1.Interpretation of the management guidelines for quality agreements of pharmaceutical packaging materials under the new situation
Mingxia GU ; Lei CHEN ; Hong CAI ; Yonghua GAO ; Hong JIN ; Xiao HAN ; Ruiling HE
Drug Standards of China 2025;26(4):355-358
Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.
2.Construction and optimization of 1, 4-butanediamine biosensor based on transcriptional regulator PuuR.
Junjie LIU ; Minmin JIANG ; Tong SUN ; Xiangxiang SUN ; Yongcan ZHAO ; Mingxia GU ; Fuping LU ; Ming LI
Chinese Journal of Biotechnology 2025;41(1):437-447
Biosensors have become powerful tools for real-time monitoring of specific small molecules and precise control of gene expression in biological systems. High-throughput sensors for 1, 4-butanediamine biosynthesis can greatly improve the screening efficiency of high-yielding 1, 4-butanediamine strains. However, the strategies for adapting the characteristics of biosensors are still rarely studied, which limits the applicability of 1, 4-butanediamine biosensors. In this paper, we propose the development of a 1, 4-butanediamine biosensor based on the transcriptional regulator PuuR, whose homologous operator puuO is installed in the constitutive promoter PgapA of Escherichia coli to control the expression of the downstream superfolder green fluorescent protein (sfGFP) as the reporter protein. Finally, the biosensor showed a stable linear relationship between the GFP/OD600 value and the concentration of 1, 4-butanediamine when the concentration of 1, 4-butanediamine was 0-50 mmol/L. The promoters with different strengths in the E. coli genome were used to modify the 1, 4-butanediamine biosensor, and the functional properties of the PuuR-based 1, 4-butanediamine biosensor were explored and improved, which laid the groundwork for high-throughput screening of engineered strains highly producing 1, 4-butanediamine.
Biosensing Techniques/methods*
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Escherichia coli/metabolism*
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Promoter Regions, Genetic/genetics*
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Green Fluorescent Proteins/metabolism*
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Transcription Factors/genetics*
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Escherichia coli Proteins/genetics*
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Diamines/metabolism*
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Gene Expression Regulation, Bacterial
3.Erratum: Author correction to "SHP2 inhibition triggers anti-tumor immunity and synergizes with PD-1 blockade" Acta Pharm Sin B 9 (2019) 304-315.
Mingxia ZHAO ; Wenjie GUO ; Yuanyuan WU ; Chenxi YANG ; Liang ZHONG ; Guoliang DENG ; Yuyu ZHU ; Wen LIU ; Yanhong GU ; Yin LU ; Lingdong KONG ; Xiangbao MENG ; Qiang XU ; Yang SUN
Acta Pharmaceutica Sinica B 2025;15(5):2810-2812
[This corrects the article DOI: 10.1016/j.apsb.2018.08.009.].
4.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
5.The current situation and prospect for the diagnosis and treatment of metanephric adenoma
Wujie CHEN ; Jun GU ; Enxiu LUO ; Mengdi ZHOU ; Yinglong HUANG ; Haohao LI ; Haidan LI ; Zhiyong TAN ; Haifeng WANG ; Mingxia DING
Chinese Journal of Urology 2025;46(6):472-475
Metanephric adenoma is a rare renal epithelial tumor with a low incidence and lack of specific clinical manifestations,resulting in a lack of uniformity in clinical understanding and treatment. Its etiology and pathogenesis are still unclear,and it may be related to the abnormal number and structure of chromosomes 2,7,and 17,as well as mutations in genes such as BRAF V600E,NF1,and NOTCH1,etc. There may be a transformed relationship between this tumor and Wilms’ tumor and papillary renal cell carcinoma. For diagnosis,it has diverse but non-specific clinical manifestations,and it is difficult to accurately differentiate it from other tumors in the imaging examination,and the confirmation of diagnosis relies on pathological and immunohistochemical staining. Treatment is mainly based on surgery to preserve the renal unit,such as partial nephrectomy,etc.,but the difficulty of preoperative diagnosis often leads to over-treatment,and there is a lack of standardized treatment protocols for metastatic posterior renal adenoma. The aim of this article is to provide a reference for the in-depth understanding of posterior renal adenomas and to optimize the clinical diagnosis and treatment strategies.
6.Interpretation of the management guidelines for quality agreements of pharmaceutical packaging materials under the new situation
Mingxia GU ; Lei CHEN ; Hong CAI ; Yonghua GAO ; Hong JIN ; Xiao HAN ; Ruiling HE
Drug Standards of China 2025;26(4):355-358
Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.
