorescence quantitative PCR was used to detect liver tissue NF-κB p65 and TGF-β1 mRNA expression levels; the correlations of oxidative stress indicators with NF-κB p65 and TGF-β1 mRNA expression levels were analyzed by Pearson correlation. Results Compared with the control group, at 24 h after different doses of X-ray radiation, early injury-related histopathological changes were observed in liver, and the serum levels of AST and ALT were significantly increased in the 4 Gy group (P<0.05); the numbers of peripheral blood leukocytes and lymphocytes were decreased in the radiation exposure groups (P<0.05), showing a decreasing trend with increasing radiation doses; the levels of liver oxidative stress indicators (MDA, SOD, and GSH) in exposed mice were significantly increased (P<0.05), showing an increasing trend with increasing radiation doses. The liver 8-OHdG were significantly increased in the 1.6 Gy and 4 Gy groups compared with the control and the 0.8 Gy groups, respectively (P<0.05). The NF-κB p65 and TGF-β1 mRNA expression levels in the liver of mice were significantly increased in the 1.6 Gy and 4 Gy groups compared with the control group (P<0.05). The TGF-β1 mRNA expression level also exhibited an increasing trend with increasing radiation doses. The results of correlation analysis showed that the levels of MDA, SOD, GSH, and 8-OHdG in liver tissues were significantly and positively correlated with the expression levels of NF-κB p65 and TGF-β1 mRNA (P<0.05). Conclusion X-rays of various doses can affect the degree of liver injury, peripheral blood cell count, serum levels of AST and ALT, and liver oxidative stress levels in mice. The level of oxidative stress induced by X-ray is positively correlated with NF-κB and TGF-β1 in liver tissues, and it may participate in the process of radiation-induced liver injury.


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