7.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
8.The current situation and prospect for the diagnosis and treatment of metanephric adenoma
Wujie CHEN ; Jun GU ; Enxiu LUO ; Mengdi ZHOU ; Yinglong HUANG ; Haohao LI ; Haidan LI ; Zhiyong TAN ; Haifeng WANG ; Mingxia DING
Chinese Journal of Urology 2025;46(6):472-475
Metanephric adenoma is a rare renal epithelial tumor with a low incidence and lack of specific clinical manifestations,resulting in a lack of uniformity in clinical understanding and treatment. Its etiology and pathogenesis are still unclear,and it may be related to the abnormal number and structure of chromosomes 2,7,and 17,as well as mutations in genes such as BRAF V600E,NF1,and NOTCH1,etc. There may be a transformed relationship between this tumor and Wilms’ tumor and papillary renal cell carcinoma. For diagnosis,it has diverse but non-specific clinical manifestations,and it is difficult to accurately differentiate it from other tumors in the imaging examination,and the confirmation of diagnosis relies on pathological and immunohistochemical staining. Treatment is mainly based on surgery to preserve the renal unit,such as partial nephrectomy,etc.,but the difficulty of preoperative diagnosis often leads to over-treatment,and there is a lack of standardized treatment protocols for metastatic posterior renal adenoma. The aim of this article is to provide a reference for the in-depth understanding of posterior renal adenomas and to optimize the clinical diagnosis and treatment strategies.
9.SHP2 inhibition triggers anti-tumor immunity and synergizes with PD-1 blockade.
Mingxia ZHAO ; Wenjie GUO ; Yuanyuan WU ; Chenxi YANG ; Liang ZHONG ; Guoliang DENG ; Yuyu ZHU ; Wen LIU ; Yanhong GU ; Yin LU ; Lingdong KONG ; Xiangbao MENG ; Qiang XU ; Yang SUN
Acta Pharmaceutica Sinica B 2019;9(2):304-315
Tyrosine phosphatase SHP2 is a promising drug target in cancer immunotherapy due to its bidirectional role in both tumor growth promotion and T-cell inactivation. Its allosteric inhibitor SHP099 is known to inhibit cancer cell growth both and . However, whether SHP099-mediated SHP2 inhibition retards tumor growth anti-tumor immunity remains elusive. To address this, a CT-26 colon cancer xenograft model was established in mice since this cell line is insensitive to SHP099. Consequently, SHP099 minimally affected CT-26 tumor growth in immuno-deficient nude mice, but significantly decreased the tumor burden in CT-26 tumor-bearing mice with intact immune system. SHP099 augmented anti-tumor immunity, as shown by the elevated proportion of CD8IFN- T cells and the upregulation of cytotoxic T-cell related genes including , which decreased the tumor load. In addition, tumor growth in mice with SHP2-deficient T-cells was markedly slowed down because of enhanced anti-tumor responses. Finally, the combination of SHP099 and anti-PD-1 antibody showed a higher therapeutic efficacy than either monotherapy in controlling tumor growth in two colon cancer xenograft models, indicating that these agents complement each other. Our study suggests that SHP2 inhibitor SHP099 is a promising candidate drug for cancer immunotherapy.
10.Study on correlation between plasma NT-proBNP with essential hypertension complicating left ventricular dysfunction
Jianwen GU ; Qingping WANG ; Lina YAO ; Mingxia GU ; Weifeng SHI
International Journal of Laboratory Medicine 2017;38(6):796-798
Objective To investigate the clinical values of NT-proBNP in left ventricular enlargement(LVE) and left ventricular dysfunction(LVD) of the patients with essential hypertension(EH) to provide a diagnostic basis for their diagnosis .Methods Plas-ma NT-proBNP concentrations in 120 patients with EH and in 29 normal controls were measured ,then the echocardiography exami-nation was performed to determine the left ventricular ejection fraction ( LVEF) ,left ventricular end-diastolic diameter(LVEDD) , left atrium(LA) and left ventricular systolic diameter(LVSDD) .The correlation between plasma NT-proBNP with LVE and LVD was analyzed .The diagnostic accuracy of NT-proBNP was analyzed by using receiver operating characteristic (ROC) curve .Results There were no statistically significant differences in the aspects of age ,sex and serum creatinine between the EH group and con-trol group ,but plasma NT-proBNP level of the former was significantly higher than that of the latter .The NT-proBNP level in the patients with LVE was significantly higher than that in the patients with normal left ventricle (P<0 .05) .The NT-proBNP level in the LVD patients was significantly higher than that in the patients with normal left ventricular function (P<0 .05) .The plasma NT-p roBNP level was positively correlated with LA ,LVEDD and LVSDD(r=0 .518 ,0 .58 ,0 .48 ,P<0 .01) while negatively crrelated with LVEF(r= -0 .61 ,P<0 .01) .The ROC curve showed that when the NT-proBNP was set at 380 pg/mL ,the sensitivity and specificity of NT-proBNP for diagnosing LVE were 80 .6% and 72 .4% ;which for diagnosing LVD were 80 .8% and 77 .4% ,re-spectively .Conclusion NT-proBNP is closely correlated with multiple ultrasonic indicators reflecting the left ventricular function and its level can reliably reflect the left ventricular contraction function ,which can serve as the marker for screening LVE and LVD in the patients with EH .

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